80 research outputs found
Putting a number on the harm of death
Donors to global health programs and policymakers within national health systems have to make difficult decisions about how to allocate scarce health care resources. Principled ways to make these decisions all make some use of summary measures of health, which provide a common measure of the value (or disvalue) of morbidity and mortality. They thereby allow comparisons between health interventions with different effects on the patterns of death and ill health within a population. The construction of a summary measure of health requires that a number be assigned to the harm of death. But the harm of death is currently a matter of debate: different philosophical theories assign very different values to the harm of death at different ages. This chapter considers how we should assign numbers to the harm of deaths at different ages in the face of uncertainty and disagreement
Post‐trial access to antiretrovirals: Who owes what to whom?
ABSTRACTMany recent articles argue that participants who seroconvert during HIV prevention trials deserve treatment when they develop AIDS, and there is a general consensus that the participants in HIV/AIDS treatment trials should have continuing post‐trial access. As a result, the primary concern of many ethicists and activists has shifted from justifying an obligation to treat trial participants, to working out mechanisms through which treatment could be provided. In this paper I argue that this shift frequently conceals an important assumption: that if there is an obligation to supply treatment, then any party who could provide it may be prevailed upon to discharge the obligation. This assumption is false. The reasons why trial participants should get ART affect who has the duty to provide it. We should not burden governments with the obligations of sponsors, nor researchers with the obligations of the international community. And we should not deprive a group of treatment because their need is less salient than that of research participants. Insisting otherwise may lead to people being wrongfully deprived of access to antiretrovirals
The Ethics of Placebo-controlled Trials: Methodological Justifications
The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling
Ethics and health research priority setting : a narrative review
Funding: This work was supported by Wellcome [222525].This narrative review aims to describe current practice and ongoing discussions in the academic literature regarding ethics and health research priority setting. It begins with some preliminary distinctions regarding types of research priority setting. It then gives some background on current practice with respect to formal research priority setting exercises, including summaries of The Ad Hoc Committee on Health Research method, the Child Health and Nutrition Research Initiative (CHNRI) method, the Combined Approach Matrix (CAM), the Delphi method, the Essential National Health Research (ENHR) strategy for priority setting, and the James Lind Alliance (JLA) framework. The majority of the paper reports the results of a literature review covering specifically ethical issues under the thematic headings of process criteria, substantive criteria, global justice, the obligations of specific actors, and research topics. It closes with some summary thoughts about apparent gaps and directions for future investigation.Peer reviewe
Informed consent to HIV cure research
Trials with highly unfavourable risk–benefit ratios for
participants, like HIV cure trials, raise questions about
the quality of the consent of research participants. Why,
it may be asked, would a person with HIV who is doing
well on antiretroviral therapy be willing to jeopardise his
health by enrolling in such a trial? We distinguish three
concerns: first, how information is communicated to
potential participants; second, participants’ motivations
for enrolling in potentially high risk research with no
prospect of direct benefit; and third, participants’
understanding of the details of the trials in which they
enrol. We argue that the communication concern is
relevant to the validity of informed consent and the
quality of decision making, that the motivation concern
does not identify a genuine problem with either the
validity of consent or the quality of decision making and
that the understanding concern may not be relevant to
the validity of consent but is relevant to the quality of
decision making. In doing so, we derive guidance points
for researchers recruiting and enrolling participants into
their HIV cure trials, as well as the research ethics
committees reviewing proposed studies
Should health research funding be proportional to the burden of disease?
Public funders of health research have been widely criticized on the grounds that their allocations of funding for disease-specific research do not reflect the relative burdens imposed by different diseases. For example, the US National Institutes of Health spends a much greater fraction of its budget on HIV/AIDS research and a much smaller fraction on migraine research than their relative contribution to the US burden of disease would suggest. Implicit in this criticism is a normative claim: Insofar as the scientific opportunities are equal, each patient merits research into their condition proportional to the burden of disease for which that condition is responsible. This claim—the proportional view—is widely accepted but has never been fully specified or defended. In this paper, I explain what is required to specify the view, attempt to do so in the most charitable way, and then critically evaluate its normative underpinnings. I conclude that a severity-weighted proportional view is defensible. I close by drawing out five key lessons of my analysis for health research priority-setting.Publisher PDFPeer reviewe
How to allocate scarce health resources without discriminating against people with disabilities
One widely used method for allocating health care resources involves the use of cost-effectiveness analysis (CEA) to rank treatments in terms of quality-adjusted life-years (QALYs) gained. CEA has been criticized for discriminating against people with disabilities by valuing their lives less than those of non-disabled people. Avoiding discrimination seems to lead to the ’QALY trap’: we cannot value saving lives equally and still value raising quality of life. This paper reviews existing responses to the QALY trap and argues that all are problematic. Instead, we argue that adopting a moderate form of prioritarianism avoids the QALY trap and disability discrimination
Introduction: The Fogarty International Research Ethics Education and Curriculum Development Program in Historical Context
In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection
Ethical considerations in international clinical trial site selection
New medicines and vaccines are predominantly tested in high-income countries. However, as the COVID-19 pandemic highlighted, the populations who can benefit from these interventions are not limited to these wealthier regions. One-third of novel Food and Drug Administration approved drugs, sponsored by large companies, treat infectious diseases like tuberculosis and HIV, which disproportionately affect low-income and middle-income countries (LMICs). The medicines for non-communicable diseases (NCDs) are also relevant to LMIC health needs, as over three-quarters of deaths from NCDs occur in LMICs. There are concerns clinical trial data may not extrapolate across geographical regions, as product effectiveness can vary substantially by region. The pentavalent rotavirus vaccine, for example, had markedly lower efficacy in LMICs. Efficacy variations have also been found for other vaccines and drugs. We argue there are strong ethical arguments for remedying some of this uneven distribution of clinical trial sites by geography and income. Chief among them, is that these disparities can impede equitable access to the benefits of clinical research, such as representation in the evidence base generated to guide prescribing and use of medicines and vaccines. We suggest trial site locations should be made more transparent and for later stage trials their selection should be informed by the global distribution of disease burden targeted by an experimental product. Countries with high prevalence, incidence, severity or infection transmission rates for targeted diseases should have real opportunities to engage in and enrol their populations in trials for novel medicines and vaccines.Publisher PDFPeer reviewe
A Theory of Bioethics
Intended for students, scholars, and others interested in bioethics, this volume offers a compelling theory of bioethics while eliciting practical implications for issues including medical assistance-in-dying, the right to health care, abortion, animal research, and the definition of death. This title is available as Open Access on Cambridge Core
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