Research Proposal for all Commercial Organizations€¦ · Questionnaire For Sending New Project Proposal For Ethical ... The letter should be written on the printed ... (English,

SGCCRI_Research Proposal_Format 1/26

Format of Research Proposal for use by Pharmaceutical Companies/CRO/SMO seeking Research Collaboration with and acquiring patients from Saroj Gupta Cancer Centre & Research Institute. CONTENTS Sr No Subject Page Nos

1 Contents 1

2 Forwarding Research Proposal Procedure for Application 2 - 6

3

Appendix 1 Questionnaire For Sending New Project Proposal For Ethical Clearance And Permission Of The Management Of Cancer Centre Welfare Home And Research Institute, Thakurpukur, Kolkata 700 063

7-8

4

Appendix 2 Special declaration by the Head of the proposing Institute/ Head of the proposing Department/ Principal Investigator: Suggested prototype.

9-12

5 Appendix 3 Explanatory notes to Special Declaration of the Principal Investigator/ Proposer.

13-14

6 Appendix 4 Excerpt from General Consent Form of SGCCRI 15

Please note that the Proposal including photocopies of references, special declaration and filled-up questionnaire must be submitted IN DUPLICATE.


Executing research project at Saroj Gupta Cancer Centre & Research Institute, Thakurpukur, Kolkata 700 063.

Forwarding Research Proposal: Procedure for application

1. Please arrange to send a “Forwarding Letter” from the Head of the Institute/

Department/ Division/ Laboratory addressed to the Research Sub Committee,

Saroj Gupta Cancer Centre & Research Institute, Mahatma Gandhi Road,

Thakurpukur, Kolkata 700 063. The letter should be written on the printed

letterhead of the Pharmaceutical Company/Institute/Laboratory and addressed to

the Co-coordinator, Clinical Studies Division. The forwarding letter should

neither be addressed to (a) any other officials of SGCCRI nor to (b) the

Chairperson/ other members of the Institutional Ethics Committee of SGCCRI.

2. The forwarding letter should contain the followings:

a. Full name of the proposing Pharmaceutical Company and its Coordinator,

heading the study along with its full postal address, e-mail address,

website (if any), full telephone, FAX numbers and Jurisdiction.

b. Mobile and other contact numbers of the key person(s) who can be

contacted from SGCCRI.

c. A brief synopsis of the trial

3. The forwarding letter should accompany a “Project Proposal”. The “Project

Proposal should contain the followings:

a. Exact title of the project being proposed.

b. An executive summary of the proposal.

c. An Introduction that will specify the relevance of the proposed study with

work already done and a review of literature.

d. The specific “Aims and Objectives”- any vague statement is not

acceptable.

e. Material & Methods. In this section, “Materials” would include details of

i) Subjects themselves (patients/ their relatives etc) or

ii) Biological materials (tissue or other biological samples of the subjects).

iii) Clinical data required.


“Methods”

Details of methodology are essential. Positively include a “schematic

diagram” (flow sheet/ algorithm) of the entire project procedure.

“Methods” would include details. Any vague/ambiguous description of

method will make the project proposal liable for rejection.

f. Each study should have a specified informed consent form (ICF). The

informed consent form should be preceded by plain language information

leaflet that can be well understood by lay persons. The ICF should be tri-

lingual (English, Bengali & Hindi). Three copies of the consent form

should be signed by the patient or the guardian identified by the patient. A

copy of the consent form must be given to the patient, the second copy

should be maintained as a record in the trial office of SGCCRI and the

third consent form should be retained by the Pharmaceutical Company/

CRO/ Institute/ Laboratory. This should be mentioned in the footer of all

the pages of the consent form. Final format of this informed consent form

is to be attached with the Project Proposal. All consent forms should

contain the ORIGINAL SIGNATURES OF (1) The Subject (2) Their

relations (3) The investigators (4) One witness – may be a staff of

SGCCRI in presence of whom the consent is signed.

g. A section on “Expected Results/ Outcome “with time frame.

h. A section on possible hazards with either the materials or methodology

should be mentioned. The hazards may be categorized into– fire/

explosive/ corrosive/ biological / chemical/ biochemical, radioactive

hazard etc. The extent of possible hazard (to the subject, to their relatives,

to medical/paramedical staff, to public in general) should be categorically

mentioned. Preventive and remedial procedures should accompany each

hazard specified.

i. A listing of relevant references (include only those that have been

published in reputed peer reviewed scientific journals or monograms or

text-books).


j. Photocopies of at least 5 key references. Kindly include the title page of

the book & monogram. If it’s a reprint, kindly be sure that the first page

contains the full print line. Otherwise the cover page of that particular

journal should be photocopied.

(The entire “Project Proposal” including references & photocopies of key

references should be submitted in DUPLICATE.)

k. The following documents are necessary for consideration of the project by

the Research sub-committee (RSC) and later also by the Institutional

Ethics Committee (IEC) –

i. Certificate of purity of the trial molecule

ii. Certificate of DCGI approval, and Insurance certificate for the

study

iii. Informed consent form (ICF)

iv. Case record form (CRF)

v. Compensation procedures in case of Adverse Event/Serious

Adverse Event (the method of calculation).

l. An application fee of Rs.5000 should be submitted by Cheque/Draft

drawn in favor of “SGCC&RI Clinical Studies Division” at the time of

submission of proposal to the Research sub-committee. The Research Sub

Committee (RSC) shall discuss the primary feasibility of the project and

shall forward it to IEC for final approval. The application fee for this

approval procedure at IEC is Rs. 20,000(Rupees Twenty Thousand only).

This amount is to be submitted by cheque/draft drawn in favor of

“SGCC&RI Clinical Studies Division”. For an expedited ethical

approval (on written request of the proposer) the fees is fixed at Rs.

40,000 (Rupees Forty Thousand Only). All fees are non-refundable and in

no way guarantees a clearance/approval/otherwise positive response from

SGCCRI. The Research Sub Committee (RSC) or Institutional Ethics

Committee (IEC) of SGCCRI reserves the right to reject any proposal

without showing any cause. The decision of the RSC and/or IEC will be

considered final and the same proposal once rejected, cannot be


resubmitted without necessary modification. The provision for expedited

ethical clearance is there. However, it may not be possible for members of

IEC to meet early as per request of the proposer. In such case, the Division

of Research, SGCCRI cannot arrange for such expedited IEC meeting.

Charges, if already deposited by the proposer will be refunded. Under no

circumstances, the SGCCRI shall be held responsible either reemit any

compensation to the proposer.

4. “Statutory Papers”. To avoid future complications, the statutory papers should be

submitted only after careful scrutiny. The Statutory papers should contain the

followings:

a. Feasibility questionnaire ; Filled-up questionnaires (vide Appendix 1). The

questionnaires (2 pages) are provided by SGCCRI. Kindly fill-up the

forms carefully. Add extra papers if necessary. You may fill-up the form

by hand or may copy it in a PC and use suitable space. All the pages have

to be signed by all the proposers/ investigators in full and a seal of the

proposing Institute/ Department is to be affixed on every page.

b. Final format of the informed consent form (ICF) (in English, Bengali and

preferably in Hindi also)

c. A special declaration by the Head of the proposing Institute/ Head of the

proposing Department/ Principal Investigators. A format has been

provided in Appendix 2. An explanatory note for the declaration

(Appendix 3) is also enclosed herewith (Appendix 4).

d. To facilitate the special declaration as mentioned above, excerpts from the

general consent form (for patients) of SGCCRI is also provided herewith

(Appendix 5)

e. Prior Ethical clearance of the proposed project by the proposing Institute

is essential. An attested photocopy of the Ethical clearance certificate has

to be submitted. At the time of submission of the project proposal, the

original certificate of clearance has to be brought for comparison. The

same will be returned after comparing it with the attested photocopy. It is

desirable to submit the minutes of the Institutional Ethics Committee


meeting as well. In case, Institutional Ethics Committee of the proposing

Pharmaceutical company/CRO/SMO/Institute/ Laboratory does not,

possess such clearance this should be clearly mentioned in the special

declaration of the Head of the proposing pharmaceutical

Company/CRO/SMO/Laboratory.

Procedures followed by the Research sub-committee

Upon receipt of the documents (2-4) as mentioned above, the Research Sub-

Committee (RSC) of SGCCRI, shall duly arrange to review the proposed project and

may request you to submit further documents/explanatory notes and/or sit in an

interview. When satisfied about the feasibility of the study at SGCCRI, the Research

sub-committee shall forward the project proposal to the Institutional Ethics

Committee for approval. It takes a minimum of 2 weeks for the RSC and further 2

weeks for Institutional Ethics Committee to furnish its verdict. It is customary that the

proposer or his/her knowledgeable assistants should attend a “presentation” in the

presence of the member of the IEC. During the presentation, the proposer will also be

interviewed. The IEC, after such presentation & interview may:

a) Outright reject the proposal.

b) Demand further clarification of the proposed project.

c) Demand modification of the proposed project.

d) Demand further presentation & interview after further

clarification/modification of the proposal.

e) Accept the proposal.

In all such cases, the IEC informs its verdict to Clinical Studies Division of SGCCRI

who communicates the same to the proposer. For major clarification/modification, the

proposal has to be re-routed through the RSC.

The decision of the Institutional Ethics Committee shall be final. The proposer(s) are

advised NOT to indulge in any type of undue solicitation or uninvited meeting/similar

adventurous/frivolous procedure directly or through a third party/agency with the

Chairperson or other members of Institutional Ethics Committee or Research Sub

Committee. Such act may make the proposal liable to be canceled /rejected.


5. Upon receipt of the verdict of the Institutional Ethics Committee, the Clinical

Studies Division of SGCCRI shall issue a letter to the proposers regarding the

ethical clearance/ objection of their proposed project. This letter will preferably be

handed over physically to one or all of the proposers upon signature of receipt.

Alternatively a copy of the Certificate will be mailed to the CRO/Pharmaceutical

Company/SMO under Registered post with A/D and a soft copy will also be

emailed to them. Please note that the letter of clearance should be considered as a

bonafide certificate of Ethical Clearance/ Objection from SGCCRI regarding the

specified proposal. It cannot be dispatched in a way by which it may be stolen by

any third party and misused.The letter of clearance may also mention the name(s)

of the relevant staff of SGCCRI with whom the proposer(s) should contact before

actually starting the work on the project.

6. The proposers cannot start the proposed work in the premises of SGCCRI till they

physically receive the said clearance letter from the Clinical Studies Division of

SGCCRI.

7. After receiving the clearance, the proposer(s) should approach the In-Charge of

Clinical Studies Division for issue of a “work order”. The proposer(s) can only

start to work on the proposal after receiving the work order.

8. Kindly note that SGCCRI is a designated “Scientific & Industrial Research

Organization” (SIRO) recognized by Department of Scientific & Industrial

Research (DSIR), Govt. of India. As such, SGCCRI has to provide a progress

report of all the works/projects/studies undertaken to the DSIR regularly. The

proposer has to forward a progress report of the works/projects/studies

annually/when desired by SGCCRI. In case the proposer fails to start the

proposed project within 6 months from the date of issue of the clearance of the

IEC of SGCCRI, the proposer has to inform the Division of Research, SGCCRI

about the fact and reasons for such delay. If such communication is not received

by the Head, Division of Research/In-Charge of Clinical Studies Division of

SGCCRI or if some vague/unacceptable reaons are cited, the proposal also

becomes liable to be cancelled and a re-application through Research Sub

Committee shall be necessary.


Procedure of Application & Ethical Clearance (Schematic)

PROPOSER

Research Sub Committee (RSC),

SGCCRI

Documents required as given under section 2-4

Discussion with RSC member(s) of SGCCRI regarding suitability/ validity/ scientific merit of the proposal.

Forwarded to Institutional Ethical Committee of SGCCRI by the Research sub committee if project is found suitable and valid.

Returned to Proposer for further clarification and re-submission.

INSTITUTIONAL ETHICS COMMITTEE (IEC) OF SGCCRI

Returned to proposer (REJECTED) if unsuitable.

Passed by IEC. Chairperson sends clearance letter to RSC with his comments.

RSC issues clearance letter to Proposer.

Proposer starts to work on the project after discussing with the liaison of SGCC&RI and obtaining a work order

IEC wants some clarifications/modifications from the Proposer.

Proposer is referred to RSC for necessary clarifications/modifications.


Appendix 1

PROFORMA

QUESTIONNAIRE FOR SENDING NEW PROJECT PROPOSAL FOR

ETHICAL CLEARANCE AND PERMISSION OF THE MANAGEMENT OF SAROJ GUPTA CANCER CENTRE AND RESEARCH INSTITUTE,

THAKURPUKUR, KOLKATA 700 063

The proposer is requested to kindly fill up the form, put his signature and seal and send it to the office of The Research sub committee, SGCCRI, Thakurpukur. The proposers may

also use their own stationeries.

PART A: GENERAL INFORMATION (Please put your signature & seal in every page) Sr No

Questions (Put forward by SGCCRI)

Answer/ Response (From proposer)

1 Name and address of the Director/Chief of CRO/Pharmaceutical Company/SMO responsible for conducting this study. Please also mention the various other institutes participating in this study.

2 Is the primary proposer of the study an employee of the CRO/Pharmaceutical Company/ SMO

3 Has any other Ethics Committee reviewed & approved the study? Furnish details if pending/obtained. Please mention if no such clearance is available.

4 If the project is accepted by SGCCRI, Thakurpukur/ If SGCCRI agrees to be a collaborating center, who shall sign the MOU (Memorandum of Understanding) and on whose behalf?

5 If fund is released by an authority who shall be the recipient of the fund? Who shall be responsible for providing the utilization certificate to the funding authority?

6 What will be the benefit to SGCCRI if it accepts collaboration?

Sign

atur

e &

Sea

l


7 What will be the general liabilities of SGCCRI if it accepts collaboration?

PART B: INFORMATION RELATED TO THE PROPOSED PROJECT (Please put your signature & seal in every page) Sr No

Questions (Put forward by SGCCRI)

Answer/ Response (From proposer)

1 Will the patients be interviewed only, with no intervention to management of the patient?

2 If any intervention to the patient/s’ management is necessary, please provide the principal on which the study is based, what intervention is planned, which patients are to be included and excluded and what safety measures for the patients have you planned during the intervention.

3 Will the investigators assure that the personal data gathered from the patients will remain totally confidential? Please go through the following documents attached herewith:

(1) Excerpts from General Consent Form of SGCCRI.

(2) Special declaration by the proposer & its guidelines.

(3) Agreement Form for sponsored external Research Scholars who wishes to work at this center by interviewing the patients and/ or their relations

4 Source of funding for the present project (Please give details) (Please attach attested photocopies of relevant papers relating to the funding). If there is no external grant and your Institute/Pharmaceutical Company/Laboratory/CRO/SMO bears the entire expenses of the project, kindly declare the same. If grant applications are pending approval, kindly mention that also.

5 Please categorically mention the help SGCCRI, Thakurpukur is expected to provide to the proposer(s) of this project. Please detail the help you require from


SGCCRI in terms of: a) Infrastructure b) Logistics c) Office support d) Pathology laboratory facilities e) Imaging facilities f) Others

6 For utilization of manpower and machine time of this Institute, is there any provision of fund for this Institute in the proposed budgetary requirements?

7 Will you allow review and assessment of study by the IEC & RSC and other relevant bodies at 1 year/or as requested? The proposer has to initiate the study within 1 year/or as requested of issue of ethical clearance/work-order of the project. If initiation of project is not possible within the stipulated time, the proposer has to inform the Head, Division of Research SGCCRI about such delay before expiry of the stipulated time. The information should contain reasons for the delay. The work-order is liable to be withdrawn by SGCCRI if such information and cause(s) of delay is not received in writing by SGCCRI or if the causes cited are found to be insufficient/invalid/vague/frivolous. The proposer can neither demand refund of application fees nor seek any compensation from SGCCRI if the work-order is withdrawn on such ground. The proposers, hereby, accept this clause without reservation and solemnly agree to follow it.

8 Have you attached and ICF and CRF 9 What measures are being taken to avoid a serious

Adverse Event (SAE)

10 What measures are being planned if there is an SAE 11 Incase of death, due to a study related event, are you

aware of the revised guidelines of DCGI?

12 How much compensation will you provide to a trial participant in case of a study- related injury or death. Please attach a copy of insurance certificate.

Signature & Seal


Appendix 2

Special declaration by the Head of the Pharmaceutical Company/Head of the

CRO/Head of the SMO/ Head of the proposing Institute / Principal Investigator.

Suggested prototype

• This is a prototype intended to help formatting the special declaration. • Please add/ alter/ remove clauses to make it suitable for your proposed project.

• This declaration is to be written/ typed on the letterhead of the proposing

Institute/Pharmaceutical Company/CRO/SMO.

• Signature and seal on all the pages are mandatory.

• Two original copies are to be submitted complete with signature and seal.


Dated: 03/03/2011

To Head Division of Research OR In-Charge of Clinical Studies Division Saroj Gupta Cancer Centre & Research Institute Mahatma Gandhi Road. Thakurpukur. Kolkata 700 063

Sub: Special Declaration in connection to the proposed project by the PI (Please mention full title of the proposal)

Dear Sir

I hereby declare that:

1. The work shall be executed in the specific form as detailed in the proposal being submitted herewith (Vide Clause 1, Appendix 3).

2. The interview with the patient/ subject shall be conducted according to the present format and with an informed consent only. The Informed Consent Form (ICF) has to be signed in triplicate. One copy should be retained by the PI, the second copy should be kept in custody of SGCCRI and the third copy has to be given to the patient.

3. Tissue samples/ samples of body fluid will be collected from the patient/ subject with an informed consent only.

4. The entire processing of the tissue/ Fluid samples will be done in laboratory/ suitable work place. Please mention the full address & communication details of the laboratory. No procedure will be done on the patient/ subject after collecting sample of the tissue/ blood/ body fluid (Vide Clause 2, Appendix 3)

5. The data gathered from the interviews shall NOT be utilized for any other purpose other than what is specifically mentioned in the project proposal. (Vide Clause 3, Appendix 3)

6. The biological samples (tissue/ blood/ body fluid) will NOT be utilized for any other purposes other than that mentioned in the present project proposal. (Vide Clause 4, Appendix 3)

7. I/ We fully understand that law prohibits exporting biological samples to foreign countries. I/ We shall neither export the biological samples to any foreign country nor shall allow our co-workers or any other person/ party to do such export. (Vide Clause 5, Appendix 3)

8. I/ We shall not disclose the identity of the patients/ subjects in any of our communications, scientific or otherwise, to any third party/ person/ group/ Institute/ Business concerns/ Pharmaceutical Companies and others including general population. (Vide Clause 6 & 7, Appendix 3)


9. I/ We shall NOT allow any other person/ party/ concerns to avail and utilize the full or part of the data or report of analysis that have been obtained from SGCCRI in connection with the present project proposal even if such transfer of data/ report of analysis does not lead to any gain, monitory/ in kind/ otherwise. (Vide Clause 8, Appendix 3)

10. Neither me nor any of my co-workers/ subordinates/ agents/ employees/ employers/ operators shall contact or try to contact the subjects/ patients outside the hospital premises. (Vide Clause 9, Appendix 3). Such contact(s) should be done with full knowledge of SGCCRI and in connection of the present proposal only.

11. Neither me/ nor our co-workers shall interfere, in any way, with the investigations, treatment or other medical management of the patients. We shall also be careful not to interfere with feeding, rest and other personal work of the patients and their relations. (Vide Clause 10 & 11, Appendix 3)

12. We/ our scholars/ representatives will interview the patients/ the patients’ relations. The format of interview questionnaires is provided herewith. The interviewer shall never subject the patients or their relations with questions and comments that may cause mental suffering/embarrassment grievances in them. Patient/ their relations, as an individual, has right not to respond to any particular question or not to agree to sit for an interview at all even if they have signed a consent form. They may not want to sit for an interview at a certain time/ for sometime/ forever. They may revoke their consent at any point of time without showing any reasons whatsoever. We/ our scholars/ representatives shall never try to pursue further interviews with such patients or their relations.

13. When a patient gets registered himself/ herself at this Institute, it forms a part of agreement of treatment and confidentiality in between SGCCRI, Thakurpukur and the patient. The management of SGCCRI, Thakurpukur has allowed us/ our Scholars/ representatives to work with their patients in GOOD FAITH and as per our proposal. In case there is violation to clauses as mentioned above, and in case, a medico-legal suit or any other form of litigation is initiated by the patient or party as a result of such violation by the aggrieved patient/ their relations, the entire onus of breach of conduct solely lies on us (myself and the sponsored scholars). Neither the management of SGCCRI nor any individual or group of doctors under whom the patient was registered/ admitted / treated, shall be held liable for such action.

14. Any publication coming out of the material / data collected from SGCCRI should mention and acknowledge the name of SGCCRI and the individuals who directly participated/helped. This acknowledgement shall be necessary even if some members of faculty of SGCCRI co-authors the publication. (vide Clause 12, Appendix 3)

15. The management of SGCCRI may need to know (from time to time) the progress of the project after initiation. I/ We shall furnish the details of the status of the project when asked by the authority of SGCCRI. (vide Clause 13, Appendix 3)

16. We have applied for grant to an authority (name) that will cover part/ full expense of the project. The application of grant is pending approval. I shall communicate


to you the details of grant approval giving photocopies of the relevant pages of the original approval documents with a week of receipt of the approval of funding.

17. The management of Saroj Gupta Cancer Centre & Research Institute, Thakurpukur may desire to recover overhead expenses for the project from us. We agree to render the same after mutual discussion.

18. If the outcome of the project includes issues that may attract “Intellectual Property Benefits”, we will consider Saroj Gupta Cancer Centre & Research Institute, Mahatma Gandhi Road, Thakurpukur, Kolkata 700 063 as a natural beneficiary and appropriate benefits will be shared between us. I solemnly agree to this.

19. The Research Sub Committee of Saroj Gupta Cancer Centre & Research Institute may monitor the progress of the work. I/We fully understand that the management of Saroj Gupta Cancer Centre & Research Institute, Thakurpukur reserves the right to stop the project and revoke our agreement on the basis of the recommendation of the Research Sub Committee or Institutional Ethics Committee. In such case, we shall not hold Saroj Gupta Cancer Centre & Research Institute, Thakurpukur liable for any loss or compensation.

Signature Full name

Designation Institute

Date Place


Appendix 3

Explanatory notes to Special Declaration of the Principal Investigator/ Proposer

1. The work shall be executed in the specific form as detailed in the proposal being submitted. If any deviation from the present form of the study becomes inevitable, the proposer has to stop the work and seek further permission from the Institutional Ethics Committee of SGCCRI through its Research sub committee.

2. In the project proposal, please mention the exact procedure that shall be done on the patient for collection of tissue/ body fluid. If further procedure has to be done on the patient’s/ subject’s body, please mention the details of the procedure with enumeration of the probable side effects and their remedial measures.

3. The data gathered from the interviews shall NOT be utilized for any other purpose other than what is specifically mentioned in the project proposal. If, in future, such data need be utilized for any other purpose, the proposer shall have to seek a written permission from the Institutional Ethics Committee of SGCCRI through the Research sub committee.

4. The biological samples (tissue/ blood/ body fluid) will NOT be utilized for any other purposes other than that mentioned in the present project proposal. If, in future, these biological samples need be utilized for any other purpose, the proposer shall have to seek a written permission from the Institutional Ethics Committee of SGCCRI through Research sub committee.

5. Exporting biological samples to a foreign country is a legal offence. If it is found that the biological materials collected from the patients/ subjects of SGCCRI has been exported by the proposers/ their team or any other third party, the entire onus of breach of law will befallen upon the proposers. SGCCRI shall revoke any responsibility by the power of the present agreement.

6. Disclosing identification of the patients/ subject. Identity shall mean: (a) The full name/ part of the name by which the person can be identified in

the society. (b) Exact address or part of the address by which the person can be identified

in the society. (c) Land Line Telephone Numbers, Mobile Phone Numbers, FAX number, e-

mail Addresses and any other personal communication numbers by which the exact identity of the person may be found out.

(d) Exact professional designation by which the identity of the person may be established.

(e) Photographs/ Video of the patients/ subjects that may reveal the exact identity of the patient. If such photographs/ recordings are part of the proposed work, the identifying characters like the face/ the eyes etc are to be suitably blocked/ blurred.

7. In case, photographs/ video etc are taken as part of the procedure of the present proposal, they should, never, under any circumstances, be of a nature that might embarrass/ aggrieve or otherwise threaten the modesty of the individual. A copy of the photographs or video footage shall have to be submitted to the office of the Research sub committee of SGCCRI for permission before these materials are sent for publication.


8. Utilization of full or part of the data by a third party. After publication in a scientific journal, any member of the public may utilize such data in pursuance of scientific studies. The existing copyright laws that protect the journals and the authors shall guide this utilization. The utilization of data as mentioned in the special declaration does not include/ inter alias means utilization of data after publication. It only refers to sharing/ utilization of unpublished data before publication.

9. Contacting patients/ subjects outside the premises of SGCCRI at a later date. In case such contacts are necessary as part of the proposed work, the informed consent shall fully explain this action. If the party, as a result of such contacts at home/ office visits, takes any legal/ Medico-legal actions, the onus shall be entirely on the proposers. SGCCRI shall not be held liable.

10. The workers of the proposer(s) will always report to the Nursing Staff in Charge or Floor Manager or any other staff designated by SGCCRI before they start working with the subjects/ patients in the various sections, departments or waiting areas. Mere possession of a working order permission does not entitle the workers to move around/ working freely among the patients/ subjects at any time convenient to them. (Vide Clause 10, Appendix 3)

11. Interfering with medical management/ personal duties/ schedules of the patient/ subjects. Even if the nursing staff/ floor manager permits the workers to work with the patients/ subjects, the patients/ subjects have full right to refuse the procedures permanently or for the time being. Even if the consent form is signed, the patients/ subjects shall have the full right to revoke such consent any time they wish even without showing any reason whatsoever. The informed consent shall fully mention this right of the patients/ subjects.

12. It has been found earlier that the proposer(s) went on publishing communication to scientific journals utilizing the materials obtained from SGCCRI without even acknowledging the name of SGCCRI in the paper. They did not even inform SGCCRI about such publications. Kindly note that such actions on the part of the proposer will be considered as a breach of contract and the proposer(s) may be prosecuted by the management of SGCCRI for this.

13. Non-compliance of furnishing reports of the status of the project will also be considered as a breach of contract. The proposers may be even prosecuted by the management of SGCCRI is such cases.


Appendix 4

Format of Patient Information Leaflet & Informed Consent Form (From a previous trial passed by IEC, SGCCRI)

Study Title

Informed Consent Form (Patient Information Leaflet)

Your decision to take part in the study is totally voluntary. You should read this form carefully. You are encouraged to ask either the investigator or the person who is taking the consent any relevant questions you may have. This form contains very important information; hence you should keep a copy of this form for your reference throughout the study proceedings.

1.0. Introduction:

1.1. Investigators of the study: 2.0. Purpose of the study: 3.0. Description of the study: 4.0. Risks and Discomforts: 5.0. Benefits: 6.0. Alternatives: 7.0. Confidentiality: 8.0. Voluntary Participation:

(Consent Form)

(Please note that the patient information leaflet and the consent from should be read in

conjunction)

Study Title: Name of the patient: Subject Initials: Signature/LTI of Patient: Date of Birth: Age: Sex: Address:


Contact No: Name of Investigator Signature of Investigator Date: Name of Witness: Signature/LTI of Witness: Date: Name of Relative: Relation with Patient: Signature/LTI of Relative: Date:


INFORMED CONSENT (as per Schedule Y)

1. Checklist for study Subject’s informed consent documents

1.1 Essential Elements:

1. Statement that the study involves research and explanation of the purpose of

the research

2. Expected duration of the Subject's participation

3. Description of the procedures to be followed, including all invasive procedures

and

4. Description of any reasonably foreseeable risks or discomforts to the Subject

5. Description of any benefits to the Subject or others reasonably expected from

research. If no benefit is expected Subject should be made aware of this.

6. Disclosure of specific appropriate alternative procedures or therapies available

to the Subject.

7. Statement describing the extent to which confidentiality of records identifying

the Subject will be maintained and who will have access to Subject’s medical

records

8. Trial treatment schedule(s) and the probability for random assignment to each

treatment (for randomized trials)

9. Compensation and/or treatment(s) available to the Subject in the event of a

trial-related injury

10. An explanation about whom to contact for trial related queries, rights of

Subjects and in the event of any injury

11. The anticipated prorated payment, if any, to the Subject for participating in the

trial

12. Subject's responsibilities on participation in the trial

13. Statement that participation is voluntary, that the subject can withdraw from

the study at any time and that refusal to participate will not involve any penalty

or loss of benefits to which the Subject is otherwise entitled


14. Any other pertinent information

1.2 Additional elements, which may be required

a. Statement of foreseeable circumstances under which the Subject's

participation may be terminated by the Investigator without the Subject's consent.

b. Additional costs to the Subject that may result from participation in the

study.

c. The consequences of a Subject’s decision to withdraw from the research and

procedures for orderly termination of participation by Subject.

d. Statement that the Subject or Subject's representative will be notified in

a timely manner if significant new findings develop during the course of the

research which may affect the Subject's willingness to continue participation

will be provided.

e. A statement that the particular treatment or procedure may involve risks to the

Subject (or to the embryo or fetus, if the Subject is or may become pregnant),

which are currently unforeseeable

f. Approximate number of Subjects enrolled in the study


2. Format of informed consent form for Subjects participating in a clinical trial

Informed Consent form to participate in a clinical trial

Study Title:

Study Number:

Subject’s Initials: _______________ Subject’s Name:_______________

Date of Birth / Age: _________________

Please initial

box (Subject)

(i) I confirm that I have read and understood the information sheet

dated ___ for the above study and have had the opportunity to ask

questions.

[ ]

(ii) I understand that my participation in the study is voluntary and that

I am free to withdraw at any time, without giving any reason,

without my medical care or legal rights being affected.

[ ]

(iii) I understand that the Sponsor of the clinical trial, others working on

the Sponsor’s behalf, the Ethics Committee and the regulatory

authorities will not need my permission to look at my health

records both in respect of the current study and any further research

[ ]


that may be conducted in relation to it, even if I withdraw from the

trial. I agree to this access. However, I understand that my identity

will not be revealed in any information released to third parties or

published.

(iv) I agree not to restrict the use of any data or results that arise from

this study provided such a use is only for scientific purpose(s)

[ ]

(v) I agree to take part in the above study.

[ ]

Signature (or Thumb impression) of the Subject/Legally Acceptable

Representative:_____________

Date: _____/_____/______

Signatory’s Name: ______________________________________________________

Signature of the Investigator: ____________________________ Date:

_____/_____/______


Study Investigator’s Name:

__________________________________________________

Signature of the Witness ______________________

Date:_____/_____/_______

Name of the Witness:

_______________________________________________________


SAROJ GUPTA CANCER CENTRE & RESEARCH INSTITUTE

GENERAL CONSENT FORM I, ________________________________, of ___________________________________ seek registration of myself/ for Shri/ Srimati __________________________of _________________________(who is, for the present, in my lawful charge) to this hospital for my/ his/ her medical treatment. I do so with full knowledge of the following conditions and possible hazards and risks which were explained to me in my vernacular and were fully understood and realized by me before registration of the name of myself/ said person in this Institute. 1. For the medical treatment, the following may be needed:

• Various Pathological, Radiological, Radionuclide and other diagnostic tests. • Surgical operation under General/ other anesthesia and/ or Radiotherapy and/ or Chemotherapy.

2. The course of investigations/ diagnosis/ treatment may lead to side effects, damage or dysfunction of any organ/ part or even death.

3. It is understood that the SGCCRI is engaged in clinical and epidemiological research. To contribute in the research activities, the following will be necessary: • Voluntary participation in the program without any financial or monetory benefit/ gains with the

consent of the concerned patient or his/ her guardian. • Permission to the concerned Medical Officer/ authority to use clinical/ relevant data including data

arising out of medical investigations/ treatment without disclosing the full identity of the patient. • Permission to take clinical photographs of the patient or any part/ area of the body/ organ of the

patient without disclosing the full identity of the patient. • Using the data and clinical photographs in appropriate journals without disclosing the full identity

of the patient. • To use body fluids, excreta, tissue samples, blood etc. for medical research without disclosing full

identity of the patient and obeying the law of the land. 4. For the benefit of the patient and also for the safety of other patients and health care professionals,

including doctors, nursing staff, technical assistants, other paramedics and General Duty Attendants, testing of HIV and Hepatitis antibodies in the patient’s blood/ body fluids may be required.

5. Under certain conditions and circumstances, the patient may be admitted to this Hospital/ Ashavari guest House with obligation by the patient and his/ her party to abide by the rules and regulations of this Hospital and Ashavari Guest House.

6. Some adult and responsible relative of an admitted patient at this Hospital must maintain daily contact with the Medical Officers, Nursing Personnel and Staff of this Hospital in-charge of the medical management of the patient and also Medical Administrator/ Medical Superintendent and Managers of Personnel and Administration Departments as and when necessary.

7. After admission in this Hospital/ Ashavari Guest House, the patient may be shifted under certain circumstances from one bed to other in same Ward or other Ward, including ITU.

8. The patient/ his or her party is required to pay the necessary charges as per the hospital schedule for the bed and other services given to the patient periodically and clear all such charges before the patient’s discharge / transfer from this Hospital/ Ashavari Guest House.

9. The patient is required to pay the necessary charges for investigations in advance when advised. [In case the investigation (s) is/ are not done, the charges will be refunded.

10. Urgent or life saving treatment, investigation(s) or medication(s), when the patient’s relative/party/ guardian is not available/ cannot be contacted, may be done by the hospital on the judgment of the attending Medical Officers and charges therefore, would be required to be paid by the patient or his/ her guardians/ relations/ party/ those in lawful charges of the patient without undue delay.

11. The Department of Health & Family Welfare, Government of West Bengal has passed an order (No HF/O/PHP/402/5C-05/2010) dated December 20, 2010 making Cancer a notifiable disease in this state. This Institute is now instructed by the said order to furnish all the relevant data to proper authority. I do not have any objection to this.


12. This hospital is included in the Population Based Cancer Registry of Kolkata under Nation Cancer

Registry Programme, Indian Council of Medical Research. This authority regularly collects the Epidemiological data from this Institute. I/We do not any objection to this.

13. Apart from the above mentioned authorities, this Centre is required to furnish some Epidemiological/Statistical data to certain other authorities under statute, eg Division of Health Intelligence, Department of Health, Govt. of West Bengal, etc. We do not have any objection to this.

__________________________________ ____________________________________ Signature of Witness Signature of the Patient/ Person having

lawful charge of the patient Date: ____________________ Date:________________________