{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T02:11:01Z","timestamp":1787019061386,"version":"build-2736575974"},"reference-count":73,"publisher":"Cambridge University Press (CUP)","issue":"1","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":366,"URL":"https:\/\/www.cambridge.org\/core\/terms"},{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["J. Law. Med. Ethics"],"published-print":{"date-parts":[[2020]]},"abstract":"<jats:p>Critical ethical questions arise concerning whether studies among adolescents of new behavioral and biomedical HIV preventive interventions such as Pre-Exposure Prophylaxis (PrEP) should obtain parental permission. This paper examines the relevant regulations and ethical guidance concerning waivers of parental permission, and arguments for and against such waivers. Opponents of such waivers may argue that adolescent decision-making is \u201ctoo immature\u201d and that parents always have rights to decide how to protect their children. Yet requiring parental permission may put adolescents at risk, and\/or limit adolescent participation, jeopardizing study findings\u2019 validity. This paper presents recommendations on when researchers and Institutional Review Boards (IRB) should waive parental permission, and what special protections should be adopted for adolescents who consent for themselves, e.g., assuring adolescent privacy and confidentiality, screening for capacity to consent, and identifying adolescents who are at elevated risk from study participation. We also present a series of specific areas for future research to design tools to help make these assessments, and to inform researcher and IRB decisions. These recommendations can help ensure that research is conducted that can aid adolescents at risk for HIV, while minimizing risks and protecting these individuals' rights as much as possible.<\/jats:p>","DOI":"10.1177\/1073110520917010","type":"journal-article","created":{"date-parts":[[2020,4,28]],"date-time":"2020-04-28T06:04:54Z","timestamp":1588053894000},"page":"188-201","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":19,"title":["Whether to Waive Parental Permission in HIV Prevention Research Among Adolescents: Ethical and Legal Considerations"],"prefix":"10.1017","volume":"48","author":[{"given":"Laurie J.","family":"Bauman","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claude Ann","family":"Mellins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Klitzman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"56","published-online":{"date-parts":[[2021,1,1]]},"reference":[{"key":"S1073110500023883_bib45","unstructured":"45. 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Office for Human Research Protections, 45 CFR 46, Pre-2018 Requirements, available at <https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/regulations\/45cfr46\/index.html> (last visited July 31, 2019); Office for Human Research Protections, 45 CFR 46, 2018 Requirements, available at <https:\/\/www.hhs.gov\/ohrp\/regulations-andpolicy\/regulations\/45cfr46\/index.html> (last visited July 31, 2019)."},{"key":"S1073110500023883_bib71","unstructured":"71. See Office for Human Research Protections, supra note 31 (for both the Pre and 2018 Requirements)."},{"key":"S1073110500023883_bib39","unstructured":"39. See Guttmacher Institute, supra note 33."},{"key":"S1073110500023883_bib23","unstructured":"23. See Field and Berman, supra note 12."},{"key":"S1073110500023883_bib55","unstructured":"55. See Mustanski and Fisher, supra note 37; Knopf et al., supra note 50."},{"key":"S1073110500023883_bib57","first-page":"449","article-title":"\u201cMaturation of the Adolescent Brian,\u201d","volume":"9","author":"Arian","year":"2013","journal-title":"Neuropsychiatric Disease and Treatment"},{"key":"S1073110500023883_bib24","unstructured":"24. See Mustanski, supra note 16."},{"key":"S1073110500023883_bib43","unstructured":"43. See Santelli, supra note 12."},{"key":"S1073110500023883_bib44","unstructured":"44. See Office for Human Research Protections, supra note 31 (for both Pre and 2018 Requirements)."},{"key":"S1073110500023883_bib37","doi-asserted-by":"publisher","DOI":"10.1016\/j.amepre.2016.02.026"},{"key":"S1073110500023883_bib17","unstructured":"17. See Field and Berman, supra note 12."},{"key":"S1073110500023883_bib54","unstructured":"54. See Culp and Caucci, supra note 35."},{"key":"S1073110500023883_bib58","unstructured":"58. 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