We explore the ethics of deliberately exposing consenting adults to SARS-CoV-2 to induce immunity to the virus (“DEI” for short). We explain what a responsible DEI program might look like. We explore a consequentialist argument for DEI according to which DEI is a viable harm-reduction strategy. Then we consider a non-consequentialist argument for DEI that draws on the moral significance of consent. Additionally, we consider arguments for the view that DEI is unethical on the grounds that, given that large-scale DEI (...) would be highly likely to result in some severe illnesses and deaths, DEI amounts to a form of killing. Our thesis is that incorporating a DEI program alongside the status-quo “calibrate-the-curve” responses could have significant advantages at the early stages of pandemics. These potential advantages mean that, at a minimum, research into DEI would have been justified early in the COVID-19 pandemic, and that DEI programs should be explored as potential additions to our overall approach to emerging pandemics in the future. (shrink)

As biomedical research with volunteers was expanded in the United States, the rule of subject selection, constituting scientific and ethical criteria, was generated in 1981 to resolve selection bias in research. Few historical studies, however, have investigated the role of this new hybrid rule in institutional review systems. This paper describes how bioethics commissions and federal agencies have created the subject selection rule based on the concept of justice. I argue that the standardization of this rule as temporal measures, linked (...) with risk-benefit assessment, has reformed the review mechanism, specifically investigators’ modification of research plans, thereby developing justice as balancing. (shrink)

This article addresses two areas of continuing controversy about consent in clinical research: the question of when consent to low risk research is necessary, and the question of when consent to research is valid. The article identifies a number of considerations relevant to determining whether consent is necessary, chief of which is whether the study would involve subjects in ways that would (otherwise) infringe their rights. When consent is necessary, there is a further question of under what conditions consent is (...) valid or successful in waiving a right. The most influential account of validity conditions is non-moralized, in the sense that the conditions make no essential reference to whether the researcher soliciting consent has obtained it in a way that wrongs the subject. The article examines the implications of this account, and compares it with recent accounts that moralize some of the validity conditions. -/- . (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)

This paper argues that research on normative issues in the life sciences will benefit from a tighter integration of philosophy of science. We examine research on ethical, legal and social issues in the life sciences (“ELSI”) and discuss three illustrative examples of normative issues that arise in different areas of the life sciences. These examples show that important normative questions are highly dependent on epistemic issues which so far have not been addressed sufficiently in ELSI, RRI and related areas of (...) research. Accordingly, we argue for the integration of research on the epistemic aspects of the relevant areas of science into ELSI research to provide a better basis for addressing normative questions. (shrink)

The purpose of this dissertation is to identify some of the most pressing problems in the dominant contemporary approach to research ethics, and to devise an alternative approach that avoids these problems. I contend that the fundamental ethical values invoked in human research are often appealed to in contradictory or ambiguous ways, or in ways that do not adequately capture or do not show an adequate understanding of the specific ethical concerns of human research. One significant problem in this domain (...) is that values for ethical research are often unreflectively imported from medical therapy, producing ill-suited guidelines that cannot capture the different ethical situations that arise in the context of research. Furthermore, ethical guidelines in this area are often not developed with a sufficient understanding of the deep philosophical issues that they invoke. I suggest that we can address these problems through examining the fundamental ethical concerns of research on a philosophical level. This method will reveal severe problems with the approach to two of the ethical values underlying research; beneficence and respect for autonomy (or respect for persons). Once the nature of these problems has been revealed, and with reference to ethical problems that typically arise in the domain of research, I construct a coherent philosophical foundation for research ethics, which both avoids these deep-seated problems and better captures the ethical issues that arise in the domain of human research. I argue that we need to radically depart from the values of beneficence and autonomy/respect for persons as they are currently understood in the guidelines. We need an idea of beneficence that is clearly distinct from that which is used in the therapeutic medical context from which this notion is currently drawn. I also contend that we need to move away from autonomy as a central value in research ethics. I posit an alternative choice-based approach to informed consent which is concerned both with respecting agents’ freedom of choice, and also with their wellbeing, as providing a good means of protecting and promoting the interests of the individual research subject. Although these two imperatives are often thought to clash on a fundamental level, I will show that, in research ethics, they can be reconciled with minimal conflict. Though this represents a departure from the ethics of medical therapy, this approach is far more suited to the context of research. This theoretical basis for informed consent can help to clarify the ethical problems that are specific to this domain and provide us with relevant ethical guidance in research ethics. (shrink)

Social scientists have begun elucidating the variables that influence public trust in science, yet little is known about hype in biotechnology and its effects on public trust. Many scholars claim that hyping biotechnology results in a loss of public trust, and possibly public enthusiasm or support for science, because public expectations of the biotechnological promises will be unmet. We argue for the need for empirical research that examines the relationships between hype, public trust, and public enthusiasm/support. We discuss the complexities (...) in designing empirical studies that provide evidence for a causal link between hype, public trust, and public enthusiasm/support, but also illustrate how this may be remedied. Further empirical research on hype and public trust is needed in order to improve public communication of science and to design evidence-based education on the responsible conduct of research for scientists. We conclude that conceptual arguments made on hype and public trust must be nuanced to reflect our current understanding of this relationship. (shrink)

In this commentary, I critically discuss the respective views of Gert and Beauchamp–Childress on the nature of so-called common morality and its promise for enriching ethical reflection within the field of bioethics. Although I endorse Beauchamp and Childress’ shift from an emphasis on ethical theory as the source of moral norms to an emphasis on common morality, I question whether rouging up common morality to make it look like some sort of ultimate and universal foundation for morality, untouched by the (...) dialectics of time and reflective equilibrium, was an equally good move. As for Gert’s magisterial conception of common morality, I conclude that certain elements of his system are controversial at best and woefully inadequate at worst. He has a tendency to find in common morality what he himself put there, and his highly restricted conception of duties of assistance strikes this reader as ad hoc, inadequately defended, and unworthy of a project whose goal is to lessen the amount of misery in the world. (shrink)