{"doi":"10.1002/jia2.25500","title":"Why ethics guidance needs to be updated for contemporary HIV prevention research","abstract":"Despite existing effective antiretroviral treatments and means of prevention, the human immunodeficiency virus (HIV) epidemic persists globally [1]. While efforts to scale-up access to these modalities is critical, research is needed to expand the range of options available to curb HIV incidence. Nevertheless, conducting high-quality HIV prevention research necessitates surmounting a range of obstacles. For instance, much HIV prevention research encounters ethical challenges in practice, particularly in settings with high incidence marked by weak healthcare infrastructures, poverty, laws adversely affecting key populations, inequality, discrimination and/or stigma. In addition, since HIV transmission is a high consequence, but relatively low probability event in the context of research, HIV prevention efficacy trials tend to be very large, sometimes requiring thousands of participants, making them extremely expensive. Furthermore, in order to show that an intervention is generalisable in diverse environments, these trials tend to be multisite and multinational, adding complexity. As a result of such realities associated with conducting HIV prevention research, major funders have looked to networks and other research consortia, like the HIV Prevention Trials Network (HPTN), to coordinate these trials. Moreover because of the sensitive nature of HIV prevention research being conducted globally, ethics guidance that is universally applicable is needed. Practical ethics guidance for contemporary HIV prevention research must not only be sensitive to these issues, but also be responsive to numerous developments. For example, advances in HIV prevention science (e.g. treatment as prevention and oral pre-exposure prophylaxis) introduce complex ethical issues in the design of HIV prevention trials, such as selecting ethically appropriate comparator arms [2-4]. Here there are important tensions between the need to protect research participants by providing them with known means of HIV prevention and the ability to implement trials capable of meaningfully evaluating potentially powerful new interventions. In addition, ethicists and others increasingly emphasize the importance of addressing research questions that are relevant to local populations and responsive to host communities’ health priorities [5-8], but which can complicate conventional approaches to selecting research sites that may have simply relied upon HIV incidence data within a particular locality. While community engagement and capacity building have long been part of much HIV prevention research, many guidance documents articulate specifications for robustly engaging communities and strengthening local capacity beyond health care and performing research [9-17], making explicit a broad range of responsibilities for HIV prevention researchers that necessitate careful attention. Several guidelines, policies and regulations have also evolved recently, introducing a range of expectations and requirements for HIV prevention research. The updated Council for International Organisations of Medical Sciences guidelines place greater importance on the social value of research, which ought to be considered when considering whether particular research endeavours are pursued. They also delineate requirements for research among those who might become pregnant during the course of a study, which are essential to consider given the public health and ethical mandates to test HIV prevention modalities in this population [5]. The latest version of the Declaration of Helsinki emphasizes the importance of post-trial provisions “for all participants who still need an intervention identified as beneficial in the trial,” establishing privacy protections, assessing capability of giving informed consent, and providing study results to participants [18]. All of these issues are relevant to HIV prevention research. Further, the revised US federal regulations for research with human subjects, known as ","journal":"Journal of the International AIDS Society","year":2020,"id":81925,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":13,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.96,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":323987,"name":"Jeremy Sugarman","orcid":"0000-0001-7022-8332","position":1,"is_corresponding":false},{"id":328437,"name":"Brandon Brown","orcid":"0000-0002-6348-4108","position":0,"is_corresponding":true}],"reference_count":19,"raw_metadata":null,"created_at":"2026-07-18T21:52:58.921847Z","pmid":"32406990","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}