Informed Consent in Molecular HIV Epidemiology: A Rapid Review of the Literature to Identify Concerns and Recommendations

In the United States, molecular HIV epidemiology (MHE) is a key part of the National HIV/AIDS Strategy, which incorporates the evaluation of HIV genetic sequences for cluster detection and response. Data collection for MHE occurs without any requirement for formal consent from patients, which has sparked ethical concerns among community members, ethicists, and advocates. We conducted a rapid review of the current literature on informed consent and MHE to understand the key concerns and recommendations. We searched 4 academic databases and included articles that examined the issue of informed consent in MHE practices. We screened a total of 119 articles and selected 30 articles for inclusion. From these, we extracted data pertaining to concerns and recommendations related to informed consent in MHE, including MHE in the context of both research and surveillance. Our findings revealed 2 main categories of concerns: (1) challenges in obtaining valid informed consent and (2) concerns related to the current lack of consent such as risks of data misuse, privacy violations, and potential stigma. We identified 3 main categories of recommendations: establishing stronger data governance, developing ethical consent practices, and increasing community engagement. A key theme identified was an unresolved contestation about the ethics of using MHE without consent and whether the potential public health benefits of MHE justify concerns about autonomy, privacy, and potential harm. Future directions include the need for empirical research to evaluate the risks and benefits of MHE and the development of practices for meaningful community engagement to ensure ethical and context-sensitive approaches.