Table of Contents - mrinstitute.orgmrinstitute.org/upload/Guideline for PI-2017.pdf · Mochtar Riady Institute for Nanotechnology Ethics Committee (MRIN EC) Page 3 of 61 3. Procedure

Mochtar Riady Institute

for Nanotechnology

Ethics Committee (MRIN EC)

Page 1 of 61

Table of Contents 1 The Importance of Ethics …………………………………………………………………………………… 2 2 Who has to submit an Ethics Application?.................................................................................... 2 3 Procedure for Protocol Submission for Initial Review and Resubmission…………….. 3 4 Procedure for Submission for Protocol Amendment………………………………………….. 7 5 Procedure for Continuing Review……………………………………………………………………… 8 6 Serious Adverse Event and Unexpected Adverse Drug Reaction 9 7 Final Report of Study………………………………………………………………………………………… 11 8 Study Termination……………………………………………………………………………………………. 12 9 Type of Review…………………………………………………………………………………………………. 12 10 Length of Review……………………………………………………………………………………………… 12 11 Appendices………………………………………………………………………………………………………. 14 11.1 Application Form for Initial Review…………………………………………………………… 14 11.2 Summary Sheet of Study Protocol……………………………………………………………… 16 11.3 Protocol Submission for Clinical Trial Research 19 11.4 Protocol Submission Form for Health-Related Research including Survey,

Registry, Surveillance, Epidemiology, Humaniora, Stored Biological Specimen, Non-Clinical……………………………………………………………………………………………………..

24

11.5 Protocol Amendment Submission Form …………………………………………………... 31 11.6 Continuing Review Application Form ……………………………………………………… 43 11.7 Serious Adverse Event Report Form………………………………………………………… 46 11.8 Unexpected Adverse Event Summary Report……………………………………………. 49 11.9 Unexpected Adverse Event Summary Report…………………………………………… 51 11.10 Study Report Form………………………………………………………………………………… 52 11.11 Study Termination Memorandum…………………………………………………………… 54 11.12 Flow Chart of Application Submission Process………………………………………… 55 11.13 Glossary………………………………………………………………………………………………… 56 11.14 List of Abbreviation………………………………………………………………………………… 58 11.15 Template for Information Subject 59 11.16 Template Informed Consent Form 61


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1. The Importance of Ethics

Research involving human participants, animals or biological materials should be

based on a fundamental moral commitment to the individual or animal concerned.

The research should also result in advancing human welfare, knowledge and

understanding. It is a universal requirement mandated by all research bodies that all

institutions should establish an Ethics Committee to monitor research activities.

2. Who has to submit an Ethics Application?

Anyone employed in Mochtar Riady Institute for Nanotechnology (MRIN), Faculty of

Medicine, Universitas Pelita Harapan (FK UPH), Universitas Pelita Harapan or Siloam

Hospitals who intends to undertake a research or teaching project involving any form

of human participation or animal studies has an ethical responsibility toward the

subjects of that project. This includes research carried out on MRIN premises or

conducted elsewhere.

The MRIN Ethics Committee is the body that reviews and approves such projects to

ensure that the ethical responsibilities are appropriately addressed in the project.

Their review is based on details provided by the completion of an ethics application

for research involving human subjects or animals.

The following guideline is prepared to assist Researcher/ Principal Investigator (PI)

to outline the submission requirements for full or expedited review of new protocols

and modification to an approved protocol. As an ethics conduct has to be maintained

throughout a study, this guideline describes procedure for additional report

mechanism after a protocol is approved.


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3. Procedure for Protocol Submission for Initial Review and Resubmission

New research protocol should be submitted for Initial Review by the MRIN EC to

obtain ethics approval. Investigation and/ or collection of data on human subjects or

laboratory animals for research purposes;requires ethics approval by MRIN EC prior

to implementation.

The Procedure for Protocol Submission for Initial Review or Resubmission is as

follows:

1. Complete Application Form for Initial Review (Form AF/01-010/2017/01.2).

2. Complete Summary Sheet of Study Protocol (Form AF/02-010/2017/01.2).

3. Complete Protocol Submission Form AF/03-010/2017/01.2 for Clinical Trial

Research, or Form AF/04-010/2017/01.2 for Health-Related Research including

Survey, Registry, Surveillance, Epidemiology, Humaniora, Stored Biological

Specimen, Non-Clinical, or Form AF/05-010/2017/01.2 for the use and care of

Animal/ Animal Tissue in Research/ Teaching/ Testing.

4. Submit to the Secretariat of MRIN EC the following documents:

a. three (3) sets of Form AF/01-010/2017/01.2

b. three (3) sets of Form AF/02-010/2017/01.2 and

c. three (3)sets of either Form AF/03-010/2017/01.2 or AF/04-010/2017/01.2

or AF/05-010/2017/01.2 depending on the type of research including the

attachments

d. one (1) set of Cover Letter from referring Institute

e. one(1) set of original research proposal as approved by Advisor or

Institutional Head.

f. Research Proposal should contain:

Title

Table of Content

Summary of Research


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Background

Problem

Aim /Objective

Hypothesis

Aim/ Objective

Materials and Methods including

a. Theoretical and Conceptual Frame Work

b. Time and Place

c. Study design,

d. Sample Recruitment, Sample Number

e. Inclusion , Exclusion Criteria, With draw Criteria

f. Definition of Operation

g. Process of Data Collection

h. Management and Data Analysis

i. Method of Analysis, etc

Detailed Budged

Timeline

References

Example of Incidence Card for Study Subjects

Example of Informed Consent (In Bahasa Indonesia)

Guidelines for Informed Consent:

Informed Consent should be written in Bahasa Indonesia, and

include all of the “elements of consent” listed below. Write in plain

language that is easy for a potential participant to understand.

Avoid long words or sentences, and write in short, to-the-point

sentences. Avoid repetition of sentences, and make the document

as short as possible without leaving out important information.

Obtaining participant’s consent is a process. Participation in a study

should be truly voluntary, and the participant should understand

what he or she is agreeing to do. The investigator must make sure


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that the participant understands all the important elements of the

consent form at the time the consent form is signed, and during the

research study. The participant should understand that

participation is voluntary and that he or she can withdraw from the

study at any time.

Elements of Informed Consent:

1. A statement that the study involves research, with an explanation of the purposes of the research. The expected duration of the participant's participation; A description of the procedures to be followed and identification of any procedures which are experimental.

2. A description of any reasonably foreseeable risks or

discomforts to the participant. 3. A description of any benefits to the participant or to others

which may reasonably be expected from the research. 4. A disclosure of appropriate alternative procedures or courses

of treatment, if any, that might be advantageous to the participant

5. A statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained;

6. For research involving more than minimal risk, an explanation as to whether any compensation is available. If injury occurs, an explanation as to whether any medical treatments are available, what they consist of, or where further information may be obtained;

7. An explanation of whom to contact for answers to related questions about the research and research participants' rights; and whom to contact in the event of a research-related injury to the participant;

8. A statement that participation is voluntary. A statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled. A statement that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.


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In addition, the Informed Consent may contain the following items when appropriate:

To assist the Principal Investigators (PI) in the design of their informed

consent, a Template is attached in the Appendix (chapter 10)

5. All documents are to be submitted inboth formats, hard and soft copy (pdf file)

with the signatures. The soft copy with the signature of the PI must be emailed

to MRIN EC Secretariat ([email protected]).

6. MRIN EC Secretariat will verify the completeness of submitted documents. The

MRIN EC will only consider complete documents for ethical review.

7. If necessary, MRIN EC may invite the Principal Investigator (PI) to give

clarification on issues that can arise during review process.

8. When the review process has been concluded, MRIN EC Secretariat will notify

the PI about MRIN EC’s Decision, if the approval is granted, requires major or

minor modification, or rejected.

9. In case a minor or major revision is required, after revision the PI has to

resubmit all forms again (items a – e) to MRIN EC for a re-review. Changes made

in any of the documents must be typed/ written in bold letters, and indicated in

the cover letter when the documents are resubmitted.

a. A statement that the particular treatment or procedure may involve risks to the participant (or to the embryo or fetus, if the participant is or may become pregnant), which are currently unforeseeable

b. Anticipated circumstances under which the participant's participation may be terminated by the investigator without regard to the participant's consent

c. Any additional costs to the participant that may result from participation in the research

d. The consequences of a participant's decision to withdraw from the research and procedures for orderly termination of participation by the participant.

e. A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject

f. The approximate number of subjects involved in the study

mailto:[email protected]


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10. The decision on the resubmission will be communicated to the PI once MRIN EC

has finished conducting the re-review.

4. Procedure for Submission for Protocol Amendment

During the course of the study, investigators can amend the contents of the

protocolfrom time to time. The PI should submit the amendments to the MRIN EC for

either “expedited” or full review,by submitting 3 sets of the Protocol Amendment

Submission Form (AF/01-013/2017/01.4) including the letter from the referring

institution.

All documents are to be submitted in both formats, hard and soft copy (pdf file) with

the signatures. The soft copy with the signature of the PI must be emailed to MRIN EC

Secretariat ([email protected]).

Criteria for “expedited” review may include:

administrative revisions, such as correction of typos

addition or deletion of non-procedural items, such as the addition of study

personnel names, laboratories, research population , etc

non-significant risk research activity

the research activity with only minor changes from previously approved

protocol

Changes in protocol, which increase risk to study participant are subject to full review

by the MRIN EC. Examples are changes in study design, which may include but are not

limited to:

additional treatments or the deletion of treatments

any changes in inclusion/exclusion criteria

change in method of dosage formulation, such as, oral changed to intravenous

significant change in the number of subjects

significant decrease or increase in dosage amount



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MRIN EC Secretariat will notify the PI if the protocol amendment is approved or not.

In case the MRIN EC votes to require modifications to any of the documents, or the

protocol amendment, the Secretariat sends a written request about the specific

changes to the PI asking him or her to make the necessary changes and resubmit the

documents to MRIN EC.

5. Procedure for Continuing Review

The purpose of a continuing review is to monitor the progress of the entire studyto

ensure continuous protection of the rights and welfare of research participants.

Depending upon the degree of risk to the participants, the nature of the studies, and

the vulnerability of the study participants and duration of the study, the MRIN ECmay

choose to review or monitor the protocols more frequently.

MRIN EC Secretariat will inform the ‘Study team’ in advance of the due date for the

continuing review by fax, post, e-mail or by other appropriate means. The PI is

required to fill up and submit 3 sets of the Continuing Review Application Form

(AF/01-014/2017/01.4). The MRIN EC will conduct a review of the study and the

Secretariat will inform the PI after a decision has been reached no later than 7

working days after the review has taken place.




Elements for Progress Report including:

1. Have there been any changes to the project since the previous ethics approval

(Renewal or Amendment)?

2. Please provide a brief summary of the progress of the study.

3. Include information surrounding study implementation details (such as the

recruitment of participants) and whether or not the study is progressing as planned.



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4. Please document any issues that might pose a challenge to the study meeting its

proposed timelines. Attach supporting documents if necessary.

5. During the course of the project have any ethical concerns or difficulties arisen?

6. Please list any Amendments that have been submitted since the date indicated on

the Letter of Initial Ethics Approval

7. Has your study experienced any unanticipated problems?

8. Have all SAEs been reported since your study was initially approved?

9. If SAEs have occurred but have not been reported, please explain why they have

not been reported, give details of these events, and provide your opinion on whether

these are study-related, whether they affect the ethics of continuing the study, and

whether they necessitate any changes to the informed consent process. Please

provide an overall assessment.

Additional elements for Animal Research Progress Report:

1. Explain any major discrepancies between the number of each species of animal

which were approved and the number used.

2. Were any changes made to the approved experimental procedures?

3. Problems/adverse events: Describe any adverse effects and/or unexpected

mortalities that occurred, the procedures undertaken to establish the causes, steps

taken to avoid or minimize any pain or distress, and how these problems were

resolved. If none, this should be indicated.

4. Problems associated with post-operative or post experimental recovery. Describe

any problems that occurred, steps taken to avoid or minimize any pain or distress,

and how these problems were resolved. If none, this should be indicated.

6. Serious Adverse Event and Unexpected Adverse Drug Reaction

Unanticipated risks are sometimes discovered during the course of studies.

Information that may impact on the risk/benefit ratio should be promptly reported to

and reviewed by the MRIN EC to ensure adequate protection of the welfare of the

study participants.

The unanticipated risks may as well include any event that in the investigator’s

opinion may adversely affect the rights, welfare or safety of subjects in the study.

The investigators or sponsors must report the SAE within 10 working days after the

incident occurred and unexpected events should be included in the continuing review

report submitted to MRIN EC. Investigators should use Forms Serious Adverse Event


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Report (AF/01-019/2017/01.2) or Unexpected Adverse Event Summary Report

(AF/02-019/2017/01.2) to inform the MRIN EC about the event.

Categories of incidence for Serious Adverse Event (SAE) and Unexpected Adverse

Drug Reaction (ADR) are listed in Table 1.

Table 1. Criteria for SAE and Unexpected ADR

Serious Adverse Event (SAE)

The adverse event is SERIOUS and should be reported when the patient outcome is:

Death - Report if the patient's death is suspected as being a direct outcome of the adverse event.

Life-Threatening - Report if the patient was at substantial risk of dying at the time of the adverse event or it is suspected that the use or continued use of the product would result in the patient's death.

Examples: Pacemaker failure; gastrointestinal hemorrhage; bone marrow suppression; infusion pump failure which permits uncontrolled free flow resulting in excessive drug dosing.

Hospitalization (initial or prolonged) - Report if admission to the hospital or prolongation of a hospital stay results because of the adverse event.

Examples: Anaphylaxis; pseudomembranous colitis; or bleeding causing or prolonging hospitalization.

Disability- Report if the adverse event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.

Examples: Cerebrovascular accident due to drug-induced hypercoagulability; toxicity; peripheral neuropathy.


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Congenital Anomaly - Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.

Examples: Vaginal cancer in female offspring from diethylstilbestrol during pregnancy; malformation in the offspring caused by thalidomide.

Requires Intervention to Prevent Permanent Impairment or Damage – Report if suspect that the use of a medical product may result in a condition which required medical or surgical intervention to preclude permanent impairment or damage to a patient.

Examples: Acetaminophen overdose-induced hepatotoxicity requiring treatment with acetylcysteine to prevent permanent damage; burns from radiation equipment requiring drug therapy; breakage of a screw requiring replacement of hardware to prevent malunion of a fractured long bone.

Unexpected Adverse Drug Reaction (ADR)

Unexpected ADR is an adverse reaction, the nature or severity of which is not consistent with the informed consent / information sheets or the applicable product information (e.g., investigator’s brochure for the unapproved investigational product or package insert / summary of product characteristics for an approved product.

7. Final Report of Study

Once a study has been completed, Principal Investigators are required to submit final

report for any study approved by the MRIN EC. Although MRIN ECprovides 3 sets of

Study Report Form (AF/01-015/2017/01.3), report written in letter format, or in a

format provided by the Sponsor (in case of Clinical Trial) may be used. Each Board

member will review the Final Report, and if appropriate to the discussions, MRIN EC

may call for consensus on whether to request further information or to take other

action with the investigator.


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8. Study Termination

Protocols are usually terminated at the recommendation of the MRIN EC, Data Safety

Monitoring Board (DSMB), Scientific Director, sponsor or other authorized bodies

when subject enrollment and subject follow-up are discontinued before the scheduled

end of the study; or when the safety or benefit of the study participants is doubtful or

at risk. Upon notification from MRIN EC Secretariat the Principal Investigator is then

required to prepare and submit Study Termination Memorandum (AF/01-

018/2017/01.3) to MRIN EC. Once the review has been completed, MRIN Secretariat

will inform the PI of MRIN EC’s decision on the study termination.

9. Type of review

The protocol submission will be determined as Exempted, Expedited or Full Board by

the Secretary of EC.

10. Length of Review

PI will receive notification from Secretariat within 1-4weeks after the submission of

completed document for expedited and exempted and 7 working days after the full

board meeting.

11. References

1. World Medical Association (WMA) Declaration of Helsinki - Ethical Principles

for Medical Research Involving Human Subjects, 2008



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2. World Health Organization (WHO) - Standards and Operational Guidance for

Ethics Review of Health-Related Research with Human Participants, 2011

3. Institutional Animal Care and Use Committee Guidebook, 2002

4. Pedoman Nasional Etik Penelitian Kesehatan, Komisi Nasional Etik

Penelitian Kesehatan, 2011.

5. Standard Operating Procedures Mochtar Riady Institute for Nanotechnology

Ethics Committee (MRIN EC), 2013

6. Policy and Guidance of Office for Human Research Protections (OHRP). US

Department of Health and Human Services. (30 Sep. 1998). Retrieved 7 April

2014 from http://www.hhs.gov/ohrp/policy/consentckls.html.

7. Informed Consent Guidance. Johns Hopkins Medicine Office of Human Subjects

Research - Institutional Review Boards (October 2012). Retrieved 7 April 2014

from http://www.hopkinsmedicine.org/institutional_review_board/

guidelines_policies/guidelines/informed_consent_i.html.


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11. Appendices

11.1. Application Form for Initial Review (AF/01-010/2017/01.2)

APPLICATION FORM for INITIAL REVIEW

Protocol Title:

Protocol number: Total Participants to be included:

STUDY TYPE: (Mark “ “ whichever apply to the study) Survey Social Medical Community based Individual based Screening Observational Epidemiology Intervention study Clinical Trial: Phase I Phase II Phase III Phase IV Genetic Study Retrospective Prospective Others………………………………..

STUDY POPULATION:: Healthy Patient Vulnerable groups

CHARACTERISTICS of PARTICIPANTS PARTICIPATED : Age Range: 0 -17 yrs 18 - 44 yrs 45 - 65 yrs > 66 yrs Pediatric None < 1 yr 1-3 yrs 4 -14 yrs Impaired None Physically Cognitively Mentally

REQUESTED EXCLUSION OF PARTICIPANTS: None Male Female Children Other (specify) ) SPECIAL RESOURCE REQUIREMENTS (check all that apply):

Intensive Care Isolation unit Surgery Pediatric Intensive Care Transfusion CAT scan

Gene therapy Controlled substances (Narcotics/Psychotropics) Prosthetics Gynecological services Others, specify…………….

Organ transplantation, specify………………………… ……………………………. IONIZING RADIATION USE (X-rays, radioisotopes, etc): None Medically indicated only INVESTIGATIONAL NEW DRUG (IND) / DEVICE (IDE): None IND IDE FDA No.:……………… FDA No:……………………

Name:…………………. Name:……………………… Sponsor:………………. Sponsor:…………………...

Holder:………………… Holder:……………………...

PROCEDURE USE: Invasive Non-invasive

MULTI-SITE COLLABORATION: YES NO FINANCIAL DISCLOSURE: YES NO INSTITUTE RESEARCH CONTACT Name:……………………………………………………………………………………

Address: ………………………………………………………………………………… Telephone:…………………………………………

Fax:………………………………………………… E-mail:……………………………………………...


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APPLICATION FORM for INITIAL REVIEW

PARTICIPATING INVESTIGATORS (add extra pages if necessary):

First / Last Name Institution Telephone / Fax No.

E-mail

1.

2.

3.

4.

5. CONTACT PERSON: Name:……………………………………………………………………………………. Institute/ Address:…………………………………………………………………….. ……………………………………………………………………………………………. Telephone:……………………………………………………………………………… Fax:………………………………………………………………………………………. E-mail:…………………………………………………………………………………… SIGNATURE:

__________________ Date: ………………..

Principal Investigators

TYPE OF INITIAL REVIEW:* ASSIGNED REVIEWERS:*

☐ Exempted from Review

☐ Expedited Review

☐ Full Board Review

1.

2.

3.

SIGNATURE: Date:…………………

Secretary *to be filled by Secretary MRIN EC


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11.2. Summary Sheet of Study Protocol

(AF/02-010/2017/01.2)

SUMMARY SHEET OF STUDY PROTOCOL

Title of the Protocol*

Principal Investigator (Name, Institution)*

Sponsor

Abstract*

Type of Protocol (Screening, Survey, Clinical Trial, etc)*

Aims*


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Anticipated Outcome*

Inclusion and Exclusion Criteria*

Withdrawal or discontinuation Criteria

Mode of Intervention to the Human/ Animal Subjects*

Methodology (Synopsis of Study Design)*

Analysis method*


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Timeline*

Schedule and Duration of Treatment

Efficacy or Evaluation Criteria (Response/ Outcome)

Safety Parameters Criteria (Toxicity)

* indicates required field Principal Investigator Signature _____________________________________ ___________________ Name Date


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11.3. Protocol Submission for Clinical Trial Research (AF/03-010/2017/ 01.2)

PROTOCOLSUBMISSION FORM FOR CLINICAL TRIAL

To be filled by Principal Investigator (copy of 5)

Please fill out the form completely and return to the Secretariat of MRIN Ethics Committee (MRIN-EC), Jalan Boulevard Jendral Sudirman 1688, Lippo Karawaci, Tangerang 15810, Tel. +62 21 54210123, Fax. +62 21 542 10110, Email : [email protected] Protocol Registration No. (To be filled by the Secretariat of MRIN EC) A. General Information

1 Principal Investigator: (Title, Name, Institution)

2 Title of Research:

3. Type of Research: Non-Cooperation National Collaboration International Collaboration (Attach ethical approval from corresponding country) Involvement of Foreign Researcher (Attach approval from the State Ministry for Science and Technology)

4 Description of the Study in brief: Mark whatever applied to the study.

Randomized Stratified Randomized Open-labeled Double blinded Placebo controlled Treatment controlled Cross-over Parallel Interim Analysis Use of Tissue samples Use of Blood samples Use of genetic materials Multicenter study Screening Descriptive

5 Type of Proposal: New Protocol Continued Protocol


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Modified Protocol Amendment Protocol If continued or modified, please state previous SP3 No.:

6 Institution

7 Funding Resources 8 Total of Research Funding Rp

9 Research Location 10 Research Period Start................................

End............................... 11 Has this protocol been

submitted to other Ethics Committee before

Yes; accepted rejected No

12 Document Completeness (Tick box when appropriate) One set cover letter from referring institution Three copies of original proposal as approved by advisor or institute director

Three copies of application form for initial review Three copies of medical research ethics submission form for clinical trial

Three copies of research proposal summary supplemented with supporting attachments

Attachment 1. Information for Subject

Attachment 2. Informed Consent Form

Attachment 3. List of Research Team with Corresponding Expertise

Attachment 4. CV of Principal Investigator

Attachment 5. Memorandum of Understanding between Researcher, Sponsor and Research Institution (For Research Collaboration)

Attachment 6. Ethical Approval from Other Institution (When Available)

Attachment 7. Case Report Form/ Incidence Card

Attachment 8. Forms: Questionnaire, Laboratory/Radiology Examination Request, Laboratory/Radiology Examination Results

Attachment 9. Adverse Event Report Form

Attachment 9. Investigator’s Brochure (When Necessary)

Attachment 10. Investigational Drugs Approval from BPOM (New Drugs/Food Trial)

Attachment 11. Budgeting Details and Funding Resources


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Attachment 12. Others (e.g. Workflow)

B. Clinical Trial 13 Type of Research: (Tick more than one when appropriate)

Explorative/Descriptive Quantitative (Deductive)

Cross-

sectional

Case-

control

Pre-

Post test

Cohort Clinical

Experiment

Quantitative (Inductive)

14 Clinical Trial Phase Phase I Phase II Phase III Phase IV

15 Purpose of Clinical Trial:

16

Subject Inclusion Procedures: a. Number of Subjects

b. Inclusion Criteria

c. Exclusion Criteria

d. Withdrawal/Drop Out Criteria

e. Acquisition of Subject’s Informed Consent

e.1 Summarize information disclosure procedure to subject (Materials conveyed; Speaker; Means of information delivery; Self-informing through provided manuscripts/Group Session/Accompanied by family/Close acquaintance/Private session; Compensation; Q&A session, etc.)

e.2 Detail relationship between information giver with observed subject

Physician – Patient Teacher- Student Employer-Employee

No Relationship Others: …………………..(please specify)


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17 Information on subtance or medical measure on trial (Has such clinical trial taken place before, are safety data and benefits of previous identical/similar study or studies from other countries available?)

18 Will biological samples be sent abroad? Yes No If Yes, Please include Material Transfer Agreement

19 Clinical Trial Process a. Administration of Intervention (Dose regimen, invasive measures, reference drugs,

placebo) Provide explanatory guidance on procedure: dose and administration, frequency, interval, invasive measures taken, radiation, etc.

b. Selection of Outcome Indicator c. Interim Analysis

d. Clinical Trial Termination Procedure

e. Time Estimate for Processing of One Subject

(minute(s)/hour(s)/day(s)/week(s)/month(s)/year(s)) f. Possible occuring subject involving ethical problem (e.g. inconvenience, please put

to record)


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Date

Principal Investigator

(……………………………………)

20

Adverse Event (AE) a. Documentation (Details of events occurring during treatment)

b. Analysis c. Emergency Rescue System d. Subject Withdrawal from Research at the Cause of AE e. Subject Compensation

21 Data Analysis a. Efficacy

b. Safety

22 Post-Research Responsibility (Capacity building, benefits for local community, treatment maintenance on subjects, etc.)


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11.4. Protocol Submission Form for Health-Related Research including Survey, Registry, Surveillance, Epidemiology, Humaniora, Stored Biological Specimen, Non-Clinical

(AF/04-010/2017/01.2)

PROTOCOL SUBMISSION FORM FOR HEALTH RELATED RESEARCH SURVEY, REGISTRY, SURVEILLANCE, EPIDEMIOLOGY, HUMANIORA, STORED

BIOLOGICAL SPECIMEN, NON-CLINICAL To be filled by Principal Investigator (copy of 5)

Please fill out the form completely and return to the Secretariat of MRIN Ethics Committee (MRIN-EC), Jalan Boulevard Jendral Sudirman 1688, Tangerang 15810, Tel. +62 21 54210123, Fax. +62 21 54210110, Email : [email protected] Protocol registration no.:

(To be filled by the Secretariat of MRIN EC) A. General Information


2 Title of Research:

3 Type of Research Survey Registry Surveillance Epidemiology Humaniora Stored/ Archived Biological Specimen Non-Clinical


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Non-cooperation National collaboration International collaboration (Attach ethical approal from corresponding country) Involvement of foreign researcher (Attach approval from the State Ministry for Science and Technology)



5 Type of Proposal New Protocol Continued Protocol Modified Protocol Amendment Protocol If continued or modified, please state previous SP3 No.:

6 Institution

7 Funding Resources

8 Total of Research Funding

Rp

9 Research Location


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10 Period of Research Start................................ End...............................

11 Has this protocol been submitted to other Ethics Committee before


12 Document Completeness (Tick on box when appropriate) One copy of cover letter from referring institution

Three copies of original proposal as approved by advisor or

institute director

Three copies of application form for initial review

.

Three copies of protocol submission form for health related

research

Three copies of research proposal summary supplemented with supporting attachments

Attachment 1. Information for Subject Attachment 2. Informed Consent Form Attachment 3. List of Research Team with Corresponding

Expertise Attachment 4. CV of Principal Investigator Attachment 5. Memorandum of Understanding between

Researcher, Sponsor and Research Institution (For Research Cooperation)

Attachment 6. Ethical Approval from Other Institution (When Available)

Attachment 7. Case Report Form/ Incidence Card

Attachment 8. Forms: Questionnaire, Laboratory/Radiology Examination Request, Laboratory/Radiology Examination Results

Attachment 9. Adverse Event Report Form

Attachment 10. Investigator’s Brochure (When Necessary)

Attachment 11. Budgeting Details and Funding Resources


B. Health-Related Research


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13 Research Description

a. Research Type and

Design

Explorative/Descriptive

Quantitative/Deductive

Cross

Sectional

Case

Control

Cohort

Community

Experiment

Public/population

Experiment

Qualitative/ Etnographical participatory

b. Type of Samples Individual

Population

Institutional

c. Number of Samples 1). Based on problem

Yes No

2). Based on minimum requirement for function:

- participant observation

- indepth interview

Yes

No

3). Based on population number (representative ness of the samples)

Yes

No

d. Sample Collection 1). Probability :

Simple Random

Progressive Random

Point Prevalence Survey


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Cluster

2). Non Probability

Purposive Samples

Quota Samples

Chunk Samples Volunteer Samples

e. Type of Data Primary

Secondary

f. Data Collection . Interview

Physical Examination

Laboratory and/or Radiology Examination Document Analysis

g. Time estimate for processing of one subject: ................. (minute(s)/hour(s)/day(s)/week(s)/month(s)/year(s)*) * delete as applicable

14 Will biological samples be sent abroad? Yes No If Yes, Please include Material Transfer Agreement

15 Possible occurring subject involving ethical problem a. Data Confidentiality Yes No

b. Research Risk

b.1. Interference of routine healthcare service activities

Yes No

b.2. Causing adverse effects on subject

Yes No

b.3. In opposition to common cultural values

Yes No


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b.4. Occurrence of economical loss and stigmatization of subject

Yes No

c. Participation Stimulation

c.1. Incrementing on new knowledge

Yes No

c.2. Provision of medical attention

Yes No

d. Compensation

Yes No

If yes, state form of compensation: Item(s)

Cash

Insurance

e. Factors affecting compensation (coercion)

e.1. Researcher-Subject Relationship

Yes No

e.2. If yes, state type of relationship:

Physician-Patient

Teacher-Student

Employer-Employee

Others

16 Informed Consent

a. Informed Consent Grouping: Individual

Public

b. Please detail means to invite subjects in participating in research when using individual/public groups. By verbal consent or situations where no informed consent is available, please provide explanatory feedback.

17 If the research involves healthy individuals, please state the method of examination If the research involves affected individuals, please state the method of examination


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18 Please name type of intervention (Information session, mass treatment,

training, etc.)

19 Please details documentation procedure during research, including adverse effects and subsistent complications.

Date.............................20.....


(..........................................)


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11.5. Protocol Submission Form for the use and care of Animal/ Animal Tissue (AF/05-010/2017/01.2)

PROTOCOL SUBMISSION FORM FOR THE USE AND CARE OF ANIMAL/ ANIMAL TISSUE IN RESEARCH/ TEACHING/ TESTING To be filled by Principal Investigator (copy of 5)

Please fill out the form completely and return to the Secretariat of MRIN Ethics Committee (MRIN-EC), Jalan Boulevard Jendral Sudirman 1688, Tangerang 15810, Tel. +62 21 54210123, Fax. +62 21 54210110, Email: [email protected] Protocol registration no.:

(To be filled by the Secretariat of MRIN EC) A. General Information


2 Title of Research (include the species of animals to be used):

3 Type of Research Non-cooperation National collaboration International collaboration (Attach ethical approval from corresponding country)

Involvement of foreign researcher (Attach approval from the State Ministry for Science and Technology)




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5 Type of Proposal New Protocol Continued Protocol Modified Protocol Amendment Protocol If continued or modified, please state previous SP3 No.:

6 Institution

7 Funding Resources

8 Total of Research Funding Rp

9 Research Location

10 Period of Research Start................................ End................................

11 Has this protocol been submitted to other Ethics Committee before


12 Document Requirements for Protocol Completeness (Tick box when appropriate) One copy of cover letter from referring institute

Three copies of original proposal approved by advisor or institutional head (Attach approval from authorized parties)

Three copies of application form for initial review

Three copies of medical ethics submission form for animal research Three copies of proposal summary with following attachments: Attachment 1. List of Research Team with Corresponding Expertise Attachment 2. Personal Information of Principal Investigator (Including

Research Experience)


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Attachment 3. Approval from Authorized Supervisor Attachment 4. Approval from Appointed Animal Research Expert Attachment 5. Memorandum of Understanding between Researcher,

Sponsor and Research Institution (For Research Cooperation)

Attachment 6. Investigator’s Brochure (When necessary)

Attachment 7. Budgeting Details


B. ANIMAL STUDY

13 Has this research protocol been discussed with animal research expert/ attending/ consulting veterinarian? Yes No

14 If yes, are there recommendations on proposed research protocol? Yes No (Attach recommendation if applicable)

15 Purpose of this project Research Antibody Production

Teaching/ Training Breeding Animal/Veterinary Care Other, please specify: or Health Surveillance

16 Information on Research Animal Data: Animal Species :

Strain : Age : Body Weight :

Gender :

Quantity : Animal Origin:

17 Animal Housing ( ) Individual ( ) Pair ( ) Group Provide justification for social animals to be housed individually

18 Information on Project


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a. Lay Summary Please describe the objective of study, and the experimental approaches to used that easily understood by non-scientists.

b. Background This should include a brief statement of the requirement or need for the information being sought. Lengthy explanations are not required. Typically, the "literature or the experience that led to the proposal will be briefly reviewed", and a description of the general approach should be provided. Unnecessary duplication of effort should be strictly avoided. c. How long will the animal be held for the project? Study Duration: .........(.............) month(s) (.....................-........................)

..........(.............) year(s) (......................-.......................) d. Objectives In non technical terms, state the objective of this protocol

e. Hypothesis State the hypothesis to be accepted or rejected

f. Literature search

g. Project Description and Procedures Please describe all procedures carried out on each animal species/ tissue, including experimental design and methods in detail


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19 Ethical Consideration a. Species Justification

Please describe the characteristic of this animal model that makes it the most appropriate for the study (e.g. size, previous data, unique physiological characteristics, supported by reference if possible, or based on experience). And, please explain if there is no alternative model, other than the use of animal described above for this research. b. Animal Number Justification Please, explain how the number of animals were determined and explain statistical methods used, if applicable.

c. Pain Category The PI or primary user should estimate the number of animals that will be counted in each pain category. There are many situations where there are animals in more than one category, e.g., control animals. If more than one species is requested in the proposal, reflect those animals in a duplicate table in this paragraph. The total numbers reflected in these three categories should add up to the number and percent of animals requested for the entire protocol in Project Description and Procedures.

Description Pain Category C

No Pain D Alleviated Pain

E Unalleviated Pain

Category C: Studies involving no pain or distress beyond that expected on a momentary nature such as would occur with an injection, a deep palpation, grooming activities, etc. Category D: Procedures wherein anesthesia or analgesia will be administered to avoid or alleviate pain or distress. General anesthesia given for surgical preparations, or the use of analgesia or anti-inflammatories would be examples for this category. Category E: Procedures where alleviation of pain or distress are contraindicated for some justifiable reason such as; would confound the experimental results if drugs relieving pain were administered. Detailed justification for putting animals into this category is required. Category E Justification:

20 Animal Use Procedures a. Anesthesia

a.1. Will any of the animal procedures in this protocol be conducted under anesthesia?


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( ) No (Please continue to b) ( ) Yes Please complete the table below. Please include anesthetic, pre-anesthetic, sedation, or tranquilizing agent/ compound which will be used.

Drug (active compound) Dose (mg/ kg BW)* Route (IM/IP/SC/ID/PO)

* - For small animal dose can be given in mg/ 100gram. - Unit in ml/ kg BW or other volume unit/ BW unit is not acceptable. With exception, if only the concentration of the compound is explained. IU/ BW or Unit/ BW can be used for compound such as hormone or other compound generally known to use this unit. a.2. What is the frequency of anesthetic procedures in each animal? a.3. What is the estimated duration of each anesthetic procedure? a.4. Please explain how the animal will be monitored during anesthetic procedure, and how often

b. Pain and Distress b.1. Will any of the procedures, minimal 1, known potentially, cause more than momentary pain and/ or distress? ( ) No (Please continue to c) ( ) Yes, Type of procedure: b.2. Please explain how the animal will be monitored? b.3. Will analgesic agent/ pain relief be given prior/ during/ after this particular procedure. ( ) No Please explain, and also state if analgesic agent is contraindicated for the study result. ( ) Yes Please complete the table below.

Drug Dose (mg/ kg BW)*

Route Frequency and duration


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c. Administration of drug/ reagents/ vaccine/ cells/ agents/ substances, etc Please explain any drugs or any agents or substances (other than anesthesia, pre-anesthetic, sedation, tranquilizing, and analgesia agents) that will be used in this study (including for experimental purpose or therapeutic, like antibiotic for post surgical, if any).

Drug Dose (mg/ kg BW)*

Route Route

c.1. Is there any agents/ drugs known to be contraindicated/ cause to invalidate the data if administered to the study animal? (Including drug/ agent used for veterinary care purpose.) ( )No (Please continue to d) ( )Yes Please listed. c.2. Is there any non-pharmaceutical-grade chemicals and other subtances to be used on the animals? ( )No (Please continue to d) ( )Yes The use of a non-pharmaceutical-grade chemicals or substances should be described and justified.

d. Survival Surgery d.1. Does this experiment involve surgery/ surgical procedures? ( ) No (Please continue to e) ( ) Yes, Please specify: ( ) Terminal (Non survival) (Please continue to 3) ( ) Survival (Please complete the table below) d.2.

Experimental group (number of animal)

Number of major survival surgery per animal *

Number of minor survival surgery per animal **

Type of surgery


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e. Adjuvatants and Antibody Production e.1. Will adjuvant or antibody production be part of this project? ( ) No (Please continue to f) ( )Yes e.2. How will you monitor the animal and what category will be used to terminate the animal from the production?

f. Behavioral Testing f.1. Will behavioral testing be done in this project? ( )No (Please continue to g ( ) Yes f.2. Will training the animal be required prior to data collecting? ( ) No ( ) Yes f.3. Will food or water deprivation method be conducted? ( ) No (Please continue to 13.7.) ( ) Yes Please explain the method of deprivation, amount given, and the monitoring of the animal.

g. Hazardous Agents Radioactive, chemicals and biological agents g.1.Will hazardous agents be used in this project? Or will any of the experimental procedures pose any health risk to staff or other animals? ( ) No (Please continue to h) ( ) Yes Please state specific dose, whether to be used on live animal or tissue, effect on animals, danger to humans, monitoring, precaution to protect personnel. Name the agents: _______________________________________________ Chemical Formula (if applicable): _______________________________ Carcinogen: ( )Yes ( ) No Infectious agent: ( )Yes ( ) No Toxic chemical: ( ) Yes ( ) No Other: please explain ____________________ g.2. Which Biosafety level of this procedure/ agent will apply? Please explain. (Please, refer to Reference) g.3. Where is the procedure involving hazardous agents will be conducted? g.4. Please explain the restrictions, if any, to handle or discard this substance and animal waste.


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g.5. Will Radioisotopes be used in live animals? ( ) No (Please continue to h) ( ) Yes (Please explain the half-life time).

h. Blood sampling h.1.Will blood collection procedure be required in this experiment? ( ) No (Please continue to i) ( ) Yes (Please complete the table below)

Experimental Group

Route Volume (ml, or ml/kg BW)

Frequency

i. Food and Fluid Regulation i.1.Will special diet be given for animal in this project? ( ) No ( ) Yes (Please explain) i.2.Will food or water deprivation method be conducted? ( ) No (Please continue to j) ( ) Yes Please explain the method of deprivation, amount given, and the monitoring of the animal.

j. Paralytic Agents Will paralytic agent/ neuromuscular or similar blocking agent administration to the animal be used in this study? ( ) No (Please continue to k) ( ) Yes Please explain the necessity to use this agent, dose, frequency, and method to monitoring the depth of anesthesia. No use of paralytic agents without anesthesia is allowed unless scientifically justified by the PI and approved by the IACUC.


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k. Euthanasia k.1.Will any animal in the study undergo euthanasia ? ( ) No (Please continue to l) ( ) Yes k.2.Please describe the method of euthanasia (refer to AVMA Guidelines on Euthanasia).

l. Study End Point Will death of animal be used as an end point of study, instead of euthanasia? ( ) No Please specify what is the projected end point or termination of the study for the animals? Is euthanasia, or recovery expected; and what is the specific plan for determining when the animal experimentation phase will be stopped? Explain the plan for the disposition of surviving animals. ( ) Yes Please provide justification, explain the method and frequency of monitoring to ensure that unnecessary pain or distress is prevented.

m Prolonged Restraint Will animal undergo prolonged restraint (more than 12 consecutive hours)? ( ) No (Please continue to 13.14.) ( ) Yes Please explain the method of restraint (e.g. primate chairs, restraint boards, metabolism cages, e.tc.), frequency, and the duration. Also describe habituation procedures for the prolonged restraint.

n. Tumor Transplantation or Induction n.1.Will tumor development be expected to grow from any animal in this study? ( ) No (Please continue to o) ( ) Yes Please explain the type, site, functional deficit, method and frequency of monitoring? Also, please specify the end point use to terminate the animal from the study.


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o. Toxicity Testing o.1.Will tumor development be expected to grow from any animal in this study? ( ) No (Please continue to 13.15.) ( ) Yes Please explain the type, site, functional deficit, method and frequency of monitoring? Also, please specify the end point use to terminate the animal from the study.

p. Collection of Tissue Please identify the tissue will be collected from this study, and method (euthanasia (postmortem), surgery/ biopsy with or without opening body cavity).

21 Adverse Effect

If you expect any adverse effects (including pain and distress) of your procedures or stimuli on the animals (e.g. weight loss, fever, poor appearance, neurological deficits or behavioral abnormalities), please describe in the space below. Describe the conditions, complications and criteria (e.g. 20% weight loss, maximum tumor size, vocalizing, and lack of grooming) that would lead to euthanasia of an animal before the expected completion of the experiment. Note : if any unanticipated adverse effects not described below do occur during the course of the study, a complete description of those effects and any action taken in response to them must be submitted to the ACUC as an amendment to this protocol.

22 Project Classification( *)

A B C D E (*) A : Research on Invertebrae or Plants, Bacterias, Amoebas B : Research on Vertebrae with Minimal or No Perceived Inconvenience C : Research on Vertebrae with Minimal Stress or Physical Suffering in a Substantially

Short Period

D : Research on Vertebrae where Stress and Physical Suffering is Inevitable E : Procedures That Can Cause Physical Suffering Above Acceptable Threshold When

Performed in a Concious State without Anaesthesia 23 Assurances


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As the Principal Investigator on this protocol, I will provide the following assurances: Animal Use: The animals authorized for use in this protocol will be used only for the study and in the manner described herein, and any deviation from this protocol will be requested and approved by the MRIN IACUC. Duplication of Effort: I have made a reasonable, good faith effort to ensure that this protocol is not an unnecessary duplication of previous experiments. Statistical Assurance: I can assure you that I have consulted with an individual who is qualified to evaluate the statistical design or strategy of this proposal, and that the “minimum number of animals needed for scientific validity are used”. Biohazard/Safety: I have taken into consideration and I have made the proper arrangements regarding all applicable rules and regulations concerning radiation protection, biosafety, recombinant issues, etc., in the preparation of this protocol. Training: I verify that the personnel performing the animal procedures and manipulations described in this protocol are technically competent and have been properly trained to ensure that there is not any unnecessary pain or distress that will be caused as a result of the study procedures or manipulations. Responsibility: I acknowledge the inherent moral administrative obligations associated with the performance of this animal use protocol, and I assure that all individuals associated with this project will demonstrate a concern for the health, comfort, welfare, and well-being of the animals to be used in this research protocol. Additionally, I pledge to conduct this study in the spirit of the fourth “R”, namely, “Responsibility” for implementing animal use alternatives where feasible, and conducting humane and lawful research. __________________ Principal Investigator


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Painful Procedures: I am conducting biomedical experiments which may potentially cause more than momentary or slight pain or distress to animals that WILL BE / WILL NOT BE (circle one) relieved with the use of anesthetics, analgesics and or tranquilizers. I have considered alternatives to such procedures. However, using the methods and sources described in this protocol, I have determined that alternative procedures are not available to accomplish the objectives of this proposed experiment.

Tangerang, Date.............................20...


(……………………………….)


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11.6. Protocol Amendment Submission Form (AF/01-013/2017/01.4)

Protocol Amendment Submission Form

PROTOCOL NUMBER: SUBMITTED DATE:

PROTOCOL TITLE:

PRINCIPAL INVESTIGATOR:

INSTITUTE:

Telephone:

APPROVED DATE: NO. OF AMENDMENT:

REASON FOR THE AMENDMENT: (filled by PI)

SIGNATURES: Date:…………….. Principal Investigator

TYPE OF AMENDMENT REQUESTED: filled by Secretary

EXPEDITED

FULL BOARD


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COMMENTS: (filled by Reviewer) :

SIGNATURES: Date:……………. Protocol Reviewer

DECISION :

Approved

Minor revision

Major revision

Disapproved

APPROVALS Date: …………... Chairperson, MRIN EC COMPLETION Date: ………….. Secretary, MRIN EC


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11.7. Continuing Review Application Form

(AF/01-014/2017/01.4)

Continuing Review Application Form

PROTOCOL No.: Submission date :

PROTOCOL TITLE:

ETHICAL APPROVAL PERIOD :

INSTITUTE MEDICAL ADVISOR:

ACTION REQUESTED: Renew - New participant accrual to continue

Renew - Enrolled participant follow up only

Terminate - Protocol discontinued HAVE THERE BEEN ANY AMENDMENTS SINCE THE LAST REVIEW?

NO

YES (Describe briefly in attached narrative)

SUMMARY OF PROTOCOL PARTICIPANTS:

Accrual ceiling set by MRIN EC/KEPK MRIN New participants accrued since last review Total participants accrued since protocol began

ACCRUAL EXCLUSIONS

NONE

MALE

FEMALE

OTHER (specify: ) IMPAIRED PARTICIPANTS

None

Physically

Cognitively

Both HAVE THERE BEEN ANY CHANGES IN THE PARTICIPANT POPULATION, RECRUITMENT OR SELECTION CRITERIA SINCE THE LAST REVIEW?

NO

YES (Explain changes in attached narrative) HAVE THERE BEEN ANY CHANGES IN THE INFORMED CONSENT PROCESS OR DOCUMENTATION SINCE THE LAST REVIEW?

NO

YES (Explain changes in attached narrative)

HAS ANY INFORMATION APPEARED IN THE LITERATURE, OR EVOLVED FROM THIS OR SIMILAR RESEARCH THAT MIGHT AFFECT THE MRIN EC/KEPK MRIN’S EVALUATION OF THE RISK/BENEFIT ANALYSIS OF HUMAN SUBJECTS INVOLVED IN THIS PROTOCOL?

NO

YES (Discuss in the attached narrative)

HAVE ANY UNEXPECTED COMPLICATIONS OR SIDE EFFECTS BEEN NOTED SINCE LAST REVIEW?

NO

YES (Discuss in the attached narrative) HAVE ANY PARTICIPANTS WITHDRAWN FROM THIS STUDY SINCE THE LAST MRIN EC/KEPK MRIN APPROVAL?

NO

YES (Discuss in the attached narrative) INVESTIGATIONAL NEW DRUG/DEVICE NONE IND IDE

FDA No. ………………………….. Name: …………………………… Sponsor: …………………………

Holder: ……………………………

IONIZING RADIATION USE (X-rays, radioisotopes, etc)

None

Medically indicated only

HAVE ANY PARTICIPATING INVESTIGATORS BEEN ADDED OR DELETED SINCE LAST REVIEW?

NO

YES (Identify all changes in the attached narrative) HAVE ANY NEW COLLABORATING SITES (INSTITUTIONS) BEEN ADDED OR DELETED SINCE THE LAST REVIEW?

NO

YES (Identify all changes and provide an explanation of changes in the attached narrative)


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CHANGE IN MEDICAL ADVISOR / INVESTIGATOR?

NONE

DELETE:…………………………………………….

ADD: …………………………………………………

HAVE ANY INVESTIGATORS DEVELOPED AN EQUITY OR CONSULTATIVE RELATIONSHIP WITH A SOURCE RELATED TO THIS PROTOCOL WHICH MIGHT BE CONSIDERED A CONFLICT OF INTEREST?

NO

YES (Append a statement of disclosure)

Results: (Use extra blank paper, if more space is required.)

Refer to Guideline for PI item 5 (Procedure for Continuing review)

Signature of P.I.:

Date:

MRIN EC/KEPK MRIN

Comment/Decision:

Approved

Minor revision

Major revision

Disapproved

SIGNATURES:

Date:………………… Protocol Reviewer


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APPROVALS

Date:…………………

Chairperson, MRIN EC

COMPLETION

Date:…………………

Secretary, MRIN EC


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11.8. Serious Adverse Event Report Form (AF/01-019/2017/01.2)

Serious Adverse Event Report Form

Principal Investigator:…………………………………….. Application No:

Study Title:………………………………………………………. Protocol No.:

Name of the study medicine/device………………………..…………………

Report Date :………… initial follow-up Onset date:……………

Sponsor:………………………………………………… Date of first use: ………………………..

Subject’s initial/number: Age: Male Female

Subject’s history:

Laboratory findings:

SAE:

Treatment: Outcome: resolved on-going

Seriousness: Death

Life Threatening Hospitalization – initial prolong Disability / Incapacity Congenital Anomaly Other…………………………………

Relation to Drug Device study Not related Possibly Probably Definitely related Unknown

Changes to the protocol recommended?

No Yes , attach proposal

Changes to the informed consent form recommended?

No Yes , attach proposal


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Reviewed by:………………………………………………… Comment:…………………………………………………….…………………………………………………………………

Date:……………

Action:…………………………………


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11.9. Unexpected Adverse Event Summary Report (AF/02-019/2017/01.2)

Unexpected Adverse Event Summary Report

Principal Investigator:………………………………………………………………………….

Application No:

Study Title:……………………………………………………………………………………... Protocol No.:

Name of the studied medicine/device………………………..…………………………….. This report covers the period :

Sponsor:………………………………………………………………………………………... From…………………To……………….

# Description of Unexpected Adverse Events

Date of Event (D/M/Y)

Date start and end of Tx (D/M/Y)

F or M

Initial

Age (Y)

Serious Yes No

Related to Study Yes No

Concomitant medication

Intervention


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11.10. Study Report Form (AF/01-015/2017/01.3)

Page 1 of 2

Study Report Form

Protocol No.: Submission date :

Protocol Title : Principal Investigator: Ethical Approval Period

Phone number: E-mail address : Sponsor’s Name

Address:

Phone : E-mail : Study site(s): Total Number of study participants :

No. of Study Arms:

Number of participants who received the test articles: Study materials:

Treatment form:

Study dose(s):


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Duration of the study

Objectives:

Results: (Use extra blank paper, if more space is required.)

Signature of P.I.:

Date:

Accepted Accepted with remarks : …….

SIGNATURES:

Date:………………… Protocol Reviewer

ACCEPTED:

Date: ……………….. Chairperson, MRIN EC COMPLETION:

Date:…………………

Secretary, MRIN EC


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11.11. Study Termination Memorandum

(AF/01-018/2013/01.3)

Study Termination Memorandum

PROTOCOL NUMBER: ASSIGNED No.:

PROTOCOL TITLE:

PRINCIPAL INVESTIGATOR:

PHONE : E-MAIL:

INSTITUTE:

SPONSOR:

MRIN EC/KEPK MRIN APPROVAL DATE:

DATE OF LAST REPORT:

STARTING DATE: TERMINATION DATE:

NO. OF PARTICIPANTS:

NO. ENROLLED:

SUMMARY OF RESULTS

ACCRUAL DATA:

P.I.SIGNATURE: DATE:


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11.12. Flow Chart of Application Submission Process


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11.13. Glossary Initial Review The first time review of that protocol made by two or

three individual reviewers (MRIN EC members or non-members) in advance of the full Committee meeting, and comments of the reviewers will be reported to the full Committee meeting.

Phase I studies Initial introduction of an investigational new drug (IND) into humans, studies designed to determine the metabolism and pharmacological actions of drugs in humans, and studies designed to assess the side effects associated with increasing doses.

Phase II study A Study of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.

Phase III study A Study expands controlled and uncontrolled trials performed after preliminary evidence suggesting effectiveness of the drug has been obtained. They are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

Phase IV study A study that seeks to expand an approved medication’s use into a new population, new indication, or new dose.

Stipulation Specify as terms of or condition for an agreement, contract, etc. state, put forward for a necessary condition.

Expedited review A review process by only two or more designated MRIN EC/KEPK MRIN members who then report the decision to the full Board meeting. An expedited review is a speedy one for minor changes to the approved protocol and for research proposal with minimal risk in nature.

Approved Protocols Protocols that have been approved by the MRIN EC/KEPK MRIN may proceed.

Protocols that have been approved with recommendations by the MRIN EC/KEPK MRIN may not proceed until the conditions set by the MRIN EC/KEPK


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MRIN in the decision have been met. Protocols should be amended and submitted to the MRIN EC/KEPK MRIN within one month for re-review.

Suspension Termination

Stop until further clarification Permanently stop of the study

Adverse Event Any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product and which does not necessarily have a causal relationship with this treatment. The adverse event can therefore be any unfavorable or unintended sign or experience associated with the use of the investigational product, whether or not related to the product.

Adverse Drug Reaction

In the pre-clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not established all noxious or unintended responses to the product related to any dose should be considered adverse drug reactions. The phrase “responses to a medicinal product” means that a causal relationship between the product and the adverse event is at least a reasonable possibility, i.e., the relationship can not be ruled out.

Regarding marketed products, a response to a product which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of diseases or for modification of physiological function.

IND Investigational New Drugs means substances with

potential therapeutic actions during the process of scientific studies in human in order to verify their potential effects and safety for human use and to get approval for marketing.


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11.14. List of Abbreviation ADR Adverse Drug Reaction DSMB Data Safety Monitoring Board EC Ethics Committee IND Investigational New Drugs MRIN Mochtar Riady Institute for Nanotechnology PI Principal Investigator SAE Serious Adverse Event


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11. 15. Template Information for Subject

1. Latar belakang, tujuan dan manfaat penelitian bagi pasien/peserta

Contoh :

Selamatpagi/siangBapak/Ibu, saya ………….. (Sebutkan NAMA ANDA), dokter

bidang ….. (sebutkan keahlian dokter dalam bidang apa) di rumahsakit ……,

bermaksud untuk memberikan informasi bahwa saat ini sedang berlangsung penelitian

terhadap ………….... (sebutkan penelitian dalam bahasa sederhana /non medis

atau ilimiah), untuk keperluan pengembangan ilmu pengetahuan, dimana hasil nya

akan sangat bermanfaat untuk kepentingan perbaikan…………(sebutkan manfaat

penelitian tersebut bagi peserta)

2. Lama dan jumlah subyek penelitian

Contoh :Penelian ini akan mengumpulkan data (sample) sebanyak ………. , dimana

penelitian ini akan berlangsung dari ….. sampai…..

3. Perlakuan terhadap subyek penelitian

Contoh :

Penelitian ini adalah pemeriksaan laboratorium dan pemeriksaan USG (contoh

saja, sesuaikan dengan jenis penelitian yang akan anda lakukan). Bapak/ibu akan

diambil sedikit darahnya, sekitar setengah sendok teh (contoh saja, sesuaikan

dengan jenis penelitian) untuk pemeriksaan laboratorium (contoh saja, sesuaikan

dengan penelitian), kemudian akan dilakukan pemeriksaan …….. Pemeriksaan

pertama saat masuk rawat inap seperti saat ini, dan pemeriksaan kedua

…….(sebutkan kapan dilakukan dan sebutkan kapan pemeriksaan

selanjutnya).

4. Kemungkinan Resiko

Contoh :

Efek samping pengambilan darah akan menyebabkan akan

menyebabkan………,sedangkan pemeriksaan ……… tidaka ada efek sampingnya.

5. Kesediaan dari subjeck penelitian

Contoh :

Kami sangat berharap bapak/ibu secara sukarela dengan kesadaran penuh dapat

mengikuti program penelitian ini, demi manfaat kepentingan kita bersama, yang

akanberujung pada peningkatan pelayanan serta mutu pengobatan kepada para pasien.

6. Hak Mengundurkan diri

Contoh :

Apabila bapak/ibu bersedia, Bapak/Ibu akan diminta menanda-tangani lembar

persertujuan yang tersedia.


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Bapak/Ibu bebas untuk mengundurkan diri /berubah pikiran setiap saat tanpa dikenai

denda ataupun sanksi apapaun atau ke hilangan hak untuk memperoleh pelayanan

kesehatan di rumah sakit……….(sebutkan nama RS tempat penelitian).

7. Penjelasan terjadinya rahasia subject :

Contoh :

Semua data – data penelitian yang berkaitan dengan diri Bapak/Ibu akan dirahasiakan

dan hanya akan diketahui oleh peneliti /anggota peneliti (sebutkan sponsor bila ada

sponsor) . Hasil Penelitian akan dipublikasikan / disampaikan tanpa adanya informasi

yang berkaitan dengan diri Bapak /Ibu.

8. Kompensasi

Bapak/Ibu akan mendapatkan ongkos jalan sebesar. Rp….(sesuaikan dengan jarak

untuk datang ke tempat penelitian serta uang lelah pengganti penghasilan yang hilang

akibat turut serta dalam penelitian ini (Sebutkan bila tidak memberi kompesensai

apapun atau hanya mendapatkan hadiah)

9. Nama Jelas, alamat penangung jawab medis & nomortelepon

Contoh :

Bapak/Ibu diberi kesempatan untuk bertanya tentang hal-hal yang belum jelas

mengenai penelitian ini . Jika sewaktu –waktu terjadi akibat samping dari penelitian

ini atau membutuhkan keterangan lebih lanjut. Bapak /Ibu dapat menghubungi

dokter/peneliti yang namanya tertulis di bawah ini :

Nama : ………………………… Alamat : ……………………… No HP : ……………………...

10. Penutup

Contoh :Demikianlah penjelasanini, semogadapa tberpartisipasi. Terimakasih.

.


for Nanotechnology


Page 61 of 61

11. 16. Template Informed Consent Form

SURAT PERSETUJUAN SETELAH PENJELASAN (INFORMED CONSENT)

Yang bertanda-tangan di bawah ini, N a m a :

No. Med Rec :

U s i a :

Setelah diberikan penjelasan dan memahami, dengan ini saya menyatakan dengan sukarela, tanpa paksaan dari pihak manapun bersedia/tidak bersedia* sebagai peserta pada penelitian …..(SEBTUKAN JUDUL PENELITIAN) ,……(NAMA PENELITI) Saya bersedia diwawancara, diperiksa atau diambil darahnya ……(SEBUTKAN BAGIAN MANA SUBYEK AKAN DIPERIKSA) maupun kegiatan lain yang berhubungan dengan penelitian ini. Saya bersedia menerima segala risiko yang mungkin timbul dan bersedia data hasil pemeriksaan dianalisis serta ditampilkan/dipresentasikan untuk publikasi ilmiah. Identitas pribadi saya hanya diketahui oleh Peneliti, Sponsor dan yang berhubungan dengan penelitian ini saja. Sewaktu –waktu saya berhak untuk mundur dari penelitian tanpa kehilangan hak saya sebagai pasien. Demikian Surat Persetujuan ini dibuat dengan sebenar-benarnya, tanpa tekanan dari pihak manapun. Tempat/Tanggal, ………………….. Saksi, Yang menanda-tangani Surat Persetujuan, Hubungan dengan subyek : …………… (……………………………) (………………………………..) NamaJelas & Tanda-Tangan Nama Jelas &Tanda-Tangan

Peneliti,

(………………………………..) Nama Jelas &Tanda-Tangan

*coret yang tidak perlu

Documents

Table of Contents - mrinstitute.orgmrinstitute.org/upload/Guideline for PI-2017.pdf · Mochtar Riady Institute for Nanotechnology Ethics Committee (MRIN EC) Page 3 of 61 3. Procedure