Which body must approve the inclusion of subjects for whom consent may be provided by a legally acceptable representative in non-therapeutic trials?

• A. The sponsor
• B. The IRB/IEC
• C. The regulatory authority
• D. The investigator

Answer: (B)

When subjects cannot give consent themselves, the approval to enroll them through a legally acceptable representative rests with the IRB/IEC. This board’s role is to protect the rights, safety, and welfare of participants by reviewing and approving the study protocol, the use of legally authorized representatives, and the informed consent process. They assess whether including such subjects is justified, that a proper legally authorized representative is identifiable, and that the risks are minimized and clearly explained in the consent materials. The sponsor can design and fund the study, but they do not authorize enrollment decisions for individuals lacking capacity. Regulators oversee compliance with laws and may require reporting, but they do not approve the specific inclusion of each subject. The investigator carries out the study in accordance with the IRB/IEC-approved protocol and obtains consent from the representative (and assent from capable subjects when appropriate).