Jeff Taylor

Introduction Despite progress in antiretroviral therapy (ART), an effective cure for HIV remains out of reach. End-of-life (EOL) research studies involving individuals with a prognosis of six months or less offers an opportunity to advance cure science but has so far been limited to observational designs focused on HIV reservoirs. As interventional approaches at the EOL are now being considered, it is essential to assess their acceptability before moving forward. Understanding how long-term survivors (LTS) of HIV perceive these potential interventions, along with their motivations and ethical considerations, is critical to guiding the design of future EOL-HIV interventional research. Methods We conducted in-depth qualitative interviews with 16 LTS of HIV from across regions in United States to examine their views on hypothetical interventional HIV cure research at the EOL. To ensure representation, we recruited participants through community-based organizations and HIV cure collaboratories using purposive-sampling. We conducted interviews via secure teleconferencing, transcribed the recordings, and used inductive thematic analysis to identify key themes related to motivations, acceptability, and ethical considerations surrounding interventional EOL HIV cure research. Results Participants viewed hypothetical interventional HIV cure research at the EOL as a way to contribute to science, despite expecting no personal benefit. They prioritized autonomy and informed-choice in ethical participation. Many supported latency-reversing agents but raised safety concerns; in contrast, they viewed block-and-lock strategies as promising and less risky. Participants generally welcomed immune-based approaches, though some questioned their suitability for older adults near the EOL. LTS found cell and gene-based interventions innovative but expressed caution about safety and feasibility. While they valued the scientific potential of combination strategies, they noted their complexity and burden. Opinions on analytical treatment interruptions were mixed and depended on ethical safeguards, including medical oversight and reversibility. Willingness to participate in hypothetical HIV cure research at the EOL reflected individual health status, perceived burden, and personal values. Conclusions LTS are willing to engage in interventional EOL HIV cure research but emphasize the importance of ethical safeguards and participant autonomy. As HIV cure research progresses, integrating LTS perspectives is critical to designing feasible, ethical, and scientifically impactful interventional studies at EOL.

Nancy Scheper-Hughes is one of the most prominent critics of markets in human organs. Unfortunately, Scheper-Hughes rejects the view that markets should be used to solve the current shortage of transplant organs without engaging with the arguments in favour of them. Scheper-Hughes’s rejection of such markets is of especial concern, given her influence over their future, for she holds, among other positions, the status of an adviser to the World Health Organization on issues related to global transplantation. Given her influence, it is important that Scheper-Hughes’s moral condemnation of markets in human organs be subject to critical assessment. Such critical assessment, however, has not generally been forthcoming. A careful examination of Scheper-Hughes’s anti-market stance shows that it is based on serious mischaracterisations of both the pro-market position and the medical and economic realities that underlie it. In this paper, the author will expose and correct these mischaracterisations and, in so doing, show that her objections to markets in human organs are unfounded

The introduction of National Institute for Health and Clinical Excellence (NICE) guidance on Alzheimer's medication in November 2006 will have a significant effect on the treatment of patients, and is opposed by the Royal College of Psychiatrists and many charities dealing with the elderly. The use of the Quality-Adjusted Life Year (QALY) in the guidance formulation is much debated due to questions of ageism. This article seeks to examine the basis of these accusations and whether NICE can be justified using a utilitarian calculation in a principally egalitarian system such as the NHS

The U.S. National Institute of Allergies and Infectious Diseases and the National Institute of Mental Health have a new research priority: inclusion of terminally ill persons living with HIV in HIV cure-related research. For example, the Last Gift is a clinical research study at the University of California San Diego for PLWHIV who have a terminal illness, with a prognosis of less than 6 months. As end-of-life 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 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. EOL 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.

The Last Gift is an observational HIV cure-related research study conducted with people with HIV at the end of life (EOL) at the University of California San Diego. Participants agree to voluntarily donate blood and other biospecimens while living and their bodies for a rapid research autopsy postmortem to better understand HIV reservoir dynamics throughout the entire body. The Last Gift study was initiated in 2017. Since then, 30 volunteers were enrolled who are either (1) terminally ill with a concomitant condition and have a prognosis of 6 months or less or (2) chronically ill with multiple comorbidities and nearing the EOL. Multiple ethical and logistical challenges have been revealed during this time; here, we share our lessons learnt and ethical analysis. Issues relevant to healthcare research include surrogate informed consent, personal and professional boundaries, challenges posed conducting research in a pandemic, and clinician burnout and emotional support. Issues more specific to EOL and postmortem research include dual roles of clinical care and research teams, communication between research personnel and clinical teams, legally required versus rapid research autopsy, identification of next of kin/loved ones and issues of inclusion. Issues specific to the Last Gift include logistics of body donation and rapid research autopsy, and disposition of the body as a study benefit. We recommend EOL research teams to have clear provisions around surrogate informed consent, rotate personnel to maintain boundaries, limit direct contact with staff associated with clinical care and have a clear plan for legally required versus research autopsies, among other recommendations.