In the first five of these articles I have questioned the justice, and effectiveness, of total dependence in clinical research on willing volunteers. I have explored ways that might better and more equitably spread the burden of participating in clinical research as subjects of it. Here I consider this question: if consent is the barrier, must we regard consent as indispensable?

What relationship between investigators and subjects of clinical research would best meet the needs and wants of both – and of society, which has an interest not only in clinical research being done but also in its being done well? This series of articles argues that investigators and subjects should work together in a partnership based in shared aims. Other relationships are possible, however, and here I examine two.

In this article we examine ethical aspects of the involvement of children in clinical research, specifically those who are incapable of giving informed consent to participate. The topic is, of course, not a new one in medical ethics but there are some tensions in current guidelines that, in our view, need to be made explicit and which need to be responded to by the relevant official bodies. In particular, we focus on tensions between the World Medical Association Declaration of Helsinki, (...) and the guidance offered by the British Medical Association, the Royal College of Paediatrics and Child Health , and the Council for International Organizations of Medical Sciences. We conclude with a call for these organisations to make their guidance explicit in relation to the World Medical Association Declaration. (shrink)

Some anomalies in the legislation governing National Research Ethics Service Research Ethics Committee (REC) member categories are discussed. It is suggested that not only may some members be in the wrong category, but that the legislation identifies individuals who are simply ineligible for any form of REC membership.

The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest faced by investigators and researchers in clinical investigations, an area that is (...) less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection. (shrink)

This thesis is a contribution to the ethical justification for clinical research with children. A research subject’s participation in a trial is usually justified, in part, by informed consent. Informed consent helps to uphold the moral principle of respect for persons. But children’s limited ability to make informed choices gives rise to a problem. It is unclear what, if anything, justifies their participation in research. Some research ethicists propose to resolve this problem by appealing to social utility, proxy consent, arguments (...) explaining why it is permissible to expose children to some harm, and an argument concerning the appropriate balance between research harms and benefits. I argue that each of these is a necessary part of the justification for research with children, but that the argument concerning harms and benefits is under-developed. It relies on the concept of minimal risk, but minimal risk is inadequately justified. I propose an interpretation of minimal risk. I defend the idea that minimal risk should be interpreted according to the risks of daily life. I reject the most prominent defense of daily life, which claims that daily risks are morally relevant because they replace, rather than add to, the risks a child would ordinarily face. Instead, I propose that these risks are part of a reasonable trade-off between personal safety and our ability to pursue meaningful lives. I then examine whose daily life should be captured in the concept of minimal risk. I reject arguments that minimal risk should refer to healthy children or the subjects of the research and propose instead that the referent should be children who are not unduly burdened by their lives. I argue that children are not unduly burdened when they fare well and defend the idea that children fare well when they possess sufficiently high degrees of the substantive goods of childhood. I conclude by analyzing a controversial case study using my interpretation of minimal risk. I draw on this case to argue that my interpretation offers clear guidance for research ethics review and contributes to a determination that is more plausible than its rivals. (shrink)

If, as is alleged, challenge trials of vaccines against COVID-19 are likely to save thousands of lives and vastly diminish the economic and social harms of the pandemic while subjecting volunteers to risks that are comparable to kidney donation, then it would seem that the only sensible objection to such trials would be to deny that they have low risks or can be expected to have immense benefits. This essay searches for a philosophical rationale for rejecting challenge trials while supposing (...) that they have huge benefits and relatively low risks. Although it finds some force in objections to challenge trials grounded in the obligations of researchers to limit the harms imposed on some individuals for the benefit of others, it argues that there is no compelling objection to challenge trials of vaccines for COVID-19—if they have the benefits and risks that have been claimed. (shrink)

In a series of articles, I set out my belief that investigators and subjects of research should work together in a partnership based in shared aims. Such a relationship – quite different from what is usual today – would impose duties on both partners. In earlier papers I explored the origin and nature of the duties that would fall on patients; here I examine their limits.

If patients are to be partners rather than subjects, contributing effectively to clinical research in which they have an interest, both they and investigators must change their ways. The case is argued here that the conduct of clinical research fulfils an essential need of society and that, therefore, in the interests of society, there is a moral imperative that it be done. Further essays will develop this theme, questioning along the way whether consent is a redundant concept.

A medical profession which did not seek improved means to conquer disease would be condemned for dereliction of its duty, Members of the public will not accept the current state of the medical arts as finite but feel justified in expecting the development of more effective therapies for illness, and the promotion of improved means of preventive care.With this assertion, the distinguished academic, Bernard Dickens, places research firmly in the domain of the public interest. Foster agrees, saying that, “[t]o improve (...) medical care as much as we can, if not to perfect it, means that we have to accept the need for research.” Giesen adds a further emphasis to the search for medical advancements, saying that “freedom of research and scientific inquiry is, in itself, an important aspect of open societies.“. (shrink)

Anderson and Dyck claim that the current trend of almost exclusively using citation-based evaluative metrics to assess the research output of scholars is unsound. I agree with them in this, but I feel that, for practical reasons, this system will not disappear in the near future, so we must concentrate on making it fairer. Both commentators doubt whether numerically expressing each contributor's relative contribution is feasible. I admit that an important precondition for this task is the possibility of an informed, (...) democratic debate among equals about the relative contribution of each contributor to the article. Mechanisms should be established to protect vulnerable researchers in the academic field in the same way as safeguards exist today to protect vulnerable research participants. Theoretically, however, I think that the fair allocation of authorship credit is possible, and much of this task is already being performed routinely when contributors determine the order of their names in the byline, being well aware of the widespread assumption that this order mostly mirrors the order of their relative contributions. All they would have to do as an additional task is to express this order in numbers. If they cannot reach a consensus, they could always choose not to express their relative contribution in numbers, in which case the presumption would be that they contributed equally. My proposal could, at best, make the system fairer and, at worst, not reduce the options that evaluators already have. (shrink)