Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this (...) gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. (shrink)

To arrive at their final evaluation of a manuscript or grant proposal, reviewers must convert a submission’s strengths and weaknesses for heterogeneous peer review criteria into a single metric of quality or merit. I identify this process of commensuration as the locus for a new kind of peer review bias. Commensuration bias illuminates how the systematic prioritization of some peer review criteria over others permits and facilitates problematic patterns of publication and funding in science. Commensuration bias also foregrounds a range (...) of structural strategies for realigning peer review practices and institutions with the aims of science. (shrink)

Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants. Since there are insufficient willing research participants to power all the trials that are currently undertaken,1 addressing underenrolment will require prioritisation decisions that reduce the number of trials competing for participants. While there are multiple levels at which research priority-setting can and does take place, competition between trials often plays out in (...) real time at the institutional or site level, where complex decisions must be made about how to manage overlapping trials in ways that balance different considerations, including the risk of non-completion. We sought to explore what research institutions in particular might ethically do to mitigate the risk that competition between trials will contribute to recruitment shortfalls. Against this backdrop, we appreciate the thoughtful replies to our article and are especially encouraged that all three respondents acknowledge the importance and indeed necessity of setting research priorities in ways that respect the rights and interests of various parties. The key question raised by the commentaries primarily concerns not whether research prioritisation should take place but rather how it is best accomplished. In what follows, we clarify our argument in the original article, and then focus on several points raised in the commentaries regarding the role of institutions in research priority-setting. Our approach is animated by the risk that competition between clinical trials for the same population of participants can be a cause of underenrolment when there are insufficient participants to meet the statistical needs of all open studies. In such situations, one or more of the competing studies will fail to meet recruitment targets, reducing their statistical ability to answer the research question. There are strong ethical reasons to avoid …. (shrink)

Contemporary research ethics policies started with reflection on the atrocities perpetrated upon concentration camp inmates by Nazi doctors. Apparently, as a consequence of that experience, the policies that now guide human subject research focus on the protection of human subjects by making informed consent the centerpiece of regulatory attention. I take the choice of context for policy design, the initial prioritization of informed consent, and several associated conceptual missteps, to have set research ethics off in the wrong direction. The aim (...) of this paper is to sort out these confusions and their implications and to offer instead a straightforward framework for considering the ethical conduct of human subject research. In the course of this discussion I clarify different senses of autonomy that have been confounded and present more intelligible justifications for informed consent. I also take issue with several of the now accepted dogmas that govern research ethics. These include: the primacy of informed consent, the protection of the vulnerable, the substitution of beneficence for research's social purpose, and the introduction of an untenable distinction between innovation and research. (shrink)

Several influential ethical guidelines and frameworks endorse the view that research with human participants is ethically acceptable only when it has “social value,” meaning that it generates knowledge which can be used to benefit society. For example, the Nuremberg Code requires that medical experiments on human beings “yield fruitful results for the good of society, unprocurable by other methods or means of study”. The Council for International Organizations of Medical Sciences guidelines hold that “health-related research with humans... must have social (...) value” or the “prospect of generating the knowledge and the means necessary to protect and promote people’s health” (CIOMS... (shrink)

In controlled human infection (CHI) studies, investigators deliberately infect healthy individuals with pathogens in order to study mechanisms of disease or obtain preliminary efficacy data on investigational vaccines and medicines. CHI studies offer a fast and cost‐effective way of generating new scientific insights, prioritizing investigational products for clinical testing, and reducing the risk that large numbers of people are exposed to ineffective or harmful substances in research or in practice. Yet depending on the pathogen, CHI studies can involve significant risks (...) or burdens for participants, pose risks to individuals or communities not involved in the research, and lead to public controversy. It is therefore essential to ensure that the risks of CHI studies are justified by their social value—that is, their potential to generate benefits for society—and that public trust can be maintained. In this paper, we aim to clarify how research sponsors, research ethics committees and other reviewers should judge the social value of CHI studies. We develop a list of relevant considerations for making social value judgments based on the standard view of social value. We then use this list to discuss the example of potentially conducting dengue virus CHI studies in endemic settings. We argue that dengue virus CHI studies in endemic settings would fall on the higher end of the spectrum of social value, mostly because of their potential to redirect all fields of future dengue research. Drawing on this discussion, we derive several general recommendations for how reviewers should judge the social value of CHI studies. (shrink)

To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards, sometimes called Research Ethics Committees, have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not only for academics, (...) but for the whole nation.” One member of the President's Council on Bioethics went so far as to assert, “There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both.” Locked in the bureaucratic “iron cage” of IRB oversight, critics charge that researchers have been transformed into a vulnerable, exposed population, subject to domination, that has been likened in one case to a kind of “Tuskegee in reverse.”. (shrink)