Constitution of Institutional Ethics Committee

Sanjay Gandhi Postgraduate Institute of Medical Sciences

 

Standard Operating Procedures  of Institutional Ethics Committee (SOPs, IEC)

 

Useful link (Form/template)

 

 

Forms 1-Project submission

 

Form 2-Intimation of start of study

 

Forms 3-Annual status report

 

A. For Interventional study

 

B. For non Interventional study

 

Form 4-Study Completion Report form

 

A. For Interventional study

 

B. For non Interventional study

 

Form 5-Amendment Reporting

 

Form 6-SAE reporting  

 

A. Onsite

                         

B. Offsite

 

Form 7-Deviation-Waiver-Violation-Reporting

 

Form 8-Premature Termination/Suspension/Discontinuation Report

 

Form 9-Review exemption application

 

Form 10-Request for Waiver of Written Informed Consent

 

Form 11-Formulation of New/Revision of SOP

 

Form 12-List of IEC Members

 

Appendices (Policy and Guideline)

 

Useful link (Form/Template)

 

 

Forms 1-Project Submission-Word / PDF

 

Form 2-Intimation of start of study

 

Forms 3-Annual status Report

 

A. For Interventional study

 

B. For non Interventional study

 

Form 4-Study Completion Report

 

A. For Interventional study

 

B. For non Interventional study

 

Form 5-Amendment Reporting

 

Form 6-SAE Reporting          

 

A. Onsite

                      

B. Offsite

 

Form 7-Deviation-Waiver-Violation-Reporting

 

Form 8-Premature Termination/Suspension/Discontinuation Report

 

Form 9-Review exemption application

 

Form 10-Request for Waiver of Written Informed Consent

 

Form 11-Formulation of New/Revision of SOP

 

Form 12-List of IEC Members

 

Appendices (Policy and Guideline)

Click here to download

Complete SOPs of IEC, SGPGI

The Institutional Ethics Committee is constituted by Director, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS) in consultation with the existing Chairperson of Institute Ethics Committee (IEC) and the Academic Board. The Institutional Ethics Committee (IEC) of SGPGI was established in 1988.

 

Purpose

 

The IEC has been established to formalize and specify the Institution’s commitment to promotion of high ethical standards in clinical research, and teaching.

 

Mandate

 

The IEC through its delegated sub-committees functions independently for maintaining consistent ethical framework in research, and in the integration of ethical values into practice, policy relationships, and organizational activities.

1. The purpose of IEC is to cultivate a pluralistic and democratic exchange of ethical values, concerns and to critically analyze them looking for opportunities to enhance the ethical integrity of the Institution.

2. The mandate of IEC, SGPGI essentially targets ethical aspects of research and education.

 

The terms of reference for the IEC are as follows:

 

1. To ensure that all proposed research projects conform to standard national and international ethical guidelines and that dignity, right and wellbeing of research participants is protected.

2. To initiate and commission research studies on ethical aspects of practice in SGPGI.

3. Continuing education in research bioethics and ethical aspects of clinical practice by seminars, workshops and interactive discussions for all categories of staff  members including nursing and paramedical staff.

4. The Ethics committee endeavors to produce guidance on a broad range of topics.

5. Assessments of risk benefit ratio, informed consent process etc. are some examples.

6. The committee does not address or interfere in matters of an administrative nature, nor does the committee function as a grievance cell for staff members.

 

Responsibility

 

IEC has responsibility within the institution with the following objectives:

 

1. To ensure the competent review and evaluation of all ethical aspects of research projects received, to ensure compliance with the appropriate laws and safeguard welfare of subjects.

2. Clinical ethics consultation.

3. Education of professional, administrative, and support staff about ethical issues.

4. Creation, developing revising and implementing ethical guidelines (SOPs).

5. Initiate studies in ethics.

6. Continuing education and training programs to ensure that IEC members are qualified to perform their specific duties.

 

Ethical basis

 

1. The committee consists of members who collectively have the qualifications and experience to review and evaluate the scientific, medical, and ethical aspects of a proposed research project/Clinical Trials.

2. The IEC recognizes that the protocols it approves be required to be approved by national and/or local ethics committees also prior to their implementation in case of collaborative research.

3. In evaluating protocols and ethical issues, the IEC is aware of the diversity of laws, cultures and practices governing research and medical practices in various countries around the world.

4. The IEC also seeks to be informed, as appropriate, by national/other local ethics committees and researchers of the impact of the research it has approved.

 

The IEC is guided in its reflection, advice and decision by;

 

1. The ethical principles expressed in WMA Declaration of Helsinki (Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964, and finally amended by 59th  WMA General Assembly, Seoul, October 2008).

2. It makes further reference to the International Ethical Guidelines like. The Nuremburg Code (1945), the Belmont Report 1979, the CIOM International Ethical Guidelines for Biomedical Research Involving Human Subjects (Geneva 1993), and the European Convention on Human Rights and Biomedicine 1997.

3. The IEC establishes its own Standard Operating Procedures taking recognition of,  Good Clinical Practices For Clinical Research In India by Central Drugs Standard Control Organization (2001), the ICMR guidelines (2006),   Schedule   Y   (Drugs   and   Cosmetics   Act   1940, amendment 20th Jan 2005), Operational Guidelines for Ethics Committees that Review Biomedical Research (WHO 2000), and ICH-GCP, 1996.

4. The IEC seeks to fulfill the requirements for international assurances and is established and functions in accordance with the national law and regulations.

5. In view of the tremendous growth of clinical research in the institution, the Director, SGPGI has accepted a SOP prepared by IEC to facilitate the work of IEC and maintain high standard of ethical review in 2007.

 

Composition

 

IEC will be multidisciplinary and multi-sectorial in composition. It will comprise of a Chairperson, Member Secretary, and 7-13 active members who represent an appropriate balance of professional, ethical, legal, cultural, educational, and community interests. The committee will have a minimum of 7, and maximum of 13 members. The members are selected to have an equitable representation of all specialties and gender. It includes scientific and non-scientific persons, clinicians and non-clinicians, clinical pharmacologist, persons of the community, a legal expert, a social worker/layperson/patient representative to represent different point of view. The external members shall be in majority to ensure independence of the committee. It should have adequate representation of age, gender, community, etc. to safeguard the interests and welfare of all sections of the community/society. Members are expected to be aware of local, social and cultural norms, as this is the most important social control mechanism.

 

The composition should be as follows:-

 

1. Chairperson (not – affiliated to SGPGI)

2. Member secretary (SGPGI faculty member)

3. Two faculty members of SGPGI

4. Dean, SGPGI

5. One to two clinicians (not affiliated to SGPGI)

6. Basic medical scientists

7. Clinical pharmacologist.

8. One legal expert or retired judge or medico-legal expert

9. One social scientist/representative of non-governmental voluntary agency

10. One philosopher/ethicist/theologian

11. Lay person from the community

 

Independent consultants

 

The IEC may call upon, or establish a standing list of, independent consultants who may provide special expertise to the IEC on proposed research protocols, when the Chairperson or the IEC members determine that a study will involve procedures or information that is not within the area of expertise of the IEC members. These consultants may be specialists in ethical or legal aspects, specific diseases or methodologies, (e.g. genetic disorders, stem cell research etc.) or they may be representatives of communities, patients, or special interest groups. These   consultants   must   sign the Confidentiality Document regarding meeting, deliberations, and related matters. These consultants or subject experts cannot vote for decision. They will attend the IEC meeting as special invitee as per the requirement for the research protocol only.

 

IEC subcommittee

 

A subcommittee of IEC may be formed as when required for expedited review of revised proposal where major changes not required. The subcommittee will consist of the Member Secretary (convener) and 2 outside IEC members. The decision of the subcommittee will be reported to the next meeting of IEC by the Member Secretary.

                           

Roles and responsibilities of the IEC members

 

1. The Committee’s primary responsibilities will be protection of safety, rights, dignity and confidentiality of the research subjects.

2. Review and discuss research proposals submitted for evaluation.

3. Review progress reports and monitor ongoing studies.

4. Monitor SAEs and recommend appropriate action(s).

5. Maintain confidentiality of the documents and deliberations of the IEC meetings.

6. Declare conflict of interest, if any.

7. To carry out work delegated by Chairperson and Member Secretary.

8. To participate in continuing education activities in biomedical ethics and biomedical research.

9. To provide information and documents related to training obtained in biomedical ethics and   biomedical research to the Bioethics cell.