Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

1. CLINICAL TRIALS
(IRB/IEC)
- Presented By -
Mr. Rushikesh S. Shinde
(FYMPH- Semester-1)
COLLEGE NAME- MARATHWADA MITRA MANDAL’S COLLEGE OF PHARMACY, THERGAON, PUNE-411 033
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- Guided By -
Dr. Avinash R. Tekade
(Professor & HoD- Pharmaceutics)

2. OBJECTIVE
• History of IRB
• Introduction
• Composition of IRB/IEC
• Responsibilities of IRB/IEC
• Procedure of IRB/IEC
• Maintenance of IRB/IEC
• Inform Concent Form
• End of presentation
• Q & A
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History
 In Aug. 1947,during Nuremburg war crime trial at conclusion of worlds war II, the Nuremburg
code was drafted as set of human research subjects.
 In July12,1974, the national research act established the existence of IRBs to review biomedical
and behavioral research involving human subjects.
 In March 1983, Federal regulation detailing the basis U.S. department of health and human
services policy for protection of human research subjects were adopted.
 On Aug.19,1991, the 1983 regulation were updated- regulation provide comprehensively
detailed information about the duties and responsibilities if IRB.

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Introduction
 IRB/IEC serves as an independent body that review, evaluates, approves and decided on the
scientific and ethical aspects of clinical trial protocol as well as the benefits and risk to the
study participant .
 Main purpose of IRB/IEC is to protect the rights, safety and well-being of subjects who
participate in a trial.
IRB- Institutional review Board
IEC- Independent ethics committee

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• Also known as independent ethics committee (IEC), ethical review board (ERB), or
research ethics board (REB)
• A group of scientists, doctors and patient advocates that reviews and approves the detailed
plan for a clinical trial.
• IRBs are meant to protect the people who take part in a clinical trial.
• They check to see that the trial is well designed, legal, ethical, does not involve unneeded
risks, and includes a safety plan for patients.
• There is an IRB at every health care facility that does clinical research, and every trial is
reviewed by an IRB before the trial begins. Also called Institutional Review Board
Continue….

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Composition of IRB/IEC
 Should consist of at least SEVEN members, who collectively have the qualifications and
experience to review and evaluate the science, medical aspects, and ethics of the
proposed trials.
o Chairperson- Appointed (who is outside the institution)
o 1-2 basic medical scientists
o 1-2 clinicians from various institute
o 1 legal expert or retired judge
o 1 social scientist
o 1 philosopher or ethicist
o 1 lay person from community
o Member secretary- Appointed

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

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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 trials 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
deviation from the protocol, adverse drug reaction etc.)

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Process of Approval !!!

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Maintenance of Records of IRB/IEC
 IRB/IEC retains all relevant record (eg. Written procedures, listed of occupations/affiliations of
members, submitted documents, minutes of meeting, etc ) for period of at least 3 years after
completion of the trial and makes them available upon request from the regulatory authorities.
 IRB/IEC may be asked by investigators, sponsors, or regulatory authorities to provide copies of
its written procedures and membership list.

11. REFERANCES
• https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-
boards-irbs-and-protection-human-subjects-clinical-trials
• https://hub.ucsf.edu/protocol-development
• https://en.wikipedia.org/wiki/The_Hastings_Center
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12. THANK YOU !!!
Any Question ???
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“FREQUENTLY ASKED QUESTIONS”
 Who Chooses IRB members ??
 IRB Chair and IRB Director are responsible for selecting members to serve on the IRB
 How long is IRB Valid ??
 3 years
 Who is the chairman of IRB ??
 Virendra D. Mhaiskar
 What are two main roles of the institutional review boards ??
 The responsibilities of IRBs fall into two main categories: initial review and continuing review of
research involving human subjects.
 What is the minimum number of IRB members required ??
 Each IRB shall have at least five members