What is the requirement for voting within the IRB/IEC?

• A. All members should vote on every decision to ensure fairness.
• B. Only the sponsor and investigator may vote.
• C. Voting is optional and not required.
• D. Only members who are independent of the investigator and the sponsor should vote or provide an opinion.

Answer: (D)

Independent input is essential for a fair and objective review of research protocols. The requirement is that voting on a study’s approval should come from IRB/IEC members who are independent of the sponsor and the investigator. This independence helps prevent conflicts of interest from swaying the risk–benefit assessment, consent protections, and subject safeguards. If someone has a relationship with the sponsor or investigator that could bias the review, they should not vote on that protocol and should recuse themselves from the decision, though they may still contribute non-binding input as appropriate. Requiring all members to vote, letting only sponsor or investigator vote, or making voting optional would undermine objectivity and the integrity of the review process.