Ethical considerations for HIV remission clinical research involving participants diagnosed during acute HIV infection

BMC Medical Ethics

Maartje Dijkstra¹  Karine Dubé²  Joseph D. Tucker³  Adam Gilbertson⁴  Stuart Rennie⁵ 

[1] Department of Infectious Diseases, Amsterdam Infection and Immunity Institute, Amsterdam University Medical Centers, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands;Department of Infectious Diseases, Public Health Service Amsterdam, Amsterdam, The Netherlands;Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA;Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, 27599, Chapel Hill, NC, USA;Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel Street, WCE1, London, UK;UNC Project-China, 2 Lujing Road, Guangzhou, China;Pacific Institute for Research and Evaluation, Chapel Hill Center, 101 Conner Drive, Suite 200, 27514-7038, Chapel Hill, NC, USA;UNC Center for Bioethics, Department of Social Medicine, University of North Carolina at Chapel Hill, 27599, Chapel Hill, NC, USA;UNC Center for Bioethics, Department of Social Medicine, University of North Carolina at Chapel Hill, 27599, Chapel Hill, NC, USA;

关键词: Acute HIV;    Primary HIV;    Early HIV;    HIV remission;    HIV cure;    Ethics;    Bioethics;    Medical ethics;    Clinical trials;   

DOI  :  10.1186/s12910-021-00716-1

来源: Springer

【 摘 要 】

HIV remission clinical researchers are increasingly seeking study participants who are diagnosed and treated during acute HIV infection—the brief period between infection and the point when the body creates detectable HIV antibodies. This earliest stage of infection is often marked by flu-like illness and may be an especially tumultuous period of confusion, guilt, anger, and uncertainty. Such experiences may present added ethical challenges for HIV research recruitment, participation, and retention. The purpose of this paper is to identify potential ethical challenges associated with involving acutely diagnosed people living with HIV in remission research and considerations for how to mitigate them. We identify three domains of potential ethical concern for clinicians, researchers, and ethics committee members to consider: 1) Recruitment and informed consent; (2) Transmission risks and partner protection; and (3) Ancillary and continuing care. We discuss each of these domains with the aim of inspiring further work to advance the ethical conduct of HIV remission research. For example, experiences of confusion and uncertainty regarding illness and diagnosis during acute HIV infection may complicate informed consent procedures in studies that seek to recruit directly after diagnosis. To address this, it may be appropriate to use staged re-consent procedures or comprehension assessment. Responsible conduct of research requires a broad understanding of acute HIV infection that encompasses its biomedical, psychological, social, and behavioral dimensions. We argue that the lived experience of acute HIV infection may introduce ethical concerns that researchers and reviewers should address during study design and ethical approval.

【 授权许可】

CC BY