An Institutional Review Board (IRB) is a committee that protects research participants by thoroughly reviewing study designs, monitoring safety, and ensuring consent is obtained equitably. The IRB must have at least five members from different professions and genders. It convenes regular meetings where a majority must vote to approve research based on minimizing risks compared to potential benefits. Federal regulations require the IRB to include at least one scientific and non-scientific member, as well as a member not affiliated with the institution.

1. What is
IRB?
an
Ensure the rights,safety and well-being of potential study participants
Perform thorough reviews of research design and materials
Continually review updates on safety information,consent form
amendments,protocol deviations,and the number of participants
enrolled in a study (as well as the number of participants who
withdraw)
Required to follow written,standard operating procedures (SOP’s)
Convened meetings which requires a majority of IRB members present
voting to approve the research study
In order for the research study to be approved,Board members must
find that the risks to study participants will be minimized in relation
to the study’s potential benefit (if any).They must also find that the
study recruitment will select participants in an equitable fashion and
that Informed Consent will be sought (if applicable) in accordance with
21 CFR 50
Who?
A committee of at least 5 members
representing different professions and genders
What
do they do?
How
do they do it?
Protect participants, review studies, and monitor safety
Convene meetings and analysis of risks vs. benefits
At least 5 members
At least one member whose primary concerns are in the scientific area
An“IRB”(Institutional Review Board or Indepedent Review
Board) is a committee designed to review clinical studies.
The Code of Federal Regulations 21 CFR 56 says that an IRB
must be composed of the following membership:
At least one member whose primary concerns are in a non-scientific area
At least one member who is not otherwise affiliated with the institution
or an immediate family member of anyone affiliated with the institution
DoctorEXAMPLES: Ethicist Clergy
For more information about how an IRB functions,please visit www.QuorumReview.com
or call us at (206) 448-4082 or 1-888-776-9115 (toll free)