What must be true for conducting non-therapeutic trials with legally acceptable representatives?

For non-therapeutic trials involving participants who cannot provide informed consent, the requirement that the trial must have low foreseeable risks is fundamental. This principle is rooted in the ethical considerations surrounding participant safety and welfare.

Non-therapeutic trials, by their nature, do not provide direct benefits to the participants, making it even more crucial to minimize any potential harm. The ethical justification for involving legally acceptable representatives is primarily to protect individuals who may not be able to advocate for themselves. Therefore, ensuring that risks are kept to a minimum serves to safeguard these vulnerable participants while permitting the trial to proceed under the right ethical framework.

Moreover, having low foreseeable risks aligns with the principles of beneficence and non-maleficence in clinical research, which require that the potential benefits of research justify any risks involved. In contrast, while considerations such as a beneficial trial, a large participant pool, or the inclusion of alternative treatments may play a role in the overall design and ethical considerations of clinical trials, they do not directly address the foundational requirement for reducing risk in non-therapeutic trials involving legally acceptable representatives.