{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T01:06:53Z","timestamp":1789693613575,"version":"4.0.1"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T00:00:00Z","timestamp":1789689600000},"content-version":"vor","delay-in-days":79,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","award":["R01AI108368"],"award-info":[{"award-number":["R01AI108368"]}],"id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Med Ethics"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Clinical trials often require women and girls of childbearing potential to adhere to contraceptive mandates, typically requiring the use of two forms of contraceptives for the duration of the study. Understanding adolescent perspectives on contraceptive mandates within HIV prevention and treatment trials is critical for evaluating whether and when such requirements are ethically justified and, if so, how they might be appropriately applied in trials involving this group.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted semi-structured interviews with adolescents age 15\u201324 in the U.S. on their perspectives about contraceptive requirements. Interviews were audio-recorded and transcribed verbatim. We used Nvivo qualitative analysis software to code transcripts, and then conducted thematic analysis to identify emergent patterns in adolescents\u2019 perceptions of the advantages and disadvantages of requiring contraception use for adolescent participants of HIV research studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Forty adolescents were interviewed in total. Overall, most participants expressed support for a contraceptive requirement. Regardless of their stance, perceived advantages and disadvantages of such requirements stood in tension, including the ability to prevent pregnancy and desires to become pregnant, desirable health benefits and concerning side effects, and voluntary participation and violated decisional autonomy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Our findings illustrate that although contraceptive mandates are intended to facilitate and promote inclusion in research, they can simultaneously work to restrict adolescent participation in research and limit access to its potential benefits. In doing so, these requirements risk undermining their ethical justification and obstructing the generation of data needed to advance health outcomes for adolescents.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12910-026-01546-9","type":"journal-article","created":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T03:07:42Z","timestamp":1782875262000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Ethical complexities in contraceptive mandates for adolescent clinical trial participation: a qualitative analysis of U.S. adolescents\u2019 perspectives"],"prefix":"10.1186","volume":"27","author":[{"given":"Margaret","family":"Waltz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne Drapkin","family":"Lyerly","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hadas Clementine","family":"Baron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita Vanessa","family":"Masese","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Day","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,7,1]]},"reference":[{"issue":"1","key":"1546_CR1","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1007\/s40290-025-00555-0","volume":"39","author":"T Dubich","year":"2025","unstructured":"Dubich T, Roffel AF. 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Informed consent to participate was obtained from all participants in the study prior to conducting the interview. We obtained a waiver of parental consent for participants who were legal minors by the UNC IRB (protocol #22-2256).","order":1,"name":"Ethics","label":"Ethics approval and consent to participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","label":"Consent for publication","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":3,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"197"}}