Institutional Review Board IRB / Independent Ethics committee IEC
Unit IV Clinical trials, BP804 ET: Pharmaceutical Regulatory Science Notes
The ICH defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing aspects of the trial and approving its start-up.
IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risk and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risks in relation to any benefits that might result from the research.
An IRB/IEC: Reviews all study-related materials before and during the trial. Must operate in accordance with national and/or local regulations, as well as with ICH good clinical practices (GCPs) guidelines.
Composition of an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC):
An IRB/IEC should have a reasonable number of members who have collectively assumed sufficient expertise and experience to review and evaluate the scientific, medical and ethical aspects of a research proposal.
It is recommended that the IRB/IEC should include:
(a) At least five members.
(b) At least one member whose primary area of interest is in a non- scientific area.
(c) At least one member who is independent of the institution/trial site.
The IRB/IEC should establish a document in writing and follow its procedures, which should include:
- Determine composition and source of authority under which it is established.
- Schedule, notify members and conduct meetings.
- Conduct initial and continuing review.
- Determine frequency of continuing review.
- Provide expedited review mechanism for minor changes.
- Specify that no subject may be enrolled and no deviation prior to approval.
- Specify that investigator promptly report protocol changes or deviations, increased risks to subjects, ADRs (serious and unexpected), new information related to subject safety.
- Promptly notify in writing the investigator/ institution about its decisions, reasons for its decisions and procedures for appeal.
Maintain all relevant records at least three years after completion of the trial.
- Written procedures.
- Membership files.
- Submitted documents (protocol related files).
- Minutes of meetings.
The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists.
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