Third-Party Perspective in Medical Research Ethics: A Case Series of Clinical Trials Involving Individuals with...

It is a central principle in modern research ethics that the rights, safety, and well-being of research participants are the most important considerations. This should also apply to third-party individuals, that is, individuals who are not research participants but may be affected by the research. Despite this, international research ethics guidelines give limited attention to protecting third parties. This gap became evident when we were involved in the design and conduct of a series of clinical trials involving individuals with sexual interest in children, where children may constitute an identifiable third-party group at risk of harm. In response, we systematically analysed these ethical challenges and developed preventive strategies to safeguard third parties alongside the protection of research participants. We discuss specific risk mitigation measures implemented in our clinical trials and propose that international guidelines be revised to strengthen the protection of third parties at risk of harm in medical trials.