Standard Operating Procedures Father Muller Institutional Ethics …fathermuller.edu.in/.../2019/FMIEC-SOP-2018.pdf · 2019. 2. 15. · 16 SOP-16 : Waiver of written or verbal informed

FMIEC SOP

FMIEC SOP . Version 1. .

Date of Preparation : 25.08.2018. Issue Date : 20.09.2018. Validity Date : 19.09.2019.

Next Revision Due Date : 24.08.2019.

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Standard Operating Procedures

Father Muller Institutional Ethics Committee (FMIEC),

Father Muller Charitable Institutions,

Father Muller Road, Kankanady,

MANGALORE-575002.

Copy No :

Issued to :

FMIEC SOP




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FMIEC : SOP

i. Prepared by : Dr.Shivashankara A.R., Member Secretary, FMIEC, Dr. PJ Kurian

and Mrs.Anuradha Shetty, Members

ii. Reviewed, Approved and Issued by :

Dr. Shalini Shenoy ,

Chairperson, FMIEC

Contact Details of FMIEC :

E mail : [email protected]; Phone : 08242238327.

mailto:[email protected]

FMIEC SOP




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Distribution List

Following are the Authorized Holders of Controlled Printed Version No. 1 of FMIEC SOP.

Copy

No.

Name of Member Role/Designation in Ethics Committee

1 Dr. Shalini Shenoy Chairperson

2 Dr. Shivashankara A.R. Member Secretary

3 Mrs. Anuradha Shetty Member – Social Scientist and Vice Chairperson

4 Dr. Devina F.Rodrigues Member – Nursing Expert; Joint Secretary

5 Dr. K.Shreedhara Avabratha Member- Clinician

6 Dr. Nicole Pereira Member- Basic Medical Scientist

7 Mrs. Sheril Maria D’Souza Member- Lay Person

8 Fr. Roque Victor D’Sa Member- Theologian/Ethicist

9 Mr. Sushanth F.Sequeira Member – Legal Expert

10 Dr. Kurian PJ Member – Homeopathy Expert

11 Dr. Vivek Sakthidharan Member – Homeopathy Expert

12 Dr. Santhosh Kumar Member – Speech and Hearing Expert

Soft copy of the FMIEC SOP (PDF ) is made available in website of Father Muller Charitable

Institutions.

Member Secretary of FMIEC is the custodian of the soft copy (MS word) and office copy of

the FMIEC SOP.

FMIEC SOP




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Amendment Record

Sl. No. Date Details of Amendment Done Page No. Reason for

Amendment

1

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Table of Contents

Sl.No. Content Details Page No.

A Title Page 1 of 194

B SOP preparation and Issue Details 2 of 194

C Distribution List 3 of 194

D Amendment Record 4 of 194

E Table of Contents 5 of 194

F List of Abbreviations 7 of 194

G List of Annexures 8 of 194

H Individual SOPs Page 11

onwards

I. SOPs

1 SOP-1 : Preparation of FMIEC SOP 12 of 194

2 SOP-2 : Constitution of FMIEC 15 of 194

3 SOP-3 : Handling conflict of interest among Ethics Committee members 38 of 194

4 SOP-4 : Selection of Independent Consultants/Subject Experts 42 of 194

5 SOP-5 : Allowing Guests or Observers to FMIEC Meetings 47 of 194

6 SOP-6 : Guidelines for Submission of Protocols to FMIEC 49 of 194

7 SOP-7 : Review Procedures : Categorization Review for Review, Initial Review 95 of 194

8 SOP-8 : Agenda Preparation, Meeting Procedures and Minutes 102 of 194

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9 SOP-9 : Continuing Review 116 of 194

10 SOP-10 : Review of resubmitted and amended protocols and protocol-related

documents

124 of 194

11 SOP-11 : On-Site Monitoring of Protocols 130 of 194

12 SOP-12 : Review of Protocol Violations/Deviations 140 of 194

13 SOP-13 : Review of Final Reports and Study Completion Reports 147 of 194

14 SOP-14 : Training and Assessment of IEC Members 150 of 194

15 SOP-15 : Review Serious Adverse Events (SAE) Reports 154 of 194

16 SOP-16 : Waiver of written or verbal informed consent 168 of 194

17 SOP-17 : Management of premature termination , suspension, discontinuation of

the study

170 of 194

18 SOP-18 : Reviewing proposals involving vulnerable populations 173 of 194

19 SOP-19 : Dealing with participants’ requests and complaints coming to IEC 184 of 194

20 SOP-20 : Maintenance of active study files, administrative records of IEC,

archival of closed files and retrieval of documents

187 of 194

21 SOP-21: Protection of rights, privacy of confidentiality of subjects 191 of 194

J References 194 of 194

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List of Abbreviations

AE : Adverse Event

COI : Conflict of Interest

CTRI : Clinical Trial Registry of India

DSMB : Data and Safety Monitoring Board

FMCI : Father Muller Charitable Institutions

FMIEC : Father Muller Medical College Institutional Ethics Committee

GCP : Good Clinical Practice

ICD : Informed Consent Documents

ICMR : Indian Council of Medical Research

IP Investigational Product

LAR : Legally Acceptable Representative

PI : Principal Investigator

SAE : Serious Adverse Event

SUSARS Serious Unexpected Serious Adverse Reactions

SOP : Standard Operating Procedures

TOR : Terms of Reference

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List of Annexures

Annexure

No.

Name Page No.

2.1. IEC member Appoint Proposal Letter 25 of 194

2.2. Acceptance Letter from Member 26 of 194

2.3 . Final Appointment Letter : Member 27 of 194

2.4. Final Appointment Letter : Chairperson 29 of 194

2.5. Final Appointment Letter : Vice Chairperson 31 of 194

2.6. Final Appointment Letter : Member Secretary 32 of 194

2.7. Consent Letter : Member 35 of 194

2.8. Confidentiality Agreement to be Signed by Members 36 of 194

2.9. Confidentiality Agreement to be Signed by the Secretariat 37 of 194

3. Conflict of Interest Declaration Form 41 of 194

4.1. Appointment Letter : Subject Expert/Independent Consultant 44 of 194

4.2. Consent Letter : Subject Expert/Independent Consultant 45 of 194

4.3. Confidentiality Agreement to be Signed by Subject Expert/

Independent Consultant

46 of 194

5. Confidentiality Agreement to be Signed by Guest/Observer 48 of 194

6.1. Guidelines for Conducting Clinical Research in FMCI 54 of 194

6.2. Guidelines for Submission of Documents for Review to FMIEC 56 of 194

6.3. Protocol Submission Form for Clinical Trials 57 of 194

6.4. Checklist for Submission of Documents of Clinical Trials 67 of 194

6.5. Protocol Submission Form for Academic Studies 69 of 194

6.6. Budget Form for Academic Studies 73 of 194

6.7. Format of Informed Consent Documents 75 of 194

6.8. Assent form and parental consent form 81 of 194

7.1. Review Form of FMIEC 99 of 194

8.1. Agenda of Meetings 109 of 194

8.2. Leave Letter Format 110 of 194

8.3. Minutes of Meetings 112 of 194

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8.4. Decision Letter (Clinical Trials) 114 of 194

9.1. Continuing Review Application Form (Clinical Trials) 118 of 194

9.2. Continuing Review Application Form (Academic Studies) 120 of 194

9.3. Continuing Review : Review Form 121 of 194

9.4. Decision Letter (Continuing Review) 122 of 194

10.1. Resubmission Form For Investigators 126 of 194

10.2. Resubmission Checklist 127 of 194

10.3. Resubmission Form Review Form 127 of 194

10.4. Protocol Amendment Request Form 128 of 194

10.5. Protocol Amendment Review Form 128 of 194

10.6. Decision on Protocol Amendments 129 of 194

11.1. On –Site Monitoring Checklist 134 of 194

12.1. Protocol Deviation/Violation Reporting Form 145 of 194

12.2. Protocol Deviation/ Violation Record Form 145 of 194

13 Study Completion Report Form 149 of 194

14.1. Assessment Form For IEC Members 152 of 194

14.2. Training Records of the Member 153 of 194

14.3. Self-assessment Form for IEC Chairperson 153 of 194

15.1. SAE data elements 159 of 194

15.2. SAE reporting form 161 of 194

15.3. SAE analysis form 165 of 194

16 Application Form for Requesting Waiver of Consent 169 of 194

17 Study Premature Termination Report 172 of 194

18.1. Checklist for Research Involving Children 175 of 194

18.2. Checklist for Research Involving Pregnant Women and Fetuses 177 of 194

18.3. Checklist for Research Involving Cognitively Impaired Individuals 180 of 194

18.4. Checklist for Research Involving Students, Employees or Residents 182 of 194

18.5. Checklist for Genetic Research 183 of 194

19 Request/Complaint Form for Participants 186 of 194

20.1. Document Request Form 190 of 194

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20.2. Log for Disposal of Study Documents 190 of 194

21 Measures taken to protect rights, confidentiality and privacy of subjects 193 of 194

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I. STANDARD OPERATING PROCEDURES

(SOPs)

1 to 21

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1. SOP-1 : PREPARATION OF STANDARD OPERATING PROCEDURES

OF FMIEC

1.1. Purpose: To define the process for writing, reviewing, distributing and amending SOPs of

FMIEC. These SOPs ensure that the activities of FMIEC are conducted in accordance with

Indian regulations and relevant, national and international ethical guidelines. Uniformity of

the processes of FMIEC is ensured by SOPs.

1.2. Scope : Writing, verifying, reviewing, revising/amending and issuing the SOPs of FMIEC

1.3. Responsibilities: The SOPs are reviewed and revised once a year. In the interregnum,

amendments if required are done and notified. The Chairperson of FMIEC appoints the

teams for preparation/ revision of SOPs. The prepared SOPs are reviewed by all members

of FMIEC in a meeting. The Chairperson verifies and approves the SOPs. The Chairperson

authorizes the Member Secretary to issue the SOPs as per the distribution list. The

secretariat staff of FMIEC assist in clerical work and distribution.

1.4. Procedure :

1.4.1. The Chairperson of FMIEC appoints teams for preparation/revision of SOPs.

Number of teams will depend on the amount of work involved.

1.4.2. Each team will have a leader and two or three members. The team leader should be

the one who has thorough understanding of the ethical review process, evident by

his/her experience and the training he/she has undergone. The leader will discuss

with the team members and design the SOPs.

1.4.3. Each SOP will have following headings :

1) Purpose

2) Scope

3) Responsibilities

4) Procedure in detail

5) Flow Chart (as applicable)

6) Annexures

1.4.4. The draft of the SOP will be presented in the meeting of full committee.

Suggestions or corrections from the members will be incorporated.

1.4.5. The SOPs are reviewed by the Chairperson, the Member Secretary and a senior

member of FMIEC. The Chairperson will be the final approving authority for SOPs

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1.4.6. The Member secretary, FMIEC is authorized by the Chairperson, and will be

responsible for printing the SOP

1.4.7. The members are trained on the SOPs, and then they are issued a hard copy of the

SOP

1.4.8. The new SOP is effective from the date of issue

1.4.9. Soft copy (PDF) will be made available in the website of Father Muller Charitable

Institutions (www.fathermuller.edu.in ) for reference of all stake holders.

1.4.10. Soft copy (PDF) will be issued to principal investigators and sponsors of regulatory

trials, NABH coordinator of FMMCH, CDSCO, NABH assessors, any other

stakeholders after permission from the Chairperson , FMIEC

1.4.11. One each of soft copy in MS-Word, soft copy in PDF , hard copy of the current

version, will be maintained in the secretariat of FMIEC.

1.4.12. The SOP will be reviewed once a year. The procedure for preparation will be

followed for revision of SOP as well.

1.4.13. When the revised SOP is made, it becomes the current version, and the previous

version will be considered “obsolete”. The Member secretary will take back the

“obsolete” version and then issue “current” version to the members. The members

will not keep the “obsolete” versions with them.

1.4.14. Secretariat will mark the “obsolete versions” and will keep only one copy of the

“obsolete” version for reference. Other copies will be disposed off by shredding.

1.4.15. If any changes are required in the SOP in between (other than regular revision) due

to any suggestions from members of FMIEC, implementation of revised guidelines,

etc., amendments will be made. The Chairperson will assess the need for

amendment and authorize the Member Secretary to do the needed amendments.

Only the soft copy in PDF will be issued to all members within seven days of

amendment approval.

http://www.fathermuller.edu.in/

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1.5. Flow Chart : SOP Preparation

Appointment of SOP Teams by Chairperson of FMIEC

Teams prepare drafts of SOPs

Discussion of the SOP Drafts in the Meeting of Full Committee

Incorporating Suggestions of Members

Review of SOPs by Chairperson, Member Secretary and a Senior Member of FMIEC

Approval by Chairperson

Training the Members of FMIEC on SOPs

Issue of SOPs; Effective date of SOP.

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2. SOP-2 : Constitution of IEC : Selection, Roles and Responsibilities of Members

of FMIEC

2.1. Purpose: The purpose of this SOP is to define and describe the terms of reference, which

provide the framework for constitution, selection, roles and responsibilities of members of

FMIEC, and the procedure for maintaining confidentiality of all activities and documents.

2.2. Scope : This SOP is applicable to appointment of members of FMIEC; defining their roles

and responsibilities

2.3. Responsibility: The appointment of the members of FMIEC will be done by the Head of

the Institution. Every member is expected to follow this SOP

2.4. Procedure :

2.4.1. The FMIEC reviews the research proposals of Institutions of Nursing, Speech

and Hearing, and Homeopathy of Father Muller Charitable Institutions. The

research proposals of Father Muller Medical College do not come under the

purview of FMIEC.

2.4.2. The Director of Father Muller Charitable Institutions is the authority for

constitution of FMIEC.

2.4.3. The Director sends an official request letter to the members who will confirm

their acceptance by providing all required information such as curriculum vitae,

and certificates of training on research ethics and good clinical practice. The

consent letter includes consent from the member, declaration of maintaining

confidentiality of research project- related data/documents/discussions, and

willingness to get updated on research ethics, good clinical practice and

regulations on human research. On receiving this consent, the Director will

issue the final appointment order. The members need to sign the consent letter

and confidentiality agreement.

2.4.4. Composition of FMIEC :

2.4.4.1.The FMIEC is multi-disciplinary and multi-sectorial in composition. It is

independent and shall have 7 to 15 members. The Chairperson shall be

from outside the institution. The member Secretary will belong to the

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institution. There will be adequate representation of age and gender, and

mix of scientific and non-scientific members. The basic composition of

FMIEC is as per the guidelines of CDSCO.

2.4.4.2. The Composition shall be as follows : (as per CDSCO guidelines)

1) Chairperson (Non-affiliated to the institution)

2) Member Secretary (From the institution)

3) Joint Secretary (From the institution) –one of the members will be designated.

4) Two Clinicians (From the institution)

5) One Legal expert (Non-affiliated to the institution)

6) Basic medical scientist (Person with basic MBBS degree and post-graduation in

Biochemistry/Pathology/Microbiology / Pharmacology)- (From the institution)

7) One Philosopher/Theologian/Ethicist (Non-affiliated to the institution)

8) One Social Scientist/Representative from non-governmental organization/social

worker(Non-affiliated to the institution)

9) One Lay person from the community (Non-affiliated to the institution)

10) Subject experts from Homeopathy, Nursing, and Speech and Heating will be included.

2.4.4.3. The Chairperson and Member Secretary will not have the dual roles in the ethics

committee. They can’t fulfil the role of a member (clinician/basic medical scientist/social

scientist/legal expert, etc..) as it interferes with their own responsibilities.

2.4.4.4. All members including Chairperson, Member Secretary and joint Secretary will review

the research proposals.. One of the members (non-affiliated) is designated as Vice Chairperson.

2.4.5. Criteria for Selection of FMIEC members:

2.4.5.1. Chairperson:

1) Should be from outside the institution

2) Should have a minimum of three years experience as a member of an IEC

3) Should have undergone training in “Good Clinical Practice” and “guidelines for

conducting biomedical research on human beings”

4) Should not have any known record of professional misconduct

2.4.5.2. Vice Chairperson:

1) Should be from outside the institution; he/she is selected from the members of IEC

2) Should have a minimum of three years experience as a member of an institutional ethics

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Committee


2.4.5.3. Member Secretary:

1) A senior faculty from the institution with a postgraduate degree, and with a minimum

experience of five years in the institution.

2) Should have undergone training in “Good Clinical Practice” and “guidelines for

conducting biomedical research on human beings”

3) Should have a minimum of three years experience as a member of an institutional ethics

Committee

4) Should have worked as a convener/member of any committees/core teams of the

Institution

5) Should have good communication skills


2.4.5.4. Joint Secretary:

1) A faculty from the institution with a postgraduate degree

2) Should have attended any training/workshop on research methodology/good clinical

Practice/ethical guidelines for clinical research

3) Should have good communication skills


2.4.5.5. Members:

1) Members will be selected in their personal capacities based on their qualification,

experience in domain field, interest, ethical and/or scientific knowledge and expertise, as well

as on their commitment and willingness to volunteer the necessary time and effort for the IEC.

2) They should not have any known record of professional misconduct.

3) The basic medical scientists and clinicians should have post graduate qualifications.

4) The Lay Person should not have any graduate or post graduate qualification in any science

discipline. He/she is a literate person from the public or community. He/she is aware of the

local language, cultural and moral values of the community

5) The legal expert should have a basic degree in law from a recognized university with a

minimum experience of three years in the legal field .

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6) The social scientist is someone expert in the study of human society and its personal

relationship like anthropologist, scientist and penologist. He/She also may be a representative

of a non-governmental organization.

7) Theologian is a person involved in preaching of various religious activities while an ethicist

has a background in law or philosophy. One of them is included as a member in FMIEC.

8) A newly appointed member who has not undergone any training in ethics/good clinical

practice /ethical guidelines of biomedical research on human beings does not have the voting

rights. He/she has to undergo training within six months of the appointment. The member gets

the voting rights once he/she undergoes training.

2.4.6. Requirements from Members when they give consent to be the members of

FMIEC:

The secretariat should collect a copy of recent curriculum vitae from all the members. The

copies of degree certificates and medical council registration certificates should be collected

from medical members of committee. In addition, certificates of training if any, in research

methodology/ethics in clinical research/good clinical practice/Guidelines for biomedical

research on human beings should be collected and filed in the IEC office.

2.4.7. Consent Letter and Confidentiality agreement from Members:

1) When the members agree to be part of FMIEC, they need to sign a consent letter in

which they declare their commitment for all activities of the committee, and maintaining

confidentiality of activities and documents of FMIEC

2) The staff of secretariat of FMIEC has to sign an agreement of maintaining

confidentiality

3) Chairperson of FMIEC will sign on all the confidentiality forms of members and

secretariat staff

2.4.8. Tenure of Membership:

The tenure of membership will be for a continuous period of 2 years from the date of

appointment.

2.4.9. Appointment of New Members:

New members will be appointed under following circumstances:

1) When a regular member completes his/her tenure

2) If a regular member resigns before the completion of the term

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3) If a regular member ceases to be a member due to any reason such as death or

disqualification

4) To fulfil the membership requirements as per SOP/guidelines/regulations

The new member will be identified by the Chairperson based on the membership

requirements after discussion by the IEC. The name of new member to be appointed may

be suggested by members of IEC. The Chairperson sends the proposal to head of the

institution. The final decision on appointment is taken by head of the institution.

2.4.10. Continuation of Membership after the Tenure:

The tenure of the members in the FMIEC is two years. After the completion of two years,

at least 1/3rd

of the members will be replaced by new members. The replacement of a member will be

done with new member of the same category (clinician/lay person/social scientist/philosopher, etc…).

The decision on continuation of a member will be taken by the Director of Father Muller Medical

College. The Director may take suggestions from the Chairperson and the Member Secretary.

However, the final decision is taken by the Director. A member can have maximum two continuous

terms in FMIEC. He/she may become a member again in FMIEC after a gap of at least two years. The

Director will communicate to those who are replaced, acknowledging their service and contribution to

the ethics committee. For the Chairperson and the Member Secretary replacements, same procedure

will be followed. The Chairperson and Member secretary could get a second term after completion of

the tenure. The Chairperson and Member Secretary can have maximum two consecutive terms.

The Director will send an appointment proposal letter to the members who will replace existing

members, and also to the existing members who are going to continue. After obtaining consent, final

appointment letter will be issued.

2.4.11. Conditions to be fulfilled by a member after appointment:

1) Members must submit a recent, signed CV

2) Members must submit training certificates in ethics and GCP

(if available during induction)

3) Members should be ready to undergo training in ethical guidelines and GCP and submit

the training certificates to the Member Secretary, FMIEC

4) Members must be willing to publicize his/her full name and affiliation

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5) Should sign the confidentiality agreement, and maintain confidentiality regarding

documents, discussions, and related matters of FMIEC.

2.4.12. Termination of Membership: This refers to termination from membership even

before the member completes his/her tenure. Reasons for termination may be

resignation of the member from the FMIEC, resignation of the member from the

institution, death of the member or disqualification of the member.

2.4.12.1. Voluntary termination: It is due to resignation of the member. The resignation

has to be submitted in writing to Chairperson, FMIEC. One month prior notice is

necessary for the resignation. It will be effective from the date of acceptance by

the Chairperson.

For affiliated members: If a member resigns from the institution (Institutions of FMCI), even if

he/she does not submit resignation to FMIEC, the membership to FMIEC stands automatically

cancelled. This termination is effective once the member is relieved from the institution.

2.4.12.2. Disqualification :

A member is disqualified from the membership under following circumstances :

A) Misconduct :

a) If the Chairperson or the Member Secretary receives a communication in writing from

public /investigators/ another member of FMIEC regarding misconduct of the member

b) If the Chairperson observes/gets information on any type of professional /ethical

misconduct (not maintaining confidentiality /not declaring of conflict of interest/any

type of bias towards research studies/investigators reviewed by FMIEC)

c) Action to be taken: The Chairperson satisfies himself/herself that prima facie a case

exists before initiating any action. If in the opinion of the Chairperson, the matter of

significance and integrity of the IEC could be questioned, he/she will first keep the

member under suspension till the final decision is taken. During the period of

suspension, the member will not have any voting rights, privileges and will not perform

any duties of a member of FMIEC.

The Chairperson will call for a meeting of FMIEC, following the usual rules of

quorum. The suspended member will be given sufficient opportunity to defend

himself/herself in the meeting. The decision will be taken by consensus.

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B) Disqualification due to continuous absence: a member will be disqualified if he/she

does not attend more than three consecutive meetings of IEC. If the member has given

a prior intimation to Chairperson/member Secretary about the absence, the member will

be given an opportunity to continue with the membership. This member will be issued a

warning from Chairperson. However, the membership will cease if this habit repeats

once again.

In case of absence without intimation for more than three consecutive meetings of

FMIEC, the member is liable for disqualification. The member will be issued a one

month notice by the Chairperson seeking explanation for the absence. If the member

gives satisfactory explanation for the continued absence and assures attendance for

future meetings, the Chairperson may decide on continuation of the membership. In the

absence of any reply from the member, the Chairperson will discuss the matter of

disqualification of membership in the meeting of FMIEC. Final decision on

disqualification is taken by the Chairperson.

In all the above cases of disqualification, the Chairperson communicates to the

Director, Father Muller Charitable Institutions in writing. The decision of

disqualification is communicated to the member by the Director.

2.4.13. Roles and Responsibilities of Chairperson of FMIEC:

i) To conduct meetings and to be accountable for efficient functioning of the

committee

ii) To ensure active participation of all members in all discussions and

deliberations

iii) Seek conflict of interest from members and ensure quorum and fair decision

making

iv) Handling of complaints against investigators, IEC members, conflict of interest

issues and requests for use of IEC data

v) To ratify the minutes of previous meetings

vi) To review serious adverse events with causality assessment

vii) Is the final authority of FMIEC to take any decision on disqualification of

members and recommend to the head of the institution for termination of the

member.

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viii) Is the approval authority for SOPs of FMIEC

ix) Responsible for making any communications on behalf of the FMIEC to Head

of the institution, and any regulatory bodies

2.4.14. Roles and Responsibilities of Member Secretary of FMIEC:

i) To organize an effective and efficient procedure for receiving, preparing,

circulating and maintaining each proposal for review

i) To schedule IEC meetings, prepare the agenda and minutes

ii) To organize IEC documentation, communication and archival

iii) To arrange for training of IEC secretariat and members

iv) To ensure that SOPs are updated as and when required

v) To ensure adherence of IEC functioning as per SOPs

vi) To prepare for and respond to audits and inspections

vii) To ensure completeness of documentation at the time of receipt of protocols ,

and timely inclusion in the agenda for IEC review

viii) To assess the need for exemption from review, expedited review or full review

Joint Secretary: Will function as Secretary in his/her absence; helps the Secretary in

recording minutes of meetings, sorting out the research proposals for review,

documentation, and in preparation for audits and inspections.

2.4.15. Roles and Responsibilities of Members of FMIEC (In General for all Members):

1) All members are expected to review the research proposals and attend the ethics

committee meetings, and participate in the discussions and deliberations

2) To review the revised submissions, additional submissions, progress reports and final

reports

3) To review the reports of serious adverse events, and recommend appropriate actions

4) To carry out monitoring visits at study sites as and when needed

5) To maintain confidentiality of the documents and deliberations of ethics committee

meetings

6) To declare conflict of interest if any, to the Chairperson

7) To participate in continuing education activities in research ethics and get updated on

relevant guidelines and regulations.

2.4.16. Roles and Responsibilities of Basic Medical Scientist:

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Scientific and ethical review with special emphasis on the intervention, benefit-risk

analysis, research design, methodology statistics, continuing review process, review of

serious adverse events, progress report and final report.

2.4.17. Roles and Responsibilities of Clinician:

1) Scientific review of protocols including review of the intervention, benefit-risk

analysis, research design, methodology, sample size, site of study and statistics

2) Ongoing review of the protocol, review of serious adverse events, progress report

and final report.

3) Review of medical care, appropriateness of the facility and principal investigator,

provision for medical care, management and compensation.

4) Thorough review of protocol, investigator’s brochure and other protocol related

documents

2.4.18. Roles and Responsibilities of Lay Person:

1) Ethical review of the proposal, informed consent documents along with translations

2) Evaluate benefits and risks from the participant’s perspective, and opine whether

benefits justify the risks

3) Serve as a patient /participant/community representative and bring in ethical and

societal concerns

2.4.19. Roles and Responsibilities of Legal Expert:

1) Ethical review of the proposals, informed consent documents along with translations,

MOU, clinical trial agreement, regulatory approval, insurance document, compensation

proposals, other site approvals, investigator’s undertaking, and protocol-specific other

permissions. ; 2) Interpret and inform members about new regulations if any

2.4.20. Roles and Responsibilities of Social Scientist:

1) Ethical review of the proposals, informed consent documents along with translations

2) Assess impact on community involvement, socio-cultural context

3) Serve as representative of community/society and bring in ethical and societal

concerns

2.4.21. Roles and Responsibilities of Philosopher/Theologian:

1) Ethical review of the proposals, informed consent documents along with translations ;

2) Assess impact on religious or philosophical context; 3) Bring in ethical concerns

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2.4.22. Secretariat of FMIEC:

Secretariat is composed of the clerical staff and attenders.

Secretariat will assist the Member Secretary and joint Secretary in all their functions. The clerical staff

are involved in receiving the proposals, preparing the communication letters, approval letters, and any

other typing work assigned by Member Secretary and Chairperson .They are also involved in typing

agenda for the meeting, typing the proceedings of meetings , and preparation for the meetings. The

secretariat staff need to sign a confidentiality agreement. Attenders are involved in distribution of

research proposals to members for review and physical arrangements for the meetings.

2.4.23. Payment of Remuneration to FMIEC Members: The FMIEC members are paid honorarium

for attending meeting of IEC and onsite monitoring visit. The remuneration is decided by the head of

the institution while appointing the members. In addition, the institution may sponsor the members to

attend trainings on ethical guidelines and GCP.

2.5. Flow Chart: Constitution of FMIEC

Sending Appointment Proposal Letters : By Director, FMCI

Receiving Acceptance from Members

Sending Final Appointment Letters : By Director, FMCI

Consent Letter signed by the Members

Confidentiality Agreement Signed by the Members

Members Trained on SOP

Completion of Two Years Tenure; One third of the Members Retire and

FMIEC Reconstitution Done

FMIEC SOP




Page 25 of 194

2.6. Annexure for SOP-1

Annexure -2.1. Appointment Proposal Letter

To:

Dr./Mr/Ms. ------------------------

Address: ------------------------------

Sub: Reconstitution of FMIEC

Dear Sir /Madam,

The FMIEC has completed tenure of two years. I acknowledge your services and contribution as a

member of FMIEC for the last two years. As a part of the reconstitution of FMIEC, I request you to

be the member/Member Secretary/Chairperson of FMIEC for the next two years, effective from -------

--------------------.

A detailed appointment letter will be issued once I receive acceptance letter from you. I request you to

submit your recently updated, signed CV along with certificates of training on GCP, Bioethics and

guidelines on biomedical and health science research.

With Regards,

The Director,

Father Muller Charitable Institutions, Mangalore.

FMIEC SOP




Page 26 of 194

Annexure 2.2. FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE(FMIEC)

ACCEPTANCE OF APPOINTMENT AS A MEMBER OF FMIEC

To : The Director,


Dear Sir,

Sub : Acceptance of Appointment as a Member of FMIEC

Ref : Your Proposal Letter No. ---------------------------------------------, Dated. ------------------------------

I am thankful to you for appointing me as a member of FMIEC with effect from -------------------. I

herewith accept my appointment.

I am ready to undergo regular training on good clinical practice, ethical guidelines on biomedical and

health science research and bioethics as required . I shall regularly participate in the IEC meeting to

review and give my unbiased opinion regarding the ethical issues. I shall not keep any literature or

study related documents with me after the discussion and final review. I shall maintain the entire

research project related information confidential. I shall sign the confidentiality agreement, and shall

declare conflict of interest if any as and when applicable

I am submitting my recently updated, signed CV and certificates of training as requested by you.

Thanking You,

Yours Sincerely,

Signature :

Name :

Designation and Department/Affiliations:

Date : Place :

FMIEC SOP




Page 27 of 194

Annexure 2.3.

Father Muller Institutional Ethics Committee(FMIEC)

Appointment Letter : Member

To :

------------------------------

Sub : Appointment as member of Father Muller Institutional Ethics Committee.

Category : Basic Medical Scientist/Clinician/Theologian/Social Scientist/Lay Person/ Legal Expert

Dear Sir/ Madam, I am pleased to select you as a member of Father Muller Institutional Ethics

Committee with effect from -----------------. As a member of the committee, you will have tenure of

two years.

You will be receiving an honorarium of Rs. -----------------------------per sitting for the services

rendered by you.

I request you to kindly extend your co operation to the Chairperson and Member Secretary of FMIEC,

in effective and efficient functioning of FMIEC.

Please find the enclosed terms and conditions of your appointment, roles and responsibilities.

You will be issued a copy of the policies and standard operating procedures of FMIEC once you sign

the consent letter and confidentiality agreement .

You will have the voting rights in the IEC only after you receive the initial training on policies and

standard operating procedures.

Congratulations and all the best.

With Regards,

The Director,


FMIEC SOP




Page 28 of 194

Terms and Conditions of appointment, and Roles and Responsibilities of Member, FMIEC

1) You shall maintain high ethical standards and should not be unduly influenced while

performing assigned roles in the FMIEC

2) You should be willing to place your full name, profession and affiliation to the ethics

committee in the public domain

3) Be willing to sign a confidentiality agreement , and to maintain confidentiality of the

documents and deliberations of ethics committee meetings

4) To read, understand, accept and follow the conflict of interest policy of ethics committee, and

declare conflict of interest if any during your appointment, and initial review and final review

of research proposals .

5) As a member of FMIEC you need to do initial review, final review of research proposals and

evaluate progress reports and final reports . You need to participate in onsite monitoring visits

and review of serious adverse events as and when required. You are required to attend regular

as well as emergency meetings of FMIEC. You are expected to participate actively in all

discussions and deliberations of FMIEC.

6) You shall not keep any literature or study related documents with you after the discussion and

final review

7) Willing to undergo training or update programmes on relevant guidelines and regulations,

research ethics ,and good clinical practice during the tenure as ethics committee member

8) As per the policy of the committee, any member not attending three consecutive meetings will

be replaced by another person of the same category in IEC. Any member showing any kind of

professional misconduct will be terminated from membership.

9) One month notice on either side will be necessary prior to resignation/termination of

appointment.

The Details of the roles and responsibilities of a member of FMIEC are mentioned in the

policies and standard operating procedures of FMIEC.

FMIEC SOP




Page 29 of 194

Annexure 2.4.


Appointment Letter : Chairperson

To :

----------------------------------

Sub : Appointment as Chairperson of FMIEC

Dear Sir/Madam,

I am pleased to appoint you as the Chairperson of FMIEC with effect from ------------------. You will

have a tenure of two years from the date of appointment.

As head of the institution, I assure you that FMIEC will be provided with all required infrastructure

and facilities required for its effective functioning. The ethics committee will be independent in its

functioning and decision making, without any undue influence from anybody including the authorities

of the institution.


rendered by you.


I request your services in the effective and efficient functioning of FMIEC.


With Regards,

The Director,


FMIEC SOP




Page 30 of 194

Terms and Conditions of appointment, and Roles and Responsibilities of Chairperson, FMIEC

1) As Chairperson of FMIEC, you are required to finalise the revision of SOP of FMIEC in co

ordination with the Member Secretary, and you will be final approval authority for SOPs.

2) You shall maintain high ethical standards and should not be unduly influenced during while









6) As Chairperson of FMIEC, you shall conduct the meetings of FMIEC and ensure active

participation of all members in the discussions and deliberations.

7) You shall seek conflict of interest from members and ensure quorum and fair decision making

8) You are the authorized and responsible for handling of complaints against investigators, IEC

members, conflict of interest issues and requests for use of IEC data

9) You are the authority and responsible for ratifying the minutes of meetings, to review serious

adverse events with causality assessment.

10) You are the authority of FMIEC to discuss with members and recommend to the Director,

FMCI, the disqualification of members (if required) before the completion of their term .

11) You need to do initial review, final review of research proposals and evaluate progress reports

and final reports . You need to lead the IEC team for onsite monitoring visits


final review


research ethics ,and good clinical practice during your tenure in the FMIEC.




FMIEC SOP




Page 31 of 194


appointment.

16) You will be responsible for making any communications on behalf of the FMIEC to Head of

the institution, and any regulatory bodies

The Details of the roles and responsibilities of Chairperson and members of FMIEC are

mentioned in the policies and standard operating procedures of FMIEC.

--------------------------------------------------------------------------------------------------------------------

Annexure 2.5.


Appointment Letter : Vice Chairperson

To :---------------------------

Sub : Appointment as Vice Chairperson of FMIEC

Dear Sir/Madam,

I am pleased to appoint you as the Vice Chairperson of FMIEC with effect from ------------------. You

will have a tenure of two years from the date of appointment.

As Vice Chairperson, you will be handling the roles and responsibilities of the Chairperson in his/her

absence.

You are requested to refer to the policies and standard operating procedures of FMIEC .



With Regards,

The Director, Father Muller Charitable Institutions, Mangalore.

FMIEC SOP




Page 32 of 194

Annexure 2.6.


Appointment Letter : Member Secretary

To :

----------------------------------

Sub : Appointment as Member Secretary of FMIEC

Dear Sir/Madam,

I am pleased to appoint you as the Member Secretary of FMIEC with effect from ------------------.

You will have a tenure of two years from the date of appointment.

As head of the institution, I assure you that FMIEC will be provided with all required infrastructure

and facilities required for its effective functioning. The ethics committee will be independent in its

functioning and decision making, without any undue influence from anybody including the authorities

of the institution.


rendered by you.




With Regards,

The Director,


FMIEC SOP




Page 33 of 194

Terms and Conditions of appointment, and Roles and Responsibilities of Member Secretary,

FMIEC

1) As Member Secretary of FMIEC, you are required to do the needful for the revision of SOP of

FMIEC in co ordination with the Chairperson.

2) You shall maintain high ethical standards and should not be unduly influenced while









6) As Member Secretary, you are required to organize an effective and efficient procedure for

receiving, preparing, circulating and maintaining each proposal for review

7) To schedule IEC meetings, prepare the agenda and minutes

8) To organize IEC documentation, communication and archival

9) To arrange for training of IEC secretariat and members

10) To ensure that SOPs are updated as and when required

11) To ensure adherence of IEC functioning as per SOPs

12) To prepare for and respond to audits and inspections

13) To Ensure completeness of documentation at the time of receipt of protocols , and timely

inclusion in the agenda for IEC review

14) To assess the need for exemption from review, expedited review or full review

15) You will be responsible for making communications on behalf of FMIEC, to investigators,

members of FMIEC and sponsors .

16) You need to do initial review, final review of research proposals and evaluate progress reports

and final reports . You need to lead the IEC team for onsite monitoring visits


final review

FMIEC SOP




Page 34 of 194


research ethics ,and good clinical practice during your tenure in the FMIEC.





appointment.

The Details of the roles and responsibilities of Member Secretary of FMIEC are mentioned in

the policies and standard operating procedures of FMIEC.

--------------------------------------------------------------------------------------------------------------

FMIEC SOP




Page 35 of 194

Annexure 2.7. Father Muller Institutional Ethics Committee(FMIEC)

Consent Letter from Appointed Members

To :

The Director,


Sub : Consent to be the Chairperson/Vice Chairperson/Member Secretary/Member of Father

Muller Institutional Ethics Committee.

Ref : Your letter No.--------------------------------------; Dated ----------------------------------------

Dear Sir/Madam,

In response to your letter, I give my consent to be the Chairperson/Vice Chairperson/Member

Secretary/Member of Father Muller Institutional Ethics Committee. I shall execute my roles and

responsibilities as per the policies and standard operating procedures of FMIEC, and as mentioned in

my appointment order. I shall maintain high ethical standards, and will not be unduly influenced in

discharging my assigned work.

I will sign the confidentiality agreement during my induction. I am aware of the conflict of interest

policy of FMIEC, and I will declare conflict of interest (if any) during my induction as a member,

review of research proposals and decision making in FMIEC.

Thanking You,

Yours Sincerely,

Signature :

Name :

Designation and Department/Affiliations:

Date : Place :

--------------------------------------------------------------------------------------------------------------------

FMIEC SOP




Page 36 of 194

Annexure-2.8. : Confidentiality Agreement to be Signed By Member of FMIEC

In recognition of the fact, that I, _________________________________________________

(Member’s name, his/her position on FMIEC and affiliation) herein referred to as the “undersigned”,

have been appointed as a member of the FMIEC and have been asked to assess research studies

involving research participants in order to ensure that they are conducted in a humane and ethical

manner, adhering to the highest standards of care as per the national, and local regulations and

institutional policies and guidelines and international and national guidelines.

The appointment of the undersigned as a member of the IEC is based on individual merits and not as

an advocate or representative neither of a home province, territory or community nor as a delegate of

any organization.

The IEC must meet the highest ethical standards in order to merit the trust and confidence of the

communities in the protection of the rights and well-being of research participants and the

undersigned, as a member of the IEC, is expected to meet the same high standards of ethical behavior

to carry out its mandate.

This agreement encompasses any information deemed Confidential provided to the Undersigned in

conjunction with the duties as a member of the FMIEC. All Confidential information (and any copies

and notes thereof) shall remain the sole property of the FMIEC. The undersigned agrees to hold all

confidential information in trust or confidence and agrees that it shall be used only for contemplated

purposes and shall not be used for any other purpose or disclosed to any third party. Written

confidential information provided for review shall not be copied or retained.

I, ________________________________________________ (name of the IEC member) have read

and accept the aforementioned conditions as explained in this Agreement.

Signature Date

Chairperson’s Signature and Date

[The original (signed and dated Agreement) will be kept on file in the custody of the FMIEC. A copy

will be given to the Undersigned.]

I acknowledge that I have received a copy of this Agreement signed by the FMIEC Chairperson and

me.

Signature and Date

-----------------------------------------------------------------------------------------------------------------------

FMIEC SOP




Page 37 of 194

Annexure-2.9. : Confidentiality Agreement to be Signed By Secretariat Staff of FMIEC

I, _________________________________________________

(Staff’s name and designation) herein referred to as the “undersigned”, have been appointed as a staff

of the IEC office. This agreement encompasses any information deemed confidential provided to the

Undersigned in conjunction with the duties as a staff of the IEC. All confidential information (and any

copies and notes thereof) shall remain the sole property of the IEC.

The undersigned hereby agrees not to disclose or utilize, directly or indirectly all confidential

information known to him or her during his tenure of service.

I, ________________________________________________ (name of the IEC office staff) have read

and I accept the conditions as explained in this Agreement.

__________________________ __________________

Signature and Date

__________________________ __________________

Chairperson’s Signature Date

[The original (signed and dated Agreement) will be kept on file in the custody of the IEC. A copy will

be given to the Undersigned.]

I confirm that I have received a copy of the confidentiality agreement signed by the Chairperson of

FMIEC.

__________________________ __________________

Name of the Member, Signature and Date

FMIEC SOP




Page 38 of 194

3. SOP-3: Handling Conflict of Interest Among

Ethics Committee Members

3.1. Purpose: The purpose of this SOP is to describe the process to identify and manage conflict of

interest among FMIEC members.

3.2. Scope: This SOP covers the policy related to identification, declaration and management of

conflict of interest and is applicable to all FMIEC members.

3.3. Responsibility: All FMIEC members are responsible for self-identifying and disclosing the

conflict of interest. The Chairperson of FMIEC is finally responsible for ensuring that all members of

FMIEC self-declare conflict of interest during review of research proposals

3.4. Procedure:

3.4.1. Information to members on conflict of interest:

1) During the appointment of members, one of the conditions is “To read, understand, accept and

follow the conflict of interest policy of ethics committee, and declare conflict of interest if any

at appropriate time”.

2) The member will be signing the consent letter after going through the terms and conditions in

the appointment letter.

3) The conflict of interest policy of the FMIEC will be explained to the members on induction. It

will be a part of the trainings imparted to the members

3.4.2. Types of Conflict of Interest (COI):

3.4.2.1. Personal COI: If the investigator of a research proposal has close and immediate

family relationship with the member of FMIEC (spouse, son/daughter, parents, sibling, dependent)

; If the FMIEC member is a collaborator, Principal investigator, co investigator, financer, research

staff, consultant for a research proposal which has come for review in FMIEC;

If a research proposal is submitted by a departmental colleague with whom the member has

conflict of interest (dispute, bias, any benefits, etc.. ,) –if applicable and if the member feels there

is a conflict of interest.

FMIEC SOP




Page 39 of 194

3.4.2.2. Professional COI:

If the IEC member or his/her immediate family member serves as trustee, director, manager, or

scientific advisor of the funding agency sponsoring the research.

3.4.2.3. Financial COI:

If the IEC member or the spouse or dependent of a member receives monetary benefits including,

but not limited to, salary or payments for other services (e.g., consulting fees or honoraria), equity

interests (e.g., stock, stock options, or any other ownership interests) and intellectual property

rights (e.g., patents, copyrights, product or service being evaluated).

3.4.3. Procedure for Declaring COI:

3.4.3.1. The IEC member should identify the COI whenever a research proposal is assigned to

him/her for the review. The COI should be declared in the format provided in SOP of FMIEC, and

submitted to the member secretary.

3.4.3.2. The IEC members should not participate in discussing, or decision making on research

proposals’ applications reviewed at any level (exempt, expedited, or full-board) when they have

conflicts of interest except to provide information requested by the IEC.

3.4.3.3. If an IEC member has a COI for review outside a meeting (e.g., the expedited procedure/

amendments), he or she should notify the IEC Secretariat and return the documents.

3.4.3.4. If an IEC member has a COI for a study for which he or she has been assigned as a

primary reviewer, he or she will inform the IEC secretariat so that the review is reassigned to other

members.

3.4.3.5. If an IEC member has a COI for review of research study at a meeting, he or she will

inform the Chairperson and leave the meeting room while discussion of the study takes place.

He/she may stay in the meeting room only to answer questions about the research. This is

applicable also for IEC meetings at which discussion on serious adverse events,

deviations/violations, amendments/ continuing review reports related to studies are discussed

FMIEC SOP




Page 40 of 194

3.4.3.6. The IEC member who declares COI and leaves the meeting does not count towards the

quorum for the vote. The member’s absence under these circumstances is called a recusal, not an

abstention or an absence.

3.4.3.7. If an IEC member finds that he/she has a COI during the conduct of a research project

approved by IEC, he/she shall report the conflict to the IEC at the next IEC meeting.

3.4.3.8. At the beginning of each meeting, the FMIEC Chairperson asks the members to disclose

any COI concerning any of the items on the agenda. During the meeting, IEC member having

conflict discloses the existence of the conflict just before the review of the relevant item begins.

3.4.3.9. If the Chairperson has a conflict of interest for a particular project, this should be so

declared and handled like any other member’s conflict is handled. An acting Chairperson should

be appointed for discussion on such a project.

3.4.3.10. When determination regarding existence of COI is uncertain, more information is

gathered from relevant sources and determination is done by the IEC member with the help of the

IEC Chairperson / Member Secretary or by IEC Chairperson / Member Secretary (as applicable)

3.4.3.11. The IEC Chairperson has the final authority to determine whether a COI has been

managed or eliminated appropriately for research participant protection. The IEC shall not

approve a research study proposal where a COI is not managed or eliminated

3.4.3.12. The declaration and management of COI should be recorded in the proceedings of the

FMIEC meetings.

3.5. Annexure :

FMIEC SOP




Page 41 of 194

Annexure-3 : Conflict of Interest Declaration Form

To : Chairperson , FMIEC.

Dear Sir/Madam,

I am aware of the COI policy of FMIEC.

I herewith declare my conflict of interest with regard to the following research proposal

submitted to FMIEC for review.

Protocol No.

Study Title :

Name of Principal Investigator :

Type of COI (Personal/ Professional/Financial) and the Reason :

Hence, I stay away from reviewing this research proposal, any deliberations/discussions on

this study, and refrain from any decision making.

Name and Signature of Member

Date :

Name and Signature of Chairperson :

Date :

FMIEC SOP




Page 42 of 194

4. SOP-4 : Constitution of Subject Expert Panel :

Selection, Roles and Responsibilities

4.1. Purpose: The purpose of this SOP is to define and describe the terms of reference, which

provide the framework for constitution, selection, roles and responsibilities of independent

consultants, and the procedure for maintaining confidentiality of all activities and

documents.

4.2. Scope : This SOP is applicable to appointment of independent consultants of FMIEC;

defining their roles and responsibilities

4.3. Responsibility: The appointment of the members of subject expert panel (panel of

independent consultants) for FMIEC will be done by the Director,FMCI. The independent

consultants need to maintain confidentiality of the reviews, meetings and documents.

4.4. Procedure :

4.4.1. Appointment:

4.4.1.1. The Chairperson and the Member Secretary place a proposal to the Director, FMCI for

appointing independent consultants. Independent consultants are experts from various subjects for

which experts are not available among regular members of FMIEC. The consultants could be affiliated

or non-affiliated to FMCI. The Director of FMCI appoints independent consultants.

4.4.1.2. The Director communicates to the consultants a proposal of appointment. The consultant will

confirm their acceptance to the Director by providing all required information such as curriculum

vitae, and certificates of training on research ethics and good clinical practice. The consent letter

includes consent from the member, declaration of maintaining confidentiality of research project-

related data/documents/discussions, and willingness to get updated on research ethics, good clinical

practice and regulations on human research. On receiving this consent, the Director will issue the final

appointment order. The list of independent consultants is maintained in the office of FMIEC.

4.4.1.3.

4.4.2. Tenure: The tenure of appointment of an independent consultant is 2 years. The panel will be

reviewed and revised every two years.

4.4.3. Consulting an Independent Consultant for Review :

FMIEC SOP




Page 43 of 194

The Member Secretary in consultation with the Chairperson decides on sending a research proposal

for review depending on the requirement. The requirements are as follows:

1) If the research is from a specialty for which experts are not available in the FMIEC, and there is

need for expert opinion. The subject experts could be affiliated or non-affiliated. Preferably, subject

non-affiliated experts are invited to review to avoid any bias or conflict of interest. The suggestion for

requirement of expert may also come from the Chairperson or any member of FMIEC who feels the

necessity during review process.

2) The Member Secretary requests the independent consultant to review the research proposal

(expedited/full review as required). The review form and proposal copy along with all enclosed

documents (budget form, questionnaire, proforma, informed consent documents, etc..). For the

expedited review, the consultant is requested to do the review and submit the filled review form to the

ethics committee secretariat within one week. This review will be placed before the full committee

meeting for ratification.

3) For full review, the consultant is requested to attend the meeting of FMIEC. He/she should be

present only during the presentation of that particular proposal which was reviewed by him/her. The

opinion of the consultant is taken. However, the consultant does not have voting rights, and not

involved in decision making.

4.4.4. Requirements from Independent Consultants: The secretariat should collect a copy of recent,

signed curriculum vitae from the independent consultants. In addition, certificates of training if any,

in research methodology/ethics in clinical research/good clinical practice/Guidelines for biomedical

research on human beings should be collected and filed in the IEC office. The consultants should also

sign a confidentiality agreement

4.4.5. Conditions to be fulfilled by a consultant after appointment:

1) Must submit a recent, signed CV

2) Must submit training certificates in ethics and GCP (if available during induction)

3) Members must be willing to publicize his/her full name and affiliation

4) Should sign the confidentiality agreement, and maintain confidentiality regarding

documents, discussions, and related matters of FMIEC.

5) Should declare “conflict of interest” whenever it exists

FMIEC SOP




Page 44 of 194

4.4.6. Termination of Membership: The consultant is a member only for the review of specific

research proposals. Any independent consultant found of professional misconduct will be terminated

from the panel of subject experts.

4.5. Annexures :

Annexure -4.1. Appointment Letter of Independent Consultant

To : Dr. --------------

Dear Sir/Madam,

Sub: Proposal of Appointment as “Subject Expert” for Institutional Ethics Committee

I am pleased to appoint you as a member in “The Panel of Subject Experts” of Father Muller

Institutional Ethics Committee. Following are the terms and conditions of appointment.

1) As a subject expert, you are required to review of research proposals pertaining to your

subject/specialty area, whenever you are requested by the Member Secretary of Ethics

Committee. Whenever requested, you are required to complete the review in the stipulated time

of one week. Review form which is provided along with the proposal needs to be filled.

2) For the research proposals categorized under “Full Review”, you have to attend the meeting of

Ethics Committee along with the filled review forms. You have to be present in the meeting

only for the presentation of that proposal reviewed by you. You can clarify any queries with

the researcher/investigator during the meeting, and will share your opinion with the regular

members of ethics committee.

3) For the research proposals categorized under “expedited review”, you will not be attending the

meeting. Only the filled review form has to be sent to Member Secretary of Ethics Committee.

4) You will not have any voting rights in the Ethics Committee meeting

5) You need to sign a letter of conflict of interest, and declare to maintain confidentiality of the

discussions and reviews

6) You will be paid a remuneration of Rupees ---------- /proposal for the review work done

With Regards, Director, Father Muller Charitable Institutions , Mangalore.

FMIEC SOP




Page 45 of 194

Anenxure-4.2 : Father Muller Institutional Ethics Committee–

Consent Letter from Appointed Member of “Subject Expert Panel”

To :

The Director,


Sub : Consent to be the member of Subject expert panel of Father Muller Institutional Ethics

Committee.

Ref : Appointment letter No.--------------------------------------; Dated ----------------------------

Dear Sir,

In response the appointment letter, I give my consent to be the member of Father Muller Institutional

Ethics Committee “subject expert panel”. As a subject expert, I shall do review of research proposals

pertaining to my subject/specialty area, whenever I am requested by the Member Secretary of Ethics

Committee. I shall participate in the ethics committee meetings whenever asked to do so. I shall

maintain the entire research project related information confidential. I am ready to declare conflict of

interest whenever I have the conflict of interest with regard to any research proposal. The research

proposal-related materials given to me for review will be returned to ethics committee once I complete

the review process.

Thanking You,

Yours Sincerely,

Signature :

Name :

Designation and Department/Affiliations :

Date : Place :

FMIEC SOP




Page 46 of 194

Annexure-4.3 : Confidentiality Agreement to be Signed By Independent consultant of FMIEC

In recognition of the fact, that I, _________________________________________________

(Consultant’s name, his/her position on IEC and affiliation) herein referred to as the “undersigned”,

have been appointed as a member of the subject expert panel of FMIEC and have been asked to assess

research studies involving research participants in order to ensure that they are conducted in a humane

and ethical manner, adhering to the highest standards of care as per the national, and local regulations

and institutional policies and guidelines and international and national guidelines.

The appointment of the undersigned as a consultant of the FMIEC is based on individual merits and

not as an advocate or representative of a home province, territory or community nor as a delegate of

any organization.

The IEC must meet the highest ethical standards in order to merit the trust and confidence of the

communities in the protection of the rights and well-being of research participants and the

undersigned, as a member of the IEC, is expected to meet the same high standards of ethical behavior

to carry out its mandate.

This agreement encompasses any information deemed Confidential provided to the Undersigned in

conjunction with the duties as a member of the subject expert panel of FMIEC. All Confidential

information (and any copies and notes thereof) shall remain the sole property of the FMIEC. The

undersigned agrees to hold all confidential information in trust or confidence and agrees that it shall be

used only for contemplated purposes and shall not be used for any other purpose or disclosed to any

third party. Written confidential information provided for review shall not be copied or retained.

I, ________________________________________________ (name of the consultant) have read and

accept the aforementioned conditions as explained in this Agreement.

Signature Date

Chairperson’s Signature Date

[The original (signed and dated Agreement) will be kept on file in the custody of the FMMMCIEC. A

copy will be given to the Undersigned.]

I acknowledge that I have received a copy of this Agreement signed by the FMIEC Chairperson and

me.

Signature Date

FMIEC SOP




Page 47 of 194

5. SOP-5 : Allowing Guests or Observers to

FMIEC Office/ Meetings

5.1. Purpose: To describe procedures to be followed by Institutional Ethics Committee (IEC) and the

Guest/ Observer whenever he/she visits the IEC Office or attends an IEC full board meeting. The SOP

is needed to ensure adequate protection of confidentiality of information related to research studies

5.2. Scope: This SOP covers the procedure related to visits of guests or observers to FMIEC office

and meetings of FMIEC

5.3. Responsibility: Member secretary in consultation with chairman is responsible to decide whether

to allow a guest or observer to visit FMIEC office or attend meetings of FMIEC. The guests or

observers are responsible for maintaining confidentiality of activities, discussions and documents of

FMIEC

5.4. Procedure:

5.4.1. Request from Guest or Observer: The individuals who wish to know about the activities of

FMIEC need to submit a written request (e mail or hard copy) addressed to Member Secretary of

FMIEC. The reasons for the visit to FMIEC office or meetings of FMIEC should be clearly stated in

the request letter. The request letter should be submitted at least one week in advance to the visit.

5.4 .2. Decision on Allowing the Guest or Observer: The member secretary consults the chairman

and takes the decision to allow or not to allow the guest or observer. The guest or observer should not

have any conflict of interest with any investigator presenting the proposal on that day. If the member

secretary is not satisfied with the reasons for visit, he/she may deny permission to the guest or

observer. The decision is communicated to the person (guest/observer) in writing (e mail or hard copy

of the letter). The date and time of visit to FMIEC office and meetings is informed to the guest or

observer.

5.4.3. Responsibilities of the Guest or Observer: The guest or observer should sign the

confidentiality agreement during his/her visit to FMIEC office, before getting any details of the

functioning of the committee. If the guest/observer wants to attend only the meeting of FMIEC, he/she

should sign the confidentiality agreement before entering the meeting hall. Only after obtaining

confidentiality agreement signed by the guest or observer, he/she will be allowed to attend the

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meeting. He/she can visit the FMIEC/attend the meeting of FMIEC only on the date and time

mentioned in the permission letter from FMIEC. The guest or observer should not ask any questions to

the investigators in the meeting of FMIEC. Also, doubts or clarifications should not be asked to the

members of FMIEC in front of the investigators.

The observer or guest will not be provided with any SOPs or documents of FMIEC in hard or soft

copy. Only verbal explanations will be given. He/she is allowed to see the documents after signing the

confidentiality agreement.

5.4.4. Information Given to Guest or Observer During Visit to FMIEC: During his/her visit to

FMIEC office, the guest will get the necessary and allowable information from the member Secretary.

For any doubts or clarifications Member Secretary gives explanations.

5.4.5. Information Given to Guest or Observer During FMIEC Meeting: During the FMIEC

meetings, the guest or observer will be silently observing the proceedings. For any clarifications or

doubts, the member secretary will give explanations after the meeting.

5.5. Annexures :

Annexure 5: Confidentiality Agreement Form For Guest / Observer Attendees to IEC/ IEC

Meetings

I, ________________________________ (name), understand that I am being allowed to visit IEC

office facility / attend the IEC meeting on ___________ at _______am as a Guest. The venue of the

IEC meeting will be _____________________. I may become aware of some confidential information

during my visit to IEC / during the course of the IEC meeting. Upon signing this form, I ensure to take

reasonable measures to keep the information as confidential.

Signature of Guest/Observer Date :

Signature of Chairperson Date :

I, _________________________________________________ (name) acknowledge that I have

received a copy of this Agreement signed by the IEC –Chairperson and me.

__________________________ __________________ Signature of the Guest ; Date

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6. SOP-6 : Submission of Documents to FMIEC

and Management of Submitted Documents

6.1. Purpose: This SOP describes the guidelines for submission of protocols to FMIEC and how the

secretariat manages the submitted protocols

6.2. Scope: The Scope of this SOP include:

1. Submission of Research Project and related documents for Initial Review of the Protocol

2. Resubmission of Protocols or Research Projects with corrections

3. Submissions of written communications related to the protocol

4. Continuing Review of Approved Protocols :

a. Protocol completion/Termination

b. Protocol deviations/violation

c. SAE initial/ follow up/ final reports

d. Submission of Protocol deviations, Protocol violations

6.3. Responsibility: It is the responsibility of the Principal Investigators to submit the protocols as per

the guidelines of FMIEC. It is the responsibility of IEC Secretariat to receive and record the received

protocols and any other documents for review. The Member Secretary is responsible for scrutinizing

the received documents.

6.4. Procedure :

6.4.1. Documents to be Submitted by the Principal Investigator :

6.4.1.1. Time Line : The Principal Investigator should submit the research proposals to the Secretariat

of FMIEC as per the following time line :

1) New Proposals for Initial Review/ Re-submission of Protocols with Corrections/ Amended

Protocols and related documents: should be submitted at least 10 days prior to the scheduled

meeting of FMIEC .

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2) Submission of SAE (On-Site): As per the timelines stated in the SOP for initial and detailed

reporting of SAE.

3) All other documents for consideration at the full board meeting (except those related to

participant safety, which may be submitted any time (must be submitted at least 72 hours in

advance)

6.4.1.2. The following documents shall be submitted to the secretary of the ethics committee.

Essential Documents :

1) Covering letter to the Member Secretary

2) Project submission application form for initial review (see annexure)

3) The correct version of the research proposal: 2 sets of hard copies and one soft copy.

4) Relevant administrative approvals (if applicable)

5) Patient information leaflet in English and Kannada ( see annexure )

6) Informed consent form (see annexure) or waiver of consent form

7) Proforma for clinical data collection

8) Budget Proposal

9) Letter from the Department Head Concerned, here non routine or special tests are being done

(applicable to academic studies)

10) Any additional document(s), as required by IEC

6.4.2. Management of Protocols:

6.4.2.1. Initial Verification and Assigning Protocol Number:

1. The proposals are verified for the completeness If there are any deficiencies the proposals will

be returned to the investigator for resubmission

2. Once a protocol is deemed to be complete in all respects the FMIEC secretariat will issue a

protocol number. The No. will be in this format : FMIEC/CATEGORY/PROTOCOL

NO./YEAR.

3. The FMIEC secretary will screen the proposals and depending on the risk involved categorizes

them into types namely, exemption from review, expedited review and full committee review

4. The investigator is informed by email and SMS about the presentation date and time

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5. Final decision about the categorisation of the proposals vests with the Member Secretary and

his decision will be final and binding on the investigator

6. The criteria for the categorisation of proposals has been given in the annexure

7. The clerk will stamp the receiving date on the first page/last page of the covering letter and

initial it

6.4.2.2. Transmission and Storage of Documents:

1. The clerk will make a photocopy of the completed document receipt form and return the

original copy to the applicants for their records.

2. The hard copies of proposals categorized for full committee review will be sent to all members

of FMIEC at least 1 week prior to the meeting. The soft copies of all protocols ( full and

expedited review ) will be sent by email/CD/pen drive to those members who have opted for

the electronic version

3. The proposals categorised as exempt review will be cleared by the Member Secretary at the

earliest and the decision will be communicated to the investigators

4. All the protocols will be stored in submission file which again will be categorised as regulatory

trials/academic projects/other projects

6.4.3. Resubmission of Protocols with corrections and Amendments of protocol/ related

documents:

1. For resubmitted protocol, the PI will submit one soft copy and one hard copy of the amended

Protocol and related documents

2. The Secretariat will verify the completeness of the documents and confirm that the copy contains

the modifications highlighted with respect to the earlier protocol submitted mentioning the

justification for the amendment.

3. The protocol related documents which do not require to be changed and are already submitted for

the IEC office during initial review are not required to be submitted again.

4. The Member Secretary (MS) will decide

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a. if it is a resubmitted protocol it will follow all steps of : categorization as full review/expedited

review and initial review. All the steps followed for a new submission will be followed for the

resubmitted protocol.

b. if it is a resubmitted protocol based on query response, the Member Secretary will handle it as

decided in the meeting (e.g. Carry out review by one or more member(s) selected by the Chairperson.

The selected members are normally those who reviewed and recommended the previous version of

that protocol or keep on full board agenda)

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6.5. Flow Chart:

Submission of Documents by PI

Initial scrutiny by Secretariat of FMIEC

Allotting Protocol No.

Categorization for Review: Member Secretary

Decision on Proposals for Exempted from Review: Member Secretary

Sending the proposals for expedited/full review

Full board meeting and Decision making

Communication of Decision to PI

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6.6. Annexures :

Annexure-6.1 : Guidelines for Conducting Clinical Research in FMCI :

1. Follow the guidelines of ICMR 2017 for carrying out the biomedical research.

2. All clinical studies should be reviewed and approved by the IEC before initiation of the

study

3. No retrospective approvals will be granted

4. Studies may be considered for full board or expedited review or may be granted exemption

from review depending on the risk involved.

5. It is mandatory to register interventional studies in the Clinical Trials Registry of India

(ctri.nic.in).

6. The investigator team should be trained in GCP or ethics in clinical research ( certificates –

valid for 5 years as per FMIEC policy). For randomized controlled trials, guidelines of

Consolidated Standards of Reporting Trials (CONSORT) .

7. Studies involving AYUSH, should follow GCP guidelines of Ministry of AYUSH.

8. If a clinical study is planned on an “alternative system of medicine” (Ayurveda, Homeopathy,

Siddha, Unani etc.),by a clinician of modern medicine, a Co-Investigator/ Collaborator from

that system should be included in the study team. The co-investigator appointed should be

appropriately qualified and registered with the relevant Council and he/she should not have a

conflict of interest with the study, investigator or sponsor. This is in accordance with the

ICMR 2017 guidelines. If a principal investigator from AYUSH wants to do a study

comparing the alternate system of medicine with modern medicine, then a co investigator

from modern medicine should be included.

9. The research study protocol should be scientific and complete with respect to the following

sections:

A. Introduction with relevant literature,

B. Objectives,

C. Justification for a clinical study (demonstrate clinical equipoise) and its implications for

future,

D. Detailed methodology describing

i. Settings of the study,

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ii. Duration of entire study and duration for participation for each individual,

iii. Eligibility criteria (inclusion and exclusion criteria),

iv. Sample size (number of participants that may need screening, number that is required

to be completed for analysis)

v. Sampling method

vi. Ethical aspect : A statement saying that the study will be conducted in adherence to

relevant national/international laws; Placebo justification if applicable; Risk benefit

assessment; Compensation for participation if applicable; Compensation for research related

injury; Informed consent process, Choice of participants; If vulnerable population what

protections are in place; Policy regarding autonomy (voluntariness, right to withdraw);

Confidentiality - Statement of Participant confidentiality; including ownership of data and

coding procedures; Policy regarding dissemination of data, presentation of data, publication.

vii. Description of variables, inpatient/outpatient, number of outpatient visits

viii. Statistics: Sample size determination, Power estimates / level of significance, Tests for

comparison/ any other descriptive statistical analysis.

10. Informed consent documents should be made in English and Kannada and other relevant

regional languages

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Annexure-6.2. : Guidelines for Submission of Documents for Review to FMIEC :

1. The committee meets on fourth Saturday of every month at 3 PM in the Board Room of

FMCI Research Centre. Depending on the load of research proposals, the frequency of

meeting may be increased.

2. The research proposal should be accompanied by other documents (budget form, patient

information sheet, informed consent form, undertaking, questionnaire, proforma of data

collection) as applicable to the study. Total six sets of hard copy, and one soft copy to be

submitted.

3. For case reports, a copy of the informed consent form signed by the patient should be

submitted to FMIEC, along with a copy of the abstract and findings in the case study.

4. The research proposals will be categorized for review as : exempt review, expedited

review and full committee review.

5. For the proposals categorized for full review, the principal investigator will be asked to

present the proposal in the ethics committee meeting.

6. Principal investigator should be available for presentation of the proposal in the meeting

in case of full committee review. Co investigators may accompany the principal

investigator. Under no circumstances principal investigator will be exempted from

presentation except in extraordinary circumstances. Under such circumstances the

principal investigator should inform the Member Secretary in writing. The Chairperson of

FMIEC will decide on this matter.

7. Research proposals are sent to members of FMIEC for review atleast seven days before

the meeting. Investigators should keep this in mind while submitting proposals to FMIEC.

8. Decision of the committee will be communicated to principal investigator within two

working days after the meeting.

9. Research proposals “approved “/ “approved with suggestions” are permitted to start the

work. Research proposals for “resubmission” need to revise the proposals and resubmit

the proposals. For “Rejected” proposals, whole process of submission should be repeated

considering the reasons for rejection

10. If the ethics committee asks the investigators to do CTRI registration, it should be done

and CTRI reg.no. should be communicated to the committee .

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11. Ethical clearance is initially issued for one year; after one year the investigator has to

request for continuation of ethical approval.

12. Ethics committee has every right to monitor the research study at any point of study

duration. The principal investigator should submit a report on progress of the study.

Progress report should be submitted every year .

13. Any serious adverse events should be notified to the FMIEC within 24 hours. All protocol

deviations, violations and amendments should be informed promptly.

Annexure 6.3. : Protocol Submission Form for Clinical Trials (Homeopathy Clinical

studies)

I. Proposal Title :

Name, Designation &

Qualifications

Address Tel & Fax

Nos. Email ID

Signature

Principle Investigator

Co-Investigator

Please attach detailed curriculum Vitae of all Investigators (with subject specific publications limited

to previous 5 years)

II. Sponsor information:

1. Indian a) Government Central State Institutional

b) Private

2. International Government Private UN agencies

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3. Industry National Multinational

Contact Address of Sponsor:

Total Budget (mention here and enclose the budget form)

III. Type of Study : Epidemiological Basic Sciences Animal studies

Clinical: Single center Multicentric Behavioral

IV. Status of Review :

New Revised

V. Clinical Trials:

Drug/Vaccines/Device/Herbal Remedies:

(i) Does the study involve use of :

Drug Devices Vaccines

Indian Systems of Medicine/

Alternate System of Medicine Any other NA

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(ii) Is it approved and marketed

In India UK & Europe USA

Other countries, specify

(iii) Does it involve a change in use, dosage,

route of administration ?

If yes, whether Any other Regulatory authority’s

Permission is obtained ?

If yes, Date of Permission:

Yes

Yes

No

No

(iv) Is it an Investigational New Drug ?

If yes, IND No:

Yes

No

a) Investigator’s Brochure submitted Yes No

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b) In vitro studies data

Yes

No

c) Preclinical Studies done

Yes

No

Clinical Study is : Phase I Phase II Phase III Phase IV

d) Are you aware if this study/similar study

is being done elsewhere ?

If Yes, attach details

Yes

No

VI. Brief description of the proposal – Introduction, review of literature, aims(s) & objectives,

justification for study, methodology describing the potential risks & benefits, outcome measures,

statistical analysis and whether it is of national significance with rationale

VII. Subject selection:

(i) Number of Subjects :

(ii) Duration of study:

(iii) Will subjects from both sexes be recruited Yes No

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(iv) Inclusion / exclusion criteria given

Yes

No

(v) Type of subjects Volunteers Patients

(vi) Vulnerable subjects Yes No

(Tick the appropriate boxes)

Pregnant women children elderly

Fetus illiterate handicapped

Terminally ill seriously ill mentally challenged

Economically & socially

backward any other

(vii) Special group subjects Yes No

(Tick the appropriate boxes)

Captives Institutionalized employees

Students Nurses/dependent armed forces

Any other staff

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2. Privacy and confidentiality

(i) Study involves - Direct Identifiers

Indirect Identifiers/coded

Completely anonymised/delinked

(ii) Confidential handling of data by staff

Yes

No

3. Use of biological/hazardous materials

(i) Use of fetal tissue or abortus

Yes

No

(ii) Use of organs or body fluids Yes No

(iii) Use of recombinant /gene therapy

If yes, has department of Biotechnology (DBT) approval for

DNA products been obtained ?

Yes

No

(iv) Use of pre-existing/stored/left over samples Yes No

(v) Collection for banking/future research Yes No

(vi) Use of ionizing radiation/radioisotopes

If yes, has Bhaba Atomic Research Centre (BARC)

approval for Radioactive Isotopes been obtained ?

Yes

No

(vii) Use of Infectious/biohazardous specimens Yes No

(viii) Proper disposal of material Yes No

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(ix) Will any sample collected from the patients be sent abroad ?

If yes, justify with details of collaborators

Yes

No

a) Is the proposal being submitted for clearance from

Health Ministry’s Screening Committee (HMSC) /ICMR

for International Collaboration ?

Yes

No

b) Sample will be sent abroad because ( Tick appropriate box)

Facility not available in India

Facility in India inaccessible

Facility available but not being accessed

If so, reasons ……………………

8. Consent : Written Oral Audio-visual

i. Consent form : (tick the included elements)

Understandable language Alternatives to participation

Statement that study involves research Confidentiality of records

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Sponsor of study Contact information

Purpose and Procedures Statement that consent is voluntary

Risks & Discomforts Right to withdraw

Benefits Consent for future use of biological material

Compensation for participation Benefits if any on future commercialization

Compensation for study related injury eg: genetic basis for drug development

If written consent is not obtained, give reasons:

(ii) Who will obtain consent ? PI/Co-PI Nurse / Counsellor

Research staff Any other

9.Will any advertising be done for recruitment of Subjects ?

( posters, flyers, brochure,websites – if so kindly attach a copy

Yes

No

10. Risks & Beneifts :

(i) Is the risk reasonable compared to the anticipated

benefits subjects/community/country ?

Yes

No

(ii) Is there physical/social/psychological risk/discomfort

If Yes, Minimal or no risk

More than minimum risk

Yes

No

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High risk

(iii) Is there a benefit a) to the subject ?

Direct Indirect

b) Benefit to society

11. Data Monitoring

(i) Is there a data & safety monitoring committee/Board (DSMB) ?

Yes

No

(ii) Is there a plan for reporting of adverse events ?

If Yes, reporting is done to :

Sponsor Ethics Committee DSMB

Yes

No

(iii). Is there a plan for interim analysis of data ? Yes No

(vi) Are there plans for storage and maintenance of all trial database ?

If Yes, for how long ?

Yes

No

12. Is there compensation for participation ?

If yes Monetary In kind

Specify amount and type:

Yes

No

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13. Is there compensation for injury?

If Yes, by Sponsor by Investigator

By insurance by any other company

Yes

No

14. Do you have conflict of interest ?

(financial/non-financial)

If Yes, specify:

Yes

No

15. . Number of protocols handled by the PI at present including current Status of

ongoing studies approved by IEC and carried out by the Principal Investigator.

(Information to be given: whether study is initiated, no. of approved research

participants, no. of research participants enrolled, no. of active research

participants, no. of research participants who have completed the study and total

duration of the study. Describe briefly in a separate sheet, if required)

16 . GCP training certificates of principal investigator and coordinators (Enclose

the copies of certificates)

Yes

No

14. Is the trial registered with Clinical Trial Registry? (mandatory only

for drug trials) Clinical Trial Registry of India(CTRI)/ any other

WHO platform registry

______________________________________________________

Registration number: ____________________________________

If not registered, state the reason____________________________

Yes No

Statement of Compliance:

We hereby declare that the information given above is true and that we will comply with the Ethical

Guidelines for Biomedical Research on Human Participants by Indian Council of Medical Research

(2017) while conducting the research study.

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Signature of Principal Investigator with date: ____________________ Signature/s of Co-investigators

with date: 1.________________ 2.__________________3.______________

Forwarded by Heads of Department(s) Signature/s with date of Heads of Department(s):

Stamp/Seal of the Department(s)

Annexure 6.4. : Checklist for Submission of Documents:

Sl.No. Document Yes No

1 Protocol Submission Form Duly Filled

2 Covering Letter

3 Protocol - hard copies as required

4 Protocol – soft copy by e mail or CD

5 CV of all investigators

6 Informed Consent Documents in English

7 Informed Consent Documents in Kannada

8 Informed Consent Documents in Other Regional Languages as

Applicable

9 Translation and back translation certificates

10 Case Record Forms/Proforma

11 Research Participants Questionnaire/s (If applicable)

12 Administrative sanction from the Head of the Institution in case

of collaborative studies with other institutions / foreign agencies

(one copy) Or Memorandum of Understanding (as applicable)

13 Administrative sanction from the Head of the Institution for the

samples to be sent to outside institution (one copy) Or Material

Transfer Agreement (as applicable)

14 Budget Sheet for the Proposed Study (Format for budget sheet

stated below)

15 Signed and dated brief current curriculum vitae of the study

team members (principal investigator, co-investigator, study

coordinator ) (one copy only)

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16 Documentation of clinical trial registration (in Clinical Trial

Registry of India) / any other WHO platform registry (whenever

applicable)

17 GCP training certificates of principal investigator, co

investigator/s, study coordinator/s for interventional clinical trial

sponsored by pharmaceuticals companies of training taken in

last 5 years (one copy only)

18 Any other Documents submitted (mention)

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Annexure 6.5. : FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE(FMIEC).

E MAIL : [email protected]

APPLICATION FORM FOR SUBMISSION OF RESEARCH PROTOCOL (OTHER THAN

CLINICAL TRIALS)

For Office Use Only :

FMIEC :

1) Received on :

2) Protocol No. :

3) Categorized for : Full Review/Expedited Review/Exempted from Review

4) Signature of Member Secretary , FMIEC with Date :


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I INVESTIGATOR INFORMATION

1. NAME OF THE INVESTIGATOR

(in block letters)

2. Official Address

3. MOBILE NUMBER

4. EMAIL ID

II PROTOCOL INFORMATION

1. TITLE OF THE RESEARCH

PROJECT

2. NAME OF THE GUIDE

1. (only for UG and PG students)

3. NAME OF THE COGUIDE/

CO INVESTIGATOR

4. NATURE OF SUBMISSION

A. UNDERGRADUATE ICMR /OTHERS

B. POSTGRADUATE / PhD THESIS / PAPER /POSTER/ CASE

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REPORTS/OTHERS

C. STAFF

1

SPONSORED TRIAL/ ORIGINAL

STUDY/ POSTER / CASE REPORTS

III PROTOCOL CHECKLIST (Tick the relevant boxes)

A. TITLE

B. INTRODUCTION AND NEED FOR

STUDY

C. REVIEW OF LITERATURE

D. AIMS AND OBJECTIVES

E. MATERIALS AND METHODS –

study

design, sample size, methodology

F. STATISTICAL ANALYSIS

G. IMPLICATIONS OF THE STUDY

H. REFERENCES IN VANCOUVER

STYLE

I. PROFORMA

J. INFORMED CONSENT FORM

(in English and Kannada )

K. PATIENT INFORMATION SHEET

( in English and Kannada )

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L. BUDGET FOR THE PROJECT

(fill up the budget estimation form)

SIGNATURE OF THE INVESTIGATOR SIGNATURE OF GUIDE

SIGNATURE OF CO INVESTIGATOR/CO GUIDE

SIGNATURE OF THE HOD WITH SEAL SIGNATURE OF PRINCIPAL WITH SEAL

------------------------------------------------------------------------------------------------------------

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Annexure 6.6. : ESTIMATED BUDGET FOR THE PROJECT

NOTE:

1. This application should contain the total cost of routine and special tests done for the project

2. This form should be submitted along with the application form .

AMOUNT IN RUPEES YEAR 1 YEAR 2 YEAR 3 TOTAL

PARTICULARS

STATIONERY,

PHOTOCOPYING,

BINDING

CONSUMABLES

EQUIPMENTS

INVESTIGATIONS

ROUTINE

TESTS DONE FOR

PROJECT (SPECIAL

TESTS-IN HOUSE)

TESTS SENT OUTSIDE

(SPECIAL TESTS

OUTSOURCED)

ANY OTHER MEDICAL

DEVICES/MEDICATIONS

ADDITIONALLY USED

GRAND TOTAL

SL NO NAME OF THE

INVESTIGATION

NO OF

TESTS

TOTAL

AMOUNT

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Source of Funding for the Research:

Declare Self-funding: Rs.--------------------------

I declare that the study subjects will not be made to pay for the special

investigations/devices/medications. The cost will be born by me or procured from research grants of --

-------------------------------------------------------.

Name and Signature of Principal Investigator.

Name and Signature of Co investigators :

Name of signature of Guide (for PhD/ PG/UG research)

Date :

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Annexure- 6.7. : FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE:

Format for Patient Information Sheet and Informed Consent Form

Title of the Study :

Names of Researchers/Investigators

Name of Organization :

Name of Sponsor (Grant agency):

Name of Project and Version

This Informed Consent Form has two parts:

Information Sheet (to share information about the study with the participant)

Certificate of Consent (for signatures if the participant agrees to participate)

State that the participant will be given a copy of the full Informed Consent Form

Introduction

Briefly state who you are and explain that you are inviting them to participate in research which you

are doing. Inform them that they may talk to anyone they feel comfortable talking with about the

research and that they can take time to reflect on whether they want to participate or not. Assure them

that if they do not understand some of the words or concepts, that you will take time to explain them as

you go along and that they may ask questions now or later

Purpose

Explain in lay man's terms/simple language why the research is being conducted and what is expected

from the results. (In case research subjects are children/minors - Explain to the parents/guardian's as to

why you need to conduct the research with the child/minor.)

Type of Research Intervention

Briefly state the intervention. This will have to be expanded upon in the procedures section

Selection of Participants

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State clearly why you have chosen the participant to participate in your study. (Patients may wonder

why they have been chosen for a study and may be fearful, confused or concerned)

Voluntary Participation

Indicate clearly that the participant can choose to participate or not in the study and reassure the

participant that he/she will still receive all the services which he/she usually does in their treatment/at

the hospital, whether he/she chooses to participate or not. This can be repeated and expanded upon

later in the form as well. It is important to state clearly at the beginning of the form that participation is

voluntary so that the rest of the information can be explained to the participant in this context.

Participants are likely to be more alert at the beginning.

Procedure

Explain what each of the steps or procedures involve. Indicate when the research will commence and

where. If there are surveys, indicate where and how the surveys will be collected and distributed.

Duration

Include a statement about the time commitments of the study for the participant. Include both the

duration of the study and follow-up, if relevant

Risks and Discomforts

Explain any risks or discomforts including any limits to confidentiality.

Benefits

Describe to the participant about the benefits of the study, if any, either to him/her or to the

community, or any benefits which are expected in the future as a result of the research.

Reimbursements

State clearly what you will not provide any monetary benefits to the participant for his/her

participation. State clearly that the participant will not be entitled to any compensation beyond

reimbursements for expenses incurred as a result of participation in research. The expenses may

include, for example, travel expenses and reimbursement for time lost.

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Confidentiality:

Explain how the research team will maintain the confidentiality of data, especially with respect to the

personal information about the participant. Outline any limits there are to confidential. Note that with

focus groups confidentiality cannot be guaranteed because what is said within the group becomes

common knowledge. Participants can be asked not to share information outside the group since this

does not guarantee confidentiality

Sharing of Research Findings

Include a statement indicating that the research findings will be shared in a timely fashion but that

confidential information will remain confidential. If you have a plan and timeline for the sharing of

information, include the details. Also inform the participant that the research findings will be shared

more broadly, for examples, through publications and conferences.

Right to refuse or withdraw

Explain again the voluntary nature of consent. Inform specifically that the participant has a right to

withdraw from the study at any point of time and that the information that has been obtained will not

be used and confidentiality would still be maintained. Also inform the participant that the

facilities/services which he/she is/was being provided and availed of by the participant at the Hospital

will remain unchanged.

Whom to Contact

Provide the name and contact information of someone who is involved, informed and accessible (a

local person) who can actually be contacted. State also that the proposal has been approved and how.

Provide the contact number and address of the researchers

Mention that –This research project is reviewed and approved by Ethics Committee of Father Muller

Charitable Institutions, Kankanady, Mangalore. This is a committee whose task it is to make sure that

research participants are protected from harm.

The contact details of ethics committee are as follows:

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Dr. Shivashankara A.R.,

Member Secretary,

Father Muller Institutional Ethics Committee,

Kankanady, MANGALORE-02.

Phone : 08242238399; 9880146133. Mail : [email protected];

[email protected].

Dr.Shalini Shenoy,

Chairperson of Father Muller Institutional Ethics Committee,

Professor of Microbiology ,

Kasturba Medical College, Mangalore -01.

Phone : 9845497072 . Mail : [email protected]




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INFORMED CONSENT

I have read and understood the information/ it has been read over to me and explained to me in an

understandable language about the research project : ------------(title). I have had the opportunity to ask

questions about it and questions that I have asked have been answered to my satisfaction. I consent

voluntarily to participate as a participant in this research.

Name of Participant__________________

Signature of Participant ___________________

Date ___________________________

Day/month/year

If illiterate

A literate witness must sign (if possible, this person should be selected by the participant

himself/herself and should have no connection to the research team). Participants who are illiterate

should include their thumb-print as well.

I have witnessed the accurate reading of the consent form to the potential participant and the

individual has had the opportunity to ask questions which have been properly answered by the

Researcher in my presence. I confirm that the individual has agreed to participate in the research and

has given consent freely.

Name of witness_____________________ AND Thumb print of participant

Signature of witness ______________________

Date ________________________

Day/month/year

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Statement by the researcher/person taking consent

I have accurately read out the information sheet to the potential participant and to the best of my

ability made sure that the participant has understood the procedures to be gone through:

I confirm that the participant was given an opportunity to ask questions about the study and I have

answered all questions asked by the participant correctly and to the best of my ability. I confirm that

the individual has not been coerced into giving consent and that the consent has been given freely and

voluntarily.

A copy of this ICF has been provided to the participant.

Name of Researcher/person taking the consent________________________

Signature of Researcher /person taking the consent__________________________

Date ___________________________

Day/month/year

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Annexure 6.8. Child Assent Form and Parental Consent Form

FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE

ASSENT FORM FOR CHILDREN

Name of Principle Investigator :


Name of Sponsor :

Name of Project and Version:

This Informed Assent Form has two parts:

Information Sheet (gives you information about the study)

Certificate of Assent (this is where you sign if you agree to participate)

You will be given a copy of the full Informed Assent Form

Part I: Information Sheet

Introduction

This is a brief introduction to ensure the child knows who you are and that this is a research study.

Give your name, say what you do and clearly state that you are doing research. Inform the child that

you have spoken to their parents and that parental consent is also necessary. Let them know that they

can speak to anyone they choose about the research before they make up their mind.

Purpose: Why are you doing this research?

Explain the purpose of the research in clear simple terms.

Choice of participants: Why are you asking me?

Children, like adults, like to know why they are being invited to be in the research. It is important to

address any fears they may have about why they were chosen.

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Participation is voluntary: Do I have to do this?

State clearly and in child-friendly language that the choice to participate is theirs. If there is a

possibility that their decision not to participate might be over-ridden by parental consent, this should

be stated clearly and simply.

Information on the Trial Drug [Name of Drug]: What is this drug and what do you know about

it?

Include the following section only if the protocol is for a clinical trial:

1) give the phase of the trial and explain what that means. Explain to the participant why you are

comparing or testing the drugs.

2) provide as much information as is appropriate and understandable about the drug such as its

manufacturer or location of manufacture and the reason for its development.

3) explain the known experience with this drug

4) explain comprehensively all the known side-effects/toxicity of this drug, as well as the adverse

effects of all the other medicines that are being used in the trial

Procedures: What is going to happen to me?

Explain the procedures and any medical terminology in simple language. Focus on what is expected of

the child. Describe which part of the research is experimental.

Risks: Is this bad or dangerous for me?

Explain any risks using simple, clear language.

Discomforts: Will it hurt?

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If there will be any discomforts state these clearly and simply. State that they should tell you and/or

their parents if they are sick, experience discomfort or pain. Address what may be some of the child's

worries, for example, missing school or extra expense to parents.

I have checked with the child and they understand the risks and discomforts ____(initial)

Benefits: Is there anything good that happens to me?

Describe any benefits to the child.

Reimbursements: Do I get anything for being in the research?

Mention any reimbursements or forms of appreciation that will be provided. Any gifts given to

children should be small enough to not be an inducement or reason for participating. WHO does not

encourage incentives beyond reimbursements for expenses incurred as a result of participation in the

research. These expenses may include, for example, travel expenses and reimbursement for time lost.

The amount should be determined within the host country context.

Confidentiality: Is everybody going to know about this?

Explain what confidentiality means in simple terms. State any limits to confidentiality. Indicate what

their parents will or will not be told.

Compensation: What happens if I get hurt?

Describe to the ability of the child to understand and explain that parents have been given more

information.

Sharing the Findings: Will you tell me the results?

Describe to the ability of the child to understand that the research findings will be shared in a timely

fashion but that confidential information will remain confidential. If you have a plan and a timeline for

the sharing of information, include the details. Also tell the child that the research will be shared more

broadly, i.e. in a book, journal, conferences, etc.

Right to Refuse or Withdraw: Can I choose not to be in the research? Can I change my mind?

You may want to re-emphasize that participation is voluntary and any limits to this.

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Who to Contact: Who can I talk to or ask questions to?

List and give contact information for those people whom the child can contact (name and contact

details of the members of the research team). Tell the child that they can also talk to anyone they want

to about this (their own doctor, a family friend, a teacher).

If you choose to be part of this research I will also give you a copy of this paper to keep for

yourself. You can ask your parents to look after it if you want.

You can ask me any more questions about any part of the research study, if you wish to. Do you have

any questions?

PART 2: Certificate of Assent

This section can be written in the first person. It should include a few brief statements about the

research and be followed by a statement similar to the one identified as 'suggested wording' below. If

the child is illiterate but gives oral assent, a witness must sign instead . A researcher or the person

going over the informed assent with the child must sign all assents.

I have read this information ( or had the information read to me) I have had my questions

answered and know that I can ask questions later if I have them.

I agree to take part in the research.

OR

I do not wish to take part in the research and I have not signed the assent

below.___________(initialled by child/minor)

Only if child assents:

Print name of child ___________________

Signature of child: ____________________

Date:________________ day/month/year

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If illiterate:

A literate witness must sign (if possible, this person should be selected by the participant, not be a

parent, and should have no connection to the research team). Participants who are illiterate should

include their thumb print as well.

I have witnessed the accurate reading of the assent form to the child, and the individual has had

the opportunity to ask questions. I confirm that the individual has given consent freely.

Print name of witness (not a parent)_________________ AND Thumb print of participant


Date ________________________

Day/month/year

I have accurately read or witnessed the accurate reading of the assent form to the potential

participant, and the individual has had the opportunity to ask questions. I confirm that the

individual has given assent freely.

Print name of researcher_________________

Signature of researcher___________________

Date__________________

Day/month/year

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I have accurately read out the information sheet to the potential participant, and to the best of

my ability made sure that the child understands that the following will be done:

1.

2.

3.

I confirm that the child was given an opportunity to ask questions about the study, and all

the questions asked by him/her have been answered correctly and to the best of my ability. I

confirm that the individual has not been coerced into giving consent, and the consent has been

given freely and voluntarily.

A copy of this assent form has been provided to the participant.

Print Name of Researcher/person taking the assent________________________

Signature of Researcher /person taking the assent __________________________

Date ___________________________

Day/month/year

Copy provided to the participant ________(initialed by researcher/assistant)

Parent/Guardian has signed an informed consent ___Yes ___No _____(initialed by

researcher/assistant)

---------------------------------------------------------------------------------------------------------------------------

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FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE(FMIEC)



Name of Sponsor :

Name of Proposal and version :

This Informed Consent Form has two parts:

Information Sheet (to share information about the study with you)

Certificate of Consent (for signatures if you agree that your child may participate)

You will be given a copy of the full Informed Consent Form

ha C

PART I: Information Sheet

Introduction

Briefly state who you are. and explain that you are inviting them to have their child participate in

research which you are doing. Inform them that may talk to anyone they feel comfortable talking with

about the research and that they can take time to reflect on whether they want their child to participate

or not. Assure the parent that if they do not understand some of the words or concepts, that you will

take time to explain them as you go along and that they can ask questions now or later.

Informed Parental Consent Form for

Research Involving Children

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Purpose

Explain the problem/research question in lay terms which will clarify rather than confuse. Use local

and simplified terms for a disease, e.g. local name of disease instead of malaria, mosquito instead of

anopheles, “mosquitoes help in spreading the disease” rather than “mosquitoes are the vectors”. Avoid

using terms like pathogenesis, indicators, determinants, equitable etc. There are guides on the internet

to help you find substitutes for words which are overly scientific or are professional jargon.

Recognize that parents' feelings about involving their children in research can be complicated. The

desire and feeling of responsibility to protect their child from risk or discomfort may exist alongside

the hope that the study drug will help either their child or others. It is, therefore, important to provide

clear and understandable explanations, and to give parents time to reflect on whether they will consent

to have their child participate.

Type of Research Intervention

Briefly state the intervention if you have not already done so. This will be expanded upon in the

procedures section.

Participant selection

State clearly why you have chosen their child to participate in this study. Parents may wonder why

their child has been chosen for a study and may be fearful, confused or concerned. Include a brief

statement on why children, rather than adults, are being studied.

Voluntary Participation

Indicate clearly that they can choose to have their child participate or not. State, if it is applicable, that

they will still receive all the services they usually do if they decide not to participate. This can be

repeated and expanded upon later in the form as well. It is important to state clearly at the beginning of

the form that participation is voluntary so that the other information can be heard in this context.

Include the following section only if the protocol is for a clinical trial:

Information on the Trial Drug [Name of Drug]

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1) give the phase of the trial and explain what that means. Explain to the parent why you are

comparing or testing the drugs.

2) provide as much information as is appropriate and understandable about the drug such as its

manufacturer or location of manufacture and the reason for its development.

3) explain the known experience with this drug

4) explain comprehensively all the known side-effects/toxicity of this drug, as well as the adverse

effects of all the other medicines that are being used in the trial

Procedures and Protocol

It is important that the parents know what to expect and what is expected of them and their child.

Describe or explain the exact procedures that will be followed on a step-by-step basis, the tests that

will be done, and the drugs that will be given. It is also important to explain from the outset what some

of the more unfamiliar procedures involve (placebo, randomization, biopsy, etc.) Describe very

clearly which procedure is routine and which is experimental or research. Explain that the parent may

stay with the child during the procedures. If the researchers are to have access to the child's medical

records, this should be stated.

Use active, rather than conditional, language. Write "we will ask you to…." instead of "we would like

to ask you to….".

In this template, this section has been divided into two: firstly, an explanation of unfamiliar procedures

and, secondly, a description of process.

A. Unfamiliar Procedures

If the protocol is for a clinical trial:

1) involving randomization or blinding, the participants should be told what that means and what

chance they have of getting which drug (i.e. one in four chances of getting the test drug). A very

minimal statement is provided below to give you an example. You may need to be more explicit about

what is exactly involved.

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2) involving a placebo it is important to ensure that the participants understand what is meant by a

placebo.

3) which may necessitate a rescue medicine, then provide information about the rescue medicine or

treatment such as what it is and the criterion for its use. For example, in pain trials, if the test drug

does not control pain, then intravenous morphine may be used as a rescue medicine

B. Description of the Process

Describe the process on a step-by-step basis.

What will be done in multiple visits /single visit of the child ?

In case of a clinical research:

Explain that there are standards/guidelines that must be followed. If a biopsy will be taken, then

explain whether it will be under local anesthesia, sedation or general anesthesia, and what sort of

symptoms and side effects the participant should expect under each category.

For any clinical study (if relevant):

If blood samples are to be taken explain how many times and how much in a language that the person

understands. It may, for example, be inappropriate to tell a tribal villager that blood equal to a table-

spoon full will be taken.

If the tissues/blood samples or any other human biological material will be stored for a duration longer

than the research purpose, or is likely to be used for a purpose other than mentioned in the research

proposal, then provide information about this and obtain consent specifically for such storage and use

in addition to consent for participation in the study - (see last section)

If not, then explicitly mention here that the biological samples obtained during this research procedure

will be used only for this research, and will be destroyed after ___ years, when the research is

completed.

Duration

Include a statement about the time commitments of the research for the participant and for the parent

including both the duration of the research and follow-up, if relevant.

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Side Effects

Parents should be told if there are any known or anticipated side effects and what will happen in the

event of a side effect or an unexpected event.

Risks

A risk can be thought of as being the possibility that harm may occur. Explain and describe any such

possible or anticipated risks. Provide enough information about the risks that the parent can make an

informed decision. Describe the level of care that will be available in the event that harm does occur,

who will provide it, and who will pay for it.

Discomforts

Explain and describe the type and source of any anticipated discomforts that are in addition to the

side effects and risks discussed above.

Benefits

Benefits may be divided into benefits to the individual, benefits to the community in which the

individual resides, and benefits to society as a whole as a result of finding an answer to the research

question. Mention only those activities that will be actual benefits and not those to which they are

entitled regardless of participation.

Reimbursements

State clearly what you will provide the participants with as a result of their participation. WHO does

not encourage incentives beyond reimbursements for expenses incurred as a result of participation in

research. The expenses may include, for example, travel expenses and reimbursement for time lost.

The amount should be determined within the host country context.

Confidentiality

Explain how the research team will maintain the confidentiality of data, especially with respect to the

information about the participant, which would otherwise be known only to the physician but would

now be available to the entire research team. Because something out of the ordinary is being done

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through research, any individual taking part in the research is likely to be more easily identified by

members of the community and is therefore more likely to be stigmatized.

Sharing of the results

Your plan for sharing the information with the participants and their parents should be provided.

If you have a plan and a timeline for the sharing of information, include the details. Also inform the

parent that the research findings will be shared more broadly, for example, through publications and

conferences.

Right to Refuse or Withdraw

This is a reconfirmation that participation is voluntary and includes the right to withdraw. Tailor this

section well to ensure that it fits for the group for whom you are seeking consent. The example used

here is for a parent of an infant at a clinic.

Alternatives to participating

Include this section only if the study involves administration of investigational drugs or use of new

therapeutic procedures. It is important to explain and describe the established standard treatment.

Who to Contact

Provide the name and contact information of someone who is involved, informed and accessible (a

local person who can actually be contacted.) State also that the proposal has been approved and how.

Contact Details of the Ethics Committee :

If you have any queries /grievances/complaints on this research study, you may contact the Father

Muller Institutional Ethics Committee:

Dr. Shivashankara A.R.,

Member Secretary,

Father Muller Institutional Ethics Committee,

Kankanady, MANGALORE-02. Phone : 08242238399; 9880146133.

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Mail : [email protected];

[email protected].

Dr.Shalini Shenoy,

Chairperson of Father Muller Institutional Ethics Committee,

Professor of Microbiology ,

Kasturba Medical College, Mangalore -01. Phone : 9845497072 . Mail : [email protected]

PART II: Certificate of Consent

Certificate of Consent

This section should be written in the first person and have a statement similar to the one in bold below.

If the participant is illiterate but gives oral consent, a witness must sign. A researcher or the person

going over the informed consent must sign each consent. The certificate of consent should avoid

statements that have "I understand…." phrases. The understanding should perhaps be better

tested through targeted questions during the reading of the information sheet (some examples of

questions are given above), or through the questions being asked at the end of the reading of the

information sheet, if the potential participant is reading the information sheet him/herself.

I have been invited to have my child participate in research of a new malaria vaccine. I have read

the foregoing information, or it has been read to me. I have had the opportunity to ask questions

about it and any questions that I have asked have been answered to my satisfaction. I consent

voluntarily for my child to participate as a participant in this study.

Print Name of Participant__________________

Print Name of Parent or Guardian_______________

Signature of Parent or Guardian ___________________

Date ___________________________

Day/month/year




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If illiterate

A literate witness must sign (if possible, this person should be selected by the participant and should

have no connection to the research team). Participants who are illiterate should include their thumb

print as well.

I have witnessed the accurate reading of the consent form to the parent of the potential

participant, and the individual has had the opportunity to ask questions. I confirm that the

individual has given consent freely.

Print name of witness_____________________ AND Thumb print of parent


Date ________________________

Day/month/year


I have accurately read out the information sheet to the parent of the potential participant, and

to the best of my ability made sure that the person understands that the following will be done:

1.

2.

I confirm that the parent was given an opportunity to ask questions about the study, and all

the questions asked by the parent have been answered correctly and to the best of my ability. I

confirm that the individual has not been coerced into giving consent, and the consent has been

given freely and voluntarily.

A copy of this ICF has been provided to the participant.

Print Name of Researcher/person taking the consent________________________

Signature of Researcher /person taking the consent__________________________

Date ___________________________ Day/month/year

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7. SOP-7 : Review Procedures

7.1.Purpose : The purpose of this SOP is to describe the procedure to categorize new

research study protocols submitted by investigators for initial review into full board /

expedited review or exemption from review process

7.2.Scope : This SOP covers the process of categorization of new research study protocols

submitted to Institutional Ethics Committee (IEC) for initial review.

7.3. Responsibility: The Member Secretary is responsible for categorizing the protocols

for review as full review, expedited review and exempted from review. The

suggestions/guidance of the Chairperson is taken whenever necessary. It is the

responsibility of the members of FMIEC to do the review as per the guidelines.

7.4.Procedure :

7.4.1. Exemption from Review : Proposals that are exempted from review include those with

less than minimal risk where there are no linked identifiers. This could be seen in following situations

–i) Research conducted on data that is in the public domain for systematic reviews or meta analysis

ii) Observation of public behavior when information is recorded without linked identifiers and

disclosure would not cause harm the interests of the observed person

iii) Quality control and quality assurance audits in the institution

iv) Comparison among institutional techniques, curricula, classroom management methods

v) Consumer acceptance studies related to taste and food quality

vi) Case reports: FMIEC issues ethical clearance to case reports for presentation /publication on

receiving and verifying abstract of the case report and findings. Wherever possible patient identity

must be masked in the photographs used in case reports.The Member Secretary may ask for a copy of

the informed consent form signed by the patient whenever the identity of the patient (face) is not

masked.

Member secretary will go through (screening for documents to be submitted to IEC) the proposals

which are exempted from review, AND get the decision ratified in the full committee meeting

Exceptions : when research on educational tests, survey or interview procedures, or observation of

public behavior can identify the human participant directly or through identifiers, and the disclosure of

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information outside research could subject the participant to the risk of civil or criminal or financial

liability or psychosocial harm; when interviews involve direct approach or access to private papers

7.4.2. Expedited Review: The proposals that pose “no more than minimal risk” are considered for

expedited review. Expedited review will be conducted by Chairperson, member secretary and 1-2

designated members. The approval granted through expedited review will be ratified at the next full

committee meeting.

In following situations, expedited review will be done:

i) Minor deviations from originally approved protocols (originally approved through full

review by the IEC),

ii) Revised proposal previously approved through full review or continuing review of

approved proposals where there is no additional risk or activity is limited to data analysis

iii) Research involving non-identifiable specimen and human tissue from sources like blood

banks, tissue banks, left over clinical samples

iv) Research involving clinical documentation materials which are non-identifiable (data,

documents, records)

v) Modifications or amendment to approved protocol including administrative changes or

correction of typographical errors and change in investigator(s)

vi) Revised proposal previously approved through expedited review, full review or

continuing review of approved proposals

vii) Minor deviations from originally approved research causing no risk or minimal risk

viii) Progress/annual reports where there is no additional risk e.g. activity limited to data

analysis.

ix) When in emergency situations like serious outbreaks or disasters a full review is not

possible, prior written permission may be taken before use of test intervention. Such

research can only be approved for pilot study or preliminary work to study the safety and

efficacy of the intervention. Same participants should not be included in the clinical trial

that may be initiated based on the findings of the pilot study

7.4.3. Full Review : All research proposals presenting more than minimal risk that are not covered

under exempt or expedited review should be subjected to full committee review

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i) All studies involving interventions (clinical trials) involving trials on new drugs or combinations

of drugs

ii) Studies involving vulnerable population even if the risk is minimal

iii) Collection of blood samples by finger prick, heel prick, ear prick or venipuncture

iv) Collection of peritoneal fluid, pleural fluid, ascitic fluid and cerebrospinal fluid

v) Collection of biological specimen by research purposes by non invasive means – skin

appendages, dental procedures ,excreta and external secretions, stimulated or unstimulated saliva

collection, placenta removed at delivery ,amniotic fluid obtained at the time of rupture of the

membrane prior to or during labor, buccal scrapings, skin swab or mouth washings, sputum

vi) Use of medical devices for study population such as implants and physical sensors

vii) Use of electrocardiography, electroencephalography, echocardiography, thermography,

ultrasound and other imaging techniques, Doppler blood flow

viii) Moderate exercise, muscular strength testing, body composition

assessment, and flexibility testing where appropriate given the age,

body weight, and health of the individual

Viii) Research involving clinical materials (data, documents, records or

specimens) that will be collected solely for non-research (clinical) purposes

IX) Collection of data from voice, video, digital or image recordings made for research purposes

X) Research on individual or group characteristics or behavior not limited to research on perception,

cognition, motivation, identity, language, communication, cultural beliefs or practices, and social

behavior or research employing survey, interview, oral history, focus group, program evaluation,

human factors evaluation, or quality assurance methodologies

7.4.4. Aspects Considered During Review of Research Proposal:

1) Scientific design and conduct of the study : Use of valid scientific methods

2) Social Values : The research must have anticipated social value, and outcome should be

relevant to the health problems of the society

3) Benefit-Risk Assessment: The benefits must justify the risk inherent in the research. Risks may

be physical, psychological, economic, or social; Withdrawal criteria, and rescue medication or

procedures

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4) Selection of the Study Population and Recruitment of Research Participants : To ensure

voluntary recruitment, and fair selection of participants as per inclusion and exclusion criteria;

participant is given option to opt out without the routine care being affected; No individuals or

group of persons must bear the burdens of participation in research without any benefits except

in studies where healthy volunteers are involved; Vulnerable group is not recruited unless

proper justification is provided

5) Payment of participation and Compensation Procedures, without inducement but, reimbursing

for incurred cost and convenience

6) Protection of research participant’s privacy and confidentiality

7) Community considerations : due respect given to community and interests are protected ; no

stigma or discrimination ensues from the proposed research ; plans for communication of

results back to the community at the end of study; plan for dissemination of benefits of

research to the community

8) Qualifications of investigators and assess adequacy of study sites

9) Disclosure of potential conflicts of interest

10) Review of informed consent process

The review of proposals by members is documented in review forms , and in the minutes of meetings

of the FMIEC.

7.5. Annexures :

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Annexure -7.1. : Review form of FMIEC

Serial No of IEC Management Office (Protocol Number)

Proposal Title:

Principal Investigator:

Supporting/Funding Agency:

Project Status: New Revised

Review: Expedited Full Review

Date of Review:

1. Research Design

i. Scientifically sound enough to expose subjects to risk Yes No

ii. Relevant to contribute to further knowledge Yes No

iii Of national importance Yes No

2. Risks

a. Is there physical/social/psychological risk/discomfort? Yes No

b. Is the overall risk/benefit ratio Acceptable Unacceptable

3. Benefits

Direct: Reasonable Undue None

Indirect: Improvement in Any other

science/knowledge

4. Subject selection:

i Inclusion / exclusion criteria addressed? Yes No

ii Vulnerable subjects (woman, child, mentally challenged,

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seriously or terminally ill, foetus, economically or socially

backward and healthy volunteers) adequately protected ? Yes No

iii. Special group subjects (captives, students, nurses &

Dependant staff) adequately protected? Yes No

5. Privacy & Confidentiality maintained? Yes No

6. Patient Information Sheet: Adequate Inadequate

7. Consent form components addressed adequately? Yes No

8. Compensation, (if applicable) addressed adequately? Yes No

9. Is there a Conflict of Interest? Yes No

If yes, Acceptable Unacceptable

10. Budget: Appropriate Inappropriate

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11. Decision of review

Recommended Recommended with suggestions

Revision Rejected

Any other remarks/suggestions:

Reviewer’s name and Signature

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8. SOP-8 : Preparation of Agenda, Conduct of Meeting and

Minutes of Meetings

8.1. Purpose: The purpose of this SOP is to describe the preparation of agenda, distribution of

agenda, preparation for meeting, conducting the meeting and preparing minutes of meetings of

FMIEC

8.2. Scope: This SOP applies to administrative processes concerning the preparation of the

agenda and recording minutes of all IEC meetings.

8.3. Responsibility: The Member secretary is responsible for preparation of the agenda,

recording the minutes of meeting and circulation of the minutes to all members of FMIEC.

The Chairman conducts the meetings of FMIEC, and approves the minutes of meeting.

8.4. Procedure:

8.4.1. The meeting schedule: The FMIEC meeting is held once in two months on the fourth

Saturday. Frequency of the meeting is increased depending on the number of research

proposals for full review. The meeting day may be changed (other than fourth Saturday) if

there is a holiday for the institution or due to any other reasons because of which the

meeting is not possible on fourth Saturday.

8.4.2. Preparation of Agenda:

8.4.2.1. The research proposals received by the FMIEC are categorized for review as : exempted from

review, expedited review and full review. This is done by the Member Secretary who will do the initial

scrutiny of the research proposals. The review is done only for the proposals categorized for expedited

and full review. The expedited review will be done by the Chairperson, the Member Secretary and one

member of FMIEC. The full review will be done by all members of FMIEC.

8.4.2.2. The research proposals categorized for full review will be included in the agenda for

presentation during the meeting of FMIEC. The expedited reviews and exempted from review are

included for ratification by all members in the meeting.

8.4.2.3. The format of the agenda is enclosed in the annexure of this SOP. The agenda includes:

quorum of previous meeting (list of members present and absent), ratification of the minutes of

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previous meeting, presentation of the research proposals (full review) by the principal investigators,

ratification of the expedited reviews, presentation of the proposals categorized under “exempted from

review” by the Member Secretary, and any other issues as recommended by the members and

approved by the Chairperson. Other issues could be report of onsite monitoring, training needs,

accreditation of ethics committee, serious adverse events, review of protocol deviations/amendments,

continuing review of research studies, completion reports of research studies, revision of SOPs,

changes in the committee composition, report of subcommittees appointed by the Chairperson (if

any)and emergency concerns.

8.4.2.4. Only those research proposals and documents (informed consent documents, protocol

deviation/amendment notifications, revised submissions, progress reports, study completion reports)

received ten days before the scheduled meeting will be included in the agenda

8.4.2.5. The venue of meeting is ensured before sending the agenda to all members. The agenda will

mention the date, time and venue of the meeting.

8.4.2.6. A hard copy of the agenda, copies for research proposals for review and review forms are sent

to the members at least one week before the meeting. The secretariat is responsible for sending these

documents to all members without fail. The institution provides the transport facility for the same.

8.4.2.7. Even if there are no research proposals for review, the committee shall hold meeting at least

once in two months and discuss issues other than review of proposals.

8.4.2.8. If any member is unable to attend the meeting, he/she should inform the Chairperson (through

the Member Secretary) well in advance. (Preferably one week before the scheduled date of meeting).

The leave should be requested in a written leave letter In emergency situations if the member is not

able to inform in advance, e mail communication could be done. If the Chairperson is unable to attend

the meeting, he/she will inform the Member Secretary, and ask him to conduct the meeting with the

Vice Chairperson as the acting Chairperson for the meeting.

8.4.2.9. All regular members of FMIEC, independent consultants and principal investigators of

research proposals categorized for full review are required to attend the meeting. If any member is

unable to attend the meeting they need to inform the Chairperson or Member Secretary by any means

of communication. Independent consultants chosen for full review are intimated to attend the meeting

during the presentation of those research proposals which they have reviewed.

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8.4.2.10. The principal investigator should attend the meeting and present the proposal. Co

investigators are allowed to attend the meeting.

8.4.3. Conduct of Meeting:

8.4.3.1. The secretariat will help the Member Secretary in arrangements for the meeting

8.4.3.2. The FMIEC full board meeting will be held as per the schedule provided there is quorum as

per requirement

8.4.3.3. There should be the presence of at least 7 members out of the total 12 members of the

committee to constitute quorum.

8.4.3.4. Besides the Chairperson and the Member Secretary the quorum will consist of

One basic medical scientist

One social worker (or a social scientist, theologian, ethicist, philosopher, member

or representative of a non-governmental voluntary agency or a similar person),

A clinician,

A lay person from the community and

A legal expert

Presence of at least one subject expert member from the respective subject/area is

required (Homeopathy/Nursing/Speech and Hearing)

8.4.3.5. The signature of all members who attended the meeting will be taken on the attendance sheet

8.4.3.6. Guests or observers may be allowed in the meeting provided they have taken prior permission,

and signed confidentiality agreement

8.4.3.7. The Chairperson initiates the meeting after ensuring quorum. The Chairperson ensures the

quorum for every clinical trial presentation in the meeting.

8.4.3.8. The Chairperson will ask the members whether anyone has any conflict(s) of interest in the

projects to be discussed and if so, to declare the conflict. The Secretariat will obtain signatures on the

Conflict of Interest Agreement Form from members who declare a conflict prior to the start of the

meeting.

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8.4.3.9. If a conflict of interest has been declared by a member, the Chairperson will ask the member

concerned to leave the meeting room when the concerned issue is being discussed.

8.4.3.11. The Member Secretary will ask the members whether any points need to be discussed

regarding minutes of the previous meeting. If no points are raised, the minutes will be considered as

confirmed.

8.4.3.12. The Member Secretary will present the agenda of the day’s meeting for discussion.

8.4.3.13. The meeting shall generally proceed in the order organized in the agenda. However, the

Chairperson may allow adjustments in the order of issues to be discussed depending on the

situation.

8.4.3.14. The Principal Investigators are asked to present the research proposals as per the order of

proposals mentioned in the agenda. When one investigator is presenting the proposal, investigators of

other research proposals should not be present in the meeting room. However, co investigators of the

same research proposal (or guides in case of postgraduate dissertations) are allowed to be in the

meeting room. In case of informed absence of principal investigator, co investigator may be allowed to

make the presentation. However, if the members feel that co investigator is not familiar with the

protocol details, the principal investigator may be asked to attend the next meeting of IEC for the

presentation.

8.4.3.15. The members of FMIEC should not discuss on the decisions about the research proposals

when the investigators are inside the meeting room. The members should discuss only after the

investigator leaves the meeting room.

8.4.3.16. For other matters in the agenda (other than full review), the member secretary will present

the review findings (expedited review), list of proposals under exempted from review, protocol

deviations/amendments, etc..

8.4.3.17. Reports of any subcommittees will be presented in the meeting by the heads of respective

committees, as per the agenda

8.4.3.18. The proceedings of the meeting will be recorded by the Member Secretary . If the Member

Secretary has conflict of interest in any research proposal, the joint secretary will do this job.

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8.4.4. Decision Making:

8.4.4.1. The final decision on approval of a research proposal is by consensus... In the review forms,

the members need to tick one of the following:

1) Approved 2) Approved with suggestions

3) Resubmit with revisions 4) Rejected

In the “Suggestions” of section of the form, member can write down his/her suggestions of any and

points to be considered for revision of the research proposal. Reasons for rejecting the proposal also

should be mentioned in this section of review form.

Final decision is taken by consensus. The Chairperson ensures participation of all members in the

deliberations.

The decisions are based on risk assessment, scientific validity, and adherence to ethical principles for

the initial and periodic approvals.

8.4.4.2. The independent consultants called to the meeting will be present only for the presentation of

the concerned research proposal. He/she will give the opinion during the meeting and will leave the

meeting room. They don’t have any voting rights.

8.4.5. Minutes of the Meeting:

8.4.5.1. The minutes of the meeting are prepared by the member secretary on summarizing the

discussions held in the meeting and decision taken by consensus.

8.4.5.2. Following are the contents of the minutes of meeting:

1) Date, time and venue of the meeting

2) List of members who attended and who were absent for the meeting

3) List of guests /observers who attended the meeting

4) Name of the individual who served as chairman for the meeting

5) Ensuring of quorum by the chairman

6) Ratification of minutes of the previous meeting : to be mentioned

7) Research proposals for full review : summary of discussions and approval status

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8) Research proposals for expedited review : summary of discussions and approval

status

9) Research proposals exempted from review : list of the proposals

10) Discussion of protocol deviations/amendments , with actions taken

11) Discussion of onsite monitoring visits if any, with actions taken

12) Discussion of progress reports and final reports if any , with actions taken

8.4.5.3. The minutes are prepared within 3 working days of the meeting day

8.4.5.4. The minutes are sent to all members of the committee by e mail and their inputs are taken. The

members are required to give the inputs within two days. The Chairperson gives the final approval for

the minutes

8.4.5.5. The minutes are presented in the next meeting for ratification

8.4.6. Communication of the Decision to Investigators :

8.4.6.1. The decision of the IEC is communicated to the principal investigators. All communications

are done by the member secretary (or joint secretary in his absence). The decision is conveyed within

7 working days after the meeting of FMIEC

8.4.6.2. The communication of the decision will include:

1) Name and address of IEC

2) The date and place of the decision

3) The name and designation of the investigators

4) Protocol no. given by the IEC

5) Title of the research proposal reviewed

6) Version No., date, amendment no. of the protocol (for clinical trials)

7) List of documents reviewed (for clinical trials)-clear description of these documents along

with version No., and date.

8) List of IEC members who attended the meeting-clear description of their role and

affiliation

9) A clear statement of the decision reached

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10) Any advice by the IEC to the applicant including the schedule /plan of ongoing review by

the FMIEC

11) In case of conditional decision, any requirement by IEC, including suggestions for revision,

and the procedure for having the application re-reviewed

12) In case of rejection ,reasons for rejection will be clearly stated

13) Signature of the member secretary with date.

8.4.6.3. The investigator is asked to register the study in Clinical Trial Registry of India (CTRI) . Any

researcher who plans to conduct a trial involving human participants, of any intervention such as

drugs, surgical procedures, preventive measures, lifestyle modifications, devices, educational or

behavioral treatment, rehabilitation strategies as well as trials being conducted in the purview of the

department of AYUSH are expected to register the trial in the CTRI before enrollment of the first

participant.

8.4.7. Validity of Approval: Though the approval is granted for the entire duration of the study, the

validity of the approval letter is only up to one year. Depending on the risk involved, the progress of

the project will be monitored annually .The approval will be continued if progress is satisfactory. The

decision of IEC may be reversed if IEC receives information that may adversely affect the benefit/risk

assessment. For clinical trials, the progress report needs to be submitted once in six months, and there

will be onsite monitoring of the study progress. The investigators of all research proposals need to

submit study completion reports.

8.4.8 . Calling an Emergency Meeting of FMIEC:

8.4.8.1. The Member Secretary in consultation with the Chairperson may call for an emergency

meeting on following occasions:

1) Urgent issues which if not discussed and decided may have adverse impact on patient safety

2) Serious adverse events

3) Other issues deemed appropriate by the Chairperson or the Member Secretary

8.4.8.2. The Secretariat will endeavor to contact each and every IEC member and inform him/her

about the date, time and venue of the meeting as well as the reason for calling for the meeting.

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8.4.8.3. The documents for discussion in emergency will be sent by e mail. The notice of this meeting

may be sent at least one day in advance.

8.4.8.4. The rules of quorum will be applicable. If a quorum is not met, the meeting will be postponed

for 15 minutes. However, if there is no quorum at the end of 15 minutes; the meeting would be held

without a quorum provided at least four members (at least one scientific and one non-scientific

member) are present, given the urgency of the matter under consideration. The IEC members will act

according to the relevant IEC SOPs (Expedited Review, SAE review, Review of Protocol

deviations/violations etc.) for discussion and decision-making on the matter under consideration. The

minutes of the emergency meeting would be prepared, distributed, approved and filed as described in

the steps above for regular full board meeting.

8.4.8.5. Calling additional meetings of FMIEC: The Member Secretary in consultation with the

Chairperson can call for additional meetings depending on the requirement. These are the meetings

other than emergency meetings. Additional meetings are called if the number of research proposals for

full review are more than 15, and if the FMIEC is not able to include discussion of issues such as

progress reports, onsite monitoring, study completion reports, etc..in the monthly meeting due to

constraint of time . The procedure for agenda, conduct and minutes is the same as that followed for the

usual monthly meetings.

8.5. Annexures :

Annexure-8.1 : Agenda format

Meeting No. :

Date and Time of Meeting:

Venue of Meeting:

I. Ratification of the minutes of previous meeting

II. List of Research proposals for full review :

III. List of proposals for expedited reviews

IV. List of proposals exempted from review

V. Protocol deviations/amendments

VI. Study completion /progress reports

VII. Reports of onsite monitoring

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VIII. Reports of subcommittees

IX. Any other issues

-----------------------------------------------------------------------------------

Annexure-8.2: Format for Minutes of meeting:

Meeting No:

Date and Time :

Venue :

I. Members present and absent : list with designations

II. Guests or observers present : list with designations

III. Name of the individual who served as Chairperson

IV. Ensuring of quorum by the Chairperson

V. Ratification of the minutes of the previous meeting

VI. Research proposals for full review :

The proceedings are recorded as follows ---

Protocol No. Title of the Study Name of the

Principal

Investigator

Remarks by the members

(opinion/suggestion/other

remarks)

Approval status

VII. Research Proposals for expedited review :


Principal

Investigator

Names of the members

who did the expedited

review, with remarks

Approval status

VIII. Research Proposals exempted from review :


Principal

Investigator

New/Revised

Submission

Approval status

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IX. Discussion of Protocol Deviations/amendments and actions taken :


Principal

Investigator

Protocol

deviation/amendment

Action taken

X. Discussion of reports of onsite monitoring


Principal

Investigator

Deficiencies observed

during onsite

monitoring

Action taken , with

remarks of

monitoring team

members and Final

decision

XI. Discussion of reports of subcommittees

Team

members

Purpose of the

subcommittee

Brief

description of

the work done

by the

subcommittee

Remarks of the

Chairman

XII. Discussion of Progress Reports and Study Completion Reports :


Principal

Investigator

Remarks on the report

submitted

Action taken as per

the requirement

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Annexure-8.3. : Decision Letter Format (For clinical trials)

FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE(FMIEC) ,

Father Muller Road, Kankanady, Mangalore-575002

Ref. No. -------------------------------- Date :

Dear Dr./Ms/Mr. ---------------------------------------------------(Principal Investigator-name and address)

Your research proposal was reviewed discussed in the ethics committee meeting held on ------------------

and the decision is as follows:

Protocol title: “---------------------------------------”

Protocol No:


Co Investigators :

Version No., date, amendment no. of the protocol :

List of documents reviewed (for clinical trials)-clear description of these documents along with

version No., and date.

Name & Address of Institution :

New review: Exempt review/ Expedited review/ Full review

Review of Revised Submission:

Date of review:

Date and type of previous review, if revised application:

Decision of the Ethics Committee:

> Approved

> Approved with suggestions

> Revision/ Resubmission

> Rejected

Suggestions /Reasons/Remarks:

Recommended for a period of :

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The approval is valid for one year. After one year, you are instructed to submit an application

requesting for continuation of ethical clearance for another one year (if required).

You are instructed to register your trial in clinical registry (CTRI) before starting the study, and

submit the necessary evidence to the IEC

Your research work will be continuously reviewed by ethics committee during the study

period.

The investigator/s is/are instructed to carry out the research study as per the protocol approved

by the ethics committee. Any protocol deviations/violations should be brought to the notice of

ethics committee.

The FMIEC will be monitoring the conduct of the protocol by on-site monitoring, review of

study-related documents and review of progress reports.

You are instructed to submit progress report of the research project once in every six months

You should comply with the regulations and guidelines on biomedical research on human

participants, and follow good clinical practice

Ethics committee has the right to withdraw the approval if found necessary due to protocol

violations, non-compliance to regulations and guidelines

For any modifications/changes in protocol, investigators and study site you need to submit the

proposal to ethics committee and get the approval.

You should report any serious adverse events in your site or any other site of this clinical trial

to the ethics committee

You need to submit the final report and summary at the termination of the study.

Following members of the IEC were present and involved in decision making.

Name Affiliations Role in the Committee

Name and Signature of Member Secretary

============================================================

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Annexure -8.4. : Decision Letter Format (For studies other than clinical trials)

FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE (FMIEC),


Ref. No. -------------------------------- Date :


Your research proposal was discussed in the ethics committee meeting held on ------------------and the

decision is as follows:

Protocol title: “”

Protocol No:


Co Investigators :




Date of review:

Date of previous review, if revised application: Nil


> Approved

> Approved with suggestions

> Revision/ Resubmission

> Rejected


Recommended for a period of : 1 Year

The approval is valid for one year. After one year, you are instructed to submit an application

requesting for continuation of ethical clearance for another one year (if required).

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period.

You are instructed to submit progress report of the research project annually






Following members of the IEC were present and were involved in decision making.



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9. SOP-9: Continuing Review of Protocols

9.1. Purpose : The purpose of this SOP is to describe how continuing review of previously approved

protocols should be managed by the Institutional Ethics Committee (IEC). The purpose of the

continuing review is to periodically monitor the progress of the study, to ensure continuous protection

of the rights and welfare of research participants.

9.2. Scope : This SOP applies to conducting any continuing review of already approved study

protocols at pre-specified intervals. All the projects approved by the IEC will be reviewed at least once

a year. Depending upon the degree of risk to the participants, the nature of the studies, the

vulnerability of the study participants and duration of the study, the IEC may choose to review or

monitor the protocols more frequently.

9.3. Responsibility : It is the responsibility of the IEC Secretariat to remind the PIs and Member

Secretary regarding continued review of protocols at the correct interval. All the approved protocols

will be reviewed annually. It is the responsibility of the Member Secretary to ensure a decision

regarding whether the project needs to be reviewed more frequently is taken during the IEC meeting in

which the project is finally approved. This must be recorded in the minutes. A fresh decision to

increase review may be taken if required based on the SAE reports, monitoring reports, or safety

concerns. This is responsibility of the SAE subcommittee and Member Secretary. The IEC is

responsible for reviewing the progress made in the protocol (number of patients recruited, dropped

out, reasons for drop-out), the occurrence of unexpected events or problems, and compliance of the

investigator regarding IEC communication

9.4. Procedures:

9.4.1. The continuing review of protocols is done by FMIEC once in six months for the clinical trials,

and once in a year for the academic studies.

9.4.2. For Clinical Trials: The Member Secretary with the help of the secretariat decides the dates of

continuing review based on the date of approval for the protocol. If the principal investigators do not

send the progress report of the protocols on their own, a reminder notice is sent by the Member

Secretary 15 days before the due date. The IEC secretariat receives the documents for continuing

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review. The Member Secretary verifies the documents submitted along with the application for

continuing review.

9.4.3. For Academic Studies: An annual report is sought from the principal investigators. The reports

are reviewed by the members of FMIEC

9.4.4. Review of Submitted Documents : The documents submitted for continuing review will be

categorized for reviews as : exempted from review, expedited review and full review . The IEC

Chairperson/ Member Secretary/ Member/s will use the Continuing Review Application Form to guide

the review and deliberation process. The Secretariat will send the Continuing Review Application

Form to the designated IEC members.

9.4.5. Decision Making : The investigators of protocols listed for full review will be asked to make a

presentation in the full board meeting of IEC .Decision on the continuation of ethical approval will be

taken by consensus. Following decisions could be taken :

1. Noted - The IEC approves the continuation of the project without any modifications.

2. Modifications recommended: The study protocols that have been suggested modifications by the

IEC may not proceed until the conditions set by the IEC in the decision have been met. The

amendments and the required documents should be amended and submitted to the IEC within one

month for re-review.

3. The project cannot be continued: The reasons for discontinuation of the project should be mentioned

in the letter notifying the decision to the Principal Investigator.

9.4.8. Action to be Taken for Failure of Submission for Continuing Review :

If the PI fails to submit documents for continuing review within the stipulated date, the Member

Secretary sends a reminder notice asking the PI to submit the documents within 7 days. Further, non-

response or failure to submit documents will be discussed in the full board meeting of the IEC. Action

could be one of the following : one more reminder and asking the PI to give an explanation for the

failure to submit documents / withdrawing the ethical approval granted and asking the PI not to

continue the study/ any other action which is deemed appropriate. The head of the institution will be

informed of the decision of the IEC.

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9.5. Annexures :

Annexure-9.1. : Continuing Review Application Form (Clinical Trials) :

Name of Principal Investigator : Department :

IEC Protocol No. Title of the Study :

Date of Approval from IEC :

Summary of Protocol Participants :

No. of participants screened _____

No. of participants approved by IEC

No. of recruited participants _____

No. of ongoing participants _____

No. of completed participants ____

No. of participants who refused to consent : -------

------

If any participants have withdrawn from the study

?

Yes : No :

If yes, give the number.

Attach a separate sheet mentioning the reasons for

withdrawal of each participant

Protocol Amendments :

Have there been any amendments to the protocol

/ICD/ any other documents related to the protocol

?

Yes : No :

If yes, whether the amendments have been

brought to the notice of the IEC and approved ? -

--Yes : No :

If the amendments are not brought to the notice of

IEC and not approved , mention those

amendments. (Attach a separate sheet mentioning

the amendments)

Protocol Versions Currently Used :

What is the version No . of the ICD used at

present ? --------------------------------

What is the Version No. of the Protocol used at

present ? -------------------------------

Has any information appeared in the literature, or

evolved from this or similar research that might

affect the IEC/IEC’s evaluation of the risk/benefit

analysis of participants involved in this protocol?

Yes: No :

If Yes (attach separate sheet if needed)

Whether reports of SAEs so far have been

reviewed by the IEC- _______________

Whether reports of SAEs at other sites have been

submitted to the IEC-__________

Have any participating investigators been added

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or withdrawn since last review? Yes No

If Yes (Identify all changes in the attached

narrative)

Is report of interim data analysis available?

Yes (submit as an attachment)

No

Is report of the data safety and monitoring board

available?

Yes (submit as an attachment)

No

Have any investigators developed equity or

consultative relationship with a source related to

this protocol which might be considered a conflict

of interest?

Yes (Append a statement of disclosure)

No

Signature of the Principal Investigator with Date :

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Annexure-9.2. : Continuing Review Form (for academic studies)

Name of the Principal Investigator : Designation , Department and Institution :

Progress for the Period of :

Sl.

No.

Name of the

Principal

Investigator

Title

of the

Study

Ethics

Committee

Approval

Date

No. Study

participants

Recruited

Study

Completed/On

going

(mention)

If the project was

sponsored/funded,

mention the

funding agency

and amount

funded

If the project

was self-

funded,

mention the

amount self-

funded

I hereby declare that :

1) All the above studies are conducted as per the protocols approved by the FMIEC

2) Any Protocol changes/deviations have been informed to the FMIEC

3) The applicable ethical guidelines have been followed.

Signature of the Principal Investigator Date.

Signature of the Head of the Department with Date :

Signature of the Head of the Institution with Date :

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Annexure-9.3. : Continuing Review Form

Name of Principal Investigator : Department :

IEC Protocol No. Title of the Study :

Date of Approval from IEC :

Review to be done by :

1. Expedited Review

Names of Designated IEC Members:

2. Full Board Review

Decision After Review :

1) Approved and the project can be continued without any modifications

2) Modifications recommended - requiring protocol resubmission (State the modifications

required)

3) Protocol should be discontinued (State the Reasons):

Name and Signature of the Reviewer :

Date

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Annexure 9.4. : Decision Letter

FATHER MULLER INSTITUTIONAL ETHICS COMMITTEE (FMIEC) ,


Ref. No. -------------------------------- Date :


Your research proposal was reviewed discussed in the ethics committee meeting held on ------------------

and the decision is as follows:

Protocol title: “---------------------------------------”

Protocol No:


Co Investigators :




Date of review:

Date and type of previous review, if revised application:


> Approved ; the project can be continued

> Modifications Recommended

> The Study should be discontinued


Recommended for a period of :


period.

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You are instructed to submit progress report of the research project once in every six months

You should comply with the regulations and guidelines on biomedical research on human

participants, and follow good clinical practice





You should report any serious adverse events in your site or any other site of this clinical trial

to the ethics committee


Following members of the IEC were present and involved in decision making.



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10. Sop-10: Review of Resubmitted and Amended Protocols and

Protocol-Related Documents

10.1. Purpose: The purpose of this SOP is to describe the review and decision making for

resubmissions of research proposals, amended protocols, protocol-related documents submitted

to FMIEC.

10.2. Scope : This SOP applies to the processes involved in review and decision making for

resubmissions and amendments of protocols submitted to FMIEC

10.3. Responsibility: The secretariat of FMIEC is responsible for receiving the resubmissions,

protocol amendments and other protocol-related documents. The Member Secretary is

responsible for verifying the completeness of the documents submitted, and deciding the type

of review to be done. The Chairperson is responsible for the final decision on the submitted

documents.

10.4. Procedure:

10.4.1. Review of Resubmitted Protocols:

10.4.1.1. The research proposals are resubmitted if the FMIEC had suggested the investigator to do so

(As recorded in the minutes of the meetings of FMIEC). The investigators submit the revised protocols

to the secretariat of FMIEC

10.4.1.2. The member secretary will refer to the minutes of meeting of FMIEC and decision letters,

and verify the completeness of the revisions done by the investigator.

10.4.1.3. The member secretary will categorize the resubmission for “exempted from review”,

“expedited review” or “full review”.

10.4.1.4. Exempted from Review: If the nature of revision is minor and involves only the changes

such as change in title, name of principal investigator, inclusion of co investigators, corrections of

spelling and grammar, then the member secretary himself/herself will verify the documents without

sending for review by other members of FMIEC. The Member Secretary will confirm justification for

the changes . However, he/she will put it in the agenda of next meeting of FMIEC, and get the

decision ratified by full committee, with final approval by the Chairperson.

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10.4.1.5. Expedited Review: If the original decision of the FMIEC meeting was “Resubmit with

revisions” and involves minor changes in study procedure, and submission of informed consent

documents, budget and proforma of data collection, the resubmission is listed for expedited review.

However, if the study protocol involves more than minimal risk, it is listed for full review. The

expedited review will be done by the Chairperson, the member secretary and one member of FMIEC

10.4.1.6. Full Review: If the resubmissions involve major changes in study objectives, procedures,

and if the protocols involve more than minimal risk, the member secretary lists them for full review.

The full reviews will come up for discussion in the full committee meeting of FMIEC.

10.4.2. Decision on Resubmitted Protocols: The decision of FMIEC will be communicated by the

same procedure which is followed for “new submission”.

10.4.3. Review of Protocol Amendments:

10.4.3.1. The documents for amendments (hard and soft copy) forwarded by the PI will be received by

the Secretariat and verified. The Secretariat will confirm the request for review of amended

Protocol/Protocol related documents from the Principal Investigator on previously approved

Protocol/Protocol related documents. The secretariat will confirm that the amended version of the

protocol and related documents are attached with the application and that the changes or modifications

in the protocol are underlined or highlighted in the amended version.

10.4.3.2. The Secretariat will inform the Member Secretary of receipt of the protocol amendment

10.4.3.3. The Member Secretary will decide on the type of review required for the protocol

amendments submitted by the investigator.

10.4.3.4.The protocol amendments will be categorized for full review if any of the following criteria

are met :

The Protocol amendment changes the risk-benefit assessment such as a change in study design,

additional treatments or the deletion of treatments, changes in inclusion/exclusion criteria, change in

method of dosage formulation, such as, oral changed to intravenous, a significant change in the

number of research participants (if the decrease/increase in the number of research participants alters

the fundamental characteristics of the study, it is significant)

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10.4.3.5.The protocol amendments will be categorized for expedited review if they do not fit into the

criteria for full review. The expedited review will be done by the Chairperson, the member

secretary and one member.

10.4.3.6.The review will be done using the protocol amendment review form.

10.4.3.7.Full reviews are discussed in the meeting of FMIEC. Expedited reviews are ratified in the

meeting.

10.4.4. Decision on Protocol Amendments :

1) Approved

2) Approved with suggestions

3) Resubmit with revisions

4) Not approve the amendment request, stating the reason – but allow the study to

continue as previously approved.

5) Suspend the study until further information is obtained

The procedure for preparation of minutes of meeting, approval for minutes and communication of

decision are same as that followed for “new submissions”.

10.5. Anenxure-10.1.: Resubmission Form For Investigators (to be used for resubmission of

revised protocols /submission of additional documents

1. FMIEC - Protocol No.: 2.Date of Ethical Clearance (if approved already)

3. Title : 4. Name of Principal Investigator :

5. Purpose of this submission :

6. Submission details :

Sl. No. Revision/Corrections Suggested by IEC Corrections done :

Yes/ No

What correction is

done ? Mention.

7 .List of documents submitted during resubmission:

1)

2)

3)

Date :

Signature of Principal Investigator :

Department and Designation :

Note : Please submit this form along with a covering letter to member secretary, Father Muller

Medical College Institutional Ethics Committee, and one soft+one hard copy of the revised proposal,

and other documents.

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Annexure-10.2. : Checklist to be used by FMIEC Member Secretary for Resubmitted

/Revised Protocols

Sl. No. Corrections/Revisions

suggested by Ethics

Committee

Revision Done : Yes/No Remarks on Adequacy

of Revisions

List of Documents submitted by Investigator and seen by FMIEC :

1)

2)


-----------------------------------------------------------------------------------------------------------

Annexure-10.3 : Resubmission Review :

Title : Protocol No. :

Date of previous review by FMIEC : Nature of Review : Full /Expedited

Number of Review : 2nd

/ 3rd

/4th

Decision of FMIEC in the Previous Review :

Opinion of Reviewer :

Tick the

appropriate :

Recommended for Approval

Approved with suggestions Mention the suggestions :

Resubmission not approved Mention the reasons for not

approving :

Further discussions required in the full

committee meeting before giving decision

(applicable for expedited reviews)

Name and Signature of the Reviewer : Date :

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------------------------------------------------------------------------------------------------------------

Annexure-10.4 ; Protocol Amendment Request Form

FMIEC Protocol Number :

Title :

Name of Principal Investigator : Date of Approval from FMIEC :

Number of Amendments : Nature of Amendments :

Briefly state the amendments done :

Reasons for Amendments :

Impact of your amendment on your present study at this site: (modifications in the ICD, re-consent of

research participants, untoward effects likely to occur because of the amendment or any other ) :

Have the changes modifications in the amended versions been highlighted/ underlined? :

Yes/No

Signature of Principal Investigator : Date :

-------------------------------------------------------------------------------------------

Annexure-10.5 : Protocol Amendment Review Form

FMIEC Protocol Number :

Title :

Name of Principal Investigator : Date of Approval from FMIEC :

Number of Amendments : Nature of Review : Expedited/ Full

Decision : (Tick the appropriate decision )

Approved

Approved with Suggestions

Not Approved but, could continue with the approved version of the protocol

Not Approved and Study to be Suspended until Further Information is Obtained

------------------------------------------------------------------------------------------------------------------

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Annexure-10.6 : Decision on Protocol Amendments

To : XXXXX (PI) : Department :

Ref: - IEC No.

Project title -----------------------

Dear Dr._________

We have received from you the following document(s).

1. 2.

At the Institutional Review Board meeting held on _________ the above mentioned documents

were reviewed. After consideration, the IEC has decided to :

Approve: (a) The above mentioned study-related documents

OR (b) The following documents:

1. 2.

The members who attended this meeting held on __________ at which the above mentioned

document was discussed are listed below.

It is to be noted that neither you nor any of your proposed study team members were present

during the decision-making procedures of the Institutional Review Board. OR After reviewing

the documents, the IEC has decided to approve the aforementioned study-related documents.

Yours truly,

_________________________________________

Signature of FMIEC Member Secretary with Date

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11. SOP-11 : Procedure for On-Site Monitoring of Protocols

11.1. Purpose : The purpose of this SOP is to describe the process of on-site monitoring of protocols

approved by FMIEC.

11.2. Scope : This SOP is applicable to the regulatory trials and intervention studies for which on-site

monitoring is undertaken by FMIEC.

11.3. Responsibility : The Chairperson and the Member Secretary of FMIEC are responsible for

conducting the on-site monitoring. The members of FMIEC are responsible to participate in the

monitoring process as and when they are assigned.

11.4. Procedure :

11.4.1. Time and Site of Visit : The decision letter issued to the PI during approval of the protocol

will have the statement on on-site monitoring of the study.

The routine monitoring of the protocols will be done at least once in a year.

Three minimum visits are done for a study from initiation till completion.

Visit -1 : During recruitment of the first subject (The team of members from FMIEC to visit the site

and witness the process of informed consent and recruitment of the subject); Verification of the written

record

Visit-2 : During the progress of the study.

After the PI submits the first progress report (six months after initiation of the study) ; Verification of

written records

Visit-3 : At the completion. Once the final report is submitted by the PI

“For-cause monitoring” will be performed at sites for reasons identified by any member of the IEC,

after approval by the Chairperson. The reasons for identifying a particular site for “for-cause

monitoring” could include any one or more of the following:

a. High number of protocol violations,

b. Large number of studies carried out at the study site or by the investigator,

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c. Large number of Serious Adverse Events (SAE) reports

d. Scientific misconduct

e. High recruitment rate,

f. Large number of Protocol deviations,

g. Complaints received from subjects, head of the institution or any other person, ( anonymous

complaints received shall be entertained if they affect subject safety )

h. Frequent failure to submit the required documents

i. Any other cause as decided by IEC.( any scientific misconduct by the ethics committee during

periodic monitoring)

11.4.2. Before the Visit:

Irrespective of the cause for conducting monitoring the following procedure will be followed :

1. The Chairperson will identify and select one or more IEC members (henceforth referred to as

monitors) to conduct monitoring of a site. The team will have the Chairperson, the Member Secretary,

One clinician, basic medical scientist, lay person/philosopher/social scientist and legal expert.

2. An appointment letter will be issued by the Chairperson

3. The Member Secretary will consult the team members and the principal investigator to decide the

date of monitoring visit.

3. The agenda of monitoring will be decided by the Member Secretary and the Chairperson

4. The final date will be communicated to the PI (with a request to be available) and monitors.

6. The monitor will receive from secretariat and review the relevant project documents and make

appropriate notes.

7. The Secretariat will provide Monitors with relevant reference material / documents related to the

project

8. Monitors will carry with them Site Monitoring Visit Report Forms collected from the Secretariat

11.4.3. During the Visit:

The Monitoring team will follow the check list and:

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1. Check the log of delegation of responsibilities of study team,

2. Check if the site is using latest IEC approved current versions of the protocol, informed consent

documents, case record forms, diaries, advertisements, etc.

3. Observe the informed consent process, if possible,

4. Review randomly selected participants files to ensure that participants are signing the correct

informed consent,

5. Check investigational product accountability is adequately controlled and documented throughout

the product flow at the study site (arrival, dispensing, use, return from the subject and

return/destruction after the study),

6. Check for storage times, conditions and expiry dates to be acceptable and sufficient supplies

available, wherever applicable,

7. Verify that the investigator follows the approved protocol and all approved amendment(s), if any,

8. Ensure that the investigator and the investigator's trial staff are adequately informed about the trial,

9. verify that the investigator and the investigator's trial staff are performing the specified study

functions, in accordance with the approved protocol and any other written agreement between the

sponsor and the investigator/institution, and have not delegated these functions to unauthorized

individuals,

10. Verify that the investigator is enrolling only eligible subjects,

12. Determine whether all SAEs are appropriately reported within the time as per the applicable

regulatory requirement(s). Case record forms would be checked to review the safety data i.e. Adverse

Events (AEs) and SAEs for the volume or severity of adverse events,

13. Review the project files of the study to ensure that documentation is filed appropriately,

14. Review the source documents for their completeness,

15. Collect views of the study participants, if possible.

The team will fill the site monitoring visit form and record the observations.

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11.4.4. After the Visit:

The Member-Secretary will present the monitoring report at the next full board IEC meeting. The IEC

will discuss the findings of the monitoring process and take appropriate specific action by voting or

combination of actions, some of which are listed below:

a. Continuation of the project with or without changes,

b. Restrictions on enrollment,

c. Recommendations for additional training,

d. Recruiting additional members in the study team,

e. Revising/ providing qualifications/ experience criteria for members of the study team, termination

of the study, o Suspension of the study, etc.

f. If the findings have serious implications on patient safety, the decision will be taken at the earliest

(emergency meeting within one working day after the visit).

f. The Secretariat will convey the decision to the Principal Investigator in writing within 7 working

days of the meeting. Opportunities for improvement in any area will be emphasized in the report

7. The Secretariat will place the copy of the report in the protocol file.

11.5. Annexure

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Annexure-11.1. Site Monitoring Visit Report /Checklist

I. General Details :

FMIEC Protocol No. : Study Title :

Date of Approval of the Protocol by FMIEC : Name and Address of Principal Investigator :

Date of Visit of FMIEC team :

Names of Monitoring Team Members :

Date of initiation of the Study :

Duration of the Study :

Type of Study : Regulatory Trial /Funded

Intervention Study/Any Other

Reason for Monitoring (Tick whichever is

appropriate)

Routine :

For Cause : State Reasons

Protocol Violations/Deviations :

SAE :

Recruitment Rate :

Others :

Stage of Visit :

Commencement of the Trial

Trial Progress

Completion of Trial :

Date of last monitoring , if any : Trial Status :

1. Ongoing

2. Completed

3. Recruitment Completed

4. Follow-up, extension study

5. Suspended

6. Terminated

In case of suspended/terminated, give

reasons.

II. Legal and Administrative Aspects :

Yes No NA Remarks

Permission of Regulatory

authority (as applicable)

If the Subsequent protocol

amendments have been

approved by the Regulatory

authority ? (as applicable)

Site Facilities are adequate

III. Conduct of Trial :

Organization and Personnel :

Recruitment Status :

Total number of subjects

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To be recruited :

Screened :

Screen Failures :

Enrolled :

Withdrawn :

Reasons for withdrawal :

Discontinued :

Reason for Discontinuing :

Completed :

Active :

Yes No NA Remarks

The investigators are appropriately qualified and

trained to conduct the trial.

Check the Medical Council Registration

certificate and CV of the investigators.

Check for GCP training certificates of

investigators.

Determine whether authority for conducting

various clinical trial activities were delegated

properly by Investigator to competent personnel

(obtain the list of personnel and duty delegation

log).

Check whether the person whom the authority is

delegated is adequately qualified and trained for

the activity/activities assigned.

Obtain the list of all clinical trials performed by

Investigator (Preferably for last three years)

Ensure that the Investigator is involved in

conduct of not more than three clinical trials at a

time.

Recruitment of Subjects : Screening and Informed Consent

Yes No NA Remarks

Informed Consent Documents : Current version is

Approved by the FMIEC ?

Check and review the informed consent for the

screening of the subjects

Check site screening log & enrolment log and

obtain authenticated copy.

Check whether the subjects are meeting the

inclusion/exclusion criteria as per the approved

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protocol w.r.t review of source documents &/or

CRF.

Clinical Examination by Investigator ( Check

patient file/Source documents)

Verify ,Clinical Laboratory Evaluation ( Check

Blood Cell Counts, Biochemical test, Urine

analysis etc.as required by protocol)

Verify X-Ray, MRI, ECG, USG or any other

technique required to ascertain the

inclusion/exclusion criteria.

Verify, Whether all conditions of Clinical trial

NOC are followed or not?

Whether IC has been obtained from each subject

prior to participation of the subject in the study.

Whether signature/thumb impression of the

subjects/legal representative have been affixed

with date.

Whether in case of illiterate subjects or illiterate

representative of a subject, there are signature and

details of an impartial witness.

Have witness/ signature being personally dated.( If

applicable).

Have patient/witness signature been personally

dated?

Has the dated signature of the designated person

for administering informed consent (IC) been

affixed?

Is the designated person for administering IC

medically qualified?

If IC has been administered by a designated person

who is not medically qualified, is there evidence

that subject's queries of a medical nature were

answered by a medically qualified person or the

investigator?

Is the completed ICF signed and dated by the

investigator?

Check weather re-consenting is done for changes

in ICF, if any.

Whether appropriate vernacular consent has been

taken from all patients?

Whether audiovisual recording of informed

consent is done for vulnerable subjects ?

Is audio-visual recording conducted in a room

conducive to recording of disturbance free audio

and video of the consent process?

Check whether the video recording is free from

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disturbance to ensure that the image is

recognizable and the audio is clearly audible.

The consent is taken in language the

participant/LAR understands best and is literate in.

Introduction of each person (person conducting the

informed consent discussion participant/ legally

acceptable representative (LAR) / impartial

witness) involved during informed consent process

and information about necessity for audiovisual

recording

Information to the participant/ LAR and impartial

witness (as applicable) that the process of taking

the consent is being recorded for the purpose of

documentation as required by the government

rules.


witness (as applicable) that the confidentiality of

information and privacy of participants is assured.


witness (as applicable) that the recording may be

shown to government agencies or members from

the IEC.

Explanation or narration by the person conducting

the informed consent discussion.

Questions asked by the potential participant/LAR

are answered satisfactorily.

Allowing ample time and opportunity to

read/understand the information in the informed

consent document or discuss the same with family

members.

Reading out by the participant/LAR (or having

read out by impartial witness) the statements

mentioned in Informed Consent and stating

whether participant agrees or not for each

statement.

Documentation of signatures of all those involved

in the Informed Consent Process.

Clarity and completeness of AV recording

Storage of recording in password protected laptop/

desktop computer and/ or hard drive and labelled

CD with access allowed only to the principal

investigator and designated members of the study

team.

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IV. Source Documentation and Case Record Form :

Yes No NA Remarks

Verify condition, completeness, legibility,

accessibility of the investigators source data file. (

source data includes study subject’s files,

recording from automated instruments, tracings,

X-ray and other films, laboratory notes,

photograph negatives, magnetic media, hospital

records, clinical and office charts, subject’s

diaries, evaluation checklists and pharmacy

dispensing records)

Whether subject received the test drug with respect

to dose and frequency according to the protocol;

Does medical record mentions subject ID/ name

/hospital registration number / and indication that

subjects are participating in a clinical trial

Compare the source document with CRF and

determine whether source data have been correctly

transcribed in CRF;

Verify the drop-outs and reason for drop-out of

subject is appropriately recorded

Whether the withdrawal of subject from the study

is recorded and appropriately justified in

accordance with approved protocol.

Verify whether Standard Operating Procedure of

handling of Serious Adverse Event occurred in

clinical trial is available.

Verify whether all SAE’s have been reported to

the sponsor and IEC

No. of deaths reported:

Any other non-death study related injury :

Compensation paid for study related injury or

death

Verify whether adequate medical care have been

given to the subject especially in the event of inter

current illness, adverse events including abnormal

lab parameters;

Any Protocol Deviations/Violations ?

Are the Protocol Deviations/Violations Reported

to FMIEC ?

V. Investigational Product-related Details :

Yes No NA Remarks

Review individual subject record to verify the

correct dose administration with respect to dose,

frequency, route of administration

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Determine whether unqualified /unauthorised

persons administered/dispensed the test drug

Determine whether adequate record of quantity of

test drug received , dispensed is maintained.(

Check the test drug reconciliation and verify the

leftover drug or balance on the day of inspection).

Determine whether storage condition/monitoring

method are as per protocol/recommendation;

Whether trial medication are maintained in

secured manner with controlled access

Have un-used trial medications been returned to

the sponsor or disposed of according to protocol?

Are the drugs dispensing records being maintained

properly?

Whether the records for reconciliation of all IP’s

are maintained?

Are electronic or hand-written temperature logs

available for the storage area of the investigational

products?

Verify that investigation product is appropriately

labelled. (For clinical trial use only).

VI. Record Keeping and Data Handling :

Yes No NA Remarks

Is adequate space available for document retention?

Determine whether documents are maintained

properly and for the period as specified

Whether necessary measures have been taken to

prevent accidental or premature destruction

Whether the archival access controlled or restricted

to authorized personnel.

Whether SOP available to document all steps in data

management in order to allow step by step

retrospective assessment of data quality and study

performance.

Whether corrections in documents carry the date and

initials of Investigators and authorized person.

Name and Signatures of all Monitoring Team Members, with Date :

Decision of IEC, at Full Board Meeting:

Signature of Chairperson and Member Secretary, with Date:

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12. SOP-12 : Review of Protocol Deviations and Violations

12.1. Purpose : The purpose of this SOP is to describe action(s) to be taken by the FMIEC when

investigator(s)/trial site(s) fail(s) to:

follow the procedures written in the approved protocol,

comply with national and/or international guidelines, statutory provisions, institutional

guidelines or rules or procedures mandated by the FMIEC for the conduct of human research,

respond to the FMIEC requests regarding statutory, ethical, scientific or administrative matters,

Willfully change the study technique/study resources which would compromise patient safety

and/or have monetary burden on the study participant.

12.2. Scope

This SOP applies to all FMIEC approved research protocols involving human research

participants.

12.3. Responsibilities :

a. Principal investigator :- to submit any deviation/violation in the study protocol in the format,

(annexure ) as mentioned in the SOP. Any other reporting format of deviation/violation

submitted will not be accepted.

b. Member secretary :- to present the report in the agenda of the meeting for decision

c. FMIEC members :- to review such reports

d. Chairperson : Take a final decision on the protocol with consensus of members

12.4.Procedures :

12.4.1. Glossary :

a) Protocol Deviation and Protocol Violation:

Protocol Deviation- A protocol deviation is any change, divergence, or departure from the study

design or procedures of a research protocol that is under the investigator’s control and that has not

been approved by the IEC. Upon discovery, the Principal Investigator is responsible for reporting

protocol deviations to the IEC using the standard reporting form.

Protocol Violation- A protocol violation is a deviation from the IEC approved protocol that may

affect the subject's rights, safety, or wellbeing and/or the completeness, accuracy and reliability of

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the study data. If the deviation meets any of the following criteria, it is considered a protocol

violation. Example list is not exhaustive.

I. The deviation has harmed or posed a significant or substantive risk of harm to the research

subject. For example

• A research subject received the wrong treatment or incorrect dose.

• A research subject met withdrawal criteria during the study but was not withdrawn.

• A research subject received an excluded concomitant medication.

II. The deviation compromises the scientific integrity of the data collected for the study.

For example

• A research subject was enrolled but does not meet the protocol's eligibility criteria.

• Failure to treat research subjects per protocol procedures that specifically relate to primary

efficacy outcomes. (if it involves patient safety it meets the first category above)

• Changing the protocol without prior IEC approval.

• Inadvertent loss of samples or data.

III. The deviation is a willful or knowing breach of human subject protection regulations,

policies, or procedures on the part of the investigator(s). For example

• Failure to obtain informed consent prior to initiation of study-related procedures

• Falsifying research or medical records.

• Performing tests or procedures beyond the individual's professional scope or privilege

status (credentialing)

IV. The deviation involves a serious or continuing noncompliance with federal, state, local or

institutional human subject protection regulations, policies, or procedures. For example

• Working under an expired professional license or certification

• Failure to follow federal and/or local regulations, and intramural research or CC policies

• Repeated minor deviations.

V. The deviation is inconsistent with the NIH Human Research Protection Program’s research,

medical, and ethical principles. For example

A breach of confidentiality.

Inadequate or improper informed consent procedure.

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Minor Protocol Deviation- A minor protocol deviation is any change, divergence, or departure from

the study design or procedures of a research protocol that has not been approved by the IEC and which

does not have a major impact on the subject's rights, safety or well-being, or the completeness,

accuracy and reliability of the study data.

12.4.2. Detection of Protocol deviation/ violation

Protocol deviation/ violation may be detected in one the following ways (but not limited to those

listed below):

a. Self reporting by Principal investigator.

b. The FMIEC members while performing on site monitoring.

c. The Secretariat may detect protocol deviation/ violation from failure to comply with

statutory requirements/ failure to respond to requests from FMMICEC within

reasonable time limit/ failure to respond to communication made by FMIEC.

d. The FMIEC members may detect protocol deviation/ violation when scrutinizing

annual/ periodic reports/ SAE reports/ any other communication received from the

Investigator/ trial site/ sponsor/ study monitor/ contract research organization.

e. The FMIEC Secretariat and/ or FMIEC members may become aware of a protocol

deviation/ violation while reviewing study-related documents including reports filed

in by the PI.

f. Communication/ complaint/ information received from a research participant who has

been enrolled or any individual who has been approached for enrolment.

g. Any report/ communication brought to the notice of Member, Secretary/ Jt. Secretary/

Chairperson of FMIEC by an independent person.

h. Communication received from the Head of the Institution informing FMIEC about an

alleged protocol violation/ protocol deviation.

12.4.3. Receipt of protocol deviation / violation report by the Secretariat

1. The PI will report the protocol deviation/violation as per Annexure .

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2. In case protocol deviation/violation is detected by any other person and reported to the

FMIEC, the Member Secretary will write to the PI to submit a protocol deviation/violation

as per Annexure

3. The Secretariat will notify the Member Secretary of any protocol deviation/violation report

received from the PI/ from any source within 2 working days of receipt of the notification.

12.4.4. Actions to be taken

1. The action of the IEC will be based on:

o The nature and seriousness of the deviation / violation.

o Frequency of deviation/ violation in the study in the past.

o Frequency of deviation/ violation in previous studies conducted by the same PI/

Co-PI or in the same department.

2. Member Secretary will decide on the impact of the protocol deviation / violation and act

accordingly. Depending upon the seriousness, the FMIEC shall do the following:

o Ask PI for written clarification as soon as the deviation is received

o If the impact is serious, this report will be shared with the Chairperson and two

or more FMIEC members designated by the Chairperson.

o If the impact of the protocol deviation is serious enough, the Member

Secretary will instruct the Secretariat to call for and schedule a full-board

meeting specifically to discuss the issue within 7 working days of the initial

scrutiny

o The Secretariat will put up the information and communication at the next full

board meeting for discussion.

3. The Member Secretary in consultation with FMIEC members will review the

information available and deliberate on it.

4. The Chairperson will take a final decision depending on the seriousness of the violation.

The decision will be taken to ensure that the safety and rights of the research participants

are safeguarded. The decision will be taken by consensus, and the quorum required for the

meeting is same as that required for the initial approval of the protocol.

5. The decision taken by IEC could include one or more of the following:

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o Determine that no further action is required, or take other actions as

appropriate.

o Inform the PI that the FMIEC has noted the violation / deviation, and

instruct the PI to ensure that deviations/ violations do not occur in future

and to follow FMIEC recommendations.

o Enlist measures that the PI would undertake to ensure that such

deviations / violations do not occur in future.

o Observe the research or consent process (depending on the nature and

frequency of the deviation).

o Suggest modifications to the protocol.

o Alter the interval for submission of the continuing review/ annual project

status.

o Ask for additional training of the investigator and study team

o Reprimand the PI.

o Seek additional information from the PI.

o Conduct audit of trial by the FMIEC.

o Suspend the study till additional information is made available and

scrutinized.

o Suspend the study till recommendations made by the FMIEC are implemented

by the PI and found to be satisfactory by the FMIEC.

o Suspend the study for a fixed duration of time.

o Suspension or termination of the study.

o Revoke approval of the current study.

o Inform relevant regulatory authorities.

o Keep other research proposals from the PI/ Co-PI under abeyance. Review

and/ or inspect other studies undertaken by PI/Co-PI.

6. This final decision will be recorded by the Member Secretary.

12.4.5. Procedure for notifying the PI and other concerned authorities

The Member Secretary will draft a notification letter.

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The signed letter by Member Secretary will be sent to the PI and Department Head(s) (if

required on case to case basis) and Institutional Officials (if required on case to case basis).

The FMIEC secretariat will send a copy of the notification to the relevant national

authorities (if required on case to case basis) and institutes (if required on case to case basis in case

of multi-centric trials ).

12.4.6. Records and follow up to be kept by FMIEC secretariat

The Secretariat will keep a copy of the notification letter in the respective project file.

12.5. Annexure

Annexure 12.1 : PROTOCOL DEVIATION/VIOLATION REPORTING

FORMAT

Project no

Project title

Name of PI

Nature of deviation

Nature of violation

Reasons for deviation/violation

Signature of PI

Signature of member secretary/ Chairperson with date

Annexure – 12.2 : Protocol deviation/violation record

FMIEC Protocol no.:

Study Title:


Department:

Deviation from protocol

Violation

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Description of deviation (s)/violation(s)

Corrective Actions Taken by the Principal Investigator:

__________________________________________________________

Reported by (Name of Principal Investigator/ Study Team Member):

___________________________________________________________

Signature with date:_________________________

Provisional Decision by the Reviewer (Member Secretary and/or Chairperson

and/or FMIEC Member/s)

Noted

Request the PI not to perform such deviations/ non compliances/

violations in future

Specific recommendations stated below to be followed

a. Suspend the study till IEC recommendations are implemented

b. Suspend the study till information is available

c. Terminate approval of current study

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13. SOP- 13 : Review of Final Reports and Study Completion Reports

13. 1. Purpose- The purpose of this Standard Operating Procedure (SOP) is to provide

instructions on the review of Study Completion Report submitted for studies approved by

the Institutional Ethics Committee (IEC).

13.2.. Scope- This SOP applies to the review of the Study Completion Report which is a

written report of every completed study submitted by the Principal Investigator (PI).

13.3. Responsibility- It is the responsibility of the Secretariat/ IEC Chairperson/ Member

Secretary/ Member/s to review the study report and act on it.

13. 4. Procedure :

13.4.1. Receipt of Study Completion Report The Secretariat will receive 1 copy each (soft and

hard) of Study Completion Report for the regulatory trials; and one soft copy only for the

academic projects.

13.4.2. The study completion report is expected from the investigator within 1 month of

completion of the study at the site.

13.4.3. It is the responsibility of the IEC Secretariat to review the report for completeness

The Secretariat shall verify the submitted Study Completion Report along with Study

Completion Report Form and forward it to the Member Secretary within 7 working

days of receipt. The Member Secretary will review the Study Completion Report,

confirm that it is complete and present it at the next full board meeting.

13.4.4. If there is a need felt (e.g. a deviation/ violation is noted), the Member Secretary will

handle it as per the relevant SOP. The Secretariat shall include the Study Completion Report

Form in the agenda for IEC members for discussion at the full board meeting.

13.4.5. During the Board meeting The Member Secretary will present the report and members

can discuss as needed. Following the discussion, the Chairperson may take one of the

following decision:

a) noted / approved b) request for additional information / clarification The Secretariat will

note the decision in the meeting minutes

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b) The Member Secretary will draft a letter to the PI conveying decision on the study

completion report. The study shall be considered as closed if the decision by IEC is “Noted” or

“Approved”.

c) The Secretariat will accept and file the Report and get the Study Completion Report Form

signed by the Chairperson . The final report will be placed in the master file and kept in the

archival area.

d) The Secretariat will archive the entire study for a period of 5 years from the date of

completion of the project if the decision is noted and closed.

13.5. Annexure :

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Annexure-13 : STUDY COMPLETION REPORT FORM (Filled by principal

Investigator)

FMIEC Protocol No. :

Project Title: ______________________________________________________________

Principal Investigator

Department

Total no. of study participants recruited

Total no. of study participants approved by the IEC for recruitment

Duration of the study *

Results (summary) with Conclusion: (use extra blank paper, if more space is required).

__________________________________________________________________________

__________________________________________________________________________

*Note: If the final report is not available from sponsor, it may be submitted later to the IEC

once it is ready.

Number of SAEs at our center:

Whether all SAEs intimated to the IEC Yes No

No. of patients withdrawn :

Reasons for Withdrawal of Patients:_____________________________________________

__________________________________________________________________________

__________________________________________________________________________

Signature of Principal Investigator: Date

Action taken: Noted/ Requires more information/ action as follows:

__________________________________________________________________________

__________________________________________________________________________

IEC Meeting date (If reviewed in the meeting)__________________________________ Final

Decision:_______________________________________________

__________________________________________________________________________

Signature of Member Secretary with date: ___________________________

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14. SOP-14 : Procedure for Training and

Assessment of Members

14.1. Purpose : The purpose of this SOP is to describe requirements and methodology for training and

performance assessment of the FMIEC) members and the Secretariat.

14.2. Scope : This SOP applies to all the FMIEC members and the FMIEC secretariat.

14.3. Responsibilities

It is the responsibility of the FMIEC Chairperson with the assistance of Member Secretary to ensure

that there is adequate initial and continued training of the FMIEC members and the secretariat. The

Chairperson is responsible for assessment of all FMIEC members and complete a self-assessment

exercise at prescribed intervals.

14.4. Procedure

14.4.1. Topics for training

1) FMIEC members should have knowledge of the following:

Relevant research ethics and regulatory guidelines

Roles and Responsibilities of FMIEC members

Review of protocol and related documents, including concepts of Risk Benefit assessment,

Equity in recruitment, Autonomy, Confidentiality and Privacy

Recent Developments in relevant health science specialities

SOPs of the FMIEC

2) Secretariat should have knowledge and relevant skills for conducting the following activities:

Knowledge about FMIEC SOP’s and also guidelines for submission

Good communication skills – oral and written

Maintenance of FMIEC records – both soft and hard copy

14.4.2. Induction Training of new FMIEC Members

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1) Every time a new committee is constituted, the members must undergo initial training

within one month on ethics in clinical research and good clinical research and SOPs. An

individual selected as a new member of the FMIEC will be required to attend one meeting

as an ‘Observer’ before being inducted as a member of the FMIEC. The Member Secretary

will provide an introductory training to the new member. The member during the observer

period will not have voting rights, but will have to sign letter of confidentiality.

Appointment of observer as member would be on discretion of Chairperson in consultation

with members, following which the appointment letter would be issued to the member.

2) The newly inducted member will be encouraged to undergo training on good clinical

practice, bioethics and guidelines on clinical research. The authorities of FMMC may

sponsor the member for such trainings.

3) The new member will receive trainings from any member of FMIEC or Chairperson or

Member Secretary on the above topics. An expert from clinical research, bioethics or GCP

will be invited to FMIEC to give training

4) The in house training sessions of FMIEC will have pre test and post test to assess the

effectiveness of trainings.

5) The Member Secretary and the Chairperson will orient all the members on the SOP of

the FMIEC.

14.4.3. Ongoing (On Job and Developmental) Trainings at FMIEC:

1) Member Secretary, member, Chairperson will be encouraged to receive continued training

by participating in a workshop, conference and/ or retraining program related to research ethics,

as a delegate, faculty, facilitator, etc. at least once every year. The authorities of FMCI may

sponsor the members for such trainings.

2) The Member Secretary of FMIEC in consultation with the Chairperson prepares an annual

training schedule, and will conduct trainings or workshops on good clinical practice, bioethics,

relevant guidelines on clinical research and other relevant topics. The resource persons for such

trainings could be a member of FMIEC, or an external GCP trained personnel or a bioethics

expert. The trainings is imparted not only to the FMIEC members but, also to the institutional

faculty who are investigators of ongoing research studies or potential investigators .

14.4.4. Training of the Secretariat : The FMIEC Member Secretary along with other members will

train the Secretariat on SOPs. There will be initial training and at least one training session per year

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on SOPs. The competency of staff in computers and communication skills will be evaluated and

ensured initially at the time of appointment by the Member Secretary and Chairperson.

14.4.5. Assessment of IEC members

1. The FMIEC members’ performance should be evaluated once a year using an assessment

form by the Chairperson.

2. The Chairperson should do self-assessment once a year

14.4.6. Maintenance of training records of the FMIEC Members and the Administrative Staff

The secretariat should maintain copies of the certificates of all training workshops and conferences

in research ethics attended by the individual FMIEC members. The copies will be filed in the

individual members’ files. The records regarding training copies of the secretariat will also be

maintained in their respective files.

14.5. Annexures

Annexure 14. 1:

Assessment Form for Ethics Committee Members

1. Current tenure

2. Terms served

3. Training received (Training record to be attached)

4. Type of training received

5. No of meetings attended

6. No of projects reviewed per meeting as primary reviewer

7. Participation in SAE report review process- yes/no

8. Participation in site monitoring visits - yes/no

9. Number and type of continuing training workshops organized for FMIEC members (applicable

to Member Secretary)

10. Number and type of continuing training workshops organized for staff of the FMIEC

secretariat (applicable to Member Secretary)

11. Any other significant contribution to the field of research ethics

12. Remarks by the Chairperson on the self-assessment

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Annexure-14.2. Training Records of the Member (Trainings in house+attended outside):

Name of the Member :

Designation in FMIEC :

Date In

House/Outside

Name/Names

of Trainer/s

Topic Organizer Place

Annexure 14.3: Self Assessment Form for IEC Chairperson

1. Current tenure-

2. Terms served -

3. Training received -

4. Type of training received -

5. No. of meetings held in current year -

6. No of meetings attended-

7. Whether quorum requirement fulfillment ensured as per schedule Y in FMIEC meetings

8. Whether considerations related to conflict of interest considered

9. Any significant contribution to the field of research ethics

10. Any other comments ___________________________________________________

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15. SOP-15: Review of Serious Adverse Events (SAE) in clinical trials

15.1. Purpose : The purpose of this SOP is to describe procedures for the review of initial and

follow-up reports of serious adverse events (SAE) occurring in a clinical trial reported to the IEC

for any study under the oversight of the FMIEC.

15.2. Scope : This SOP applies to the review of SAE reports (Adverse events/ SAE onsite as well

as SAEs of the multicenter studies occurring at other sites/offsite) submitted to the FMIEC.

15.3. Responsibility: It is the responsibility of the principal investigator/investigator at site to submit

an SAE report to FMIEC as well as to sponsor . It is the responsibility of the IEC to review all SAEs

reported to the IEC in a timely manner

15.4. Procedures :

15.4.1. Definitions :

1] Serious Adverse Event:

Any untoward medical occurrence that at any dose results in death, is life-threatening,

requires inpatient hospitalization or prolongation of existing hospitalization, results in

persistent or significant disability/incapacity, or is a congenital anomaly/birth defect

2] Serious Adverse Event (AE) or Serious Adverse Drug Reaction (ADR)

An AE or ADR that is associated with death, hospitalization, prolongation of hospitalization,

persistent or significant disability or incapacity, a congenital anomaly or birth defect, or is otherwise

life threatening.

3] Adverse Event

An AE is any untoward medical occurrence in a patient or clinical investigation subject administered

a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.

An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory

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finding), symptom, or disease temporally associated with the use of a medicinal (investigational)

product, whether or not related to the medicinal (investigational) product.

4] Suspected Unexpected Serious Adverse Reactions (SUSARS) : An unexpected adverse reaction

(UAR) is an adverse reaction that is not consistent with the product information in summary of

product characteristics. . A suspected unexpected serious adverse reaction (SUSAR) is any UAR that

at any dose results in death; is life threatening (i.e. the subject was at risk of death at the time of the

event; it does not refer to an event which hypothetically might have caused death if it were more

severe); requires hospitalization or prolongation of existing hospitalization; results in persistent or

significant disability or incapacity; is a congenital anomaly or birth defect.

15.4.2. SAE subcommittee :

1. The Chairperson of FMIEC constitutes a SAE subcommittee.

2. The subcommittee consists of members who collectively have the qualifications and

experience to review and evaluate the scientific, medical and ethical aspects of adverse event

reports involving human participants. The subcommittee is be headed by a senior member of

IEC, and comprises clinician, Basic Medical Scientist, Legal Expert, Subject Expert (if a

member from the subject is not there in the IEC) and one representative of the vulnerable

populations (for those trials involving vulnerable populations). The subject expert and the

representative of the vulnerable population are included depending on the area/subject

speciality . The Chairperson can include more members from the medical background

depending on the felt need.

15.4.3. Receipt of Report of SAE :

15.4.3.1. The IEC Secretariat will receive the following documents within the specified time frame if

an SAE is experienced by any research participant:

i) Initial SAE report to be submitted by the Principal Investigator (PI) within 24 hours of occurrence.

ii). Due analysis should be submitted by the PI within 14 days from the occurrence of the SAE

iii) Due analysis will also be submitted by the sponsor within 14 days

iv). The follow up reports of all on-site SAE till the event is resolved.

15.4.3.2. The IEC Secretariat will verify that the report is complete in all respects and that it has been

received at the IEC office within the specified timelines. If the report has been received beyond the

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specified time, it will be considered as a protocol violation and action should be taken as described in

SOP for protocol deviations. The IEC Secretariat will sign and write the date on which the report is

received. The Secretariat will forward these reports to the IEC Member Secretary within two working

days.

15.4.4. . Review and Decision on SAE Reports and Communication to PI and Regulatory

Authority by IEC :

15.4.4.1. The Member Secretary will review the SAE report and present to the SAE subcommittee

for review and opinion.

15.4.4.2. At the meeting of SAE subcommittee, the SAE reports will be reviewed with a special focus

on relatedness to the clinical trial, medical management and financial compensation to be given to the

research participants. The applicable formulae and guidelines from the regulatory authority will be

used during this discussion. The SAE subcommittee hold the meeting and site visits as required.

15.4.4.3. If deemed necessary, the SAE subcommittee may refer the issue to the IEC full board. The

report of SAE subcommittee will be presented in the IEC full board meeting. An emergency meeting

of IEC may be held for this purpose. The emergency IEC meeting will be scheduled within 7 days for

the same. The minutes of the SAE Subcommittee/ IEC meeting will include the information on SAE

at the site along with the opinion on the above points on the onsite SAE . The minutes will be

circulated to the IEC members via email and approval/ objection will be sought from the members in a

period of 5 working days. After approval from the Chairperson, the Member Secretary communicates

the decision of FMIEC to the PI, within 7 working days after the meeting of SAE subcommittee.

15.4.4.4. The PI will be requested to reply to the query letter on the SAE report within 7 working days.

The FMIEC will take a decision on the compensation to be paid to the participant and give directions

to the PI and sponsor.

15.4.5. Review during Full Board Meeting of FMIEC: A report of the SAEs is presented in the full

board meeting of FMIEC during the monthly meeting. In case of the SAE occurring at the site to be

discussed at the full board meeting, the member secretary will also provide the relevant information

including updates on SAE that have occurred earlier at the site. The Chairperson will invite members

to voice their opinions and ensure free and frank discussion. The decision is arrived at by consensus.

15.4.8. Decision of FMIEC on SAE :

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The FMIEC arrives at one or more of the following decisions on review of SAE report.

4) Following detailed review of the SAE reports and related documents, the IEC/

SAE Subcommittee can suggest one of the following actions:

Note the information about the SAE in records for future reference.

Request further follow up information and/ or additional details.

Ask for periodic follow-up of the research participant till SAE is resolved

Depending on complexities of issue, IEC/ SAE Subcommittee may decide to

seek opinion of outside expert consultant who is requested to respond within 14

working days.

Provide recommendations regarding/ raise queries related to compensation for

study related injury and death

5) Type of Action Taken following Full Board Meeting :

Suggest changes/ amendments in protocol, Patient Information Sheet/ Informed

Consent Document/ Investigators’ Brochure/ any other study related documents.

Suspend the study till additional information is available.

Suspend the study till review is completed (safety monitoring of ongoing

patients to be continued).

Suspend the study till amendments requested for by the IEC are carried out.

Suspend enrolment of new participants.

Suspend certain activities under the protocol.

Direct the PI to inform participants already enrolled in the study about the AEs

and if required obtain their consent again (re-consent) regarding continuation in

the research trial.

Direct the PI to inform participants already enrolled in the study about the AE

and request them to undertake additional visits, additional procedures,

additional investigations, etc. as prescribed in the amendment.

Terminate the study.

Any other appropriate action

15.4.9. The decision shall be recorded in the minutes of the full board IEC meeting.

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15.4.10. If the recommendation from the IEC includes suspension of the study or suspension of

any one or more of the study-related procedures or activities, amendments in the protocol or

other study-related documents (excluding Investigators’ brochure), re-consenting of research

participants, the decision will be conveyed to the PI through telephone, fax or email within 24

hours. Such a communication will be documented by the IEC Member-Secretary in the study

file. A formal letter to the PI informing about the IEC recommendations in such situations will

be sent within 5 working days of the IEC meeting having taken place.

15.5. Flow Chart :

IEC Secretariat Receives SAE Report

SAE Report Submitted to Member Secretary

Verification of SAE Report for Completeness: Member Secretary

Review by SAE Subcommittee

Presentation of SAE Subcommittee Report in IEC Full Board

Decision Making in IEC: by Consensus

Communication of Decision to PI : Member Secretary

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15.6. Annexures :

Annexure-15.1. Data Elements for reporting serious adverse events occurring in a clinical

trial.

1. Patient Details :

Initials & other relevant identifier (hospital/OPD record number etc.) :

Gender : Age and/ or date of birth ;

Weight : Height :

2. Suspected Drug/Drugs :

Generic name of the drug

Indication(s) for which suspect drug was prescribed or tested

Dosage form and strength o Daily dose and regimen (specify units - e.g., mg, ml,

mg/kg) Route of administration

Starting date and time of day

Stopping date and time, or duration of treatment

3. Other Treatment(s) :

4. Details of Suspected Adverse Drug Reaction(s)

Full description of reaction(s) including body site and severity, as well as

the criterion (or criteria) for regarding the report as serious. In addition to

a description of the reported signs and symptoms, whenever possible,

describe a specific diagnosis for the reaction

Start date (and time) of onset of reaction

Stop date (and time) or duration of reaction.

Dechallenge and rechallenge information.

Setting (e.g. hospital, out-patient clinic, home, nursing home).

5. Outcome :

Information on recovery and any sequelae; results of specific tests and / or

treatment that may have been conducted.

For a fatal outcome, cause of death and a comment on its possible

relationship to the suspected reaction; Any post mortem findings.

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Other Information: anything relevant to facilitate assessment of the case,

such as medical history including allergy, drug or alcohol abuse; family

history, findings from special investigations etc.

6. Details about Investigator :

Name o Address o Telephone number

Profession (speciality)

Date of reporting the event to Licensing Authority:

Date of reporting the event to Ethics Committee overseeing the site:

Signature of the Investigator

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Annexure – 15.2. : Checklist SAE Report Submission (For Onsite SAE)

Sl. No. Details

1. Country Name :

2. SAE report of death or other than

death, Please tick (✓)

Death : Other Than Death :

3. In case of Serious Adverse

Event(SAE), please specify if there

is any injury to the participant

(Please specify Yes/No) in the box

4. Protocol Title

5. Protocol Study No./ ID /Code

6. Copy of Clinical Trial permission

obtained from CDSCO

7. CTRI Registration No.

8. Sponsor(Address with contact no

and Email)

9. CRO (Address with contact no and

Email)

10. Initial / Follow-up (FU) : Mention

11 In case of follow-up: Date & Diary

no of initial or recently submitted

report information


a) Initials & other relevant identifier

(hospital/OPD record number etc.)

b) Gender

c) Age and /or Date of Birth

d) Weight

e) Height

13. Suspected Drugs

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a) Generic Name of the Drug

b) Indication(s) for which suspect drug

was prescribed or tested

c) Dosage form and strength

d) Daily dose and regimen (specify

units - e.g., mg, ml, mg/kg)

e) Route of administration

f) Starting date and time of day

g) Stopping date and time, or duration

of treatment

14. Other Treatment(s)

Provide the same information for

concomitant drugs (including non

prescription/OTC Drugs) and

nondrug therapies, as for the

suspected drug(s).

15. Details of the events

a) Full description of event (s)

including body site and severity, as

well as the criterion (or criteria) for

regarding the report as serious. In

addition to a description of the

reported signs and symptoms,

whenever possible, describe a

specific diagnosis for the reaction.

b) Start date (and time) of onset of

reaction.

c) Stop date (and time) or duration of

reaction.

d) Dechallenge and rechallenge

information

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e) Setting (e.g., hospital, out-patient

clinic, home, nursing home).

16. Outcome

a) Information on recovery and any

sequelae; results of specific tests

and/or treatment that may have been

conducted.

b) For a fatal outcome, cause of death

and a comment on its possible

relationship to the suspected

reaction; any post-mortem findings.

c) Other information: anything relevant

to facilitate assessment of the case,

such as medical history including

allergy, drug or alcohol abuse;

family history; findings from special

investigations etc.

17. Details about the Investigator

a) CT Site Number, if any

b) Name

c) Address

d) Telephone/Mobile Number & Email

e) Profession (specialty)

f) Date of reporting the event to

Licensing Authority:

g) Date of reporting the event to Ethics

Committee overseeing the site:

h) Signature of the Investigator

18. Details about the Ethics

Committee

a) Name & Address

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b) Name of Chairperson & Address

c) Telephone/Mobile Number

d) Email

19. Adverse Event Term/ Details of

SAE

20. Causality Assessment

(Related/Unrelated) by

Investigator.

21. Causality Assessment

(Related/Unrelated) by

Sponsor/CRO.

22. Details of compensation provided

for injury or death. In case no

compensation has been paid,

reason for the same :

23.a) Duly filled SAE Form as per

Appendix XI of Schedule Y

23.b) Laboratory investigations report

/Discharge summary (if available

and applicable)

23.c) Post-mortem report (if applicable)/

Any additional documents)

Note: Information not relevant to a particular SAE should be marked with NA

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Annexure -15.3. : Serious Adverse Event (SAE) Analysis Report (For Onsite SAE)

Sl.

No.

Details

1. Country Name :

2. SAE report of death or other than death, Please tick (✓) Death : Other

Than

Death :

3. In case of Serious Adverse Event(SAE), please specify if there is any

injury to the participant (Please specify Yes/No) in the box

4. Protocol Title

5. Protocol Study No./ ID /Code

6. Copy of Clinical Trial permission obtained from CDSCO

7. CTRI Registration No.

8. Sponsor(Address with contact no and Email)

9. CRO (Address with contact no and Email)

10. Initial / Follow-up (FU) : Mention

11 In case of follow-up: Date & Diary no of initial or recently submitted

report information


a) Initials & other relevant identifier (hospital/OPD record number )

b) Gender

c) Age and /or Date of Birth

d) Weight

e) Height

13. Suspected Drugs

a) Generic Name of the Drug

b) Indication(s) for which suspect drug was prescribed or tested

c) Dosage form and strength

d) Daily dose and regimen (specify units - e.g., mg, ml, mg/kg)

e) Route of administration

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f) Starting date and time of day

g) Stopping date and time, or duration of treatment

14. Other Treatment(s)

Provide the same information for concomitant drugs (including non

prescription/OTC Drugs) and nondrug therapies, as for the suspected

drug(s).

15. Details of the events

a) Full description of event (s) including body site and severity, as well as

the criterion (or criteria) for regarding the report as serious. In addition

to a description of the reported signs and symptoms, whenever possible,

describe a specific diagnosis for the reaction.

b) Start date (and time) of onset of reaction.

c) Stop date (and time) or duration of reaction.

d) Dechallenge and rechallenge information

e) Setting (e.g., hospital, out-patient clinic, home, nursing home).

16. Outcome

a) Information on recovery and any sequelae; results of specific tests

and/or treatment that may have been conducted.

b) For a fatal outcome, cause of death and a comment on its possible

relationship to the suspected reaction; any post-mortem findings.

c) Other information: anything relevant to facilitate assessment of the case,

such as medical history including allergy, drug or alcohol abuse; family

history; findings from special investigations etc.

17. Details about the Investigator

a) CT Site Number, if any

b) Name

c) Address

d) Telephone/Mobile Number & Email

e) Profession (specialty)

f) Date of reporting the event to Licensing Authority:

g) Date of reporting the event to Ethics Committee overseeing the site:

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h) Signature of the Investigator

18. Details about the Ethics Committee

a) Name & Address

b) Name of Chairperson & Address

c) Telephone/Mobile Number

d) Email

19. Adverse Event Term/ Details of SAE

20. Causality Assessment (Related/Unrelated) by Investigator.

21. Causality Assessment (Related/Unrelated) by Sponsor/CRO.

22. Details of compensation provided for injury or death. In case no

compensation has been paid, reason for the same :

23.a) Duly filled SAE Form as per Appendix XI of Schedule Y

23.b) Laboratory investigations report /Discharge summary (if available and

applicable)

23.c) Post-mortem report (if applicable)/ Any additional documents)

Details of payment for medical management of SAE? (please give information who paid how

much was paid, to whom, with evidence of the same)

What is the investigator’s assessment for the amount of compensation to be paid?

What is the sponsor’s assessment for the amount of compensation to be paid

Has the participant made a claim? Yes No

If yes, for how much amount _________________ If no, please ensure that the participant /

nominee have been made aware of his/her’ rights regarding compensation. Please submit

documentation regarding the same

_____________________________________________________________________

______________________________________________________________________

Signature of the Principal Investigator : Date:________________

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16. SOP-16: Waiver of Written/Verbal Informed Consent

16.1. Purpose : The purpose of this Standard Operating Procedure (SOP) is to describe the type of

research projects for which the Institutional Ethics Committee (IEC) may grant waiver for requirement

of obtaining written or verbal informed consent.

16.2. Scope : This SOP applies to the all protocols submitted for review by the IEC that ask for

consent waiver.

16.3. Responsibility : It is the responsibility of the IEC to review and approve a request for

verbal/written consent waiver. The Member Secretary will record the decision in the minutes and in

the Application Form. The Chairperson will sign and date letter conveying the decision.

16.4. Procedure :

16.4.1. The principal investigator should request for waiver of consent on those occasions which are

mentioned below in 16.4.2. When a request for waiver of consent is received from the Principal

Investigator (PI) to the IEC in the given format the following steps are taken:

The IEC Secretariat will check if the concerned documents are filled completely and the

required list of documents is enclosed.

The IEC members will review the request taking into consideration the types of studies for

which waiver of consent may be granted.

The IEC will ensure that there are adequate mechanisms described in the protocol for

protection of the identity of the research participants and maintaining confidentiality of the

study data. (This is necessary as the participant cannot be assured directly about confidentiality

of health data through a formal informed consent process, when consent waiver is granted).

16.4.2. The decision on waiver of consent is taken at the full board meeting of IEC.

The FMIEC decides granting waiver of consent on following occasions :

1) Research cannot practically be carried out without the waiver and the waiver is

scientifically justified

2) Retrospective studies, where the participants are de-identified or cannot be contacted;

3) Research on anonymized biological samples/data;

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4) Research cannot practically be carried out without the waiver and the waiver is

scientifically justified

5) Retrospective studies, where the participants are de-identified or cannot be contacted;

6) Research on anonymized biological samples/data;

16.4.3. In case of telephonic interviews, waiver of written informed consent may be requested but

verbal consent is mandatory.

16.4.4. The following documents need to be submitted for the IEC review for verbal consent :

A script for verbal consent - a verbal consent script provides all of the elements of consent in a

more informal style. In addition, each subject should be provided with an information sheet

that describes the study and gives contact names and numbers.

The interview schedule (questions to be asked) will confirm that the interview is a simple 5

minute call and that no questions are asked that compromise a person’s confidentiality or

position.

16.4.5. The decision regarding approval / disapproval of waiver is informed to the Principal

Investigator in writing. If the waiver is not granted, the IEC will provide reasons for the same.

16.5. Annexure

Annexure -16 : Application form for Requesting Waiver of Consent


Department :

Title of the project :

Please Tick the Reasons for Requesting Waiver of Consent :

Research involves ‘not more than minimal risk’ :

There is no direct contact between the researcher and participant :

Emergency situations as described in ICMR Guidelines :

Any other (please specify)

Statement assuring that the rights of the participants are not violated :

State the measures described in the Protocol for protecting confidentiality of data and privacy of

research participant

Principal Investigator’s signature with date: ______________________________________

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17. SOP-17 : Management of Premature Termination / Suspension /

Discontinuation of the Study

17.1. Purpose : The purpose of this SOP is to describe how the Institutional Ethics Committee (IEC)

manages premature termination/suspension/discontinuation of a research study. Protocols may be

terminated/suspended/discontinued at the recommendation of the IEC, Data Safety Monitoring Board

(DSMB), Principal Investigator (PI), Sponsor, Regulator or other authorized bodies wherein

participant enrolment and follow-up are discontinued before the scheduled end of the study.

17.2. Scope : This SOP applies to any study previously approved by the IEC that has been

recommended for termination/suspension/discontinuation before its scheduled completion

17.3.Responsibility : It is the responsibility of the IEC to manage the termination of any study

(recommended for termination by Data Safety and Monitoring Board, Principal Investigator,

Sponsor or other authorized bodies or by the IEC)that the IEC has previously approved.

17.4.Procedure :

17.4.1. Recommendation for Termination/ Suspension/ Discontinuation :

a) By PI/Sponsor : An investigator/ Sponsor may put on hold a previously approved

research when in the judgment of the investigator/ Sponsor this is appropriate to

protect the rights or welfare of participants or when new safety information has

appeared in the literature, or evolved from this or similar research.

b) By IEC : IEC members/Chairperson can prematurely terminate/ suspend/

discontinue the study in the following situations:

protocol non-compliance/violation following which IEC decides in full board meeting to

terminate/ suspend/ discontinue the study;

SAEs occurring at trial site may require the study to be prematurely terminated for the

safety of the patients;

When research is not conducted in accordance with IEC policies, is not in compliance with the

local regulations or that has been associated with unexpected serious harm to participants;

Zero accrual for 1-2 years or long-term, low accrual. Suspended protocols remain open and

require continuing review;

The IEC may revoke approval and recommend to stop permanently all activities in a previously

approved research protocol.

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Terminated protocols are considered closed and no longer require continuing review.

17.4.2. Receipt of Recommendation of Study Termination :

The Secretariat will receive the study protocol termination/suspension/discontinuation

report submitted by the PI and verify the contents of the report for completeness

and/or other documents.

17.4.3. Review by the IEC :

The Secretariat will inform the Chairperson and Member Secretary regarding

the recommendation for premature termination/ suspension/ discontinuation of

study protocol and the termination/ suspension/ discontinuation report within 3

working days of receipt of the report. The Member Secretary/ Chairperson

shall review the report and either call for an emergency meeting or discuss the

report at the regular full board meeting.

The Secretariat will arrange for an Emergency meeting/ keep matter for

discussion at full board meeting

The Member Secretary in the meeting will inform members of the premature

termination/ suspension/ discontinuation of the project and the reasons for the

same.

If the Premature termination/ suspension/discontinuation Report is unclear or

more information is required from the PI, the Chairperson shall instruct the

Secretariat to seek clarifications/ additional information from the Principal

Investigator.

The Chairperson shall sign and date the study termination/ suspension/

discontinuation report in acknowledgement.

If the IEC has revoked approval/suspended the study, regulatory authorities

and Head of the institution must be informed within 14 working days of the

full board meeting

17.4.4. Notifying the PI :

The Secretariat will prepare a notification letter and send to the PI within 14

working days after the meeting acknowledging the approval of termination/

letter seeking clarifications/information regarding the premature termination.

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In case a letter is sent seeking clarifications/information regarding the

premature termination/ suspension/ discontinuation, the PI shall send a written

response within 60 days of receiving the letter.If the PI does not comply, the

matter will be put to the full board meeting for discussion.

The investigator may appeal or respond to the convened IEC in writing.

17.4.5. Storing the Protocol Documents :

The Secretariat will keep the original version of the Premature Termination Report in

the Protocol file and send the file to archive. The protocol documents will be stored

for a period of 5 years from the date of project termination.

17.5.Annexure.

Annexure -17 : Premature Termination Report

Protocol No. :

Protocol Title :

Principal Investigator : Department :

IEC Approval Date : Date of the Last Six-monthly Status Reported Submitted to IEC :

Date of Initiation of the Study : Termination/Suspension/Discontinuation Date : -----------------------------

------------

No. of Participants Enrolled : No. of Participants Completed :

No. of Ongoing Participants : No: of Drop outs :

Reason for Each Drop out : ---------------------------------------------------

Any SAEs ?

No. of SAEs :

Are the SAEs Reported to IEC ?

Yes : No ;

Brief summary of results: (use extra blank paper, if more space is required.

Reason/s for termination/suspension/discontinuation:

Signature of the Principal Investigator with Date.

Discussed in the IEC Meeting Held on :

Action Taken :

Approval of the Premature Termination / suspension / discontinuation of the project

Requires more information/ action as follows:__________________________________ __

_ Signature of Chairperson, IEC with date

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SOP-18 : Review of Research Proposals Involving

Vulnerable Population

18.1. Purpose : This SOP describes the requirements and process of review of research that involves

vulnerable participants.

18.2. Scope : This SOP covers the policies and procedures applied to all research dealing with

vulnerable participants submitted to the IEC.

18.3. Responsibility: It is the responsibility of the Member Secretary with Secretariat to maintain up-

to-date tools, like checklists, for reviewing research concerning vulnerable groups based on new and

evolving applicable regulations and guidelines. IEC Chairperson / Member Secretary are responsible

for ensuring that IEC members are well-versed in new and evolving regulations and guidelines

pertaining to vulnerable populations, through regular training programmes. The Member Secretary/

Chairperson is responsible for selecting primary reviewers with appropriate expertise to conduct the

reviews of such research and for securing consulting expertise as and when required for selected

reviews. IEC member is responsible for conducting review of research planned for vulnerable

populations, including an assessment of potential for coercion.

18.4. Procedures :

18.4.1. Definition of Vulnerable Population:

Vulnerable persons are those individuals who are relatively or absolutely incapable of protecting their

own interests and providing valid informed consent. They are the individuals whose willingness to

volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of

benefits associated with participation, or of a retaliatory response from senior members of a hierarchy

in case of refusal to participate.

a) economically and socially disadvantaged (unemployed individuals, orphans, abandoned

individuals, persons below the poverty line, ethnic minorities, sexual minorities –

lesbian/gay/bisexual and transgender (LGBT), etc.);

b) unduly influenced either by the expectation of benefits or fear of retaliation in case of refusal to

participate which may lead them to give consent

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c) children (up to 18 years);

d) women in special situations (pregnant or lactating women, or those who have poor decision-

making powers/poor access to healthcare);

e) tribals and marginalized communities;

f) refugees, migrants, homeless, persons or populations in conflict zones, riot areas or disaster

situations;

g) afflicted with mental illness and cognitively impaired individuals, differently abled – mentally

and physically disabled;

h) terminally ill or are in search of new interventions having exhausted all therapies;

i) suffering from stigmatizing or rare diseases; or

j) have diminished autonomy due to dependency or being under a hierarchical system

(students, employees, subordinates, defense services personnel, healthcare workers,

institutionalized individuals, under trials and prisoners).

18.4.2. Reviewing protocols with vulnerable participants:

The protocol should be reviewed as described already under the SOP “Review Procedures”.

Additionally, the protocol should be reviewed to assess if the following points are addressed:

-- Can the research be performed in any other non-vulnerable participants?

--- Is there justification to use vulnerable population?

---- Do the benefits justify the risks

---- Are the participants selected equitably

---- Have the measures to protect Autonomy of the vulnerable population been described

Appropriate Review forms are used

Reviewers: In addition to all members of the IEC, the Chairperson and Member Secretary

include one or two experts who have a thorough understanding of the ethical review process

and experience in the field of research to review such type of protocols. A representative of the

vulnerable population also will be included.

18.4.3. Decision: The decision on allowing trials on vulnerable populations will be taken in a

full board meeting of IEC. The decision will be communicated to the PI. Wherever necessary

the IEC approval should state that if in future the vulnerability status of the participants

changes, for e.g. unconscious patient gaining consciousness or a schizophrenic patient regains

insight, the participant will be re-consented

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18.5. Annexures.

Annexure-18.1. : Checklist for Research Involving Children (To be filled by PI and

submitted to IEC ; To be cross verified by Reviewer During Review )


Title of the Protocol :

To be done by Principal Investigator To be done by Reviewer

Risk –Benefit Assessment : (Tick the

appropriate answer)

Risk –Benefit Assessment : (Tick the

appropriate answer)

Less Than Minimal Risk ; Direct Benefit Less Than Minimal Risk; Direct Benefit

Less Than Minimal Risk; Indirect Benefit Less Than Minimal Risk; Indirect Benefit

Greater Than Minimal Risk; Potential benefit to

child

Greater Than Minimal Risk ; Potential

benefit to child

Greater Than Minimal Risk; No direct benefit,

offer knowledge about child’s condition/disorder

Greater Than Minimal Risk ; No direct

benefit, offer knowledge about child’s

condition/disorder

Yes No NA

Does the research pose greater than minimal risk to children?

If yes: Are convincing scientific and ethical justifications given?

If yes: Are adequate safeguards in place to minimize these risks?

Does the study involve healthy children?

a) If yes: Is the inclusion of healthy children justified?

Are the studies conducted on animals and adults appropriate and

justified?

a) If No: Is the lack of studies conducted on animals and adults

justified?

Will older children be enrolled before younger ones?

Is permission of both parents necessary?

a) If Yes: Are conditions under which one of the parents may be

considered: “not reasonably available” described?

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b) If Yes: Are the conditions acceptable?

Will efforts be made to ensure that parents’ permission to involve

their children in research studies is free from coercion, exploitation,

and/or unrealistic promises?

Are provisions made to obtain the assent of children over 7 and,

where appropriate, honoring their dissent?

Are provisions made to protect participants’ privacy and the

confidentiality of information regarding procedures?

Are there special problems that call for the presence of a monitor or

IEC member during consent procedures?

Are special needs of adolescents such as counselling and

confidentiality accounted for in the research design?

Are there any special problems such as confidentiality and reporting

that might arise in sensitive research about child abuse or sexual

practices of teenagers?

Does the research involve possibility of findings which may have

implications for other family members?(for eg. genetic risk, HIV

infection, Hepatitis C)

If Yes: Are there adequate mechanisms in place to deal with other

members of the family?

Are parents required to be present during the conduct of the research?

(Are proposed participants’ very young? )

Signature of the Principal Investigator with Date

To be filled by Reviewer :

Comments of the Reviewer : Recommendations of the Reviewer :

Name and Signature of the Reviewer with

Date :

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Annexure-18.2. : Checklist for Research Involving Pregnant Women and Fetuses (To be

filled by PI and submitted to IEC ; To be cross verified by Reviewer During Review )



When research involves pregnant women or fetuses

Yes No NA

Where scientifically appropriate preclinical

studies, including studies on pregnant

animals, and clinical studies, including studies

on non-pregnant women, have been

conducted and provide data for assessing

potential risks to pregnant women and

fetuses?

Is the risk to the fetus not greater than

minimal, or any risk to the fetus which is

greater than minimal caused solely by

interventions or procedures that hold out the

prospect of direct benefit for the woman or

the fetus?

Any risk that is the least possible for

achieving the objectives of the research.

Is the woman’s consent or the consent of her

legally authorized representative obtained in

accordance with the informed consent

provisions, unless altered or waived?

Is the woman or her legally authorized

representative, as appropriate, fully informed

regarding the reasonably foreseeable impact

of the research on the fetus or resultant child?

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Will any inducements, monetary or otherwise,

be offered to terminate a pregnancy?

Do individuals engaged in the research have a

part in any decisions as to the timing, method,

or procedures used to terminate a pregnancy?

Do individuals engaged in the research have a

part in determining the viability of a fetus?

Note : If the answer to any of the above is “No”, the research should not be approved.

When research involves neonate after delivery

Yes No NA

Are scientifically appropriate, preclinical and clinical studies,

conducted and provide data for assessing potential risks to neonates?

. Is the individual providing consent, fully informed regarding the

reasonably foreseeable impact of the research on neonate?

Will any inducements, monetary or otherwise, be offered to terminate

a pregnancy?

Do individuals engaged in the research have a part in any decisions

as to the timing, method or procedures used to terminate pregnancy?

Do individuals engaged in the research have a part in determining the

viability of a fetus?

A. Fetuses of uncertain Viability

Does the research hold out the prospect of enhancing the probability

of survival of the particular fetus to the point of viability, and is any

risk least possible for achieving the objectives of the research?

OR

The purpose of the research is development of important biomedical

knowledge which cannot be obtained by other means. Will there be a

risk to the fetus from the research?

Is the legally effective informed consent of either parent of the

neonate or, if neither parent is able to consent because of

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unavailability, incompetence or temporary incapacity, the legally

effective informed consent of either parent’s legally authorized

representative obtained?

B. Nonviable fetuses

Will vital functions of the neonate be artificially maintained?

Is there any risk to the neonate resulting from the research?

The purpose of the research is the development of important

biomedical knowledge that cannot be obtained by other means

The legally effective informed consent of both parents of the neonate

will be obtained except that the waiver and alteration provisions do

not apply. However, if either parent is unable to consent because of

unavailability, incompetence, or temporary incapacity, the informed

consent of one parent of a nonviable fetus will suffice to meet the

requirements of this paragraph. (The consent of a legally authorized

representative of either or both of the parents of a nonviable fetus

will not suffice to meet the requirements of this paragraph.)

Note : If the answer to any of the above is “No”, the research should not be approved.

This type of research can be conducted only after The IEC finds that

(a) The research presents a reasonable opportunity to further the understanding, prevention or

alleviation of a serious problem affecting the health or welfare of pregnant women and/or

fetuses.

(b) The research will be conducted in accordance with applicable regulatory and ethical

guidelines.

Signature of Principal Investigator: __________________ Date _______________


Comments of the Reviewer :

Recommendations of the Reviewer :


Date :

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Annexure-18.3. : Checklist for Research Involving Cognitively Impaired Individuals (To

be filled by PI and submitted to IEC ; To be cross verified by Reviewer During Review )



A. Research Involving Cognitively Impaired Adults in which there is Anticipated Direct

Benefit to the participant

Yes No

Is the recruitment of participants justified considering the rationale

and objectives of the study?

The risk is justified by the anticipated benefit to the participants.

The relation of anticipated benefit to the risk is at least as favorable to

the participants as that presented by available alternative approaches

Will the participants be withdrawn if they appear to be unduly

distressed?

The proposed plan for the assessment of the capacity to consent is

adequate.

Consent will be taken from participants capable of being consulted.

Does the consent document include provision for a legally authorized

representative in case participants are not capable of being consulted?

Note : If response to any of the above is “No”, the Research should not be approved.

B. Research Involving Cognitively Impaired Adults in which there is No Anticipated

Direct Benefit to the participant

Yes No

Is the recruitment of participants justified considering the rationale

and objectives of the study?

Are the foreseeable risks to the participants low?

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Is the negative impact on the participant‘s well-being minimized and

low?

Will the participants be particularly closely monitored?

Will the participants be withdrawn if they appear to be unduly

distressed?

The proposed plan for the assessment of the capacity to consent is

adequate.

Consent will be taken from participants capable of being consulted.

Does the consent document include provision for a legally authorized

representative in case participants are not capable of being consulted?







Date :

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Annexure-18.4. : Checklist for Research Involving Students, Employees or Residents (To

be filled by PI and submitted to IEC ; To be cross verified by Reviewer During Review )



Yes No

Have the participants been assured that their status (education,

employment and/or promotion) will not be affected by any decision to

participate or not?

Have the risks to participants been minimized?

Have participants been assured that participation is voluntary (no

signs of coercion)?

Have participants been assured that privacy and confidentiality will be

protected?







Date :

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Annexure-18.5. : Checklist for Genetic Research (To be filled by PI and submitted to

IEC ; To be cross verified by Reviewer During Review )



Yes No

Will the samples be made anonymous to maintain confidentiality? If

yes, then the following checklist points are not applicable

Will the results be disclosed?

a) If yes, has the investigator established clear guidelines for

disclosure of information, including interim or inconclusive research

result?

b) Will the results be used in management of current condition of

patient?

Has the appropriateness of the various strategies for recruiting

participants and their family members been considered?

Does the proposed study population comprise family members?

Will family members be implicated in the studies without consent?

Will the samples be destroyed in the future?

Will the samples be used for future research ?

Is genetic counseling being offered?






Date :

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19. SOP-19 : Dealing with Participants’ Requests and/or Complaints to

Institutional Ethics Committee

19.1. Purpose: The purpose of this SOP is to describe procedures for dealing with requests for

information by research participants regarding their rights as a participant or to resolve their

complaint/s that is/are related to their participation in research approved by the Institutional Ethics

Committee

19.2. Scope: This SOP applies to handling of requests for information/ complaints made by

participants concerning the rights and well-being of the research participants participating in research

studies by the IEC

19.3. Responsibility: It is the responsibility of the IEC Secretariat and Chairperson/ Member Secretary

to initiate the process of giving information asked by research participants or to address any injustice

that has occurred, if any complaints are received.

19.4. Procedures:

19.4.1. A request, complaint or query, from a research participant will be accepted by the Secretariat

and forwarded to the IEC Member Secretary after entering into the request record form

19.4.2. The Member Secretary may receive a request, complaint or query directly from the participant.

He/she will record it in the request record form and notify the Secretariat.

19.4.3. The Member Secretary will additionally ascertain details of the request/ complaint by

examining any relevant documents and by interviewing the participant if necessary. If required, the

Member Secretary will call for additional relevant information and documents from the Principal

Investigator.

19.4.4. The Secretariat will inform the Chairperson about the request, query or complaint received

from the research participant.

19.4.5. In case of a request for additional information or clarification, the Member Secretary in

consultation with the Chairperson will provide the information himself / herself or will designate one

or more IEC member(s) to provide such information.

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19.4.6. In case of a complaint received from a research participant:

A) The Member Secretary, in consultation with the Chairperson will initiate a process to address any

injustice that may have occurred. Depending on the seriousness of the matter, the Chairperson will

direct the Member Secretary to:

Appoint a subcommittee of two or more IEC members for enquiry in order to resolve the

matter.

Call an emergency meeting of two or more IEC members for discussion or

Consider the matter for discussion at the next full board meeting

B) The Chairperson/ Member Secretary/ designated IEC members will assess the situation and

mediate a dialogue between the research participant and PI in an attempt to resolve the matter.

C) The IEC will insist on factual details to determine gap, if any, between truth and individual

perception

19.4.7. The final decision will be taken by the Chairperson based on the recommendation of any

one of the above and it will be informed to the research participant and the PI by the Secretariat.

19.4.8. The information including any action taken or follow-up and final decision will be recorded

in the form and the form is signed and dated.

19.4.9. The IEC members will be informed about the action taken and the outcomes in the

forthcoming IEC meeting (in case of requests/ complaints not discussed in full board meeting) and

minuted.

19.4.10. The Secretariat will place all documents in the relevant study file.

19.5. Annexure.

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Annexure - 19. : Request/Complaint Form

Date :

Received by :

Request/ Complaint

received through:

a) Telephone No. :

b) Letter , Dated :

c) E mail, dated. :

d) Walk-in , Date and Time :

Participant’s Name

Contact details

Address & Phone:

FMIEC Protocol No.

:

Title of the Project

:

Starting date of

participation :

Information

requested/

complaint/query

Action taken:

Reviewed by

Final Decision

Date of IEC meeting

(if applicable)

Signature of Member Secretary with Date

Signature of Chairperson with Date

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20. SOP-20 : Maintenance of Active Study Files, Administrative Records of IEC,

Archival of Closed Files and Retrieval of Documents

20.1. Purpose : The purpose of this SOP is to describe the process of maintenance of active study files

and other related documents approved by the Father Muller Medical College Ethics Committee

(FMIEC), FMIEC administrative documents, archival of closed files and retrieval of documents.

20.2. Scope : This SOP applies to maintenance, archival and retrieval of all study files and study related

documents and FMIEC administrative documents by the FMIEC secretariat.

20.3. Responsibilities

It is the responsibility of Member Secretary with assistance of Joint Secretary and Secretariat

to ensure that all active study files and FMIEC records are prepared, maintained during the

study period and kept securely for a period of five years after the closure/ termination of the

project.

20.4. Procedure : FMIEC maintains a master document list which has names of all

files/records/documents maintained in FMIEC.

20.4.1. Maintenance of the Active Study Files

A study master file is the file comprising all essential documents and correspondence

related to the study. This should be created for all proposals at the time of initial

submission to the FMIEC office. These should include copies of

- Protocol submission form

- Clearance from scientific committee of FMIEC (including corrections suggested by

the scientific committee and modifications made)

- Copy of study protocol/research project/trial

- Detailed budget form (including break up of funds utilized/incurred)

- Informed consent documents (patient information sheet and consent form) – in

English and also in local language

- Project timeline including start and approximate completion period

- Statement of intent from PI for periodic review of the project by ethics committee

- All other documents mandatory as per the requirements/merit of the project/trial

(eg : insurance certificate, Permission letters from Director/HOD etc)

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- All related documents of the approved study will be gathered, classified

appropriately and placed in the study master file. The protocols will be kept with all

their necessary documents by the month of clearance from the committee so as to

facilitate paper and electronic retrieval. All the necessary documents related to the

protocol will be kept in a file which could include copies of

- All original research proposals reviewed & approved,

- Reviewer’s assessment forms

- Study approval letter

- Reviewed & approved consent documents, amendments & any other correspondence

- Study progress reports and interim reports,

- Serious adverse event report forms submitted by investigators,

- Any other reports

- FMIEC correspondence

*Strict confidentiality will be maintained for the contents of the files

*All active files will be kept secured in a file cabinet with controlled access.

*A log book for accessing the files by authorized staff & members will be maintained.

20.4.2. Maintenance of Administrative Records

The FMIEC records will include the following:

1. FMIEC members' records

• Appointment and acceptance letters of each member

• Signed and dated confidentiality agreements

• Updated Curriculum vitae (hard copy or soft copy)

• Training records for each FMIEC member (GCP, SOP)

• Documentation of resignations / terminations

2. FMIEC membership roster - An FMIEC roster will be maintained which will

contain:

a. Names of FMIEC members

b. Age

c. Gender

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d. Evidence of qualifications

e. Role in the FMIEC

f. Status of affiliation to institution (e.g., unaffiliated or affiliated)

g. Regular/ Alternate member to the FMIEC (if applicable)

3. Correspondence related to changes in FMIEC membership with any

authority concerned

4. FMIEC attendance roster

5. Leave letter for absence from any of the meeting with reasons

6. Agenda and Minutes of FMIEC meetings

7. Standard operating procedures (SOPs)

8. Annual reports

9. Documents related to Workshops & conferences organized/attended by

FMIEC (Continuing education for members & staff)

10. SOP training and distribution logs

11. Financial transactions

12. List of studies approved by FMIEC with protocol numbers

20.4.3. Maintenance of Closed Study Files

1. Once the study file is closed (following completion/ premature termination), the

related study files will be shifted to the FMIEC Archival room.

2. All closed study files will be archived in the FMIEC archival room for a period of

five years from the date of closure of the study.

3. A log book for archival of study documents will be maintained.

20.4.4. Accessibility / Retrieval

1. Study files and administrative records will be made available for audit, making

photocopies on request or any other purpose if authorized by Member Secretary/

Chairperson. Representatives of regulatory authorities may have access at all

times.

2. A log book of retrieval of documents will be maintained.

20.4.5. . Disposal of Closed Files and Copies of Protocols and Documents Submitted for FMIEC

Review

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1. At the end of the archival period, the closed files will be shredded and disposed

off by authorized FMIEC personnel.

2. Extra copies of protocols and documents submitted for FMIEC review and any

other extra copies will be shredded by authorized FMIEC personnel after the

FMIEC meeting without any notification to PI.

3. A formal disposal log will be maintained, providing details of documents that will

be disposed.

20.5. Annexures :

Annexure-20.1. Document request form

Project no

Project title

Name of PI

Requested by

Documents requested

Purpose of request

Signature of requesting person

Signature of PI

Signature of member secretary/ Chairperson with date

Annexure -20.2. : Log for disposal of study documents

Project Title Name of No. of Date of Date of Date of Disposed by

No. Principal files FMIEC Study Study (Name & Sign) of

Investigator Approval Initiation Closure Authorized Individual

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21. SOP-21 : Protection of Rights, Safety , Privacy and Confidentiality of

Study Subjects

21.1. Purpose: The purpose of this SOP is to describe the mechanisms adapted by the IEC for

protection of rights, safety of study subjects , confidentiality of information of subjects

participating in research studies at FMCI

21.2. Scope : This SOP is applicable to protect the rights, safety and confidentiality of study

subjects , and to be followed by all stakeholders

21.3. Responsibility:

Primary responsibility is with the FMIEC to safeguard the interests of study subjects

while the investigators and team members of research studies are responsible as well.

21.4. Procedure :

21.4.1. FMIEC has processes in place for protection of rights, safety, privacy and

confidentiality of subjects. Rights of subjects are documented in the “Policies”

document, made known to all members of the FMIEC and the researchers through

training and the “Policies” document. For the benefit of study subjects, the patient

charter having “Rights and Responsibilities” is displayed in the clinical trial sites

(Outpatient departments), and in the offices of clinical trial and FMIEC.

21.4.2. The FMIEC ensures that the Subject’s participation in the research study and

withdrawal from the study are voluntary and with prior intimation. During the initial

review of research proposals, the informed consent documents are reviewed in detail

using a checklist. The FMIEC members go through the patient information sheet,

informed consent form and the child assent form in detail. During the review , the

contents of informed consent document ; the language; , statement that the

participation and withdrawal are voluntary; explanation of risk and benefits from the

study, availability of alternative treatment modalities are verified. If there are any

deficiencies, they are informed to the principal investigator asking him/her to do the

revision as required. Research proposals are approved only after the required changes

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are done in informed consent documents. The review procedures are explained in the

“SOP-10 : Review of resubmitted and amended protocols and protocol-related

documents”.

21.4.3. The FMIEC has the authority to verify the above by interviewing the subjects,

to witness the informed consent process, and to review the consent process in written

record.

21.4.4. The FMIEC does the periodic review and on site monitoring of research studies

to ensure equitable selection of subjects, with special attention to vulnerable and high

risk subjects. The committee verifies selection of subjects as per the inclusion and

exclusion criteria. The FMIEC verifies subject log during the periodic review. The

periodic review and on site monitoring are explained in the “SOP-11 : On-Site

Monitoring of Protocols”.

21.4.5. The FMIEC reviews the clinical trial contract and insurance documents during

the initial review to verify that the compensation paid to subjects for participation in

the trial shall be appropriate and as per the rules and regulation. During the periodic

review, the compensation paid will be verified on the basis of written records. Visit

schedule of the subjects, informed consent documents, records of payment will be

verified by FMIEC.

21.4.6. The FMIEC has the mechanism for reporting and addressing of serious adverse

events. The Chairperson of FMIEC has constituted a SAE subcommittee which

analyzes the SAE and reports to the FMIEC. The details are given in the “SOP-15 :

Review of Serious Adverse Events (SAE) Reports”.

21.4.7. The FMIEC has a mechanism of address the confidentiality and privacy of

subjects. The members of the committee sign a confidentiality agreement during the

induction and declare that they will not reveal the subjects details publicly. The study

documents issued to members for review are given back to the office of FMIEC after

the review. The FMIEC has a safe storage space of documents, and access is restricted

to ensure confidentiality of trial records.

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21.4.8. The FMIEC reviews and verifies that the investigators of clinical trials and the

team do unique coding of study subject files. Also, the statement in informed consent

documents on maintaining confidentiality and privacy are verified and ensured . During

the on site monitoring ,the compliance by the investigators is verified by the FMIEC.

21.5. Annexure :

Annexure- 21 : List of measures taken by FMIEC to protect the rights,

confidentiality and privacy of study subjects

1. Proper and detailed initial review of study proposals; detailed review of informed

consent documents and insurance documents and clinical trial agreement

2. Continuing review, on site monitoring of clinical studies

3. Witnessing the informed consent process and interviewing the study subjects

4. Grievance reddressal mechanism

5. Display of rights of study subjects at the study sites

6. Maintaining confidentiality of study documents at the ethics committee office and

meetings

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References :

1. ICMR. National Ethical Guidelines for Biomedical and Health Research Involving

Human Participants. Indian Council of Medical Research: New Delhi; 2017.

2. FERCI. Standard Operating Procedures. Forum for Ethics Review Committees in

India.