- Research ethics must prioritise participants' safety and well being and extend this central principle to third parties who may be affected by research.
- International research ethics guidelines give limited attention to protecting third parties, a gap exposed by trials involving individuals with sexual interest in children.
- Authors analysed ethical challenges, implemented specific risk mitigation measures in trials, and propose revising guidelines to better safeguard third parties at risk.
J Bioeth Inq. 2026 Sep 17. doi: 10.1007/s11673-026-10621-0. Online ahead of print.
ABSTRACT
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.
PMID:42753108 | DOI:10.1007/s11673-026-10621-0
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