In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions.

And in this book the distinguished scholar Amartya Sen offers a powerful critique of the theory of social justice that, in its grip on social and political ...

Richard Brandt is one of the most eminent and influential of contemporary moral philosophers. His work has been concerned with how to justify what is good or right not by reliance on intuitions or theories about what moral words mean but by the explanation of moral psychology and the description of what it is to value something, or to think it immoral. His approach thus stands in marked contrast to the influential theories of John Rawls. The essays reprinted in this (...) collection span a period of almost 30 years and include many classic pieces in metaethical and normative ethical theory. The collection is aimed at both those moral philosophers familiar with Brandt's work and at those philosophers who may be largely unfamiliar with his work. The latter group will be struck by the lucid unpretentious style and the cumulative weight of Brandt's contributions to topics that remain at the forefront of moral philosophy. (shrink)

This first volume in the four-volume series The Moral Limits of the Criminal Law focuses on the "harm principle," the commonsense view that prevention of harm to persons other than the perpetrator is a legitimate purpose of criminal legislation. Feinberg presents a detailed analysis of the concept and definition of harm and applies it to a host of practical and theoretical issues, showing how the harm principle must be interpreted if it is to be a plausible guide to the lawmaker.

Since it appeared in 1971, John Rawls's A Theory of Justice has become a classic. The author has now revised the original edition to clear up a number of difficulties he and others have found in the original book. Rawls aims to express an essential part of the common core of the democratic tradition--justice as fairness--and to provide an alternative to utilitarianism, which had dominated the Anglo-Saxon tradition of political thought since the nineteenth century. Rawls substitutes the ideal of the (...) social contract as a more satisfactory account of the basic rights and liberties of citizens as free and equal persons. "Each person," writes Rawls, "possesses an inviolability founded on justice that even the welfare of society as a whole cannot override." Advancing the ideas of Rousseau, Kant, Emerson, and Lincoln, Rawls's theory is as powerful today as it was when first published. (shrink)

Book reviewed in this article: Protecting The Vulnerable: A Reanalysis of Our Social Responsibilities. By Robert E. Goodin. Chicago: University of Chicago Press.

Though the revised edition of A Theory of Justice, published in 1999, is the definitive statement of Rawls's view, so much of the extensive literature on Rawls's theory refers to the first edition. This reissue makes the first edition once again available for scholars and serious students of Rawls's work.

The phrase “minimal risk,” as defined in the United States’ federal research regulations, is ambiguous and poorly defined. This article argues that most of the ambiguity that one finds in the phrase stems from the “daily life risks” standard in the definition of minimal risk. In this article, the author argues that the daily life risks standard should be dropped and that “minimal risk” should be defined as simply “the probability and magnitude of the harm or discomfort anticipated in research (...) are not greater than those encountered during the performance of routine physical or psychological examinations or tests”. (shrink)

This chapter contains section titled: General Remarks What Utilitarianism Is Of the Ultimate Sanction of the Principle of Utility Of What Sort of Proof the Principle of Utility is Susceptible On the Connexion Between Justice and Utility.

Because medicine can preserve and restore health and function, it is widely acknowledged as a basic good that a just society owes its members. Yet there is controversy over the scope of what should be provided, to whom, how, when and why. This comprehensive and authoritative book - by well-known philosophers, doctors, lawyers, political scientists, and economists - lays a theoretical foundation for understanding the debate, assesses how health care is distributed in different countries and to various social groups, and (...) analyzes practical issues in constructing a socially just health care system. (shrink)

We examined institutional review board policies from the top U.S. research universities to determine how many have policies that define or provide examples of what constitutes a “minor change” to previously approved research. We sought to describe differences among definitions and to ascertain whether funding level, accreditation, public versus private status, and geographic region impact the inclusion of a definition or example of this term. Of the 184 universities that we obtained policies from, 52.2% defined “minor change,” 43.5% gave examples (...) of what would constitute one, and 67.9% provided either a definition or examples. We found that higher funding and accreditation were positively associated with having a definition or giving examples of minor changes, but that public versus private status and geographic region had no significant impact. While our study indicates that most of the top U.S. research institutions define the term “minor change” to previously approved research, we found that the definitions vary considerably. Additional guidance from federal agencies could help promote consistency in institutional policies and ensure uniformity in protections for human research participants. (shrink)

a This paper is a revised and shortened version of my chapter, “Justice in Allocations for Terrorism, Biological Warfare, and Public Health” in Public Health Ethics, edited by Michael Boylan, Kluwer; 2004. Portions of this material were presented at the International Bioethics Retreat, Pavia, Italy, June 2003, and at the meetings of the Association for Politics and the Life Sciences, Philadelphia, September 2003.

Contemporary research ethics policies started with reflection on the atrocities perpetrated upoconcentration 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)

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)

This is Emerson's classic statement of intellectual and moral independence.

The term “exploitation” has gained wide currency in recent discussions of biomedical and research ethics. This is due in no small measure to the influence of Alan Wertheimer’s path-breaking work on the topic (Wertheimer 1999, 2011). Wertheimer presented a clear and compelling non-Marxist account of the concept of exploitation—one that stressed the connection between exploitation and unfair distributive outcomes. On this account, when one party exploits another, she takes advantage of the other to gain unfairly. A number of contemporary bioethicists (...) have accepted Wertheimer’s account of exploitation and have proceeded to apply it to a range of issues in research ethics (Hawkins and Emanuel 2008; Miller and Brody .. (shrink)

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue instead (...) that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research. (shrink)

Background: Centralization of IRB reviews have been increasing in the US and elsewhere, but many questions about it remain. In the US, a few centralized IRBs (CIRBs) have been established, but how they do and could operate remain unclear. Methods: I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate = 55%) and an additional 12 members and administrators. Results: These interviewees had often interacted with (...) CIRBs, but supported local reviews, and offered advantages and disadvantages of each. Interviewees argued that local IRBs can provide "local knowledge" of subjects and PIs, and "curbside consults" with PIs, facilitating mutual trust. PIs may interact more fully and informally, and hence effectively with local IRBs. IRBs also felt additional responsibility to protect "their own" subjects. Respondents mentioned a few advantages of CIRBs (e.g., CIRBs may streamline reviews), though far more rarely and cursorily. Overall, interviewees were wary of CIRBs, which they saw as varying widely in quality, depending on who happened to be members. Both local and centralized IRBs appear to have unintended consequences. For instance, discrepancies arose between IRBs that appeared to reflect differences in institutional culture and history, and personalities of chairs and/or vocal members, more than in local community values per se, and thus do not seem to be the intent of the regulations. While some critics see CIRBs as solutions to many IRB problems, critical tradeoffs and uncertainties emerge. Conclusions: These data have critical implications for future policy and research. Debates need to evolve beyond simply a binary discussion of whether CIRBs should replace local IRBs, to examine how and to what degree different models might operate, and what the relative advantages and disadvantages of each are. While some critics see CIRBs as panaceas, certain problems appear likely to continue. Careful consideration needs to be given to whether the advantages of local IRBs outweigh the problems that result, and whether a system can be developed that provides these benefits, while avoiding the disadvantages of local IRBs. (shrink)

This first volume in the four-volume series The Moral Limits of the Criminal Law focuses on the "harm principle," the commonsense view that prevention of harm to persons other than the perpetrator is a legitimate purpose of criminal legislation. Feinberg presents a detailed analysis of the concept and definition of harm and applies it to a host of practical and theoretical issues, showing how the harm principle must be interpreted if it is to be a plausible guide to the lawmaker.

The concept of minimal risk has been used to regulate and limit participation by adolescents in clinical trials. It can be understood as setting an absolute standard of what risks are considered minimal or it can be interpreted as relative to the actual risks faced by members of the host community for the trial. While commentators have almost universally opposed a relative interpretation of the environmental risks faced by potential adolescent trial participants, we argue that the ethical concerns against the (...) relative standard may not be as convincing as these commentators believe. Our aim is to present the case for a relative standard of environmental risk in order to open a debate on this subject. We conclude by discussing how a relative standard of environmental risk could be defended in the specific case of an HIV vaccine trial among adolescents in South Africa. (shrink)

Healthy volunteers in biomedical research often face significant risks in studies that offer them no medical benefits. The U.S. federal research regulations and laws adopted by other countries place no limits on the risks that these participants face. In this essay, I argue that there should be some limits on the risks for biomedical research involving healthy volunteers. Limits on risk are necessary to protect human participants, institutions, and the scientific community from harm. With the exception of self-experimentation, limits on (...) research risks faced by healthy volunteers constitute a type of soft, impure paternalism because participants usually do not fully understand the risks they are taking. I consider some approaches to limiting research risks and propose that healthy volunteers in biomedical research should not be exposed to greater than a 1% chance of serious harm, such as death, permanent disability, or severe illness or injury. While this guideline would restrict research risks, the limits would not be so low that they would prevent investigators from conducting valuable research. They would, however, set a clear upper boundary for investigators and signal to the scientific community and the public that there are limits on the risks that healthy participants may face in research. This standard provides guidance for decisions made by oversight bodies, but it is not an absolute rule. Investigators can enroll healthy volunteers in studies involving a greater than 1% chance of serious harm if they show that the research addresses a compelling public health or social problem and that the risk of serious harm is only slightly more than 1%. The committee reviewing the research should use outside experts to assess these risks. (shrink)

Federal policies on human subjects research have undergone a progressive transformation. In the early decades of the twentieth century, federal policies largely relied on the discretion of investigators to decide when and how to conduct research. This approach gradually gave way to policies that augmented investigator discretion with externally imposed protections. We may now be entering an era of even more stringent external protections. Whether the new policies effectively absolve investigators of personal responsibility for conducting ethical research, and whether it (...) is wise to do so, remains to be seen. (shrink)

This essay analyzesexploitation in biomedical research in terms ofthree basic elements: harm, disrespect, orinjustice. There are also degrees ofexploitation, ranging from highly exploitationto minimally exploitation. Althoughexploitation is prima facie wrongful,some exploitative research studies are morallyjustified, all things considered. The reasonan exploitative study can still be ethical isthat other moral considerations, such as theautonomy of the research subject or the socialbenefits of research, may sometimes justifystudies that are minimally exploitative. Calling a research project exploitative doesnot end the debate about the merits (...) of thestudy but invites one to ask additionalquestions about how the study is exploitative,and whether the study is justifiablenevertheless. (shrink)

This paper discusses a dispute concerning the ethics of research on preventing the perinatal transmission of HIV in developing nations. Critics of this research argue that it is unethical because it denies a proven treatment to placebo‐control groups. Since studies conducted in developed nations would not deny this treatment to subjects, the critics maintain that these experiments manifest a double standard for ethical research and that a single standard of ethics should apply to all research on human subjects. Proponents of (...) the research, however, argue that these charges fail to understand the ethical complexities of research in developing nations, and that study designs can vary according to the social, economic, and scientific conditions of research. This essay explores some of the ethical issues raised by this controversial case in order to shed some light on the deeper, meta‐ethical questions. The paper argues that standards of ethical research on human subjects are universal but not absolute: there are some general ethical principles that apply to all cases of human subjects research but the application of these principles must take into account factors inherent in particular situations. (shrink)

There is an emerging ethical consensus that injured research participants should receive medical care and compensation for their research-related injuries. This consensus is premised on notions of beneficence, distributive justice, compensatory justice and reciprocity. In response, countries around the world have implemented no-fault compensation systems to ensure that research participants are adequately protected in the event of injury. The United States, the world's leading sponsor of research, has chosen instead to rely on its legal system to provide injured research participants (...) with medical care and compensation. This article argues that US reliance on its legal system leaves injured research participants unprotected in the event of injury. Nearly every injured research participant will have difficulty receiving compensation in court, and certain classes of research participants will be barred from receiving compensation altogether. The United States’ outlier status also threatens to impede US-sponsored multinational research, potentially delaying important biomedical advances. To rectify this injustice, researchers, Institutional Review Boards, sponsors and research institutions should advocate systematic no-fault compensation in the United States to bring US law into accord with global ethical norms and ensure that injured research participants are adequately protected. (shrink)