The document discusses the role and responsibilities of an Institutional Review Board/Independent Ethics Committee (IRB/IEC). It states that an IRB/IEC reviews clinical trial protocols to ensure the ethical treatment of study participants and protection of their rights and well-being. The IRB/IEC is composed of at least five members with diverse qualifications and one member from a non-scientific discipline. It is responsible for approving, monitoring and reviewing research involving humans. The IRB/IEC conducts initial and annual reviews of trial procedures and documentation. All records are maintained for at least three years.

1. INSTITUTIONAL REVIEW
BOARD/INDEPEDENT ETHICS
COMMITTEE (IRB/IEC)
SU BM ITTED BY: R A HU L PA L SU BM ITTED TO : D R . S. BHA R AT
REGULATORY AFFAIRS

2. CONTENT
IRB/IEC
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 INTRODUCTION
 BACKGROUND
 COMPOSITION
 RESPONSIBILITIES OF
IRB/IEC
 PROCEDURE OF IRB/IEC
 MAINTENANCE OF
RECORD OF IRB/IEC

3. INTRODUCTION
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IRB/IEC serves as an independent body that reviews,
evaluate, 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. BACKGROUND
• National research act passed by congress on July 12, 1974, mandated
establishment of IRB/IEC.
• Act provide national commission for protection of human subjects of
biomedical and behavioral research and lead to publication of The Belmont
Report in 1979.
• The amended regulation on July 27, 1981.
• Submission of NDA’S approval of IRB is necessary.
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5. COMPOSITION
IRB Consists of members, who
• Collectively have the qualifications
and experience to review and evaluate the science, medical aspects and
ethics of the proposed trials.
• Include at least five members, of which at least one members whose primary
area of interest is nonscientific discipline and at least one member who is
independent of the institutional/trial site.
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IRB/IEC

6. IRB/IEC MEMBERSHIP
Members of ICE:
• Chair person.
• 1-2 basic medical scientists.
• 1-2 clinicians from various institutes.
• One legal exert or retired judge.
• One social scientist, One philosopher/ethicist.
• One lay person.
• Member secretary.
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IRB/IEC

7. RESPONSIBILITIES OF IRB/IEC
The Committee has been designated to-
• Approve
• Monitor
• Review biomedical and behavioral research, involving humans with the aim to
protect the rights, safety and welfare of the research subjects.
• Safeguard the rights, safety and well-being of all trial subjects.
• Reviews a proposed clinical trial within a reasonable time and documents its view
s in writing.
• Conducts continuing review of each ongoing trails at least once per year.
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PRESENTATION
TITLE

8. PROCEDURE 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 subjects should be admitted to atrial before the IRB/IEC
issues its written approval/favorable opinion of the trail.
• Specifies the information that the investigator should promptly report to
the IRB/IEC (like deviations from the protocol, adverse drug reactions etc)
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PRESENTATION
TITLE

9. 9
PROCESS
OF
IRB
OVERVIEW

10. MAINTENANCE OF RECORD OF
IRB/IEC
• IRB/IEC retains all relevant records (e.g. written procedures, lists of
occupations/affiliations of members, submitted document, 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 lists.
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PRESENTATION
TITLE