ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTSSeth G. S. Medical College & K. E. M. HospitalParel, Mumbai 400 012. STANDARD OPERATING PROCEDURES Version 02
November 2005
Author : Dr. Sandhya Kamat Member-Secretary ECRHS
Reviewers : ECRHS Members
Approved by : Ethics Committee for Research on Human Subjects
Confirmed by : Dr. ML Kothari Chairperson ECRHS
Distribution : Members of ECRHS & Investigators of projects submitted to ECRHS
CONTENTS
Introduction ……………………………………………………………..………..………..5Standard Operating Procedures………………………………………………………… ………6
3.1 Composition of the Committee ...………………………………………………………...6 3.2 Chairperson ………………………………………………………………………………..6 3.3 Members ………………………………………………………………………………...…7 3.4 Member Secretary ………………………………………………………………………...7 3.5 Tenure of Membership ……………………………………………………………… ..….7 3.6 Resignation of Members……………………………………………………………… ….7 3.7 Termination of Membership…………………………………………………………… ...7 3.8 Appointment of New Members………………………………………. ………………… 8
5.2 Procedures ………………………………………………………...……………………....10 5.3 Elements of Review…………………………………………………………………….….10 5.4 Meetings …………………………………………………………………………………....11 5.5 Review Outcome…………………………………………………………………………...12 5.6 Notification of Review Outcome………………………………………………………… 12 5.7 Approval……………………………………………………………………………….…….12 5.8 Review of the Modified Proposal Outcome………………………………………………13 5.9 Procedure for Appeal…………………………………………………………………........13 5.10 Review of Amendments to the Approved Research Proposal………………..…....13 5.11 Expedited Review Procedure…………………………………………………………13 5.12 Review of Subject Recruitment Procedures………………………………….…….14 5.13 Review of Ongoing Studies…………………………………………………….…......14
14.1 Appendix 1 – Guidelines for Submission of a Proposal ………………………….…18 14.2 Appendix 2 – ECRHS Application Form………………………………………......….20 14.3 Appendix 3 – Checklist of Documents…………………………………………..……23 14.4 Appendix 4 – ECRHS Approval Format……………………………………...……….24 14.5 Appendix 5 – Format of Informed Consent Document …………………………..….25 14.6 Appendix 6 – Confidentiality Agreement …………………..………………………....29
Introduction
The first International statement on the ethics in medical research using human subjects, the Nuremberg Code was formulated in 1947 and it laid emphasis on consent and voluntariness. In 1964, the eighteenth World Medical Assembly at Helsinki, Finland adopted a code of ethics for the guidance of doctors involved in clinical research. This is popularly known as the “Declaration of Helsinki.”
In 1980, the Indian Council of Medical Research released a ‘Policy Statement on Ethical Considerations involved in Research in Human Subjects’ for the benefit of all those involved in clinical research in India. Soon after, in the year 1986, a group of staff members with the Dean as the chairperson came together to set up the Ethics Committee of the Seth GS Medical College and K.E.M. Hospital, to review the ethics of any human research project conducted at our institutes. Guidelines were laid down for submitting a research project for ethics committee approval.
In the last ten years, clinical research activities in our institutes have increased, and these are expected to increase even further in future. Moreover in 1996, the International Conference on Harmonization (ICH) published a tripartite guideline for Good Clinical Practice (GCP) to harmonise technical requirements for registration of pharmaceutical products in three regions namely the United States, the European Union and Japan). Today, the ICH GCP guideline is followed globally for clinical research. This guideline elaborates the composition and functioning of an Institutional Ethics Committee to review clinical research proposals.
It was thus felt necessary to establish an Ethics Committee consistent with the ICH GCP Guideline so as to facilitate the ethical review of any human research project in our institutes and also be an asset to the sponsors of such projects, the subjects participating in them, the relevant statutory authorities, and the society at large. In June 1999, the committee was reformulated so that the chairperson was no longer the Head of the Institute. A unanimous decision was taken to change the name the committee to, ‘Ethics Committee for Research on Human Subjects’. Standard Operating procedures were drafted and the first version was printed in May 2000.
0n 20th January 2005, the Ministry of Health and Family Welfare, after consultation with the Drugs Technical Advisory Board, amended the Schedule Y of Drugs and Cosmetics Rules, 1945. In addition to requirements concerning clinical trials the new Schedule Y also outlines requirements of Institutional Ethics Committees. It was therefore mandatory to carry out minor amendments in the already existing Standard Operating Procedures in order to make them compatible with the latest Schedule Y.
The Ethics Committee for Research on Human Subjects presently functions according to the requirements laid down in Schedule Y (20th January 2005) and is guided by the ICH GCP guidelines for Good Clinical Practice, ethical principles set forth in the Declaration of Helsinki and the Ethical Guidelines for Biomedical Research on Human Subjects laid down by the Indian Council of Medical Research.
Standard Operating Procedures1. NameThis committee will be known as the Ethics Committee for Research on Human Subjects (ECRHS). This name will remain unchanged until the members choose to change it by a vote of three-fourths of the current strength.
2. PurposeThe primary purpose of this committee will be: 1. To ensure the protection of the rights, safety and well-being of human subjects involved in a research project. 2. To provide public assurance of that protection.
3. MembershipThe committee will consist members who collectively have the experience and expertise to review and evaluate the scientific, medical and ethical aspects of a proposed research project. A list of committee members, their qualifications and their affiliations (hospitals, colleges etc.) described in §13 of this document will be maintained in the committee’s records.
3.1 Composition of the Committee a. The regular members of the committee will ideally include at least 7 and a maximum of 15 individuals as follows : i. Medical scientists and clinicians with expertise in diverse health care specialities. ii. A legal expert. iii. A social worker/representative of a non-governmental organisation/theologian. iv. A lay person from the community. b. The committee will have representation from both men and women. c. At least two of the medical scientists or clinicians will be independent of the institution. d. At least one of the non-scientific members will be independent of the institution. e. Members from other areas, such as a journalist or a member from a consumer protection activity, may be included in the committee.
3.2 Chairperson a. The Chairperson will be selected and appointed by the Head of the Institute. b. The Chairperson will be independent of the institution. c. The appointed Chairperson will select and appoint members of the committee. d. The Chairperson will be responsible for conducting all committee meetings, and will lead all discussions and deliberations pertinent to the review of research proposals. e. The Chairperson will preside over all elections and administrative matters pertinent to the committee’s functions.
f. In case of anticipated absence, the Chairperson will nominate a committee member, who is independent of the institution as Acting Chairperson. The Acting Chairperson will have all the powers of the Chairperson for that meeting.
3.3 Members a. The members will be selected and appointed by the chairperson, provided they are willing to work as an Ethics Committee member. b. A member shall be willing to publicise his/her full name, profession and affiliation. c. A member will sign a confidentiality agreement described in § 14.6 of this document before every meeting. d. A member will have been trained in ethical issues or shall be willing to undergo training in ethical issues.
3.4 Member Secretary a. The committee members will elect a Member Secretary from among themselves b. In consultation with the Chairperson, the Member Secretary will be responsible for the following functions: i. Receiving all research proposals. ii. Numbering the proposals. iii. Forwarding all proposals to committee members for review. iv. Establishing time limits for receipt of reviewers’ comments. v. Preparation of agenda for all committee meetings. vi. Inviting experts from relevant therapeutic areas to the scheduled meetings. vii. Notification of review outcome to investigators of research proposals. viii. Preparation and circulation of minutes (within 14 days of the meeting). ix. Retention and safekeeping of all records and documentation. x. Performance of other duties assigned by the Chairperson.
3.5 Tenure of Membership a. A member will be a regular member for a period of up to five (5) years. b. Extension of membership will be determined by a vote of two-thirds of the members present in a quorum at a regular committee meeting. c. There is no limit to the number of times that the membership can be extended. d. New members will be appointed to replace members according to the process described in § 3.8 of this document.
3.6 Resignation of Members Members may resign before completing their terms by writing their intention to the chairperson.
3.7 Termination of Membership The membership will stand to be terminated under the following circumstances:
a. if a member resigns from the committee b. if a member remains absent for 3 consecutive meetings without informing or giving a valid reason. c. if a member is incapable of performing his/her duty as an ethics committee member d. if a member retires from the institute voluntarily or by superannuation e. in case of demise of a member.
3.8 Appointment of New Members a. New members will be selected and appointed under the following circumstances: i. When a regular member completes his tenure and does not wish to continue his/her membership. ii. If a regular member resigns. iii. In case of the termination of membership of a regular member b. A new member will be preferably but not necessarily nominated from the same category as that of the member being replaced.
4. Responsibilities of the Committee
1. The committee’s primary responsibility will be the protection of safety, rights, well-being and confidentiality of the research subjects. 2. The committee will review all research proposals submitted to it within specified time limits. 3. The committee will keep all information submitted to them confidential especially the proprietary information. 4. The committee will maintain concise but clear documentations of its views on the research proposal. 5. The committee will review the progress of each research project at appropriate and specified intervals, but not less than once a year. 6. The committee will review the qualifications of all investigators participating in the proposed research study.
5. Functions and Operations
5.1 Submission of the Research Proposal
a. All prospective and retrospective studies (on drugs, investigational techniques as well as devices or any other procedure), involving human volunteers or patients to be conducted at Seth G.S. Medical College & K.E.M. Hospital, shall have ECRHS permission before commencing such a study.
b. Each project along with a duly completed ECRHS application form shall be submitted in duplicate. The ECRHS application form will be available at the office of the ECRHS between 9.30a.m. to 4.00 p.m.. The information to be given on the application form shall be preferably typed or filled in legible handwriting. It shall have the designation and signatures of Principal Investigator, all the co-investigators and the Head of the
concerned department. If the study involves more than one department, then respective collaborator/co-investigator and head of the collaborating department shall also sign the form. All details in the form such as type of patients, phase of drug trial, duration of study, sponsoring agency, budget of the trial, availability of Drugs Controller General of India [DCG(I)] permission and other relevant approvals etc. shall be completed while submitting the proposal.
c. Studies which plan to use a new drug (as defined in 122-E of the Drugs and Cosmetics Act, 1945) shall submit along with the ECRHS application form, a copy of the permission letter issued by the DCG(I) to the pharmaceutical company/investigator. If the DCG(I) permission is awaited, a letter of provisional approval from ECRHS will be issued and final ECRHS approval will be given after a copy of DCG(I) permission is submitted to the ECRHS. A study cannot begin until the final letter of permission is issued by the ECRHS.
d. In case a clinical study is planned on an “alternative system of medicine” a co-investigator from that system will be required on that study. For ayurvedic or herbal drugs, which are not marketed, a copy of the marketing/manufacturing licence issued by FDA to the company shall be submitted.
e. A user fee of Rs. 5,000/- will be charged for all sponsored projects. The user fee will be increased to Rs. 10,000/- from 1st January 2006. Government sponsored projects will be charged Rs.1000/- and projects, which are not sponsored, will be charged a nominal-processing fee of Rs. 100/-. The fees shall be collected at the time of at the time of submission of the project. The amount to be collected, as processing fee will be reviewed at the end of 1 year.
f. The project proposal shall be submitted in duplicate. Each set shall contain the documents on A 4 size paper arranged in a file in the order mentioned below: i. ECRHS application form duly filled. ii. Summary of protocol (in not more than 500 words) iii. Protocol and any amendments to it with version and date iv. The informed consent document (ICD), including any amendments / addenda and its translation(s) into regional language(s). The ICD should be customised for the study according to the format given in § 14.5. v. Case Record Form / Questionnaire. vi. Principal investigators current Curriculum vitae. vii. Subject recruitment procedures (e.g. advertisements/letters to doctors/posters) viii. Investigator Brochure (for sponsored projects). This should give details of the study drug, toxicology studies, phase I, II, III data wherever available, safety information etc. ix. Ethics Committee clearance of other centers (if multicentre study). x. Insurance policy
xi. DCG(I) clearance[for Phase I, II, III studies] xii. Investigator’s agreement with sponsor xiii. Investigator’s undertaking to DCG(I) [for Phase I, II, III studies] xiv. Health Ministry Screening Committee (HMSC) / Bhabha Atomic Research Centre (BARC) / Genetic Engineering Advisory Committee (GEAC) / Director General of Foreign Trade (DGFT) clearance wherever applicable xv. Food and Drug Administration (FDA) marketing/manufacturing license for herbal drugs.
The guidelines for submission of a research proposal are as described in § 14.1 and the checklist for documents to be submitted is as described in § 14.3.
5.2 Procedures a. All communications with the committee shall be in writing. b. The project proposals in the format mentioned in § 5.1.g will be accepted in office of the ECRHS on or before the 20th of every month. c. The projects submitted by the 20th of a month will be circulated to all committee members and the proposal shall be reviewed for elements described in § 5.3. d. A meeting, as described in § 5.4, of all members will be held where each proposal will be discussed and decisions arrived at. 5.3 Elements of Review The submitted proposal shall be reviewed both for scientific content and ethical principles. The committee members shall review the proposal with reference to the following: a. Scientific design of the study b. Justification/Rationale of the study c. Selection criteria for subjects d. Justification for use of placebo, if any e. Potential benefits to the study subjects f. Predictable risks to the study subjects g. Criteria for discontinuation/withdrawal of subjects h. Monitoring of serious adverse events i. Compensation to subjects for participating in the study j. Subject recruitment procedures k. Patient retention activities. l. Compensation for study related injury m. Post trial benefits n. Protection of privacy and confidentiality o. Statistical analysis p. Informed consent document in English and regional languages q. Competence of investigators, supporting staff and infrastructure facility r. Approval of regulatory authorities wherever applicable
5.4 Meetings a. The committee will hold a regular meeting once every four (4) weeks on the second or third Tuesday of each month. When there are no research proposals to review, the meeting may be held less frequently, but not less than once every twelve (12) weeks.
b. Regular meetings may not be held in the months of May and November when the college closes for vacation.
c. All members will receive notification of meeting schedules at least two (2) weeks in advance.
d. The committee members will review all the proposals before the meeting.
e. The proposal may be sent to a subject expert for his/her assessment and opinion of the research proposal. The subject expert may be invited for the meeting.
f. The investigator and/ or co-investigator may be invited to the meeting to provide clarifications on the study protocol.
g. Specific patient groups such as those suffering from HIV/AIDS or genetic disorders may also be invited for the meeting based on the requirement of the research area.
h. Quorum Meetings will be held as scheduled provided there is a quorum. In accordance with Schedule Y (20th January 2005), the quorum of the ECRHS will be at least five members with the following representations: i. a basic medical scientist (preferably one pharmacologist), ii. a clinician, iii. a legal expert, iv. a social scientist and v. a lay person.
i. Hierarchy i. There will be one Chairperson and one Member Secretary. ii. The Chairman will be the head of the committee. iii. The Member Secretary will be the guardian of all documents and funds in the committee’s possession. iv. All other members will be regular committee members with equal ranking.
j. Minutes The Member Secretary will be responsible for coordination and recording of the proceedings of the meeting. The proceedings of the meetings shall be recorded in English and in the form of minutes. The minutes shall be approved by the chairperson.
k. Decision making i. Decision for each proposal shall be by voting. ii. A majority vote for approval, disapproval, request for modifications, suspension or termination of a research proposal or an ongoing study is defined as one-half of the members who have reviewed the project. iii. All members present at the ECRHS meeting will vote on the research proposal. iv. Absent members will not have a vote. v. Member(s) of the committee who is/are listed as investigator(s) on a research proposal will opt out from all deliberations on the proposal and will not vote on the proposal. vi. An investigator or study team member invited for the meeting will not vote or participate in the decision making procedures of the committee. vii. Specific patient groups invited for the meeting will not vote or participate in the decision making procedures of the committee.
5.5 Review Outcome The committee will document its view on the following: a. Final Approval b. Provisional approval subject to regulatory approval c. Request for modification giving reasons d. Request for additional information e. Clear disapproval giving reasons. f. Termination/suspension of an ongoing study giving reasons
5.6 Notification of Review Outcome The outcome of committee’s review shall be communicated to the investigator within 10 working days of the meeting. Thus, the decision will be communicated to the investigator within 40 days of submission of the proposal, except for proposals submitted in the months of April and October.
5.7 Approval All projects will be given approval for a period of one year from the date of the meeting on which the project was approved. The approval shall be in the format described in § 14.4
5.8 Review of the Modified Proposal a. When modifications to the proposal, as recommended by the committee, are minor, the revised documents may not be re-circulated. The revised proposal shall be reviewed by either the Chairperson of the committee, the Member Secretary of the committee, or by one or more experienced reviewers designed by the chairperson from among the members of the committee. An approval may then be issued if the revised documents satisfactory. The committee will keep all members of the committee informed of these approvals.
b. When modifications to the proposal, as recommended by the committee, are major, the revised proposal will be re-circulated and discussed again at next meeting.
5.9 Procedures for Appeal For research proposals rejected/disapproved by the committee, the applicant may appeal for a repeat review in within, within twelve (12) weeks of the receipt of the committee’s decision. While doing so, the applicant shall give justification relevant to the issues/objections raised by the committee.
5.10 Review of Amendments to the Approved Research Proposal a. All amendments to the approved research proposal shall be submitted to the committee immediately for its review.
b. No changes in the protocol, case record form and /or ICD shall be initiated without prior written approval from the committee, except when necessary to eliminate immediate hazards to the subject, or when the change(s) involve only logistical or administrative aspects of the trial (e.g. change of monitor(s), telephone number(s).
5.11 Expedited Review Procedures a. The committee may use expedited review procedure in case of minor changes/ amendments in the previously approved research proposal that appear to involve no more than minimal risk to the study subjects.
b. Under an expedited review procedure, the review may be carried out by the Chairperson of the committee, or by one or more experienced reviewers designed by the chairperson from among the members of the committee. The reviewers may exercise all of the authorities of the committee except that the reviewers may not disapprove the research.
c. An ongoing research activity may be disapproved only after review in accordance with non-expedited review procedure as mentioned in § 5.2
d. The committee will keep all members of the committee informed of these approvals under the expedited review procedure.
e. Only the Chairperson shall make the decision to allow an expedited review
5.12 Review of Subject Recruitment Procedures All advertisements, letters to doctors, posters, notices to be used for recruitment of subjects shall be reviewed and approved by the committee prior to their implementation in the study.
5.13 Review of On-going Studies a. The committee will conduct a continuing review of each on-going study by reviewing the reports described in § 6.
b. The committee may also ask for a status report from the investigator at earlier intervals as is felt appropriate to the degree or risk to the human subjects.
c. On the basis of the review, the committee shall recommend temporary suspension or termination of ongoing clinical trials for reasons such as patient safety.
6 Reports Required of Research InvestigatorsThe research investigator shall submit the following reports to the committee:
a. Annual progress/status report: For studies whose duration is more than a year, the first report shall be submitted at least thirty (30) days before the completion of the year following the date of the first approval.
b. Subsequent reports shall be submitted at one-year intervals following the first report.
c. In addition, the investigator shall also promptly report the following to the committee: i. Deviations from/changes to the protocol to eliminate immediate hazards to trial subjects. ii. Changes that may increase the risk to subjects and /or affect the conduct of the trial. iii. All adverse events that are both serious and unexpected within seven working days of the occurrence of the adverse event. iv. New information that may affect adversely the safety of the subjects or the conduct of the trial.
d. Study completion report: A brief report of the study shall be submitted to the committee at the end of the study.
7 Extension of ApprovalFor studies whose duration is more than one year, an extension of approval shall be given after the status report and all other relevant reports mentioned under § 6 are reviewed and approved by the committee. The approval for extension for study will be given for a period of one year.
8 On-going Training of Membersa. The Chairperson will identify the training requirements of the committee members. b. The Chairperson and the Member Secretary will organize workshops or training programmes for the committee members. c. The type of programmes, areas for training and mentors for these workshop or training programs will be decided by the committee members at a scheduled meeting. d. Members shall also be deputed by the chairperson to attend workshops to train ethics committee members.
9 Records RetentionThe committee will archive the following records for a period of at least five (5) years a. Standard operating procedures (SOPs) of the committee b. Guidelines for submission established by the committee. c. Annual reports of the committee d. Membership list e. Curriculum Vitae of the members f. Agenda of meetings g. Minutes of meetings
The committee will also archive the following records for a period of at least five (5) years following the completion of a study a. One copy of all materials submitted by a research investigator b. All correspondence by the committee with the research investigator regarding application, decision and follow –up c. A copy of the decision and any advice or requirements sent to an applicant d. All written documentation received during the study e. The notification of the completion, premature suspension or premature termination of a study f. A summary of the final report of the study
The records shall be made available to relevant statutory authorities upon request.
10 Reports to the Relevant Regulatory AuthoritiesThe committee will make a yearly activity report for submission to the relevant regulatory authorities, which will include the following elements:
a. A quantitative evaluation of the activities of the committee in a year b. The list of the proposals reviewed in a year c. Status of each study proposal
11 Location and Business Address:The location and business address of the committee is as follows :Ethics Committee for Research on Human Subjects, Department of Pharmacology & Therapeutics, College Bldg, First Floor, Seth G.S. Medical College & K.E.M. Hospital Parel, Mumbai 400 012. Tel. (KEM): 91 22 413 6051, Ext. 2515 Mobile: 9820757259 Fax(KEM) : 91 22 415 6513 e-mail: ethicscommittee@gsmc.edu
12 Amendments to the Standard Operating Procedures a. Amendments to the Standard Operating Procedures of the Ethics Committee for Research on Human Subjects (ECRHS), Seth GS Medical College & KEM Hospital shall be proposed in writing. b. The proposal for amendment shall be submitted to the Member Secretary. c. The proposal for amendment shall be presented to the regular members at a scheduled committee meeting. d. Only regular members shall vote to accept or reject the proposed amendment. e. A proposed amendment shall be approved by a vote of three-fourths of the members present in a quorum at a scheduled committee meeting, rounded to the next whole number. f. If the changes on a final version are minor the version will be indicated as Version 1.1, version 1.2 etc. If there are major amendments, the version will be indicated as Version 2.
13 List of committee members with their affiliations and qualificationsThe present composition of the Ethics Committee for Research on Human Subjects is listed in the table below:
14 Appendices
14.1 Appendix 1: Guidelines for Submission of a Proposal to the ECRHS
i. ECRHS application form duly filled. ii. Summary of protocol (in not more than 500 words) iii. Protocol and any amendments to it with version and date iv. The informed consent document (ICD), including any amendments / addenda and its translation(s) into regional language(s). A format of the ICD is available in the office of the ECRHS. The ICD should be customised for the study using this format. v. Case Record Form / Questionnaire. vi. Principal Investigator’s current curriculum vitae. (In case of dissertation the Guide’s CV may be submitted). vii. Subject recruitment procedures (e.g. advertisements/letters to doctors/posters)
viii. Investigator Brochure (for sponsored projects). This should give details of the study drug, toxicology studies, phase I, II, III data if available, safety information etc. ix. Ethics Committee clearance of other centers (if multicentre study). x. Insurance policy / Statement regarding compensation of study related injury by sponsor xi. DCG(I) clearance[for Phase I, II, III studies] xii. Investigator’s agreement with sponsor xiii. Investigator’s undertaking to DCG(I) [for Phase I, II, III studies] xiv. Health Ministry Screening Committee (HMSC) / Bhabha Atomic Research Centre (BARC) / Genetic Engineering Advisory Committee (GEAC) / Director General of Foreign Trade (DGFT) clearance wherever applicable xv. Food and Drug Administration (FDA) marketing/manufacturing license for herbal drugs.
All adverse events occurring in the study, deviations from, or changes in the protocol to eliminate immediate hazards to the trial subjects, new information that may adversely affect the safety of the subjects or conduct of the trial.
8. The ECRHS expects to be informed annually about the status of the study.
(a) For studies which are completed within the ECRHS approval period, a study completion report should be submitted to the ECRHS, by the principal investigator. If a study was not initiated, or was withdrawn or terminated, the same should be informed to the ECRHS giving reasons.
(b) For studies which will continue for more than a year, an extension of approval for the study from the ECRHS needs to be taken by the principal investigator (as ECRHS approval for a study is for one year only). The request for extension of approval should be accompanied with a project report mentioning the following: no. of screened patients, randomised patients, active patients, no. of patients who have completed the study, no of patients who have dropped out/ withdrawn, no. of patients who had an SAE, report of an interim analysis if available. The approval will be extended after the ECRHS reviews the annual project report. A user fee of Rs. 1000/- will be charged for extension of approval of projects sponsored by pharmaceuticals.
9. The Standard Operating procedures of the ECRHS, Version 2, November 2005, are available with the administrative manager in the office of the ECRHS.
14.2 Appendix 2 : ECRHS Application Form Title of the project ________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________14.3 Appendix 3: Check List of Documents
14.4 Appendix 4: ECRHS Approval Format
Date: ___________
To, Principal Investigator, Dept. of . ____________
Sub: Your project no. EC/____/200____ entitled, “________________________”.
Dear Dr. ______________,
The meeting of the Ethics Committee for Research on Human Subjects (ECRHS) was held on ___________at ______p.m. in the Boardroom, Dept. of Pharmacology & Therapeutics with __________as Chairperson. At the said meeting, the ECRHS approved the proposal for the clinical study entitled, “__________”.
It is understood that the study will be conducted under your direction, in a total of _____ subjects, at Dept. of ____________, Seth G. S. Medical College and K. E. M. Hospital as per the submitted protocol.
The ECRHS reviewed and approved the following documents submitted for the above – mentioned clinical study. “……………..List of documents ……………..”
It is the policy of ECRHS that it be informed about any serious adverse event occurring during the course of the study within seven days of the occurrence of the adverse event. The ECRHS expects to be informed about any changes in the protocol and Informed Consent Document and asks to be provided a copy of the final report. The status of the study (completed / ongoing / terminated) should be reported to the ECRHS annually.
Please note that this approval is valid till ________ and the renewal of this clinical project is subject to review of “Annual Study Report” submitted to this Ethics Committee by the Investigator.
_____ members attended the meeting held on ________ fulfilling the quorum.
The list of members who attended the meeting is as follows:
“…….Name of Chairperson, Member Secretary & members with qualification & affiliation…….”
It is hereby confirmed that neither you nor any of the study team members have participated in the voting/decision making procedures of the committee.
Yours sincerely,
Signatures of Member Secretary & Chairperson
14.5 Appendix 5: Format of Informed Consent Document
INFORMED CONSENT DOCUMENT DEPT. OF XXXXXXX SETH GSMC & KEMH PAGE 1 of 4
Project title:
To test the efficacy and tolerability of XXXXXXXX ( a test drug) as compared to XXXXX (a standard drug)
II Introduction: You are invited to participate in a research study. It is important that you read this description of the study and understand your role in it including the nature and risks of participation.
Please give your consent to participate in this clinical study only if you have completely understood the nature and course of this study and if you are aware of your rights as a participant.
III Purpose of the study: It is well known that people who suffer from XXXXX are at high risk for XXXXX. XXXXXXX medications are commonly prescribed to such patients to prevent the occurrence of XXXXX. XXXX is a new drug, which has been found to XXXXXXXXX in initial studies. The study plans to study the efficacy and safety of this drug in patients having XXXXXX.
IV Expected duration of the study and number of subjects: You will be one of approximately XXX people who will participate in this study. You will be in the study for about XXX days. (If multicentric study – mention that the study is also being carried out at xxx other centers).
V Study procedures to be followed: If you agree to participate in this study you will a)be asked about previous medical problems, your current health and your medications; b)have a brief physical examination (to give details);c) need to undergo baseline investigation such as XXXXXX(to give details) The study staff will review the results of these evaluations & test. If you are eligible to participate you will be randomly assigned (like the flip of a coin) to a study group to receive one of the two study treatments. The study would require a total of XXX visits. At each visit XXX ml (mention1-2 tsp/tbsp as applicable) of your blood will be withdrawn after fasting for XXX hours. The blood samples that are drawn, will be used to check your blood sugar levels, kidney and liver function etc. (mention whatever is applicable). Regardless of the group to which you have been assigned, you will return to the study centre after XXXX days / weeks / months. It is important that you bring all of your study medications, diary etc. along with you.
INFORMED CONSENT DOCUMENT DEPT. OF XXXXXXX SETH GSMC & KEMH PAGE 2 of 4
At each visit, a) you will be asked about your health, side effects of medications, b) your physical examination will be carried out c) you will be given a new supply of study drug.
VI Risks and discomforts of participating: The study testing 2 different therapies in high risk people that may prevent XXXXXX.
Based on studies in animals and other studies with people, the drug(s) used in this study may cause some side effects. The known risks and side effects associated with the drugs proposed for use here are summarized below. Side effects of test drug – XXXXX (Give Details) Side effects of standard drug – XXXXX (Give Details ) Other side effects that you may experience could include XXXXX (Mention allergic reactions to the medication, itching rash and pain at the injection site wherever applicable)
Finally new problems or side effects other than those that have been seen before could occur during this study. You will therefore be asked about side effects at each visit. It is important that you report any of the side effects described in this document or any other side effects to the study physician immediately at the numbers listed below.
While collecting blood from your vein, you will have to undergo the discomfort of brief pain or rarely develop bruising or even a minor infection. In case this occurs appropriate management will be provided.
Because the safety of the study drugs for an unborn fetus or newborn is unknown, if you intend to become pregnant, are pregnant or are breastfeeding you cannot participate in this study. If you are a woman who is able to have children, you will be required to undergo a urine pregnancy test. If you are no pregnant you will be asked to take precautions to prevent pregnancy until the end of the study. The doctors will discuss the contraception options with you. Pregnancy test may be repeated during the study. If you become pregnant despite these precautions you should immediately notify the study team. Pregnancy will be a reason to stop study treatment.
Any new important information that is discovered during the study and which may influence your decision to continue in the study will be provided to you or your legally acceptable representative in a timely manner. You will be told of any new risks or side effects.
VII Possible benefits of the study: By participating in this study, you may have a possible cure or improvement in your condition. However, there is no guarantee that you will receive direct health benefit from
INFORMED CONSENT DOCUMENT DEPT. OF XXXXXXX SETH GSMC & KEMH PAGE 3 of 4
being in this study. Your participation in this study may provide information that may in the future help other patients suffering from XXXXX.
VIII What happens when the research trials stops? Because this is a research trial, the test drug will not be available at the end of this trial for XXXXXX. Alternate therapy, if appropriate, will be provided once the trial is finished. Occasionally the company sponsoring the research may stop the study early – if this occurs the reason(s) will be explained to you.
IX Compensation for participation: Participation in this study will be at no cost to you. The medication and clinic visits will be provided free of charge. No compensation will be provided for your participation. Payment for things such as lost wages is not available. (Wherever applicable give details e.g. Reasonable travel assistance will be provided for your participation etc.)
X Compensation for study related injury: For academic studies: You will be provided medical care at this institute for any physical injury or illness that occurs as a direct result of your participation in this study. This medical care will be at no cost to you. You will not give up any of your legal rights by signing this form. For sponsored studies – The company has insurance for covering study related expenses. The study sponsor will compensate anyone whose health suffers as a result of participation in this trial. You do not have to prove it was anyone’s fault; if the health problem arose because of your participation in this trial, you will be compensated. You will not give up any of your legal rights by signing this form.
XI Right to withdraw from the study: Participation in this study is entirely voluntary. You may choose not to take part or you may leave the study at any time. Your decision will not affect your further treatment at this institute. If you decide to leave the study, you may have to undergo some tests and/or procedures, which will be done to protect your safety.
XII Confidentiality: All study records will be kept confidential at all times. Your identity will not be revealed except as required by law. The results of your treatment (details: laboratory tests, photographs, x-rays etc.) may be published for scientific reasons. Your identity will not be revealed in these publications.
XIII Contact for further information: Thank you for taking the time to read (or have read to you) the information about this study.
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Before you sign this document, you should ask questions about any thing that you do not understand. The study staff will answer questions before, during & after the study.
If you have questions about this study is being run, drug side effects or a possible research related illness or injury, contact the study doctor XXXXXXXX, designation, department XXX at telephone number XXXXXX during the office hours, or at XXXXX at outside office hours. If you have any questions about your rights as a research participant, or complaints regarding the research study, you may contact Dr. Sandhya Kamat, who is the Member Secretary of Ethics Committee for Research on Human Subjects on the following telephone number 24136051 extension 2515.
XIII Consent: 1. I have read or have had read to me the information given in the Informed Consent Document for this study entitled “XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX”. 2. I have received an explanation of the nature, purpose, duration, and foreseeable effects and risks of the trial and what I will be expected to do. My questions have been answered satisfactorily. 3. I understand that my participation in the trial is voluntary and that I may refuse to participate or may withdraw from the trial at any time, without penalty or loss of benefits to which am otherwise entitled. 4. I further understand that any information that becomes available during the course of the study that may affect my willingness to take part will informed to me. 5. Institutional review board authorities may wish to examine my medical records to verify the information collected. By signing this document, I give permission for this review of my records. 6. I understand that my identity will not be revealed in any report or publication. 7. I agree to take part in the above study.
_____________________ ______________________ ______________ Name of Subject/ Signature/ thumb impression Date of subject _____________________ __________________ ______________ ____________ Name of Legal Representative Relation to subject Signature Date
_____________________ _______________________ _______________Name of the Impartial Signature of the Impartial DateWitness Witness
______________________ _______________________ _____________ Name of the person Signature of the person Date administering consent administering consent
14.6 Appendix 6: Confidentiality Agreement
(To be printed on the letterhead of the Ethics Committee for Research on Human Subjects)
CONFIDENTIALITY AGREEMENT
The undersigned accept that the confidential information contained in the proposals_______________ submitted by the Investigators of Seth GS Medical College and KEM Hospital, to the Ethics Committee for Research on Human Subjects (ECRHS) for review in the ECRHS meeting dated_____________ shall be maintained in confidence with the same degree of care, the ECRHS holds its own confidential information and shall not be disclosed to any third party. However, we understand that ECRHS records may be subjected to review by the relevant regulatory authorities.
The Standard Operating Procedures of the Ethics Committee for Research on Human Subjects, Version 02, November 2005 are verified and confirmed by the following ECRHS members
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