Ethical considerations for HIV cure-related research at the end of life

Karine Dubé,Kushagra Mathur,Sean Philpott-Jones,Anshula Nathan,Davey Smith,Andy Kaytes,Stuart Luter,Brandon Brown,Sogol Javadi,Susan J Little,Hursch Patel,Susan Concha-Garcia,Jeff Taylor,Sara Gianella

doi:10.1186/s12910-018-0321-2

Abstract

BackgroundThe U.S. National Institute of Allergies and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) have a new research priority: inclusion of terminally ill persons living with HIV (PLWHIV) in HIV cure-related research. For example, the Last Gift is a clinical research study at the University of California San Diego (UCSD) for PLWHIV who have a terminal illness, with a prognosis of less than 6 months.DiscussionAs end-of-life (EOL) HIV cure research is relatively new, the scientific community has a timely opportunity to examine the related ethical challenges. Following an extensive review of the EOL and HIV cure research ethics literature, combined with deliberation from various stakeholders (biomedical researchers, PLWHIV, bioethicists, and socio-behavioral scientists) and our experience with the Last Gift study to date, we outline considerations to ensure that such research with terminally ill PLWHIV remains ethical, focusing on five topics: 1) protecting autonomy through informed consent, 2) avoiding exploitation and fostering altruism, 3) maintaining a favorable benefits/risks balance, 4) safeguarding against vulnerability through patient-participant centeredness, and 5) ensuring the acceptance of next-of-kin/loved ones and community stakeholders.ConclusionEOL HIV cure-related research can be performed ethically and effectively by anticipating key issues that may arise. While not unique to the fields of EOL or HIV cure-related research, the considerations highlighted can help us support a new research approach. We must honor the lives of PLWHIV whose involvement in research can provide the knowledge needed to achieve the dream of making HIV infection curable.

Highlights

The U.S National Institute of Allergies and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) have a new research priority: inclusion of terminally ill persons living with Human Immunodeficiency Virus (HIV) (PLWHIV) in HIV cure-related research
Following an extensive review of the EOL and HIV cure research ethics literature, combined with deliberation from various stakeholders, as well as our experience in the Last Gift study to date, we describe possible ethical considerations for the design, conduct, review and evaluation of HIV cure-related research with terminally ill persons living with HIV (PLWHIV)
We examine the context of HIV cure clinical research at the EOL and generate considerations adapted to the reality of a specific HIV cure clinical research protocol called The Last Gift: Development of End-of-Life Translational Research Model

Summary

Introduction

The U.S National Institute of Allergies and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) have a new research priority: inclusion of terminally ill persons living with HIV (PLWHIV) in HIV cure-related research. The U.S Food and Drug Administration (FDA) defines HIV cure research as “any investigation that evaluates: 1) a therapeutic intervention or approach that controls or eliminates HIV infection to the point that no further medical interventions are needed to maintain health; and 2) preliminary scientific concepts that might lead to such a therapeutic intervention [7].”. While most HIV cure-related studies occur in ‘otherwise healthy volunteers’ [8], a new research priority for the U.S National Institute of Allergies and Infectious Diseases (NIAID) and the National

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