Good Clinical Practice (GCP) Practice Exam

Which member characteristic is essential in an Institutional Review Board (IRB)?

1. All members must be from the same discipline

2. At least one member must be from a non-scientific background

3. At least two members must be researchers

4. All members must be trained researchers

The correct answer is: At least one member must be from a non-scientific background

The characteristic that is essential in an Institutional Review Board (IRB) is that at least one member must be from a non-scientific background. This requirement is crucial because the IRB's primary function is to protect the rights and welfare of human subjects involved in research. Including a member from a non-scientific background ensures that the perspectives of laypersons are considered in the review process. This diversity in backgrounds helps the IRB assess the study's ethical implications, risks, and the informed consent process from a broader societal standpoint, ultimately enhancing the protection of human subjects. Furthermore, having members with different perspectives contributes to a more comprehensive evaluation of research proposals. It encourages discussions that incorporate ethical considerations, social justice, and community concerns that may not be immediately apparent to scientific experts. This characteristic aligns with the ethical principle of ensuring that the rights and welfare of participants are upheld within the scope of research activities.