In a recent paper, Doernberg and Truog identify that physicians must routinely navigate a set of distinct “moral spheres”—clinical care, research, population health and the market.1 While the conce...

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

Many instances of scientific research impose risks, not just on participants and scientists but also on third parties. This class of social risks unifies a range of problems previously treated as distinct phenomena, including so-called bystander risks, biosafety concerns arising from gain-of-function research, the misuse of the results of dual-use research, and the harm caused by inductive risks. The standard approach to these problems has been to extend two familiar principles from human subjects research regulations—a favorable risk-benefit ratio and informed (...) consent. We argue, however, that these moral principles will be difficult to satisfy in the context of widely distributed social risks about which affected parties may reasonably disagree. We propose that framing these risks as political rather than moral problems may offer another way. By borrowing lessons from political philosophy, we propose a framework that unifies our discussion of social risks and the possible solutions to them. (shrink)

Volume 20, Issue 2, February 2020, Page 25-27.

In an insightful article published in this issue of the Hastings Center Report, Danielle Wenner criticizes what she describes as transactional approaches to the social value requirement in clinical research and defends a “basic structure approach.” Transactional approaches understand social value obligations as arising from transactions (or relationships) between research subjects, investigators, sponsors, and other parties. The basic structure approach, by contrast, understands social value obligations as stemming from the demands of Rawlsian social justice. According to Wenner, “The primary justification (...) for the social value requirement lies not in the ethics of free and fair transactions but rather in the goals of the clinical research enterprise and the nature of its impacts on society. The requirement is justified because it ensures that biomedical progress occurs in a manner constrained by considerations of justice.” In this commentary, I will not critique the basic structure approach per se but will raise some concerns that arise when oversight committees, such as institutional reviews boards, attempt to apply it to proposed studies involving human subjects. (shrink)

Clinical researchers should help respect the autonomy and promote the well-being of prospective study participants by helping them make voluntary, informed decisions about enrollment. However, participants often exhibit poor understanding of important information about clinical research. Bioethicists have given special attention to “misconceptions” about clinical research that can compromise participants’ decision-making, most notably the “therapeutic misconception.” These misconceptions typically involve false beliefs about a study’s purpose, or risks or potential benefits for participants. In this article, we describe a misconception involving (...) false beliefs about a study’s potential benefits for non-participants, or its expected social value. This social value misconception can compromise altruistically motivated participants’ decision-making, potentially threatening their autonomy and well-being. We show how the social value misconception raises ethical concerns for inherently low-value research, hyped research, and even ordinary research, and advocate for empirical and normative work to help understand and counteract this misconception’s potential negative impacts on participants. (shrink)

Volume 20, Issue 2, February 2020, Page 20-22.

In this issue of the Hastings Center Report, Danielle Wenner looks at a few prominent analyses of the social value requirement for clinical research, claiming that they are all based on what she calls a transactional model of research ethics. She argues that the transactional model fails to provide a secure foundation for the social value requirement, and then, appealing to John Rawls, she argues that a more secure foundation lies in the principles of social justice. Wenner's attempt to locate (...) the source of the social value requirement raises important questions regarding its scope and strength. To determine what the social value requirement requires, we need to know why it's a requirement. Does the social value requirement apply to all trials or only to a subset? Is it a necessary condition on ethical research or an important consideration that can conflict with, and sometimes be defeated by, other considerations? Wenner's attempt to answer these questions is obscured by the fact that she mistakenly regards a minority view of research ethics as the mainstream view. Once we correct for that, her analysis of the foundation of the social value requirement provides a valuable opportunity to consider how the ethics of research as an institution might supplement or alter the ethics of individual clinical trials. (shrink)

I heartily agree with Sam Doernberg and Robert Troug’s claims that there are important differences between “general morality” and medical ethics, and that in some instances they issue contradictory...

Volume 20, Issue 2, February 2020, Page 27-30.

Rapid growth in structural and functional brain research has led to increasing ethical discussion of what to do about incidental findings within the brains of healthy neuroimaging research participants that have potential health importance, but which are beyond the original aims of the study. This dilemma has been widely debated with respect to general neuroimaging research but has attracted little attention in the context of neuromarketing studies. In this paper, I argue that neuromarketing researchers owe participants the same ethical obligations (...) as other neuroimaging researchers. The financial resources available to neuromarketing firms and the social value of neuromarketing studies should command greater attention to the elucidation and management of incidental findings. However, this needs to be balanced against finite resources available within most public health systems. (shrink)