Research regulations around the world do not impose any limits on the risks to which consenting adults may be exposed. Nonetheless, most review committees regard some risks as too high, even for consenting adults. To justify this practice, commentators have appealed to a range of considerations which are external to informed consent and the risks themselves. Most prominently, some argue that exposing consenting adults to very high risks has the potential to undermine public trust in research. This justification assumes that (...) it is not the magnitude of the risks themselves which raises concern, but the way in which the public might respond to them. This justification thus depends on the possibility that the public will find out about the risks and respond to them in the specified way. Like the other proposed external justifications, it thereby fails to offer a reason to think that exposing consenting adults to very high risks is problematic in itself. In the present paper, we describe and endorse a different justification. Rather than appealing to external factors, we argue that limits on risks for consenting adults trace to internal limits on informed consent, to limits on the things consent can and cannot make ethically permissible. In doing so, we aim to provide a firmer conceptual basis for the view that some research risks are unacceptably high, no matter how the research is conducted. (shrink)

BackgroundThe pursuit of a cure for HIV is a high priority for researchers, funding agencies, governments and people living with HIV (PLWH). To date, over 250 biomedical studies worldwide are or have been related to discovering a safe, effective, and scalable HIV cure, most of which are early translational research and experimental medicine. As HIV cure research increases, it is critical to identify and address the ethical challenges posed by this research.MethodsWe conducted a scoping review of the growing HIV cure (...) research ethics literature, focusing on articles published in English peer-reviewed journals from 2013 to 2021. We extracted and summarized key developments in the ethics of HIV cure research. Twelve community advocates actively engaged in HIV cure research provided input on this summary and suggested areas warranting further ethical inquiry and foresight via email exchange and video conferencing.DiscussionDespite substantial scholarship related to the ethics of HIV cure research, additional attention should focus on emerging issues in six categories of ethical issues: (1) social value (ongoing and emerging biomedical research and scalability considerations); (2) scientific validity (study design issues, such as the use of analytical treatment interruptions and placebos); (3) fair selection of participants (equity and justice considerations); (4) favorable benefit/risk balance (early phase research, benefit-risk balance, risk perception, psychological risks, and pediatric research); (5) informed consent (attention to language, decision-making, informed consent processes and scientific uncertainty); and (6) respect for enrolled participants and community (perspectives of people living with HIV and affected communities and representation).ConclusionHIV cure research ethics has an unfinished agenda. Scientific research and bioethics should work in tandem to advance ethical HIV cure research. Because the science of HIV cure research will continue to rapidly advance, ethical considerations of the major themes we identified will need to be revisited and refined over time. (shrink)

Volume 20, Issue 2, February 2020, Page 20-22.

The Journal of Medical Ethics can sometimes read part Men Like Gods and part A Brave New World. At times, we learn how all controversies can resolved with reference to four principles. At other times, we learn how “every discovery in pure science is potentially subversive”.1 This issue is no exception. Here, we can read about the utopia of gene editing, manufactured organs, and machine learnt algorithmic decision-making. We can also read about the dystopia of inherited disorders from edited germlines, (...) the testing of xenotransplants on braindead patients, and misdiagnosis by artificial intelligence. What we see in the three papers that I will foreground here is the application of medical ethics to avoid the dystopia while preserving the promises of medical science. But as I seek to explain here, our ability to address the controversies that we anticipate in medical science depend on our ability to refine our understanding of what medical ethics requires of us now. From the diagnosis of eye diseases from fungus images to predicting the risk of imminent risk of suicide attempts, machine learnt medical decision making has, in some high profile instances, outperformed clinicians in medical diagnosis and treatment recommendations. While clinician and machine learnt diagnoses will both involve degrees of uncertainty and fallibility, Thomas Grote2 asks us to consider is how much weight a clinician ought to give an algorithmic diagnosis which she disagreements with. Since a clinician is held to account for …. (shrink)

Volume 20, Issue 2, February 2020, Page 30-32.