Non-therapeutic trials conducted with consent of a legally acceptable representative should be conducted under which condition?

• A. The trial must include any patient regardless of disease.
• B. The trial should be conducted in patients having a disease or condition for which the investigational product is intended.
• C. Subjects must not be closely monitored.
• D. The trial does not require IRB/IEC approval.

Answer: (B)

When a non-therapeutic study is conducted with consent from a legally acceptable representative, the participants should be those who have the disease or condition for which the investigational product is intended. This alignment ensures the study is scientifically and ethically justified: even though the study may not provide direct benefit to the individual, the data gathered are relevant to the intended patient population and the risk–benefit balance makes sense for that group. It also satisfies regulatory and ethical expectations for enrolling participants who cannot consent themselves.

Enrolling anyone regardless of disease would lack relevance to the product’s intended use. Not closely monitoring subjects would be unsafe and contrary to GCP, and assuming no IRB/IEC approval is needed ignores essential ethical and regulatory safeguards.