Which statement best describes what is involved in establishing the IRB/IEC's formal basis?

• A. Scheduling the meetings and determining meeting frequency
• B. Setting the venue for all future meetings
• C. Allocating the IRB/IEC's budget and resources
• D. Determining its composition (names and qualifications of the members) and the authority under which it is established

Answer: (D)

The main idea is that the formal basis of an IRB/IEC is defined by who sits on it and the authority that empowers it to operate. The composition—names and qualifications of the members—ensures the board has appropriate expertise, independence, and balance to review research ethically and protect participants. The authority under which it is established (the charter or regulatory framework) clarifies its legal standing and the scope of its review duties, such as approving, requiring modifications, or disapproving research, and monitoring ongoing studies. These elements together define the IRB/IEC’s formal power and legitimacy.

Operational details like scheduling meetings, choosing venues, or budgeting are important for smooth functioning, but they do not establish the IRB/IEC’s formal basis.