Which statement describes the participation of investigators and sponsors in IRB/IEC decision-making?

• A. Investigator or sponsor may vote if they agree with the majority.
• B. The investigator, investigator site staff, and sponsor may provide information but should not participate in the decision-making or voting.
• C. The sponsor may unilaterally decide the outcome.
• D. All participants in the trial may vote.

Answer: (B)

The important idea here is that IRB/IEC decision-making must be independent from those conducting or sponsoring the trial. Investigators and sponsor personnel can provide information to the IRB/IEC to help with the review, such as details about the protocol, safety data, or consent materials, but they should not participate in the deliberations or voting. This separation helps prevent conflicts of interest and ensures the rights and welfare of participants are judged solely on objective review.

So, the sponsor and investigator site staff can answer questions and supply relevant context, but the actual decision and the voting are reserved for the IRB/IEC members who review the protocol independently. They should not be influencing the outcome through participation in the decision-making process.