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