CABLES is both an acronym and metaphor for conceptualizing research participation risk by considering 6 distinct domains in which risks of harm to research participants may exist: cognitive, affective, biological, legal, economic, and social/cultural. These domains are described and illustrated, along with suggestions for minimizing or eliminating the potential hazards to human participants in biomedical and behavioral science research. Adoption of a thoughtful ethical analysis addressing all 6 CABLES strands in designing research provides a strong protective step toward safeguarding and (...) promoting the well-being of study participants. (shrink)

Respect for Autonomy has been a mainstay of medical ethics since its enshrinement as one of the four principles of biomedical ethics by Beauchamp and Childress’ in the late 1970s. This paper traces the development of this modern concept from Antiquity to the present day, paying attention to its Enlightenment origins in Kant and Rousseau. The rapid C20th developments of bioethics and RFA are then considered in the context of the post-war period and American socio-political thought. The validity and utility (...) of the RFA are discussed in light of this philosophical-historical account. It is concluded that it is not necessary to embrace an ethic of autonomy in order to guard patients from coercion or paternalism, and that, on the contrary, the dominance of autonomy threatens to undermine those very things which have helped doctors come to view and respect their patients as persons. (shrink)

In his compelling novel Blindness, José Saramago tells us about victims stricken by a contagious form of blindness who were quarantined and came to see themselves as pigs, dogs, and “lame crabs.” Of course, they were all human beings - although unable to perceive themselves, or others, as members of the human community. The disciplines of bioethics, health law, and human rights are likewise all members of the broad human rights community, although at times none of them may be able (...) to see the homologies, even when responding to a specific health challenge.The boundaries between bioethics, health law, and human rights are permeable, and border crossings, including crossings by blind practitioners, are common. Two working hypotheses form the intellectual framework of this article: we can more effectively address the major health issues of our day if we harmonize all three disciplines; and American bioethics can be reborn as a global force by accepting its Nuremberg roots and actively engaging in a health and human rights agenda. (shrink)

Medical student and resident participation in global health experiences (GHEs) has significantly increased over the last decade. In response to growing student interest and the proven impact of such experiences on the education and career decisions of resident physicians, many medical schools have begun to establish programmes dedicated to global health education. For the innumerable benefits of GHEs, it is important to note that medical students have the potential to do more harm than good in these settings when they exceed (...) their actual capabilities as physicians-in-training. While medical training programmes are beginning to provide students with the knowledge to put their GHEs in context, they must remember that they also bear the responsibility of training their students in a framework to approach these experiences in a principled and professional way. It is necessary that these institutions provide adequate and formalised preparation for both clinical and ethical challenges of working in resource-poor settings. This paper outlines potential benefits and risks of GHEs and delineates recommendations to some of the current issues. (shrink)

Modern medicine faces fundamental challenges that various approaches to the philosophy of medicine have tried to address. One of these approaches is based on the ancient concept of phronesis. This paper investigates whether this concept can be used as a moral basis for the challenges facing modern medicine and, in particular, analyses phronesis as it is applied in the works of Pellegrino and Thomasma. It scrutinises some difficulties with a phronesis-based theory, specifically, how it presupposes a moral community of professionals. (...) It is argued that Pellegrino and Thomasma's concept of phronesis corresponds to a Hippocratic concept of t�chn�, and that this latter concept seems to address many of the challenging issues Pellegrino and Thomasma also address. Thus, if modern medicine is to find its philosophical model in ancient concepts, it appears that the Hippocratic t�chn� is closer to the ancient concept of medicine than the Aristotelian phronesis, and that it might avoid many of the pitfalls of a phronesis-based approach. (shrink)

Contemporary American medical ethics was born during a period of social ferment, a key theme of which was the espousal of individual rights. Driven by complex cultural forces united in the effort to protect individuality and self-determined choices, an extrapolation from case law to rights of patients was accomplished under the philosophical auspices of ‘autonomy’. Autonomy has a complex history; arising in the modern period as the idea of self-governance, it received its most ambitious philosophical elaboration in Kant's moral philosophy. (...) In examining the Kantian construction, it is evident that neither his universal moral imperative nor his rigorous application of self-legislated ethical action can sustain our own notions of moral agency in a pragmatic, pluralistic society. But the Kantian position is useful in highlighting that self-governance is not equivalent to ‘autonomy’, and this distinction defines the limits of autonomy in the clinical setting. A critique of Engelhardt's idea of ‘principle of permission’ is used to illustrate autonomy's eclipse as a governing principle for medical ethics. (shrink)

The case of women radium dial painters — women who tipped their brushes while painting the dials of watches and instruments with radioactive paint — has been extensively discussed in the medical and historical literature. Their painful and abhorrent deaths have occupied the interest of physicians, lawyers, politicians, military agencies, and the public. Hardly any discussion has concerned, however, the use of those women as experimental subjects in a number of epidemiological studies that took place from 1920 to 1990. This (...) article addresses the neglected issue of human experimentation in relation to the radium dial painters. Although women’s medical examinations have been classified as simple, routine measurements of radiation burden on the body and presented as a great offer to humanity, for more than fifty years those women had been repeatedly used as experimental subjects without proper consent. I argue that through this case it becomes obvious that the issue of defining what counts as human experimentation shifts from an epistemological to a serious ethical and political question, concerning the making of scientific knowledge while issues of gender related to this process are also discussed. (shrink)

This collection of papers were originally presented during conferences on ethics in science and technology that UNESCO’s Regional Unit for Social and Human Sciences (RUSHSAP) has been convening since 2005. Since intercultural communication and information-sharing are essential components of these deliberations, the books also provide theme-related discourse from the conferences.

Modern medicine is built on a long history of medical experimentation. Experiments in the past often exploited more vulnerable patients. Questionable ethics litter the history of medicine. Without such experiments, however, millions of lives would be forfeited. This paper asks whether all the ``unethical'' experiments of the past were unjustifiable, and do we still exploit the poorer members of the community today? It concludes by wondering if Harris is right in his advocacy of a moral duty to participate in medical (...) research. (shrink)

Many of the same fundamental principles and regulations that govern civilian biomedical research also apply to research conducted by the US Military. Despite these similarities, the conduct of research by the US Military has additional requirements designed to preserve service members’ informed consent rights, ethical standards and information that may be deemed classified. Furthermore, there are also additional rules and regulations associated with potential research to be done in a combat setting. Before conducting battlefield research, many unique circumstances must be (...) considered to include: (1) the current legal and regulatory requirements for advanced informed consent (2) the tactical situations, and the ability to adequately document in the “austere” environment (3) the need to provide improved drugs and devices for combat casualty care and (4) the special nature of the superior-subordinate relationship. This paper discusses historical background, regulatory oversight, ethical implications and release of information as it pertains to research conducted by the US Military. (shrink)

Digital data help data scientists and epidemiologists track and predict outbreaks of disease. Mobile phone GPS data, social media data, or other forms of information updates such as the progress of epidemics are used by epidemiologists to recognize disease spread among specific groups of people. Targeting groups as potential carriers of a disease, rather than addressing individuals as patients, risks causing harm to groups. While there are rules and obligations at the level of the individual, we have to reach a (...) stage in the development of data analytics where groups are protected as entities. This chapter offers a deeper examination of harms to the groups. (shrink)

One of the key ethical requirements for biomedical research is that it have an acceptable risk-benefit profile (Emanuel, Wendler, and Grady 2000). The International Conference of Harmonization guidelines mandate that clinical trials should be initiated and continued only if “the anticipated benefits justify the risks” (1996). Guidelines from the Council for International Organizations of Medical Sciences state that biomedical research is acceptable only if the “potential benefits and risks are reasonably balanced” (2002). U.S. federal regulations require that the “risks to (...) subjects” be “reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge” to be gained from the .. (shrink)

Evidence exists that behavioral and social science researchers have been frustrated with regulations and institutional review boards (IRBs) from the 1970s through today. Making matters worse, many human participants protection instruction programs - now mandated by IRBs - offer inadequate reasons why researchers should comply with regulations and IRBs. Promoting compliance either for its own sake or to avoid penalties is contrary to the developmental aims of moral education and may be ineffective in fostering the responsible conduct of research. This (...) article explores the concept of professional virtue and argues that compliance is capable of becoming a professional virtue like scientific honesty. This requires, however, that regulatory and IRB demands contribute to human well-being and to the aims of research as a profession and that researchers, therefore, internalize the norms that underlie regulatory and IRB demands. This, in turn, requires a series of changes in the way society develops, promulgates, and enforces regulatory and IRB rules. The challenge is, simply put, to embed compliance into the world of living morality. (shrink)

In a recent issue of the Journal of Medicine and Philosophy, several scholars wrote on the topic of ethics expertise in clinical ethics consultation. The articles in this issue exemplified what we consider to be two troubling trends in the quest to articulate a unique expertise for clinical ethicists. The first trend, exemplified in the work of Lisa Rasmussen, is an attempt to define a role for clinical ethicists that denies they have ethics expertise. Rasmussen cites the dependence of ethical (...) expertise on irresolvable meta-ethical debates as the reason for this move. We argue against this deflationary strategy because it ends up smuggling in meta-ethical assumptions it claims to avoid. Specifically, we critique Rasmussen’s distinction between the ethical and normative features of clinical ethics cases. The second trend, exemplified in the work of Dien Ho, also attempts to avoid meta-ethics. However, unlike Rasmussen, Ho tries to articulate a notion of ethics expertise that does not rely upon meta-ethics. Specifically, we critique Ho’s attempts to explain how clinical ethicists can resolve moral disputes using what he calls the “Default Principle” and “arguments by parity.” We show that these strategies do not work unless those with the moral disagreement already share certain meta-ethical assumptions. Ultimately, we argue that the two trends of attempting to avoid meta-ethics by denying that clinical ethicists have ethics expertise, and attempting to articulate how ethics expertise can be used to resolve disputes without meta-ethics both fail because they do not, in fact, avoid doing meta-ethics. We conclude that these trends detract from what clinical ethics consultation was founded to do and ought to still be doing—provide moral guidance, which requires ethics expertise, and engagement with meta-ethics. To speak of ethicists without ethics expertise leaves their role in the clinic dangerously unclear and unjustified. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not expressed in local (...) cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

Responsibility for the protection of human research subjects is shared by investigators, research ethics committees, sponsors/funders, research institutions, governments and, the focus of this article, physicians who enrol patients in clinical trials. The article describes the general principles of the patient-physician relationship that should regulate the participation of physicians in clinical trials and proposes guidelines for determining when and how such participation should proceed. The guidelines deal with the following stages of the trial: when first considering participation, when deciding whether (...) to enrol patients, when asking patients to participate, when the trial is underway and when it is completed. (shrink)

The World Medical Association's ‘Declaration of Helsinki’ on Medical Research on Human Subjects is undergoing its sixth revision in its 44 years. The aim of this paper is to put the Declaration into an historical context, define and identify the core ethical principles, and illustrate how these are applied within the Declaration.

Twenty-five years after the term "therapeutic misconception’ (TM) first entered the literature, most commentators agree that it remains widespread. However, the majority of scholarly attention has focused on the reasons why a patient cum human subject might confuse the goals of research with the goals of therapy. Although this paper addresses the social and cultural factors that seem to animate the TM among subjects, it also fills a niche in the literature by examining why investigators too might operate under a (...) similar confusion. In framing these issues, the paper expressly adopts a Wittgensteinian approach to evaluating the TM, suggesting that interlocutors do not need any analytic definition of the TM to use the term meaningfully in thinking about the moral implications of the TM in practice. (shrink)

BackgroundInformed consent as stipulated in regulatory human research guidelines requires that a volunteer is well-informed about what will happen to them in a trial. However researchers are faced with a challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. We conducted a qualitative study among volunteers taking part in two HIV clinical trials in Uganda to find out how they defined informed consent and their perceptions of the trial procedures, study (...) information and interactions with the research team.MethodsBetween January and December 2012, 23 volunteers who had been in the two trials for over 6 months, consented to be interviewed about their experience in the trial three times over a period of nine months. They also took part in focus group discussions. Themes informed by study research questions and emerging findings were used for content analysis.ResultsVolunteers defined the informed consent process in terms of their individual welfare. Only two of the volunteers reported having referred during the trial to the participant information sheets given at the start of the trial. Volunteers remembered the information they had been given at the start of the trial on procedures that involved drawing blood and urine samples but not information about study design and randomisation. Volunteers said that they had understood the purpose of the trial. They said that signing a consent form showed that they had consented to take part in the trial but they also described it as being done to protect the researcher in case a volunteer later experienced side effects.ConclusionVolunteers pay more attention during the consent process to procedures requiring biological tests than to study design issues. Trust built between volunteers and the research team could enhance the successful conduct of clinical trials by allowing for informal discussions to identify and review volunteers’ perceptions. These results point to the need for researchers to view informed consent as a process rather than an event. (shrink)

On 1 May 2004 research ethics committees became legally accountable to a new government body, the United Kingdom Ethics Committee Authority. This marks the end of the self regulation of research ethics. This paper describes how this change in research ethics committee status has come about and explores the implications for research subjects, researchers, institutions, and for regulation of research.

The application of human right frameworks is an increasingly important part of efforts to accelerate progress in global mental health. Much of this has been driven by several influential legal and policy instruments, most notably the United Nations’ Convention on the Rights of Persons with Disabilities, as well as the World Health Organization’s QualityRights Tool Kit and Mental Health Action Plan. Despite these significant developments, however, much more needs to be done to prevent human rights violations. This chapter focuses on (...) a critical component of this broader challenge, which is the question of how best to regulate and reduce the use of coercive measures. The recent literature on coercion in psychiatry – which addresses involuntary commitment, seclusion, restraint, and forced medication – represents a useful resource that can help guide tractable solutions in global mental health. These issues are evaluated from the perspective of global health governance, and several general recommendations are made in order to improve monitoring and enforcement, provide guidance for domestic legislative reform, and strengthen health systems. (shrink)

Increasingly, the world seems to shrink due to our ever-expanding technological and communication capacities. Correspondingly, our awareness of other cultures increases. This is especially true in the field of bioethics because the technological progress of medicine throughout the world is causing dramatic and challenging intersections with traditionally held values. Think of the use of pregnancy monitoring technologies like ultrasound to abort fetuses of the “wrong” sex in India, the sale of human organs in and between countries, or the disjunction between (...) the haves and the have-nots in South America when it comes to bone marrow transplants, while thousands of other children die for want of fundamental goods and services like clean water, basic inoculations, and food itself. (shrink)

Although international research is increasing in volume and importance, there remains a dearth of knowledge on similarities and differences in “national human research ethics”, that is, national ethical guidelines, Institutional Review Boards, and research stakeholder’ ethical attitudes and behaviors. We begin to address this situation by reporting upon our experiences in conducting a multinational study into the mental health of children who had a parent/carer in prison. The study was conducted in 4 countries: Germany, Great Britain, Romania, and Sweden. Data (...) on NHREs were gathered via a questionnaire survey, two ethics-related seminars, and ongoing contact between members of the research consortium. There was correspondence but even more so divergence between countries in the availability of NEGs and IRBs and in researcher’ EABs. Differences in NHREs have implications particularly in terms of harmonization but also for ethical philosophy and practice and for research integrity. (shrink)

In clinical research, informed consent is both a legal document and mechanism for respecting the dignity of participating subjects and protecting their rights and wellbeing. It should include information on the purpose of the research, its justification, and the risks and the benefits involved, so as to enable a subject to decide to participate voluntarily. Because it is the researcher’s duty to ensure protection of the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of the subjects who take (...) part in a study, the researcher must establish a permanent dialogue with them to assess the risks and safety inherent in their participation. This condition becomes a dynamic process that neither begins nor ends when informed consent is signed. It goes beyond legality and becomes a question of ethics and legitimacy. (shrink)

It was not until the nineteenth century that Western nations came to replace mutilation, corporal punishment, and banishment as the favored method of criminal punishment with the more humane concept of imprisonment. Even then, however, a convicted inmate was viewed as nothing more than a slave of the state, entitled only to the most basic of human rights and subject to the whim and peril of his jailor's desire. The shift to imprisonment gradually was accompanied by the additional humanitarian demand (...) that prisons avail their charges of some minimum standard of human decency and necessity, which, by the early part of the twentieth century, had come to encompass the provision of medical care. The courts later came to acknowledge this as a fundamental right grounded in the Eighth Amendment's proscription against cruel and unusual punishments.Although the scope of a prisoner's constitutional right to medical care has been the subject of much debate before the courts, the majority of cases have focused only on the circumstances under which the deprivation of care will amount to a violation of the rights guaranteed by the Eighth Amendment. (shrink)

During the Nazi era, most German physicians abrogated their responsibilities to individual patients, and instead chose to advocate the interests of an evil regime. In so doing, several fundamental bioethical principles were violated. Despite gross violations of individual rights, many physicians went on to have successful careers, and in many cases were honored. This paper will review the case of Hans Sewering, a participant in the Nazi euthanasia program who became the President-elect of the World Medical Association. The appropriate stance (...) for the medical and scientific community toward those who violate human rights and ignore fundamental ethical principles of the healing professions will be considered. (shrink)

The idea that research with human participants should benefit society has become firmly entrenched in various regulations, policies, and guidelines, but there has been little in-depth analysis of this ethical principle in the bioethics literature. In this paper, I distinguish between strong and weak versions and the social benefits principle and examine six arguments for it. I argue that while it is always ethically desirable for research with human subjects to offer important benefits to society, the reasonable expectation of substantial (...) public benefit should be a necessary condition for regarding research as ethical only when it imposes more than minimal risks on non-consenting subjects; or it is supported by public resources. (shrink)

The requirement that animals be used in research and testing in order to protect humans was formalized in the Nuremberg Code and subsequent national and international laws, codes, and declarations. We review the history of these requirements and contrast what was known via science about animal models then with what is known now. We further analyze the predictive value of animal models when used as test subjects for human response to drugs and disease. We explore the use of animals for (...) models in toxicity testing as an example of the problem with using animal models. We conclude that the requirements for animal testing found in the Nuremberg Code were based on scientifically outdated principles, compromised by people with a vested interest in animal experimentation, serve no useful function, increase the cost of drug development, and prevent otherwise safe and efficacious drugs and therapies from being implemented. (shrink)

Monshi and Zieglmayer's case study presents Sri Lankan participants as having views on the privacy of health information that differ radically from those commonly found in Western nations. This article explores 2 questions that their case study raises for the ethical review of research in international settings: First, are allegedly universal ethical principles - of the sort promulgated in the Belmont Report (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978) - useful in international settings?, (...) and second, how should research oversight bodies address the challenges that arise in international behavioral and social science research? (shrink)

Military metaphors are pervasive in biomedicine, including HIV research. Rooted in the mind set that regards pathogens as enemies to be defeated, terms such as “shock and kill” have become widely accepted idioms within HIV cure research. Such language and symbolism must be critically examined as they may be especially problematic when used to express scientific ideas within emerging health-related fields. In this article, philosophical analysis and an interdisciplinary literature review utilizing key texts from sociology, anthropology, history, and Chinese and (...) African studies were conducted to investigate the current proliferation of military metaphors. We found the use of these metaphors to be ironic, unfortunate, and unnecessary. To overcome military metaphors we propose to give them less aggressive meanings, and/or replace them with more peaceful metaphors. Building on previous authors' work, we argue for the increased use of “journey” metaphors as meaningful, cross-culturally app... (shrink)

Payment for research participation has raised ethical concerns, especially with respect to its potential for coercion. We argue that characterising payment for research participation as coercive is misguided, because offers of benefit cannot constitute coercion. In this article we analyse the concept of coercion, refute mistaken conceptions of coercion and explain why the offer of payment for research participation is never coercive but in some cases may produce undue inducement.

The conference on Health, Law and Human Rights: Exploring the Connections held last fall in Philadelphia was a telling moment in the complex history of a movement — the “health and human rights movement” for want of a better term — inaugurated by the pioneering work of Jonathan Mann, whose memory the Conference honored. The François-Xavier Bagnoud Center for Health and Human Rights — founded by Mann and carrying on his legacy — was pleased to co-sponsor the conference. The conference (...) and this symposium issue containing the main papers provide an excellent opportunity to take stock of that movement by means of a commentary based on the papers. This commentary is made from a resolutely human rights perspective, with the aim of engaging the authors in a dialogue on whether and to what extent each article advances knowledge about the interconnectedness and mutually reinforcing character of health and human rights, which is the lasting legacy of Jonathan Mann. (shrink)

Auschwitz and Hiroshima stand out as two realities whose uniqueness must be reconciled with their inevitability as outcomes of highly rationalized processes of technoscientific progress. Contrary to Michael Walzer’s notion of “double effect”, whereby unintended consequences and the particular uses to which warfare may lead remain outside the moral purview of scientists, this paper endorses the commitment of the Society for Social Responsibility in Science to argue that members of the technoscientific community are always responsible for their work and the (...) eventual uses made of it. In what follows four related views are outlined pertaining to modern situations within which the technoscientific community operates, so as to highlight the urgency of infusing a sense of responsibility for the products of their activities into this community. A provisional “code” is suggested that may serve as a guide for increased personal responsibility of individual technoscientists (academic scientists and industrial engineers). (shrink)

Recently, religious organisations, governments and public institutions have begun to offer apologies for historical wrongs. Can they legitimately do so? Departing from the tendency, Professor Hubert Markl, President of the Max Planck Society, has offered strong reasons for not apologising for the crimes of medical scientists who experimented on human subjects during the Nazi era. He argues that only the perpetrators can meaningfully apologise. Markl’'s position is considered and rejected in favour of the view that apologies by proxy for historical (...) wrongs are justifiable and should be made by institutions that have the authority to do so. (shrink)

In Western democratic society, the specificity of the bioethical debate over the life-sciences involves bringing together many different study factors. The dilemmas raised by the new scientific discoveries highlight how contemporary common sense is plagued by a profound feeling of anguish over possible future anthropological developments. One of the central problems is the social construction of consent as a psychological strategy seeking to orient public opinion toward accepting new applications of science and technology. On the one hand, the general features (...) in the epistemological analysis of the mind-brain identity are called into question; and on the other, together with all those research directions concerned with the "meaning of life," we enter the dimension of the complex issue inherent in the possibility of establishing if there exists something transcending thought and what it may be. In both cases a problem is raised on which the meaning of human life and the world depend, while between the two universes described by medical science and ethical-philosophical thought a window of opportunity for important psychological research is opened. In order to understand such phenomena the present article defends the theory that social psychology must adopt as its subject matter "thinking society," that is, society characterized by discussion and reasoning on themes relevant to bioethics. (shrink)

Responsibility for the protection of human research subjects is shared by investigators, research ethics committees, sponsors/funders, research institutions, governments and, the focus of this article, physicians who enrol patients in clinical trials. The article describes the general principles of the patient-physician relationship that should regulate the participation of physicians in clinical trials and proposes guidelines for determining when and how such participation should proceed. The guidelines deal with the following stages of the trial: when first considering participation, when deciding whether (...) to enrol patients, when asking patients to participate, when the trial is underway and when it is completed. (shrink)