Annette Rid

Existing ethical frameworks for public health provide insufficient guidance on how to evaluate the risks of public health programs that compromise the best clinical interests of present patients for the benefit of others. Given the relevant similarity of such programs to clinical research, we suggest that insights from the long‐standing debate about acceptable risk in clinical research can helpfully inform and guide the evaluation of risks posed by public health programs that compromise patients’ best clinical interests. We discuss how lessons learned regarding the ethics of risk in one context can be fruitfully transferred to the other, using the example of a so‐called ‘rational antibiotic use’ guideline that limits antimicrobial prescribing in order to curb antimicrobial resistance.

A new problem in health care priority‐setting is currently emerging for wealthy countries: what should be done when a new drug is considered cost effective but implementing it would still be unaffordable? The standard approach to setting priorities in health care rests on cost effectiveness. This approach is now being tested by new drugs that are highly effective but very costly. Because they are so effective, these drugs deliver “value for money” despite their high cost. However, when the targeted condition affects a sizeable number of patients, implementing the drugs becomes unaffordable. There are no easy alternatives. A key virtue of setting health care priorities with a presumptive cost‐effectiveness threshold is that it provides all patients a prima facie equal claim on the available resources, and alternative approaches to addressing affordability face their own challenges.

One of the fundamental ethical concerns about biomedical research is that it frequently exposes participants to risks for the benefit of others. To protect participants’ rights and interests in this context, research regulations and guidelines set out a mix of substantive and procedural requirements for research involving humans. Risk thresholds play an important role in formulating both types of requirements. First, risk thresholds serve to set upper risk limits in certain types of research. Second, risk thresholds serve to demarcate risk categories that streamline risk-adapted systems of ethical oversight. But although risk thresholds play such an important role in research governance, there is a need both to better define the existing risk thresholds and to delineate new thresholds in order to develop more risk-adapted systems of research oversight. The present paper examines the existing minimal risk threshold and the surrounding debates with the goal of deriving a systematic approach to setting thresholds of research risk.

In his stimulating target article, 1 Philippe Calain discusses how the traditional ethical framework for clinical research was challenged during the 2013–2016 Ebola epidemic in West Africa. One of his key claims is that conventional research ethics did not have the resources to address the ‘profound tension’ 1, between individual and public interests in clinical research during this epidemic. I agree with this claim, but would like to provide a modified argument in its support. As Calain points out, although a tension between individual and public interests in clinical research always exists, this tension was heightened during the Ebola epidemic. Ebola had an average fatality rate of 40%–60% in this outbreak and reached up to 90% in some locations. Appropriate personal protective equipment was not always available; the level of benefit from supportive care was contested; and there were no targeted treatments and vaccines for the...

In his stimulating target article,1 Philippe Calain discusses how the traditional ethical framework for clinical research was challenged during the 2013–2016 Ebola epidemic in West Africa. One of his key claims is that conventional research ethics did not have the resources to address the ‘profound tension’1, between individual and public interests in clinical research during this epidemic. I agree with this claim, but would like to provide a modified argument in its support. As Calain points out, although a tension between individual and public interests in clinical research always exists, this tension was heightened during the Ebola epidemic. Ebola had an average fatality rate of 40%–60% in this outbreak and reached up to 90% in some locations. Appropriate personal protective equipment was not always available; the level of benefit from supportive care was contested; and there were no targeted treatments and vaccines for the disease. Given this situation, patients with Ebola had a strong interest in accessing potential treatments even if they were unproven. This was especially true in the early phases of the epidemic when fatality rates were very high and seemingly safe ‘repurposed’ treatments were proposed for study. Individuals at high risk of contracting Ebola—for example, frontline workers or informal carers in the community—equally had a strong interest in accessing experimental vaccines, once their safety and ability to induce an immune response had been established in phase 1/2 testing. At the same time, the exponential spread of Ebola in the second half of 2014 created a strong public interest in rigorous research results that could support the rapid marketing authorization, mass production and widespread implementation of any proven effective treatments or vaccines, as well …

The World Medical Association's Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort to maintain its influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States.

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the worry that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorization. In this paper, we show how the standard view of informed consent – consent as autonomous authorization – can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk.

The use of prisoners as research participants is controversial. Efforts to protect them in response to past exploitation and abuse have led to strict regulations and reluctance to involve them as participants. Hence, prisoners are routinely denied the opportunity to participate in research. In the absence of comprehensive information regarding prisoners’ current involvement in research, we examined UK prisoners’ involvement through review of research applications to the UK National Research Ethics Service. We found that prisoners have extremely limited access to research participation. This analysis was augmented by a survey of those involved in research and research governance (UK researchers and Research Ethics Committee members). Our results suggest that pragmatic concerns regarding the perceived burden of including prisoners are far more prominent in motivating their exclusion than ethical concerns or knowledge of regulations. While prisoners may remain a vulnerable research population due to constraints upon their liberty and autonomy and the coercive nature of the prison environment, routine exclusion from participation may be disadvantageous. Rigorous ethical oversight and the shift in the prevailing attitude towards the risks and benefits of participation suggest that it may be time for research to be more accessible to prisoners in line with the principle of equivalence in prison healthcare. We suggest the necessary first step in this process is a re-examination of current guidance in the UK and other countries with exclusions.

As a matter of justice, what do we owe each other to promote and protect health in a population and to assist people when they are ill and disabled? This is the fundamental question of Norman Daniels’ new book on justice and health. Just health is in many ways a successor to Daniels’ seminal classic Just health care. As foreshadowed by a 2001 target article in the American Journal of Bioethics, Just health integrates Daniels’ account of the special moral importance of health and healthcare with his interim work on the social determinants of health4 and the fairness of health sector reform and limit-setting in healthcare. The change of title already indicates that Just health no longer focuses solely on the provision of healthcare, but spans all socially controllable factors of health. The book’s ambitious aim is to provide an integrated theory of justice and health.

Norman Daniels’ theory of justice and health faces a serious practical problem: his theory can ground the special moral importance of health and allows distinguishing just from unjust health inequalities, but it provides little practical guidance for allocating resources when they are especially scarce. Daniels’ solution to this problem is a fair process that he specifies as "accountability for reasonableness". Daniels claims that accountability for reasonableness makes limit-setting decisions in healthcare not only legitimate, but also fair. This paper assesses the latter claim. Does accountability for reasonableness result in fair limit-setting decisions? It is argued that the answer to this question is not a clear yes. Daniels is remarkably unclear about the criterion of fairness that accountability for reasonableness satisfies. The paper discusses different options for resolving this lack of clarity and examines how they apply to Daniels’ accountability for reasonableness framework. It is concluded, first, that accountability for reasonableness is not a paradigm case of any of the classic notions of procedural justice; second, that what might be called "constrained pure procedural justice" best reflects how accountability for reasonableness results in fair limit-setting decisions; and third, that the procedural conditions of accountability for reasonableness must be further specified and amended to better achieve a fair process, and hence fair limit-setting decisions.