For a convened IRB review, what aspects does the Common Rule specifically require?

For a convened IRB review, the Common Rule outlines specific requirements that ensure the integrity and compliance of the review process. One critical aspect is the composition of the IRB committee membership. This entails having a diverse group of members, including individuals with expertise and potentially those who are not affiliated with the institution, which helps in providing an objective review of research proposals.

Another vital aspect is the establishment of a quorum; this is the minimum number of members that must be present for the IRB to conduct official business and make decisions. The Common Rule states that at least a majority of the IRB members must be present during the review process, which is essential for ensuring that decisions are representative of the group.

Documentation of IRB actions is also mandated by the Common Rule. This includes maintaining records of the deliberations and decisions made during the meetings, which is crucial for accountability, transparency, and compliance with regulatory requirements. Proper documentation supports the credibility of the IRB's processes and decisions.

Together, these components—committee membership, quorum presence, and documentation of actions—form the foundation of a properly functioning IRB, aligning with the requirements set forth by the Common Rule. Thus, the correct response encompasses all these mandatory aspects, illustrating the comprehensive nature of