{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T19:22:18Z","timestamp":1792783338027,"version":"4.5.0"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:00:00Z","timestamp":1789603200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:00:00Z","timestamp":1789603200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100007687","name":"Svenska L\u00e4kares\u00e4llskapet","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007687","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Karolinska Institute","id":[{"id":"https:\/\/ror.org\/056d84691","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Bioethical Inquiry"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>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.<\/jats:p>","DOI":"10.1007\/s11673-026-10621-0","type":"journal-article","created":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T08:53:31Z","timestamp":1789635211000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Third-Party Perspective in Medical Research Ethics: A Case Series of Clinical Trials Involving Individuals with Sexual Interest in Children"],"prefix":"10.1007","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7719-6422","authenticated-orcid":false,"given":"Manne","family":"Sj\u00f6strand","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1339-4956","authenticated-orcid":false,"given":"Niklas","family":"Juth","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0540-316X","authenticated-orcid":false,"given":"Elisabeth","family":"Karlsson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8934-5130","authenticated-orcid":false,"given":"Christoffer","family":"Rahm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,9,17]]},"reference":[{"issue":"6","key":"10621_CR1","doi-asserted-by":"publisher","first-page":"885","DOI":"10.1037\/0003-066X.44.6.885","volume":"44","author":"PS Appelbaum","year":"1989","unstructured":"Appelbaum, P.S., and A. Rosenbaum. 1989. Tarasoff and the researcher: Does the duty to protect apply in the research setting? American Psychologist 44(6): 885\u2013894.","journal-title":"American Psychologist"},{"issue":"5","key":"10621_CR2","doi-asserted-by":"publisher","first-page":"455","DOI":"10.1177\/1740774519865878","volume":"16","author":"T B\u00e4rnighausen","year":"2019","unstructured":"B\u00e4rnighausen, T. 2019. Sex partners as bystanders in HIV prevention trials: Two test cases for research ethics. Clinical Trials 16(5): 455\u2013457.","journal-title":"Clinical Trials"},{"key":"10621_CR3","doi-asserted-by":"crossref","unstructured":"Council of Europe. 1997. The convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine:\u00a0Convention on human rights and biomedicine\u00a0(ETS No. 164).","DOI":"10.1353\/ken.1997.0021"},{"key":"10621_CR4","unstructured":"Council for International Organizations of Medical Sciences (CIOMS). 2016. International ethical guidelines for health-related research involving humans. 4th ed. Geneva."},{"issue":"9","key":"10621_CR5","doi-asserted-by":"publisher","first-page":"879","DOI":"10.1111\/bioe.12830","volume":"34","author":"N Eyal","year":"2020","unstructured":"Eyal,\u00a0N., and L. Holtzman. 2020. Symposium on risks to bystanders in clinical research: An introduction. Bioethics 34(9): 879\u2013882.","journal-title":"Bioethics"},{"issue":"5","key":"10621_CR6","doi-asserted-by":"publisher","first-page":"450","DOI":"10.1177\/1740774519862783","volume":"16","author":"N Eyal","year":"2019","unstructured":"Eyal, N., J. Kimmelman, L.G. Holtzman, and M. Lipsitch. 2019. Regulating impact on bystanders in clinical trials: An unsettled frontier. Clinical Trials 16(5): 450\u2013454.","journal-title":"Clinical Trials"},{"issue":"32","key":"10621_CR7","doi-asserted-by":"publisher","first-page":"8051","DOI":"10.1073\/pnas.1810920115","volume":"115","author":"N Eyal","year":"2018","unstructured":"Eyal, N., M. Lipsitch, T. B\u00e4rnighausen, and D. Wikler. 2018. Opinion: Risk to study nonparticipants: A procedural approach. Proceedings of the National Academy of Sciences of the United States of America 115(32): 8051\u20138053","journal-title":"Proceedings of the National Academy of Sciences of the United States of America"},{"key":"10621_CR8","unstructured":"Hausman, D.M. 2007. Third-party risks in research: Should IRBs address them? IRB: Ethics & Human Research 29(3): 1\u20135."},{"key":"10621_CR9","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 2025. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)."},{"key":"10621_CR10","unstructured":"Karolinska Institutet. 2024. Mi Bridge\u2014Motivational interviewing to facilitate help-seeking among individuals with sexual interest in children (Mi Bridge). ClinicalTrials.gov registry: NCT06133595. National Library of Medicine (US). Last modified October 10. https:\/\/clinicaltrials.gov\/study\/NCT06133595. Accessed 13 June 2026."},{"key":"10621_CR11","doi-asserted-by":"crossref","unstructured":"Kimmelman, J. 2005. Medical research, risk, and bystanders. IRB: Ethics & Human Research 27(4): 1\u20136.","DOI":"10.2307\/3563953"},{"key":"10621_CR12","doi-asserted-by":"crossref","unstructured":"______. 2007. Missing the forest: Further thoughts on the ethics of bystander risk in medical research. 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Declaration of Helsinki: Ethical principles for medical research involving human subjects. JAMA 310(20): 2191\u20132194.","journal-title":"JAMA"}],"container-title":["Journal of Bioethical Inquiry"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11673-026-10621-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11673-026-10621-0","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11673-026-10621-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T08:53:41Z","timestamp":1789635221000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11673-026-10621-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,17]]},"references-count":21,"alternative-id":["10621"],"URL":"https:\/\/doi.org\/10.1007\/s11673-026-10621-0","relation":{},"ISSN":["1176-7529","1872-4353"],"issn-type":[{"value":"1176-7529","type":"print"},{"value":"1872-4353","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,17]]},"assertion":[{"value":"30 January 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 July 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 September 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"The World Childhood Foundation Sweden contributed to initial discussions regarding inclusion criteria for the Prevent It 1.0 study. Beyond that, neither of the funders had any role in the design, collection, analysis, or interpretation of data, or in the writing of the manuscripts for any of the described studies. The content of this publication reflects the views of the authors only and does not necessarily represent those of the funding organizations. In particular, the European Commission does not accept any responsibility for any use that may be made of the information contained herein.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors have no competing interests to declare that are relevant to the content of this article.","order":2,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable. This study is theoretical and does not involve sensitive personal information or material gathered from persons or animals. Hence it does not fall under the Ethical review act in Sweden and does not need ethical approval.","order":3,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable. This study is theoretical and does not involve data or material gathered from persons or animals.","order":4,"name":"Ethics","label":"Consent","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"AI tools (Grammarly and ChatGPT) were used to check grammar and spelling and provide suggestions to improve clarity and flow. ChatGPT was also used to assist with table formatting. All substantive content was written by the authors. The final text was reviewed and approved by all authors.","order":5,"name":"Ethics","label":"Use of Artificial Intelligence","group":{"name":"EthicsHeading","label":"Declarations"}}]}}