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Institutional review board or Independent ethics committee.pdf
1. Welcome
INSTITUTIONAL REVIEW BOARD OR INDEPENDENT
ETHICS COMMITTEE (IRB/IEC)
D. BHAVANI SHANKAR
PHARM D
Student ID: 155/0822
11/5/2022
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2. What is 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 trail protocols well as the
benefits and risks to the study participants.
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3. Purpose of IRB/IEC
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Main purpose of IRB/IEC is to protect the rights, safety, and well-being
of the subjects who participate in a clinical trail.
4. Composition of IRB/IEC
➢Consists of individuals with the knowledge and experience necessary to
study and assess the science, medical implications, and ethical implications
of the planned trails.
➢Consists of a minimum of five participants, at least one of whom has a
primary interest outside of science and at least one of whom is not affiliated
with the university or trail site.
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5. Members of IEC
➢Chair person
➢1-2 medical scientists
➢1-2 clinicians from various institutes
➢One legal expert or retired judge
➢One social scientist
➢One philosopher/ethicist
➢One lay man
➢Member secretary
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6. Responsibilities of IRB/IEC
➢protect each trial subject's rights, safety, and wellbeing.
➢Reviews a proposed clinical trail with in a reasonable time and document its
views in writing.
➢performs regular reviews of each active trail at least once a year.
➢Give the researchers guidance on all matters pertaining to the welfare and
safety of research participants.
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7. Responsibilities of IRB/IEC
➢Ensures that the written informed consent form and any other written
information are supplied to the subjects. This information on payment
to subjects (including the methods, amounts, and schedule of payment)
must be included.
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8. Procedures of IRB/IEC
➢Determine its composition and authority under which it is established.
➢Schedules, informs the group's participants about, and runs its
meetings.
➢Beginning and ongoing trail reviews are done.
➢Clearly states that no subject should be allowed to enter a trail before
the IRB/IEC issues a written opinion of approval for the path.
➢Explains the details that the researcher must immediately provide to
the IRB/IEC (like deviations from the protocol, adverse drug reaction
etc.)
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9. Maintenance of records of IRB/IEC
➢After the trial is finished, the IRB/IEC keeps all pertinent records
(such as written procedures, member lists by occupations and
affiliations, materials presented, meeting minutes, etc.) for at least
three years and makes them available to the regulatory authority upon
request.
➢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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