HomeBRD Medical CollegeNeharu HospitalFacultyOPD DaysDepartmentCoursesSyllabusContact Us
IECHR Language Translation :

INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH

BRD Medical College, Gorakhpur-273013

Ethics Committee Membership List

Name of the Ethics Committee: Institutional Ethics Committee for Human Research, BRD Medical College, Gorakhpur.

Address: BRD Medical College, Gorakhpur-273013 UP.

Date: 20th April, 2013

S.No.

Name

Highest Degree

Sex

Primary Speciality

Affiliation

(Institution)

1.        

Dr Ashok Kumar Saxena

PhD

Male

Social and Clinical Psychology

Ex HOD Psychology, DDU Gorakhpur University, Gorakhpur

2.        

Dr DK Srivastava

MD

Male

Social and Preventive Medicine

HOD, Dept of SPM, BRD Medical College, Gorakhpur

3.        

Dr Milind Gore

PhD

Male

Microbiology

Director, NIV Gorakhpur Unit, Gorakhpur

4.        

Dr Mahima Mittal

MD

Female

Paediatrics

Assistant Professor, Dept of Pediatrics, BRD medical College, Gorakhpur

5.        

Dr Ashok Yadav

MS

Male

Surgery

Lecturer, Dept of Surgery, BRD Medical College, Gorakhpur

6.        

Mr Ashok Chaudhary

MA

Male

Journalism

Journalist, Jansandesh Publication

7.        

Mr Prabhakar Srivastava

LLB

Male

Law

Advocate, Gorakhpur Kachheri

8.        

Dr Arvind Kumar Singh

MD

Male

Social and Preventive Medicine

Lecturer, Dept of SPM, Government Medical College, Ambedkarnagar.

9.        

Dr Jamal Haider

MD

Male

Pharmacology

Lecturer, Dept of Pharmacology, BRD Medical College Gorakhpur

 

 

 

 (Member Secretary)

Institutional Ethics Committee for Human Research

BRD Medical College, Gorakhpur.

 


 

Standard Operating Procedures

This Institutional Ethics Committee for Human Research (IECHR) has been constituted under the authority of the Dean BRD Medical College, Gorakhpur and will function with the functions and duties underlined below. 

1.    FUNCTIONS AND DUTIES

·         To provide independent, competent, and timely review of the ethics of proposed studies.

·         To contribute to safeguarding the dignity, rights, safety, and well-being of all actual or potential research participants.

·         To take into consideration the principle of justice-which requires that the benefits and burdens of research be distributed fairly among all groups and classes in society, taking into account age, gender, economic status, culture, and ethnic consideration

·         IECHR will be independent from political, institutional, professional, and market influences

·         To ensure that there is regular evaluation of the ethics of ongoing studies that received a positive decision

·         The IECHR will have due regard for the requirements of relevant regulatory agencies and applicable laws

2.    MEMBERSHIP REQUIREMENTS AND TERMS OF APPOINTMENT

·         This EC is multidisciplinary and multi-sectorial in composition, and includes individuals with relevant scientific expertise, balanced age and gender distribution, and laypersons representing the interests and the concerns of the community.

                                            i.    This EC has been constituted by direct invitation and appointment of members by the office of the Dean, BRD Medical College, Gorakhpur.

                                           ii.    There has been no conflict of interest in making these appointments.

                                          iii.    The tenure of this IECHR is two years

                                          iv.    The appointments will be renewed at the end of two years by consensus

                                           v.    Disqualification Procedure: Members who remain absent for 3 consecutive meetings without prior notice and permission of the Chairperson, can be considered for disqualification.

                                          vi.    Resignation Procedure: A member of IECHR including the Chairman may resign his membership by writing under his hand to the Dean of the Institution for the reason found fit by him. Resignation will be accepted by the Dean of Institution/Chairperson depending upon the reasons cited in the resignation and he may notify it to the members.

                                         vii.    Replacement Procedure: A casual vacancy in the IECHR shall be filled by the member of the same category by nomination and acceptance of IECHR. Mere existence of any vacancy or any defect in the constitution of the IECHR shall not be a ground for questioning any act done by the IECHR

3.    CONDITIONS OF APPOINTMENT

·         a member should be willing to publicize his/her full name, profession, and affiliation;

·         all reimbursement for work and expenses, if any, within or related to an IECHR should be recorded and made available to the public upon request;

A member should sign a consent form and provide a brief bio-data for record.

4.    OFFICES

In accordance with the ICMR guidelines for the composition of IECHR, the Chairperson of the IECHR is a member who is from outside the Institution and not head of the same Institution to maintain the independence of the Committee.

The Member Secretary is from the same Institution and should conduct the business of the Committee.

There are 7 members who are a mix of medical/ non-medical, scientific and non-scientific persons including lay persons to represent the differed points of view. The composition is as follows:

 1. Chairperson

 2. One person from basic medical science area (Pharmacology)

 3. Two clinicians from BRD Medical College, Gorakhpur

 4. One legal expert

 5. One social scientist

 6. Representative of non-governmental voluntary agency

 7. One lay person from the community

5.    QUORUM REQUIREMENTS

The minimum of 50% of the members are required to compose a quorum.

6.    INDEPENDENT CONSULTANTS

A subject expert will be called to offer expertise as and when required. The IECHR will establish a standing list of independent consultants to provide special expertise to the IECHR on proposed research protocols. These consultants may be experts in specific diseases or methodologies, or they may be representatives of communities, patients, or special interest groups.

7.    EDUCATION OF IECHR MEMBERS

IECHR members have a need for initial and continued education regarding the ethics and science of biomedical research. The IECHR members will be encouraged to keep abreast of all national and international developments in ethics through orientation courses on related topics by its own members or regular training organized by constituted bodies.

8.    REGISTRATION OF IECHR

The IECHR will register with a BIOMEDICAL RESEARCH AUTHORITY in India or abroad.  A Bill on Biomedical Research on Human Participants (Promotion and Regulation) has been proposed by ICMR and is under active consideration of the Ministry of Health, Government of India.

9.    SUBMITTING AN APPLICATION

The IECHR, BRD Medical College, Gorakhpur will review only protocols involving studies to be conducted in the BRD Medical College & Nehru Hospital, Gorakhpur. External protocols will be accepted only in the case of Government funded or approved projects

 The IECHR has established well-defined requirements for submitting an application for review of a biomedical research project.

·         This includes a Protocol checklist and Plain language Summary (non-technical language) which should accompany each protocol submitted for review.

·         An application should be submitted by a qualified researcher responsible for the ethical and scientific conduct of the research.

·         Applications should be submitted to the Member Secretary at least 2 weeks prior to the proposed date of the meeting in 10 copies.

·         Incomplete applications will be returned to the investigator. In cases where the EC requests supplementary information or changes to documents from the applicant, the application will be reviewed in the next meeting.

·         Investigators will be notified of the decision of the review within a period of 4 weeks.

·         The institute shall allocate reasonable amount of funds for the smooth functioning of the IECHR

 

10.  APPLICATION REQUIREMENTS

·         Signed and dated application form;

·         The protocol of the proposed research (clearly identified and dated), together with supporting documents and annexes;

·         Plain language summary in prescribed format

·         A protocol checklist in prescribed format

·         case report forms, diary cards, and other questionnaires intended for research participants;

·         When the research involves a study product (such as a pharmaceutical or device under investigation), an adequate summary of all safety, pharmacological, pharmaceutical, and toxicological data available on the study product, together with a summary of clinical experience with the study product to date (e.g., recent investigator’s brochure, published data, a summary of the product’s characteristics).

·         Investigator(s)'s curriculum vitae (updated, signed, and dated);

·         Material to be used (including advertisements) for the recruitment of potential research participants;

·         A description of the process used to obtain and document consent;

·         informed consent form (clearly identified and dated) in the language(s) understood by the potential research participants and, when required, in other languages;

·         A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants.

·         A description of the arrangements for indemnity, if applicable.

·         An undertaking/statement of agreement to comply with ethical principles of the research activity to the code of conduct/Good Clinical Practices (GCP) as set out in relevant guidelines formulated by ICMR and this IECHR will have to be given by the Principal Investigator/Guide regarding the adherence. This undertaking will have to be inserted in the PG Thesis/Dissertation of the candidate.

·         All significant previous decisions (e.g., those leading to a negative decision or modified protocol) by other IECHRs/ECs or regulatory authorities for the proposed study (whether in the same location or elsewhere) and an indication of modification(s) to the protocol made on that account. The reasons for previous negative decisions should be provided.

11. REVIEW MEETINGS

·         Meetings will be held once in two months and more in case there are more than 5 proposals for review.

·         EC members will be given 2 weeks’ time to read through the applications

·         Meetings will be minuted and these minutes approved at the subsequent meeting.

·         The applicant, sponsor, and/or investigator may be invited to present the proposal or elaborate on specific issues.

·         In case where an application under review has been submitted by a member of the EC, the member will not be permitted to take part in the decision making process.

12. SCIENTIFIC REVIEW

If required and deemed necessary by the IECHR, the scientific review of the protocols will be performed by a subcommittee of five members who belong to the medical discipline. When required, protocols may be sent for external review. Investigators will be advised to submit a protocol checklist which has been prepared based on the CONSORT checklist. This checklist enumerates the elements required for scientific review.

 

13. EXPEDITED REVIEW

The proposals presenting no more than minimal risk to research participants may be subjected to expedited review. The Member- Secretary and the Chairperson of the IECHR or designated member of the Committee or Subcommittee of the IECHR may do expedited review only if the protocols involve:

·         Minor deviations from originally approved research during the period of approval (usually of one year duration).

·         Revised proposal previously approved through full review by the IECHR or continuing review of approved proposals where there is no additional risk or activity is limited to data analysis.

·         Research involving clinical materials (data, documents, records, or specimens) that have been collected for non-research (clinical) purposes.

·         When in emergency situations like serious outbreaks or disasters a full review of the research is not possible, prior written permission of IECHR may be taken before use of the test intervention.

·         Clinical studies of drugs and medical devices only when - i. research is on already approved drugs except when studying drug interaction or conducting trial on vulnerable population or ii. Adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor nature is reported.

FULL REVIEW: All research presenting with more than minimal risk, proposals/ protocols which do not qualify for exempted or expedited review and projects that involve vulnerable population and special groups shall be subjected to full review by all the members.

14. EXEMPTION FROM REVIEW

Research on educational practices such as instructional strategies or effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

15. DECISION MAKING 

A member will be asked to withdraw from the meeting for the decision procedure concerning an application where there arises a conflict of interest; the conflict of interest should be indicated to the chairperson prior to the review of the application and recorded in the minutes;

·         decisions will only be made at meetings where a quorum is present;

·         only members who participate in the review will participate in the decision;

·         decisions be arrived at through consensus, where possible; when a consensus appears unlikely, the EC will vote;

·         in cases of conditional decisions, clear suggestions for revision and the procedure for having the application re-reviewed will be specified;

·         a negative decision on an application will be supported by clearly stated reasons.

·         The decision will be communicated in writing to the applicant according to EC procedures, preferably within two weeks’ time of the meeting at which the decision was made

·         ECs should receive notification from the applicant at the time of the completion of a study;

·         The investigators will be asked to provide a follow-up and progress of the trial under the following situations:

A.    Any protocol amendment likely to affect the rights, safety, and/or well-being of the research participants or the conduct of the study;

B.    serious and unexpected adverse events related to the conduct of the study or study product, and the response taken by investigators, sponsors, and regulatory agencies;

C.    any event or new information that may affect the benefit/ risk ratio of the study;

·         The Committee will give its opinion on the projects in one of the following ways:

        • Approval
        • Disapproval
        • Modification before Approval (Conditional Approval)
        • Discontinuation of previously Approved project

16. DOCUMENTATION AND ARCHIVING

·         All documentation and communication of an EC will be dated, filed, and archived according to written procedures. Documents will be archived for a minimum period of 3 years following the completion of a study.

·         Other documents to be archived will be: SOPs, minutes and agenda of meetings, bio data of members, annual report of the EC, annual accounts, one copy of application and materials submitted for review, correspondence with applicants, copy of decision, documentation received during follow-up, final summary and report of the study.

A copy of the EC composition and operating procedures can be made available to any member of the Hospital/Institute for filing of research projects, upon written request for the same to the EC.

17. PROCEDURE FOR CONDUCT OF THE MEETING

Please refer to section 11.

 

18. PROCEDURE FOR MAINTAINING INCOME AND EXPENDITURE

At the end of the working year (January to December), the statement of Income and expenditure along with the balance amount will be circulated to all members

19. SUBSTITUTION OF MEMBERS AND POWERS and DUTIES OF CHAIRPERSON, CO-CHAIRPERSON AND MEMBER SECRETARY.

As per ICMR Ethical Guidelines for Biomedical Research on Human Participants, ICMR, 2006

20. INFORMED CONSENT VULNERABLE GROUPS (Children/pregnant women/terminally ill)

As per Ethical Guidelines for Biomedical Research on Human Participants, ICMR, 2006

Sd/-

Sd/-

Chairperson    

Member Secretary

 

 

REFERENCES

A.    ICMR Ethical Guidelines for Biomedical Research on Human Participants, ICMR, 2006

B.      Operational Guidelines for Ethics Committees that Review Biomedical Research, WHO, 2000

Last Update : 18-05-2013

 

Home | RTI | Feedback | Contact Us