{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T05:39:37Z","timestamp":1789882777627,"version":"4.0.1"},"reference-count":62,"publisher":"Wiley","issue":"S7","license":[{"start":{"date-parts":[[2018,10,18]],"date-time":"2018-10-18T00:00:00Z","timestamp":1539820800000},"content-version":"vor","delay-in-days":17,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"AIDS Relief (PEPFAR)"},{"name":"US Agency for International Development (USAID)"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Intern AIDS Soc"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>Clinical trials of biomedical<jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>prevention modalities require the cooperation of multiple stakeholders. Key stakeholders, such as community members, may have stark vulnerabilities. Consequently, calls for<jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>prevention researchers to implement \u201cstakeholder engagement\u201d are increasingly common. Such engagement is held to benefit inter\u2010stakeholder relations, stakeholders themselves and the research itself. The ethics review process presents a unique opportunity to strengthen stakeholder engagement practices in<jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>prevention trials. However, this is not necessarily straightforward. In this article, we consider several complexities. First, is stakeholder engagement a legitimate component of what Research Ethics Committees (<jats:styled-content style=\"fixed-case\">REC<\/jats:styled-content>s) should review for<jats:styled-content style=\"fixed-case\">HIV<\/jats:styled-content>prevention trials? Second, what are the core features of engagement that should be under ethics review? Third, what are the key practices that should be highlighted in ethics review?<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>To address these questions, we examined the international ethics guidelines specialized for such trials (<jats:styled-content style=\"fixed-case\">UNAIDS<\/jats:styled-content>2012,<jats:styled-content style=\"fixed-case\">UNAIDS<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">AVAC GPP<\/jats:styled-content>2011) and directly applicable to such trials (<jats:styled-content style=\"fixed-case\">CIOMS<\/jats:styled-content>2016;<jats:styled-content style=\"fixed-case\">WHO<\/jats:styled-content>2011). Thematic analysis was used to code and analyse these guidelines.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results and discussion<\/jats:title><jats:p>Ethics guidelines support<jats:styled-content style=\"fixed-case\">REC<\/jats:styled-content>review of engagement. Guidance recommends that engagement be broad and inclusive; early and sustained; and dynamic and responsive. Broad engagement practices include evaluating the context, planning in writing, and resourcing.<jats:styled-content style=\"fixed-case\">REC<\/jats:styled-content>s should assess engagement as part of a comprehensive review, and recommend revisions where necessary. Researchers should profile key elements of engagement valued in ethics guidance, when they draft ethics submissions. Importantly, the ethics review process should not undermine the \u2018dynamic responsiveness\u2019 required for excellent engagement in this field.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>As evidence\u2010informed engagement strategies emerge, these should inform the ethics submission and review process. Both parties in the review process should strive to avoid a superficial, check\u2010list type approach that caricatures what should be a thorough, nuanced ethics review of a rich, responsive engagement process.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.25172","type":"journal-article","created":{"date-parts":[[2018,10,18]],"date-time":"2018-10-18T11:17:58Z","timestamp":1539861478000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Strengthening stakeholder engagement through ethics review in biomedical<scp>HIV<\/scp>prevention trials: opportunities and complexities"],"prefix":"10.1002","volume":"21","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 KwaZulu\u2010Natal South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abigail","family":"Wilkinson","sequence":"additional","affiliation":[{"name":"HIV AIDS Vaccines Ethics Group (HAVEG) School of Applied Human Sciences College of Humanities University of KwaZulu\u2010Natal KwaZulu\u2010Natal South Africa"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Salzwedel","sequence":"additional","affiliation":[{"name":"AIDS Vaccine Advocacy Coalition (AVAC) New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Ndebele","sequence":"additional","affiliation":[{"name":"Medical Research Council of Zimbabwe (MRCZ) Causeway, Harare Zimbabwe"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,10,18]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"Joint United Nations Programme on HIV\/AIDS [UNAIDS] World Health Organisation [WHO].Ethical considerations in biomedical HIV prevention trials [Additional guidance point added in 2012].2012."},{"key":"e_1_2_9_3_1","unstructured":"Joint United Nations Programme on HIV\/AIDS [UNAIDS] AIDS Vaccine Advocacy Coalition [AVAC].Good participatory practice: guidelines for biomedical HIV prevention trials 2011."},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/1472-6939-15-84"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pt.2010.02.009"},{"issue":"1","key":"e_1_2_9_6_1","doi-asserted-by":"crossref","first-page":"44","DOI":"10.1186\/s12910-015-0033-9","article-title":"Evaluating community engagement in global health research: the need for metrics","volume":"16","author":"MacQueen KM","year":"2015","journal-title":"BMC Med Ethics"},{"issue":"1","key":"e_1_2_9_7_1","doi-asserted-by":"crossref","first-page":"40","DOI":"10.1186\/s12961-016-0106-3","article-title":"Public\/community engagement in health research with men who have sex with men in sub\u2010Saharan Africa: challenges and opportunities","volume":"14","author":"Molyneux S","year":"2016","journal-title":"Health Res Policy Syst"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.actatropica.2016.03.021"},{"issue":"1","key":"e_1_2_9_9_1","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1186\/s12910-015-0014-z","article-title":"Community engagement strategies for genomic studies in Africa: a review of the literature","volume":"16","author":"Tindana P","year":"2015","journal-title":"BMC Med Ethics"},{"key":"e_1_2_9_10_1","volume-title":"Institutional review board member handbook","author":"Amdur R","year":"2011"},{"key":"e_1_2_9_11_1","unstructured":"Council for International Organizations of Medical Sciences [CIOMS].International ethical guidelines for health related research involving human subjects.2016."},{"key":"e_1_2_9_12_1","unstructured":"World Health Organisation [WHO].Standards and operating guidance for ethics review of health\u2010related research with human participants.2011."},{"key":"e_1_2_9_13_1","unstructured":"South African Medical Research Council [SA MRC].Guidelines on ethics for medical research: HIV preventive vaccine research.2003."},{"key":"e_1_2_9_14_1","unstructured":"RennieS SugarmanJ;HPTN Ethics Working Group.HIV prevention trials network: ethics guidance for research.2009."},{"key":"e_1_2_9_15_1","unstructured":"World Health Organisation [WHO].Good participatory practice guidelines for trials of emerging (and re\u2010emerging) pathogens that are likely to cause severe outbreaks in the near future and for which few or no medical countermeasures exist (GPP\u2010EP).2016."},{"key":"e_1_2_9_16_1","unstructured":"Critical Path to TB Drug Regimens [CPTR].Good participatory practice: guidelines for TB drug trials 2012.2012."},{"key":"e_1_2_9_17_1","unstructured":"AERAS.Good participatory practice: guidelines for TB vaccine research (GPP\u2010TB VACC).2017."},{"key":"e_1_2_9_18_1","first-page":"1947","volume-title":"Thematic analysis. 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