Which statement about non-therapeutic trials with LAR consent is NOT correct?

• A. They should be conducted in patients with disease/condition for which the product is intended
• B. Subjects should be closely monitored and withdrawn if unduly distressed
• C. IRB/IEC approval is expressly sought for inclusion
• D. Non-therapeutic trials may be conducted in subjects without considering disease relevance or safety oversight

Answer: (D)

In non-therapeutic research where a legally authorized representative provides consent, the study must still be ethically justified and risk minimized, with clear oversight and relevance to the disease in question.

Conducting such trials in patients with the disease or condition the product targets helps ensure relevance and safety, rather than exposing unrelated individuals to unnecessary risk. Closely monitoring subjects and withdrawing them if they become unduly distressed protects participants when there is no direct therapeutic benefit. Ethics committee review and approval are required for including participants, reinforcing that the study design and consent process meet ethical standards.

The statement that these trials may be done without considering disease relevance or safety oversight is not correct, because disease relevance and appropriate safety oversight are fundamental requirements in non-therapeutic research with LAR consent.