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

Introduction: Global Justice and Bioethics

This introduction begins with two simple case studies that reveal a background of socio-economic complexities that hinder development. The availability of healthcare and the issue of cross-border justice are the key points to be addressed in this study. The chapters consider philosophy, economics, and bioethics in order to provide a global perspective. Two theories come into play in this book—the ideal and non-ideal—which offer insight on why and how things are done

Canada’s new ethical guidelines for research with humans: A critique and comparison with the United States

Canada’s Tri-Council Policy Statement: Ethical conduct for research involving humans, first published in 1998, has recently been updated.1 The US Department of Health and Human Services has just issued an Advance Notice of Proposed Rulemaking that would substantially change the 20-year-old Common Rule governing most federally funded research involving human participants.2 A comparison of the two countries’ systems for protecting human research participants is therefore timely. This analysis situates the Canadian system in an international context, with particular attention to its similarities and differences to the US system and their shared challenges going forward with their changes

Introduction: Case Studies in the Ethics of Mental Health Research

This collection presents six case studies on the ethics of mental health research, written by scientific researchers and ethicists from around the world. We publish them here as a resource for teachers of research ethics and as a contribution to several ongoing ethical debates. Each consists of a description of a research study that was proposed or carried out and an in-depth analysis of the ethics of the study

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

Streamlining Ethical Review

The U.S. review system for human subjects research has been widely criticized in recent years for requirements that delay research without improving human subjects protections. Any major reformulation of regulations may take some time to implement. In the meantime, current regulations often allow for streamlined ethics review without jeopardizing—and possibly improving—protections for research participants. We discuss underutilized options, including research that need not be classified as “human subjects research,” categories of studies that can be exempt from ethical review, and studies that need only undergo expedited review by one IRB member. In addition, we consider ways to simplify review of multi-center research using one institution’s IRB. We speculate on multiple reasons for the underuse of these mechanisms, and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process

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

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

The 50th Anniversary of the Declaration of Helsinki: Progress but Many Remaining Challenges

Since 1964, through 7 revisions, the World Medical Association’s Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. It is consulted by ethics review committees, funders, researchers, and research participants. It has been incorporated into national legislation and is routinely invoked to ascertain the ethical appropriateness of clinical trials. There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. Nevertheless, the proposed declaration contains persistent flaws..