Institutional Review Board:Independent Ethics Committee (IRB:IEC) Institutional Review Board/Independent Ethics Committee (IRB/IEC) Composition of IRB/IEC Responsibilities of IRB/IEC Procedures of IRB/IEC Maintenance of records of IRB/IEC

1. 1 Institutional Review Board/Independent
Ethics Committee (IRB/IEC)
PRESENTED BY :
Yash P. Pote
M.Pharm (Pharmaceutics)
Vidya Bharati College of Pharmacy, Amravati

2. 2 Contents
 Institutional Review Board/Independent Ethics Committee
(IRB/IEC)
 Composition of IRB/IEC
 Responsibilities of IRB/IEC
 Procedures of IRB/IEC
 Maintenance of records of IRB/IEC

3. 3 Institutional Review Board/Independent
Ethics Committee (IRB/IEC)
 IRB/IEC serves as an independent body that reviews,
evaluates, approves and decides on the scientific and
ethical aspects of the clinical trial protocol as well as the
benefits and risks to the study participants.
 Main purpose of IRB/IEC is to protect the rights, safety,
and well-being of the subjects who participate in a trial.

4. 4 Composition of IRB/IEC
 Consists of members, who collectively have the
qualifications and experience to review and evaluate the
science, medical aspects, and ethics of the proposed trials.
 Includes at least five members, of which at least one
member whose primary area of interest is nonscientific,
and at least one member who is independent of the
institution/trial site.

5. 5 Responsibilities of IRB/IEC
 Safeguard the rights, safety, and well-being of all trial subjects.
 Reviews a proposed clinical trial within a reasonable time and
document its views in writing.
 Conducts continuing review of each ongoing trial at least once per
year.
 Ensures that information regarding payment to subjects (including
the methods, amounts, schedule of payment) is set forth in the
written informed consent form and any other written information is
provided to the subjects.

6. 6 Procedures of IRB/IEC
 Determines its composition and authority under which it is
established.
 Schedules, notifies its members of, and conducts its meetings.
 Conducts initial and continuing review of trials.
 Specifies that no subject should be admitted to a trial before the
IRB/IEC issues its written approval/favorable opinion of the trial.
 Specifies the information that the investigator should promptly
report to the IRB/IEC (like deviations from the protocol, adverse
drug reactions etc.)

7. 7 Maintenance of records of IRB/IEC
 IRB/IEC retains all relevant records for a period of at least 3 years after
completion of the trial and makes them available upon request from the
regulatory authority.
For example :-
 SOP’s,
 Membership files,
 Written procedures,
 Submitted documents,
 Minutes of meetings, etc.
 IRB/IEC may be asked by investigators, sponsors, or regulatory authorities
to provide copies of its written procedures and membership lists.

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