Who should vote on trial-related matters?

• A. Only members independent of the investigator and sponsor
• B. Any member, regardless of independence
• C. Only nonscientific members
• D. The sponsor

Answer: (A)

Independent oversight is essential when decisions about the trial are at stake. Voting on trial-related matters should be done only by members who are independent of both the investigator and the sponsor. This prevents conflicts of interest and helps ensure that safety, data integrity, and scientific validity are evaluated without bias. Independent members (for example, those on a Data Safety Monitoring Board or an independent ethics committee) review interim data, safety signals, and major changes and have the authority to make or recommend decisions based on objective criteria. Allowing anyone, including sponsors or non-independently affiliated individuals, to vote could introduce bias or inappropriate influence.