This document defines and describes the role and responsibilities of an Institutional Review Board (IRB). The key points are: 1) An IRB is responsible for reviewing and approving research involving human subjects to ensure ethical standards are met and subjects' rights and safety are protected. 2) IRBs must have diverse and qualified membership, including scientific and non-scientific experts, to conduct in-depth reviews of research protocols. 3) The IRB review process involves evaluating research protocols, consent forms, recruitment procedures and investigators to ensure all applicable regulations and ethical guidelines are followed.

1. INSTITUTIONAL REVIEW BOARD
Simran
M. Pharmacy Ist yr
GGSCOP, YNR

2. WHAT IS AN IRB?
• An “Institutional Review Board” (IRB) is a board, committee, or other group formally
designated by an institution to review research involving humans as subjects.
• IRBs have authority to approve, require modification to, or disapprove all research activities
covered by the HHS and FDA Protection of Human Subjects Regulations. Following initial
approval, IRBs must conduct periodic reviews of such research.
• Every institution engaged in human subjects research conducted or supported by a Federal
department or agency that has adopted the Common Rule (Federal Policy for the Protection of
Human Subjects) is required to designate one or more IRBs under an assurance of compliance.
• The IRB provides assurances to research subjects that every reasonable attempt has been made
to protect their rights and safety as subjects.

3. • IRB provides public assurance of that protection by, among other things, reviewing and
approving or rejecting the protocol and ensuring the investigator(s) are suitable to conduct
the trial, the facilities are adequate, and the methods and materials to be used in obtaining
and documenting informed consent of trial participants are appropriate.
• When FDA-regulated products are investigated in human subjects, the protocol is subject
to review and approval by an IRB.
• Hospitals, academic medical centers, government units, and others engaged in federally
conducted or supported health research activities involving human subjects and entities
conducting FDA- regulated clinical investigations, among others, have designated IRBs.

4. • Human subjects research that is conducted or supported by a Federal department or
agency that has adopted the Common Rule (found for HHS at 45 CFR part 46, subpart A)
and that does not meet the criteria for exemption or is regulated by the FDA is subject to
review and approval by an IRB.
• In order to approve research, an IRB must determine that specified criteria have been
satisfied. Among these criteria, an IRB must determine that, when appropriate, the
research protocol includes “adequate provisions to protect the privacy of subjects and to
maintain the confidentiality of data” (see 45 CFR 46.111(a)(7) and 21 CFR 56.111(a)(7))

5. IRB ROLE UNDER THE PRIVACY RULE
• Beginning on April 14, 2003, the Privacy Rule’s compliance date for most covered
entities, IRBs gained authority to consider, and act upon, requests for a partial or complete
waiver or alteration of the Privacy Rule’s Authorization requirement for uses and
disclosures of PHI for research.
• Although HHS and FDA Protection of Human Subjects Regulations include protections to
help ensure the privacy of subjects and the confidentiality of information, the Privacy
Rule supplements these protections by requiring covered entities to implement specific
measures to safeguard the privacy of PHI.

6. • If certain conditions are met, an IRB may grant a waiver or an alteration of the
Authorization requirement for research uses or disclosures of PHI.
• Under the Privacy Rule, an Authorization may be combined with the informed consent
document for research. If the informed consent document is combined with an
Authorization meeting the Privacy Rule’s requirements, 45 CFR part 46 and/or 21 CFR
parts 50 and 56 would require IRB review of the combined document.

7. IRB COMPOSITION
• The IRB/IEC should be multidisciplinary and multisectoral in composition.
• The number of persons in an ethics committee should be kept fairly small (8-12
members).
• The IRB/IEC should consist of a reasonable number of members, who collectively have
the qualifications and experience to review and evaluate the science, medical aspects, and
ethics of the proposed trial.
• No IRB may consist entirely of members of one profession.

8. • The IRB should consist at least SEVEN members, who collectively have the qualifications and
experience to review and evaluate the science, medical aspects, and ethics of the proposed
trial. viz.
1. Chairperson – Appointed (who is from outside the institution)
2. One-two basic medical scientists
3. One-two clinicians from various institutes
4. One legal expert or retired judge
5. One social scientist
6. One philosopher or ethicist
7. One lay person from community
8. Member secretary – Appointed

9. QUORUM OF IRB
• As per revised Schedule Y of Drugs and Cosmetics Act, 1940 amended in 2005, the ethics
committee approving drug trials should have in the quorum at least one representative form.
• For reviewing and making decision on each protocol the quorum of IRB should be at least FIVE
members with the following representations:
1. One Basic medical scientist (preferably one pharmacologist)
2. Clinicians
3. Legal expert or retired judge
4. Social scientist / Representative of non-governmental voluntary agency / Philosopher / Ethicist
5. Lay person from the community

10. • In any case, the IRB must include:
at least one member whose primary area of interest / specialization is nonscientific
at least one member who is independent of the institution / trial site
• Besides, there should be appropriate gender representation on the IRB
• If required, Subject experts may be invited to offer their views
• Further, based on the requirement of research area, e.g. AIDS, genetic disorders etc.
specific patient groups may also be represented in the IRB

11. IRB REVIEW PROCESS
• Researchers are required to submit a request for review to the IRB if their research
involves human participants or their data. The IRB will determine if the research meets
the requirements for oversight, according to the federal regulations (45CFR46). The
request must be reviewed by the IRB prior to collecting data or contacting participants.
For continuing or modifying a current protocol, use the appropriate form located on
the IRB Forms page.

13. FUNCTIONS AND OPERATIONS OF IRB
• Only those IRB members who are independent of the clinical trial and the Sponsor of the
trial should vote / provide opinion in matters related to the study.
• Only members who participate in the IRB/IEC review and discussion should vote/provide
their opinion and/or advise.
• The IRB should perform its functions according to written standard operating procedures,
should maintain written records of its activities and minutes of its meetings, and should
comply with GCP and with the applicable regulatory requirement(s).

14. • An IRB/IEC should make its decisions at announced meetings at which at least a quorum,
as stipulated in its written operating procedures, is present.
• Only members who participate in the IRB/IEC review and discussion should vote/provide
their opinion and/or advise.
• The investigator may provide information on any aspect of the trial, but should not
participate in the deliberations of the IRB/IEC or in the vote/opinion of the IRB/IEC.
• An IRB/IEC may invite nonmembers with expertise in special areas for assistance.

15. • Specifying that no subject should be admitted to a trial before the IRB issues its written
approval / favorable opinion of the trial.
• Specifying that the investigator should promptly report to the IRB
• Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial
subjects
• Changes increasing the risk to subjects and/or affecting significantly the conduct of the
trial

16. • All adverse drug reactions (ADRs) that are both serious and unexpected
• New information that may affect adversely the safety of the subjects or the conduct of the
trial
• Ensuring that the IRB promptly notify in writing the investigator/institution concerning
Its trial-related decisions/opinions
The reasons for its decisions/opinions
Procedures for appeal of its decisions/opinions

17. RESPONSIBILITIES OF IRB
• An IRB should safeguard the rights, safety, and wellbeing of all trial subjects
• The IRB should obtain the following documents:
Trial protocol(s)/amendment(s)
Written informed consent form(s)
Subject recruitment procedures
Written information to be provided to subjects
Investigator’s Brochure (IB)
Available safety information

18. • Information about payments and compensation
• Investigator’s current curriculum vitae
• Any other may need to fulfill its responsibilities

19. • The IRB should review a proposed clinical trial within a reasonable time and document its
views in writing, clearly identifying the trial, the documents reviewed and the dates for
the following :
Approval / favorable opinion
modifications required prior to its approval / favourable opinion;
disapproval / negative opinion
Termination / suspension of any prior approval / favourable opinion
The IRB should consider the qualifications of the investigator for the proposed trial, as
documented by a current curriculum vitae and / or by any other relevant documentation
the IRB requests

20. PROCEDURES
• The IRB/IEC should establish, document in writing, and follow its procedures, which
should include:
Determining its composition (names and qualifications of the members) and the authority
under which it is established.
Scheduling, notifying its members of, and conducting its meetings.
Conducting initial and continuing review of trials.
Determining the frequency of continuing review, as appropriate.
Providing, according to the applicable regulatory requirements, expedited review and
approval/favourable opinion of minor change(s) in ongoing trials that have the
approval/favourable opinion of the IRB/IEC.

21. Specifying that no subject should be admitted to a trial before the IRB/IEC issues its
written approval/favourable opinion of the trial.
Specifying that no deviations from, or changes of, the protocol should be initiated without
prior written IRB/IEC approval/favourable opinion of an appropriate amendment, except
when necessary to eliminate immediate hazards to the subjects or when the change(s)
involves only logistical or administrative aspects of the trial (e.g., change of monitor(s),
telephone number(s)

22. • Specifying that the investigator should promptly report to the IRB/IEC:
(a) Deviations from, or changes of, the protocol to eliminate immediate hazards to the trial
subjects
(b) Changes increasing the risk to subjects and/or affecting significantly the conduct of the
trial
(c) All adverse drug reactions (ADRs) that are both serious and unexpected.
(d) New information that may affect adversely the safety of the subjects or the conduct of
the trial

23. • Ensuring that the IRB/IEC promptly notify in writing the investigator/institution
concerning:
(a) Its trial-related decisions/opinions.
(b) The reasons for its decisions/opinions.
(c) Procedures for appeal of its decisions/opinions.

24. RECORDS
• The IRB/IEC should retain all relevant records (e.g., written procedures, membership
lists, lists of occupations/affiliations of members, submitted documents, minutes of
meetings, and correspondence) for a period of at least 3-years after completion of the trial
and make them available upon request from the regulatory authority(ies). The IRB/IEC
may be asked by investigators, sponsors or regulatory authorities to provide its written
procedures and membership lists.