Who may vote or provide their opinion in IRB/IEC deliberations and discussions?

• A. Only members who participate in the IRB/IEC review and discussion
• B. All members of the institution
• C. The sponsor's representative
• D. Investigators outside the IRB/IEC

Answer: (A)

Voting in IRB/IEC deliberations is limited to the IRB/IEC members who actively participate in the review and discussion. These are the individuals with the formal role, training, and fiduciary responsibility to evaluate risks, benefits, and consent issues and to make binding decisions about approval or modifications. Other people, such as sponsor representatives or investigators who are not members of the board, may provide information or answer questions but do not have voting rights. This ensures decisions come from those who are directly responsible for the ethical oversight and protects the process from external influence.