Previous edition, 1st, published in 1971.

It has long been taken for granted that clinical research involving human subjects is ethical only if it holds out the prospect of producing socially valuable knowledge. Recently, this social value requirement has come under scrutiny, with prominent ethicists arguing that the social value requirement cannot be substantiated as an ethical limit on clinical research, and others attempting to offer new support. In this paper, I argue that both criticisms and existing defenses of the social value requirement are predicated on (...) what I call the “transactional model of stakeholder obligations”. I go on to problematize this framework, and to introduce an alternative framework for conceptualizing ethical obligations within clinical research. In defending this framework, which I call the “basic structure model of stakeholder obligations”, I also demonstrate how it provides a stronger grounding for the social value requirement that is not vulnerable to critiques grounded in the transactional model. (shrink)

Scientific research that could cause grave harm, either through accident or intentional malevolence, is known as dual-use research. Recent high-profile cases of dual-use research in the life sciences have led to debate about the extent to which restrictions on the conduct and dissemination of such research may impede scientific progress. We adapt formal models of scientific networks to systematically explore the effects that different regulatory schemes may have on a community’s ability to learn about the world. Our results suggest that, (...) contrary to common wisdom, some restrictions on the conduct and dissemination of dual-use research do not inhibit scientific progress and may actually aid communities in learning. (shrink)

Gain-of-function research involves experimentation that aims or is expected to increase the transmissibility and/or virulence of pathogens. Such research, when conducted by responsible scientists, usually aims to improve understanding of disease causing agents, their interaction with human hosts, and/or their potential to cause pandemics. The ultimate objective of such research is to better inform public health and preparedness efforts and/or development of medical countermeasures. Despite these important potential benefits, GOF research can pose risks regarding biosecurity and biosafety. In 2014 the (...) administration of US President Barack Obama called for a “pause” on funding of GOF experiments involving influenza, SARS, and MERS viruses in particular. With announcement of this pause, the US Government launched a “deliberative process” regarding risks and benefits of GOFR to inform future funding decisions—and the US National Science Advisory Board for Biosecurity was tasked with making recommendations to the US Government on this matter. As part of this deliberative process the National Institutes of Health commissioned this Ethical Analysis White Paper, requesting that it provide review and summary of ethical literature on GOFR, identification and analysis of existing ethical and decision-making frameworks relevant to the evaluation of risks and benefits of GOFR, decision-making about the conduct of GOF studies, and the development of US policy regarding GOFR, and development of an ethical and decision-making framework that may be considered by NSABB when analyzing information provided by GOFR risk-benefit assessment, and when crafting its final recommendations. The ethical and decision-making framework ultimately developed is based on the idea that there are numerous ethically relevant dimensions upon which any given case of GOFR can fare better or worse : research imperative, proportionality, minimization of risks, manageability of risks, justice, good governance, evidence, and international outlook and engagement. Rather than drawing a sharp bright line between GOFR studies that are ethically acceptable and those that are ethically unacceptable, this framework is designed to indicate where any given study would fall on an ethical spectrum—where imaginable cases of GOFR might range from those that are most ethically acceptable, at one end of the spectrum, to those that are most ethically problematic or unacceptable, at the other. The aim should be that any GOFR pursued should be as far as possible towards the former end of the spectrum. (shrink)

This seminal collection on the ethical issues associated with infectious disease is the first book to correct bioethics’ glaring neglect of this subject. Timely in view of public concern about SARS, AIDS, avian flu, bioterrorism and antibiotic resistance. Brings together new and classic papers by prominent figures. Tackles the ethical issues associated with issues such as quarantine, vaccination policy, pandemic planning, biodefense, wildlife disease and health care in developing countries.

Mosquito‐borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito‐borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease‐resistant, genetically modified mosquitoes. Some of these (...) issues include: protecting the public and the environment from harm, balancing benefits and risks, collaborating with the local community, avoiding exploitation, and safeguarding the rights and welfare of research subjects. One of the most difficult problems involves protecting the welfare of community members who will be impacted by the release of mosquitoes but who are not enrolled in the study as research subjects. To address this concern, field trials should take place only when the targeted disease is a significant public health problem in an isolated area, the benefits of the trial for the community are likely to outweigh the risks, community leaders approve of the trial, and there are measures in place to protect the welfare of un‐enrolled community members, such as informing the community about the study and offering free treatment to people who contract mosquito‐borne diseases. Since the justification of any field trial depends on a careful examination of the scientific and ethical issues, proposed studies should be evaluated on a case‐by‐case basis. (shrink)

Mosquito-borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito-borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases. This article focuses on ethical issues raised by field trials of disease-resistant, genetically modified mosquitoes. Some of these (...) issues include: protecting the public and the environment from harm, balancing benefits and risks, collaborating with the local community, avoiding exploitation, and safeguarding the rights and welfare of research subjects. One of the most difficult problems involves protecting the welfare of community members who will be impacted by the release of mosquitoes but who are not enrolled in the study as research subjects. To address this concern, field trials should take place only when the targeted disease is a significant public health problem in an isolated area, the benefits of the trial for the community are likely to outweigh the risks, community leaders approve of the trial, and there are measures in place to protect the welfare of un-enrolled community members, such as informing the community about the study and offering free treatment to people who contract mosquito-borne diseases. Since the justification of any field trial depends on a careful examination of the scientific and ethical issues, proposed studies should be evaluated on a case-by-case basis. (shrink)

The Law of Peoples, with “The Idea of Public Reason Revisited”. john rawls. William James and the Metaphysics of Experience. david c. lamberth.

The dual-use dilemma arises in the context of research in the biological and other sciences as a consequence of the fact that one and the same piece of scientific research sometimes has the potential to be used for bad as well as good purposes. It is an ethical dilemma since it is about promoting good in the context of the potential for also causing harm, e.g., the promotion of health in the context of providing the wherewithal for the killing of (...) innocents. It is an ethical dilemma for the researcher because of the potential actions of others, e.g., malevolent non-researchers who might steal dangerous biological agents, or make use of the original researcher’s work. And it is a dilemma for governments concerned with the security of their citizens, as well as their health. In this article we construct a taxonomy of types of “experiments of concern” in the biological sciences, and thereby map the terrain of ethical risk. We then provide a series of analyses of the ethical problems and considerations at issue in the dual-use dilemma, including the impermissibility of certain kinds of research and possible restrictions on dissemination of research results given the risks to health and security. Finally, we explore the main available institutional responses to some of the specific ethical problems posed by the dual-use dilemma in the biological sciences. (shrink)

This is an important book precisely because there is none other quite like it.

: The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.

Regulators rely on clinical trials for drug approval and labeling decisions. Health systems and clinicians rely on the evidence from trials to determine treatment, and patients rely on it to decide which courses of care to undertake. Many of these stakeholders presume that the careful review of individual studies is enough to address the ethical and scientific questions that arise in clinical trials. In what follows, however, we demonstrate that explicit consideration of trial portfolios—series of trials that are interrelated by (...) a common set of objectives—is crucial. the ethical acceptability and evidentiary probity of individual trials can change depending on the characteristics of the portfolios in which they are embedded. Second, how trial portfolios are composed, how well they are coordinated, and how efficiently they use information determines the balance of risks and benefits they present as well as their different prospects for generating socially valuable information; these three factors also raise distinct questions of justice. (shrink)

The dual-use problem is an ethical quandary sometimes faced by scientists and others in a position to influence the creation or dissemination of scientific knowledge. It arises when an agent is considering whether to pursue some project likely to result in the creation or dissemination of scientific knowledge, that knowledge could be used in both morally desirable and morally undesirable ways, and the risk of undesirable use is sufficiently high that it is not clear that the agent may permissibly pursue (...) the project or policy. Agents said to be faced with dual-use problems have frequently responded by appealing to a view that I call scientific isolationism. This is, roughly, the view that scientific decisions may be made without morally appraising the likely uses of the scientific knowledge whose production or dissemination is at stake. I consider whether scientific isolationism can be justified in a form that would indeed provide a way out of dual-use problems. I first argue for a presumption against a strong form of isolationism, and then examine four arguments that might be thought to override this presumption. The most promising of these arguments appeals to the idea of a division of moral labour, but I argue that even this argument can sustain at most a highly attenuated form of scientific isolationism and that this variant of isolationism has little practical import for discussions of the dual-use problem. (shrink)

Although epistemic values have become widely accepted as part of scientific reasoning, non-epistemic values have been largely relegated to the "external" parts of science (the selection of hypotheses, restrictions on methodologies, and the use of scientific technologies). I argue that because of inductive risk, or the risk of error, non-epistemic values are required in science wherever non-epistemic consequences of error should be considered. I use examples from dioxin studies to illustrate how non-epistemic consequences of error can and should be considered (...) in the internal stages of science: choice of methodology, characterization of data, and interpretation of results. (shrink)

This seminal collection on the ethical issues associated with infectious disease is the first book to correct bioethics’ glaring neglect of this subject. Timely in view of public concern about SARS, AIDS, avian flu, bioterrorism and antibiotic resistance. Brings together new and classic papers by prominent figures. Tackles the ethical issues associated with issues such as quarantine, vaccination policy, pandemic planning, biodefense, wildlife disease and health care in developing countries.

Claims that science should be more democratic than it is frequently arouse opposition. In this essay, I distinguish my own views about the democratization of science from the more ambitious theses defended by Paul Feyerabend. I argue that it is unlikely that the complexity of some scientific debates will allow for resolution according to the methodological principles of any formal confirmation theory, suggesting instead that major revolutions rest on conflicts of values. Yet these conflicts should not be dismissed as irresoluble.