Annette Rid

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 standard approach to treatment decision making for incapacitated patients often fails to provide treatment consistent with the patient’s preferences and values and places significant stress on surrogate decision makers. These shortcomings provide compelling reason to search for methods to improve current practice. Shared decision making between surrogates and clinicians has important advantages, but it does not provide a way to determine patients’ treatment preferences. Hence, shared decision making leaves families with the stressful challenge of identifying the patient’s preferred treatment option. To address this concern, the present paper proposes to incorporate the use of a “Patient Preference Predictor” (PPP) into the shared decision-making process between surrogates and clinicians. A PPP would predict which treatment option a given incapacitated patient would most likely prefer, based on the individual’s characteristics and information on what treatment preferences are correlated with these characteristics. Use of a PPP is likely to increase the chances that incapacitated patients are treated consistent with their preferences and values and might reduce the stress and burden on their surrogates. Including a PPP in the shared decision-making process therefore has the potential to realize important ethical goals for making treatment decisions for incapacitated patients. The present paper justifies this approach on conceptual and normative grounds

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.

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 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.