{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T15:24:58Z","timestamp":1773415498573,"version":"3.50.1"},"reference-count":32,"publisher":"Wiley","issue":"S7","license":[{"start":{"date-parts":[[2021,11,21]],"date-time":"2021-11-21T00:00:00Z","timestamp":1637452800000},"content-version":"vor","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000200","name":"United States Agency for International Development","doi-asserted-by":"publisher","award":["AID\u2010OAA\u2010A\u201016\u201000031"],"award-info":[{"award-number":["AID\u2010OAA\u2010A\u201016\u201000031"]}],"id":[{"id":"10.13039\/100000200","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Int AIDS Soc."],"published-print":{"date-parts":[[2021,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>A major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 <jats:italic>ethical considerations in HIV prevention trials<\/jats:italic>. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p>We review recommendations related to four key issues, namely standard of prevention, post\u2010trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>There have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re\u2010certification, <jats:italic>and<\/jats:italic> for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.25796","type":"journal-article","created":{"date-parts":[[2021,11,22]],"date-time":"2021-11-22T05:54:15Z","timestamp":1637560455000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Shifts in UNAIDS ethics guidance and implications for ethics review of preventive HIV vaccine trials"],"prefix":"10.1002","volume":"24","author":[{"given":"Catherine","family":"Slack","sequence":"first","affiliation":[{"name":"HIV\/AIDS Vaccines Ethics Group (HAVEG) School of Applied Human Sciences College of Humanities University of KwaZulu\u2010Natal  Pietermaritzburg South Africa"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul","family":"Ndebele","sequence":"additional","affiliation":[{"name":"Department of Global Health MilkenInstitute School of Public Health The George Washington University  Washington DC USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mary","family":"Allen","sequence":"additional","affiliation":[{"name":"National Institute of Allergy and Infectious Diseases National Institutes of Health  Bethesda Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessica","family":"Salzwedel","sequence":"additional","affiliation":[{"name":"AIDS Vaccine Advocacy Coalition (AVAC)  New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,11,21]]},"reference":[{"key":"e_1_2_10_2_1","unstructured":"National Institute of Health [NIH].U.S. National Library of Medicine: ClinicalTrials.gov. 2021. 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