What is the role of the investigator in IRB/IEC deliberations?

• A. The investigator may participate in the deliberations and vote
• B. The investigator may provide information on any aspect of the trial but should not participate in the deliberations or vote
• C. The investigator must lead the IRB/IEC deliberations
• D. The investigator cannot provide information to the IRB/IEC

Answer: (B)

IRB/IEC deliberations are meant to be an independent assessment of participant protection. The investigator can supply information about the trial—design details, risk/benefit considerations, recruitment, and safety reporting—and answer questions, but should not participate in the deliberations or vote. This preserves objectivity and avoids conflicts of interest, ensuring the committee can make a decision based on impartial review. Participating in deliberations or voting would risk bias or undue influence on the outcome. The investigator should not lead the deliberations, and it is not correct to say they cannot provide information at all; they provide necessary facts when asked, separate from the decision-making process.