Informed consent for HIV phylogenetic research: A case study of urban individuals living with HIV approached for enrollment in an HIV study

Abstract

Introduction: Phylogenetic analyses can provide insights on HIV tansmission dynamics. Country and state-level differences in HIV criminalization and disclosure laws and advances in next generation sequencing could impact perceived study risks. Methods: We present study opt-out rates and the reasons provided during enrollment for a study conducted in Boston (6/2017-8/2018).Results: Of 90 patients approached to participate, 45 did not consent to participate. Reasons for not participating included unwillingness to discuss their HIV status, privacy and confidentiality concerns, disinterest, and lack of time.Conlusions: Given low participation rates and concerns related to HIV disclosure, privacy, and confidentiality, these questions remain (1) should informed consent be required for all phylogenetic analyses, including deidentified and surveillance data? (2) what additional steps can researchers take to protect the privacy of individuals, particularly in contexts where HIV is criminalized or there have been civil/criminal cases investigating HIV transmission? And (3) what role can community members play to minimize the potential risks, particularly for those most marginalized? These questions require input from both researchers and community members living with HIV/AIDS.

Advancing Dialogue About Consent and Molecular HIV Surveillance in the United States: Four Proposals Following a Federal Advisory Panel's Call for Major Reforms

“…One criticism of a framework where consent or opt‐out affordances are incorporated into MHS/CDR is that some people living with HIV may choose not to participate in programs, thus potentially affecting the quality or completeness of data 22,31 . Indeed, limited research has indicated that some people living with HIV may opt out if offered a choice 22,31 .…”

“…One criticism of a framework where consent or opt-out affordances are incorporated into MHS/CDR is that some people living with HIV may choose not to participate in programs, thus potentially affecting the quality or completeness of data. 22,31 Indeed, limited research has indicated that some people living with HIV may opt out if offered a choice. 22,31 Our contention is that concerns about people living with HIV not participating in surveillance if offered a choice are overridden by a new imperative for them to be given opportunities to make informed decisions about how their data are used in programs like MHS/CDR, which utilize increasingly advanced, statistically powerful, and precise bioinformatics in integrated HIV care, surveillance, and prevention programs.…”

“…22,31 Indeed, limited research has indicated that some people living with HIV may opt out if offered a choice. 22,31 Our contention is that concerns about people living with HIV not participating in surveillance if offered a choice are overridden by a new imperative for them to be given opportunities to make informed decisions about how their data are used in programs like MHS/CDR, which utilize increasingly advanced, statistically powerful, and precise bioinformatics in integrated HIV care, surveillance, and prevention programs. Further, doing the hard work of securing the buy-in of people living with HIV to participate in public health programs offers an opportunity to build trust and strengthen health systems by affording individuals more chances to engage with how they receive care and other supportive services.…”

“…Evidence on informed consent in HIV phylogenetic research and public health contexts indicates that some people living with HIV have reservations about providing consent. 22,31 "Dynamic consent" platforms used in some long-term longitudinal studies offer participants a chance to periodically revisit their preferences regarding data uses; they offer a promising set of infrastructures and practices that could potentially be translated into public health. 9 Dynamic consent is arguably particularly applicable in HIV surveillance, which requires forms of long-term data storage and reuse that resemble longitudinal studies.…”

Predictive analytics in HIV surveillance require new approaches to data ethics, rights, and regulation in public health

“…It is reasonable to suggest that some people with criminal records, who rely on poverty programs, or who come from minoritized populations would have well-justified concerns about their data being re-used in the ways described in the two cases (Guta et al, 2018;McClelland, 2019). Further, while providing people living with HIV the ability to consenting to opt out of data re-uses is not currently part of US public health programs, it is likely that many people would not consent to these data re-uses if asked (see, Benjamin, 2016;Newman et al, 2020;Rudolph et al, 2020;Buchbinder et al, 2022).…”