Program Director/Principal Investigator (Last, First, Middle): Dub, Karine Project Summary/Abstract: HIV cure research is a definite strategic priority of the National Institutes of Health (NIH), the International AIDS Society (IAS), the pharmaceutical industry, and private foundations, including the Foundation for AIDS Research (amfAR), and the Bill and Melinda Gates Foundation (BMGF). To date, there have been over 250 biomedical studies related to HIV cure conducted worldwide. As this field of research continues to grow and innovate, there has been limited work dedicated to understanding empirical ethics considerations related to such a rapidly growing body of biomedical research. Surprisingly little research exists on factors considered to be important in translating HIV cure discoveries into human studies and in ethically implementing specific HIV cure research strategies and combination regimens. This administrative supplement is tied to parent award R21-MH118120 titled: ?Pilot Integration of Participant-Centered Outcomes in HIV Cure Research in the United States: Implications for Ethical Conduct?. The proposal is directly responsive to the supplement announcement aimed at expanding ethical considerations related to biomedical research of high priority to the National Institutes of Health (NIH). Our overarching goal is to derive ethical considerations to inform the next frontiers in HIV cure research. We propose four specific empirical ethics aims: 1) Develop ethical considerations that address specific challenges related to conducting interventional HIV cure research in the novel EOL translational research model; 2) Develop ethical considerations for specific HIV cure research strategies, with a focus on cell and gene therapy (CGT) research; 3) Develop ethical considerations for conducting HIV cure research with multiple strategies (combination HIV cure research); 4) Develop ethical considerations aimed at effectively mitigating risks during analytical treatment interruptions (ATIs), particularly in diverse settings and populations. To accomplish each aim, we will conduct qualitative, in-depth informant interviews with at least ? 12 bioethicists/regulators, biomedical HIV cure researchers, HIV care providers and people living with HIV (PLWHIV) using purposely-designed interview guides and inquire about critical ethics considerations, safeguards and protections. We anticipate each aim will result in one publication. Expected outcomes will include empirical ethics considerations that will provide a robust evidence base to inform future research design, implementation and policy related to HIV cure research. To maximize impact, findings will be discussed with key stakeholders involved in the strategic areas highlighted in Aims 1 ? 4. Publications will contribute to neglected areas in HIV cure research ethics and have broad applicability for other biomedical research areas beyond HIV cure research. Project Abstract/Summary
Dub, Karine Project Narrative/Public Health Relevance: HIV cure research is growing with over 250 biomedical studies related to HIV cure conducted around the world. While the field of HIV cure research continues to expand, and innovate, the integral and complementary field of bioethics has not kept pace with the rapidly evolving pace of biomedical sciences. The proposed empirical research ethics aims ? focused on four key strategic areas of growth and interest for the NIH ? will provide much-needed and timely guidance to help ensure ethical and responsible conduct of HIV cure research moving forward. Project Narrative/Public Health Relevance
