May an IRB/IEC invite nonmembers with expertise for assistance?

• A. Nonmembers may not be invited
• B. Nonmembers may be invited but cannot provide opinions
• C. Nonmembers with expertise may be invited for assistance
• D. Only if the sponsor approves

Answer: (C)

Outside experts can be brought in to help the IRB/IEC when a protocol raises specialized questions beyond the current members’ knowledge. These individuals come in as consultants to review materials and provide opinions on risks, consent language, subject protections, or other ethical and scientific issues. Their role is advisory, not voting, so they assist the board without changing its voting dynamics. The IRB makes the decision to seek this input, and sponsor approval is not a requirement for bringing in such expertise. This is why inviting nonmembers with expertise for assistance is appropriate and often essential for a thorough, well-informed review.