IRB/IEC

1. INSTITUTIONAL REVIEW
BOARD/INDEPENDENT ETHICS
COMMITTEE (IRB/IEC)
Presented by-
Akshdeep Sharma
Clinical Research
(Student)

2. 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

3. 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

4. MEMBERS OF IEC
 Chair person
 1-2 basic medical scientists
 1-2 clinicians from various institutes
 One legal expert or retired judge
 One social scientist
 One philosopher/ethicist
 One lay person
 Member Secretary

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
Provide advice to the researchers on all aspects of welfare and safety of
research participants

6. Responsibilities of IRB/IEC
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

7. 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.)

8. Maintenance of records of IRB/IEC
IRB/IEC retains all relevant records (e.g., written procedures, lists of
occupations/affiliations of members, submitted documents, minutes of
meetings, etc.) for a period of at least 3 years after completion of the trial
and makes them available upon request from the regulatory authority
IRB/IEC may be asked by investigators, sponsors, or regulatory
authorities to provide copies of its written procedures and membership
lists