# Ethics Administrative Supplement to R21-MH118120: Advancing Empirical Research Ethics for HIV Cure Research

> **NIH NIH R21** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $155,421

## Abstract

Program Director/Principal Investigator (Last, First, Middle): Dubé, 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

## Key facts

- **NIH application ID:** 10130364
- **Project number:** 3R21MH118120-02S1
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Karine Dube
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $155,421
- **Award type:** 3
- **Project period:** 2020-05-05 → 2021-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10130364

## Citation

> US National Institutes of Health, RePORTER application 10130364, Ethics Administrative Supplement to R21-MH118120: Advancing Empirical Research Ethics for HIV Cure Research (3R21MH118120-02S1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10130364. Licensed CC0.

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