Which statement about independent membership is required?

• A. There must be at least one member whose primary interest is not in medical sciences.
• B. There must be at least one independent member.
• C. All members must be independent.
• D. At least one independent member is required.

Answer: (D)

Independent membership ensures objective, unbiased oversight of trial safety and data. An independent member is defined by having no significant ties or conflicts with the sponsor or investigators, so their judgment isn’t swayed by involved parties. The requirement that at least one independent member is present states the exact obligation to provide that external perspective; it’s not about the field of the member or about every member being independent. Having all members independent isn’t necessary, and defining independence by “primary interest outside medical sciences” isn’t the right criterion. So, having at least one independent member is the correct and sufficient rule.