It is always gratifying when another scholar endorses one's own publicly stated position on a controversial matter. It was therefore with distinct appreciation that I read John Banja's article crit...

This book provides an analysis of the debate surrounding cultural diversity, and attempts to reconcile the seemingly opposing views of "ethical imperialism," the belief that each individual is entitled to fundamental human rights, and cultural relativism, the belief that ethics must be relative to particular cultures and societies. The author examines the role of cultural tradition, often used as a defense against critical ethical judgments. Key issues in health and medicine are explored in the context of cultural diversity: the physician-patient (...) relationship, disclosing a diagnosis of a fatal illness, informed consent, brain death and organ transplantation, rituals surrounding birth and death, female genital mutilation, sex selection of offspring, fertility regulation, and biomedical research involving human subjects. Among the conclusions the author reaches are that ethical universals exist, but must not be confused with ethical absolutes. The existence of ethical universals is compatible with a variety of culturally relative interpretations, and some rights related to medicine and health care should be considered human rights. Illustrative examples are drawn from the author's experiences serving on international ethical review committees and her travels to countries in Africa, Asia, and Latin America, where she conducted educational workshops and carried out out her own research. (shrink)

What makes individuals, groups, or even entire countries vulnerable? And why is vulnerability a concern in bioethics? A simple answer to both questions is that vulnerable individuals and groups are subject to exploitation, and exploitation is morally wrong. This analysis is limited to two areas. First is the context of multinational research, in which vulnerable people can be exploited even if they are not harmed, and harmed even if they are not exploited. Second is the situation of women, who are (...) made vulnerable in cultural settings or in entire countries in which they are oppressed and powerless. (edited). (shrink)

: Following a long process of revision, a new version of the Declaration of Helsinki was approved by the World Medical Association in 2000. Two provisions of the Declaration address ongoing international controversies regarding research sponsored by industrialized countries and conducted in developing countries. Despite the issuance of the final version of the Declaration, opponents remain locked in debate. Moreover, the Declaration remained silent on other prominent controversies concerning international research. An analysis of these current controversies reveals reasons why they (...) are not likely to be readily resolved, despite apparent agreement by opponents on overarching ethical principles. (shrink)

Feminist bioethicists of a variety of persuasions discuss the 2013 case of Marlise Munoz, a pregnant woman whose medical care was in dispute after she became brain dead.

Rhodes seeks to defend her ‘conclusion that everyday ethics and medical ethics [are] incompatible’.1 She challenges ‘views that medical ethics is nothing more than common morality applied to clinical matters’.1 Beauchamp and Childress explicate the term ‘common morality’ at length.2 Nowhere do they claim that medical ethics is ‘nothing more than common morality applied to clinical matters’. Here is what they do say: “The origin of the norms of the common morality is no different in principle from the origin of (...) the norms of a particular morality for a medical or other profession … The primary difference is that the common morality has authority in all communities, whereas particular moralities are authoritative only for specific groups”.2 This critique discusses the seven examples Rhodes uses to illustrate her main point: that common morality and medical ethics are radically different. I contend that common morality accounts for the purported differences she cites. In ordinary life, people can simply mind their own business, whereas physicians have a duty to act in their professional setting. On this view, common morality cannot explain the moral obligation people have to prevent easily avoidable harm to others. A bystander …. (shrink)

A truly global bioethics involves cooperation and collaboration among countries. Most of the articles published in bioethics journals address a problem that exists in one or more countries, but the articles typically do not discuss solutions that require collaboration or cooperation. COVAX is one example of proposed international cooperation related to the current COVID-19. pandemic. Yet it is evident that nations have been proceeding on their own with little, if any collaboration. Despite international research ethics guidance from the World Health (...) Organization, an article published under WHO auspices violates an ethical principle rejecting “double standards” in the conduct of global research. The COVID pandemic provides an opportunity for countries to learn from the recent lack of international cooperation and employ a multi-national strategy in future global health crises. (shrink)

The criteria for determining what it is to do good medical ethics are the quality of ethical analysis and ethical justifications for decisions and actions. Justifications for decisions and actions rely on ethical principles, be they the ‘famous four’ or subsidiary ethical principles relevant to specific contexts. Examples from clinical ethics, research ethics and public health ethics reveal that even when not stated explicitly, principles are involved in ethical justifications. Principles may come into conflict, however, and the resolution of an (...) ethical dilemma requires providing good reasons for preferring one principle over another. (shrink)

In exploring the concept of vulnerability, we do not begin with a blank slate. In research involving human subjects, ethics guidelines typically provide a rough definition of the concept. For example, the commentary on Guideline 13 in the International Ethical Guidelines for Biomedical Research Involving Human Subjects, issued by the Council for International Organizations of Medical Sciences (CIOMS), says that "vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient (...) power, intelligence, education, resources, strength, or other needed attributes to protect their own interests" (CIOMS 2002). Because the CIOMS guidelines .. (shrink)

This paper evaluates four recent randomized clinical trials in which the informed consent of participants was either not sought at all, or else was conducted with critical information missing from the consent documents. As these studies have been taking place, various proposals to conduct randomized clinical trials without consent have been appearing in the medical literature. Some of the explanations offered for why it is appropriate to bypass consent or disclosure requirements appear to represent a fundamental misunderstanding of applicable government (...) regulations and even the research enterprise. Others are the result of conceptual disagreements about the importance and application of traditional research ethics norms to ‘comparative effectiveness research’ and modern research environments. Common among these explanations, however, is a failure to appreciate when a research intervention, rather than merely an observation or review of data, is taking place. Review committees and investigators are failing to see, or choosing to ignore, interventions in the lives of research subjects. When these studies have come to light, government agencies with oversight authority have done little or backed down. Prestigious medical journals have published research results knowing that the required consent was not obtained, or they have stood by the published studies even after the inadequacy of consent is discovered. This article critically examines this erosion of consent in theory and practice and calls for restoring the requirement of informed consent to its proper place as a priority in human subjects research. (shrink)

The Office for Human Research Protections was correct in determining that the consent forms for the National Institutes of Health -sponsored SUPPORT study were seriously flawed. Several articles defended the consent forms and criticized the OHRP's actions. Disagreement focuses on three central issues: how risks and benefits should be described in informed consent documents; the meaning and application of the concept of “standard of care” in the context of research; and the proper role of OHRP. Examination of the consent forms (...) reveals that they failed to disclose the reasonably foreseeable risks of the experimental interventions in the study, as well as the potential for differences in the degree of risk between these interventions. Although the concept of “standard of care” may be helpful in determining the ethical acceptability of other aspects of research, such as clinical equipoise, it is not helpful in discussing consent requirements. (shrink)

ABSTRACTComparative effectiveness studies, referred to here as “usual-care” trials, seek to compare current medical practices for the same medical condition. Such studies are presumed to be safe and involve only minimal risks. However, that presumption may be flawed if the trial design contains “unusual” care, resulting in potential risks to subjects and inaccurately informed consent. Three case studies described here did not rely on clinical evidence to ascertain contemporaneous practice. As a result, the investigators drew inaccurate conclusions, misinformed research participants, (...) and subjects’ safety was compromised. Before approving usual-care protocols, IRBs and scientific review committees should evaluate the quality and completeness of information documenting usual-care practices. Guidance from governmental oversight agencies regarding evidence-based documentation of current clinical practice could prevent similar occurrences in future usual-care trials. Accurate information is necessary to ensure that trials comply with government regulations that require minimizing research risks to subjects and accurate informed consent documents. (shrink)

Robert Baker and Rosamond Rhodes each argue against the universality “common morality,” the approach to ethics that comprises four fundamental principles and their application in various settings. Baker contends that common morality cannot account for cultural diversity in the world and claims that a human rights approach is superior in the context of global health. Rhodes maintains that bioethics is not reducible to common morality because medical professionals have special privileges and responsibilities that people lack in everyday life. Baker fails (...) to demonstrate how the human rights approach to global ethics is more sensitive to culture than the use of bioethics principles that comprise common morality. Rhodes has a narrow interpretation of “common morality,” which when understood more broadly, accounts for the special privileges and obligation of medical professionals. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Defense of Fundamental Principles and Human Rights: A Reply to Robert Baker *Ruth Macklin (bio)AbstractThis article seeks to rebut Robert Baker’s contention that attempts to ground international bioethics in fundamental principles cannot withstand the challenges posed by multiculturalism and postmodernism. First, several corrections are provided of Baker’s account of the conclusions reached by the Advisory Committee on Human Radiation Experiments. Second, a rebuttal is offered to (...) Baker’s claim that an unbridgeable moral gap exists between Western individualism and non-Western communalism. In conclusion, this article argues that Baker’s “nonnegotiable primary goods” cannot do the work of “classical human rights” and that the latter framework is preferable from both a practical and a theoretical standpoint.Robert baker has written two interesting and thoughtful essays in support of his theory of international bioethics (Baker 1998a & b). Both essays are rich in content and comprehensive in scope. In the first of the two, “Multiculturalism, Postmodernism, and the Bankruptcy of Fundamentalism”—hereafter, “Multiculturalism”—Baker argues that attempts to ground international bioethics in fundamental principles cannot withstand the challenges posed by multiculturalism and postmodernism. As one of the bioethicists whose writings are the object of Baker’s critique, I undertake in this reply first, to elaborate my own position and to comment on related aspects of Baker’s thesis. 1 Next, I offer some corrections of Baker’s account of the conclusions reached by the Advisory Committee on Human Radiation Experiments, of which I was a member. Finally, I compare Baker’s “nonnegotiable [End Page 403] primary goods” with “classical human rights” and conclude that the latter framework is preferable from both a practical and a theoretical standpoint.In his second essay, “The Negotiable and the Non-Negotiable”—hereafter, “The Negotiable”—Baker puts forth a positive theory designed to meet the challenges of multiculturalism and postmodernism and, at the same time, to justify transcultural and transhistorical moral judgments. Baker (1998a, p. 203) describes his theoretical model as an effort “to validate the conception of international bioethics as a continually renegotiated moral order.” Although I find Baker’s proposal intriguing, I believe his rejection of fundamental principles can result in an unacceptable ethical relativism. To abandon “classical human rights,” along with the fundamental moral principles from which they derive, opens the door to all forms of cultural oppression in the name of “the most fundamental of all human rights, the right to define primacy for oneself” (Baker 1998b, p. 246). Alternatively, one can view Baker’s “nonnegotiable primary goods” as virtually equivalent to classical human rights, but much more difficult to identify, both theoretically and practically.Moral FundamentalismThe difference between my defense of universal moral principles and Baker’s critique rests, at least in part, on an interpretation of what is meant by “moral fundamentalism.” (I must confess to a distaste for the ‘ism’ because of the connotations and consequences of fundamentalism in other spheres.) Baker (1998a, p. 203) defines “moral fundamentalism” as the position “that certain basic or fundamental moral principles are accepted in all eras and cultures and thus are universally applicable to agents and actions in any era or culture.” A central feature of this definition is the requirement that all eras and cultures accept these fundamental moral principles. By this definition, the position I embrace does not count as “moral fundamentalism,” because I maintain that certain fundamental moral principles ought to be binding on all cultures or societies even if those cultures or societies do not accept them. 2 Universal acceptance is not a necessary condition for universal applicability.Part of the problem with Baker’s (and probably also my own) analysis is that it shifts constantly and imperceptibly back and forth between a variety of concepts: “moral principles,” “ethical standards,” “morality,” and “moral judgments.” In one instance, Baker (1998a, p. 209) notes my citation of a remark of Ruth Benedict (1934) that “morality differs in [End Page 404] every society.” That is what Ruth Benedict wrote; but nowhere did she specify that she had moral principles in mind. Indeed, her complete sentence reads as follows: “Morality differs in every society and is a convenient term for socially approved habits” (Benedict 1934, emphasis added... (shrink)

A new political movement has arisen in bioethics, self‐consciously distingushed from the rest of the ield and characterized by a new way of writing and arguing. Unfortunately, that new method is mean‐spirited, mystical, and emotional. It claims insight into ultimate truth yet disavows reason.

The new reproductive technologies force us to rethink the concepts ‘mother,’ ‘father,’ ‘family.’ As we draw analogies to traditional patterns, we must distinguish between ethical and conceptual questions.

: The multicultural composition of the United States can pose problems for physicians and patients who come from diverse backgrounds. Although respect for cultural diversity mandates tolerance of the beliefs and practices of others, in some situations excessive tolerance can produce harm to patients. Careful analysis is needed to determine which values are culturally relative and which rest on an underlying universal ethical principle. A conception of justice as equality challenges the notion that it is always necessary to respect all (...) of the beliefs and practices of every cultural group. (shrink)

The type of research known as cluster randomized trials raises ethical questions not readily answered within the standard understanding of research ethics. What distinguishes a CRT is that it randomizes at the level of social groups rather than at the level of individual research participants: in a CRT, the regimen under study might be assigned to a village, hospital, or school. The organizational schemes of CRTs raise an assortment of fundamental ethical problems. In certain CRTs, the question of whether it (...) is possible to obtain individual informed consent is central. Also, if the intervention is offered at the level of a sizable social group, there is usually no realistic possibility for individuals to opt out of the trial. Other ethical questions raised by CRTs have to do with identifying the subjects of research, and indeed with whether “research” is occurring at all. (shrink)

This study explored the challenges of informed consent and understanding of the research process among Black and Latino men under community supervision. Between February and October 2012, we conducted cognitive face-to-face interviews using open-ended questions on the significant areas of research participation among 259 men aged 35 to 67 under community supervision in Bronx, New York. Content analysis of the open-ended questions revealed limited knowledge concerning the understanding of research participation. The study participants appeared to generally understand concepts such as (...) compensation after research participation and confidentiality. Participants demonstrated a lack of understanding of certain aspects of the research process—informed consent, human subject, Institutional Review Board, and clinical trials. These findings are informative to researchers conducting studies with criminal justice populations and Institutional Review Boards reviewing research studies. (shrink)

It seemed like only minutes after a team of Scottish scientists announced, in late February 1997, that they had successfully cloned a sheep, that governmental officials and private citizens throughout the world called for a ban on cloning human beings. The rush to legislate or issue executive orders was so swift, it is reasonable to wonder why the news that a mammal had been cloned ignited such a stampede to prohibit, even criminalize, attempts to clone humans. These events raise a (...) series of separate, yet related questions. Why does the prospect of cloning human beings incite such strong reactions? What reasons have been proposed for enacting national laws or international conventions to prohibit cloning? Can these prohibitions be justified by sound ethical arguments? Before attempting to answer these questions, let us look first at the responses that called for public policy measures to ban human cloning. (shrink)

Neither the George Washington University embryo splitting experiment nor the technique of embryo splitting itself has ethical flaws. The experiment harmed or wronged no one, and the investigators followed intramural review procedures for the experiment, although some might fault them for failing to seek extramural consultation or for not waiting until national guidelines for research on preembryos were developed. Ethical objections to such cloning on the basis of possible loss of individuality, possible lessening of individual worth, and concern about potential (...) harm to the resulting children are discussed and challenged, as are objections to the creation of embryos for the purpose of genetic diagnosis. Many of the ethical questions raised by the George Washington experiment are similar to those posed by existing reproductive technologies that allow the simultaneous production of several embryos. A multidisciplinary group should consider whether regulation of cloning is needed, and laws should be enacted to prohibit a commercial market for all frozen embryos. (shrink)

In recent years there has been considerable discussion and controversy concerning the concepts of mental health and mental illness. The controversy has centered around the problem of providing criteria for an adequate conception of mental health and illness, as well as difficulties in specifying a clear and workable system for the classification, understanding, and treatment of psychological and emotional disorders. In this paper I shall examine a cluster of these complex and important issues, focusing on attempts to define ‘mental health’ (...) and ‘mental illness’; diverse factors influencing the ascription of the predicates ‘is mentally ill’ and ‘is mentally healthy’; and some specific problems concerning these concepts as they appear in various theories of psychopathology. The approach here will be in the nature of a survey, directed at the specification of a number of problems—conceptual, methodological, and pragmatic—as they arise in various attempts to define and to provide criteria for applying the concepts of mental health and mental illness. (shrink)

Jehovah's Witnesses who refuse blood transfusions on religious grounds have long created ethical dilemmas for those in the medical profession trying to serve them. A bioethicist working in a clinical setting explores how one hospital ethics committee grappled with the additional problem of pregnant Jehovah's Witnesses, including the complex interdependence of maternal and fetal rights.

In lieu of an abstract, here is a brief excerpt of the content:Cloning without Prior Approval:A Response to Recent Disclosures of NoncomplianceRuth Macklin (bio)Editor's note: In September 1994, the Kennedy Institute of Ethics Journal published a special issue on the ethics of embryo splitting or "cloning," which included papers originally prepared for a workshop on embryo splitting sponsored by the National Advisory Board on Ethics in Reproduction (NABER) and NABER's report, Human Cloning through Embryo Splitting. The impetus for the (...) project was embryo-splitting research conducted by Drs. Jerry L. Hall, Robert J. Stillman, and others, at George Washington University and presented in October 1993 at a joint meeting of the American Fertility Society and the Canadian Fertility and Andrology Society. Media coverage at the time reported that the research had been approved by the university's formal review committees. However, it came to light in December 1994 that the researchers had not obtained approval from the university's institutional review board prior to conducting the research. Following a university investigation, the researchers were disciplined and instructed to destroy their data. The university also voluntarily forwarded the records of the incident to the Office for Protection from Research Risks at the National Institutes of Health. Dr. Hall resigned from George Washington University in September 1994.In the following postscript to her article on the ethics of embryo splitting (KIEJ, September 1994), Ruth Macklin discusses these events. The letters and memoranda that she cites were obtained from NIH through the Freedom of Information Act.My article, "Splitting Embryos on the Slippery Slope: Ethics and Public Policy" (KIEJ, September 1994), included a brief assessment of the ethics of the Hall-Stillman embryo-splitting experiment conducted at George Washington University (GWU). The article reviewed the researchers' stated purpose ("to help infertile couples by reproducing nature's ability to reproduce twins"), the features of the research itself (splitting embryos that never could become viable and with no plan to implant either the original or the split embryos), and the review procedures surrounding the experiment. I said that the researchers might be [End Page 57] faulted for not waiting until embryo research guidelines had been established at the national level; on the other hand, they surely could not fail to conform to such national guidelines when none existed.My conclusions were based on information that had been reported in the print media. Dr. Robert J. Stillman's statement that the experiment "had been approved by the university's formal review committees and peer reviewed by colleagues" was reported in the Washington Post on October 25, 1993, (Sawyer 1993). However, in light of the recent disclosure that the researchers had not obtained approval from George Washington University's IRB before proceeding with the research (Schwartz 1994), I now draw a sharply different conclusion about the ethics of the researchers' behavior.The most glaring flaw was the researchers' failure to submit a protocol to their institution's IRB in advance of embarking on the research. Following an investigation of the matter, the Office for Protection from Research Risks (OPRR) made the further determination that "the failure on the part of GWU research investigators and administrators to notify the IRB promptly about noncompliance in this research constitutes additional serious noncompliance" with research regulations (J. Thomas Puglisi, Chief of the Compliance Oversight Branch, Division of Human Subject Protections, OPRR, letter to Stephen J. Trachtenberg, President of George Washington University, 23 August 1994). Is it reasonable to suppose that these researchers were unaware of their obligations (a) to obtain prior review and approval from the IRB and (b) to notify the IRB promptly about their noncompliance? Regarding the latter item, Dr. Puglisi's letter to the President of GWU states that "the notification requirement has been a longstanding element of the GWU MPA [multiple project assurance], which should have been familiar to all members of the GWU research community." I shall concentrate on the researchers' more glaring ethical omission, failure to obtain prior review and approval from the IRB.Did either or both of these researchers contend that they were unaware of any review requirements for their research? Hall blames Stillman, Director of the Division of Reproductive Endocrinology, Fertility, and IVF Programs, for not making the requirement... (shrink)

Finding an effective method that can lower women’s risk of HIV infection is an ethical imperative. A vaginal microbicide is a preventive method that can be controlled by women. Well-designed scientific research has already yielded modest success, yet more research is needed in order to develop an even better product. But just as research must be scientifically sound, it must also be ethically sound. Ethical challenges in HIV microbicide research include issues of safety and level of efficacy, whether pregnant women (...) and adolescents should be included in clinical trials, and whether male partners of women participants should be involved in any way in the process of obtaining informed consent. (shrink)

The view that we must respect cultural traditions is a welcome change from the past, when colonial powers ridiculed native customs and often sought to eradicate them. Nevertheless, it is reasonable to ask whether there is a limit to tolerance of a ritual that has been designated a “harmful traditional practice” by the United Nations Office of the High Commissioner for Human Rights, the United Nations Population Fund, and the recently created agency, UN Women. The article “Seven Things To Know (...) About Female Genital Surgeries in Africa,” by the Public Policy Advisory Network on Female Genital Surgeries in Africa, contends that a need exists for more balanced critical thinking and open debate about what the authors choose to call “female genital surgery.” No one can reasonably quarrel with the call for accurate information in descriptions of the methods and consequences of female genital cutting. The network's own discussion of the facts is highly questionable, however. (shrink)