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 We conclude that the requirements for animal testing found in the Nuremberg Code were based on scientifically outdated principles, compromised by people with a vested interest in animal experimentation, serve no useful function, increase the cost of drug development, and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)

This article addresses, from a Frankfurt School perspective on law identified with Franz Neumann and more recently Habermas, the attack upon the principles of war criminality formulated at the Nuremberg trials by the increasingly influential legal and political theory of Carl Schmitt. It also considers the contradictions within certain of the defence arguments that Schmitt himself resorted to when interrogated as a possible war crimes defendant at Nuremberg. The overall argument is that a distinctly internal, or “immanent”, (...) form of critique is required of Schmitt's position, in which its is found wanting even on its own terms. In principle, the application of this dialectical mode of critique can allow a genuine debate to emerge between those seeking to continue both the Schmittian and critical theory traditions, whilst safeguarding the latter from the dangers of formulating polemical interventions that are, in effect, counterproductive to their own intentions. (shrink)

This article is a defense of the Nuremberg Trials. It addresses the standard criticism of the trials and outlines six principles of international law that constitute the legacy of Nuremberg.

The novelties of the contemporary international order require a rethinking of the normative foundations of criminal justice. Although one can understand the relevance of basic principles such as th...

The institution of crimes against humanity at Nuremberg in 1945 was an event which marked the birth of cosmopolitan law as a social reality. Cosmopolitan law has existed as an abstract idea at least since the writings of Kant in the late eighteenth century, but Nuremberg turned the notion of humanity from a merely regulative idea into a substantial entity. Crimes against humanity differ significantly from the traditional categories of international law: war crimes and crimes against peace. While (...) the latter generally treats states as subjects of right and upholds the principle of national sovereignty, the former treats individuals as subjects of right and encroaches on national sovereignty. I focus here on the writings of Hannah Arendt on the Nuremberg trials, the Eichmann trial and the actuality of crimes against humanity perpetrated in totalitarian regimes. I explore her relation to the optimistic and naive cosmopolitanism of Karl Jaspers, as well as to the two prevailing forms of critical thought: the cynical realism towards the law adopted by many of the defendants, including Carl Schmitt, and the deconstructive attitude to humanism and technology adopted by Martin Heidegger. I maintain that Arendt's rugged cosmopolitanism, tested against its critics, remains exceptionally revealing on the issue of crimes against humanity now that this issue has re-emerged, after many years of silence, as arguably the most important question of our own day. (shrink)

Codes are a well known and popular but weak form of ethical regulation in medical practice. There is, however, a lack of research on the relations between moral judgments and ethical Codes, or on the possibility of morally justifying these Codes. Our analysis begins by showing, given the Nuremberg Code, how a typical reference to natural law has historically served as moral justification. We then indicate, following the analyses of H. T. Engelhardt, Jr., and A. MacIntyre, why such general (...) moral justifications of codes must necessarily fail in a society of ‘’moral strangers’ Going beyond Engelhardt we argue, that after the genealogical suspicion in morals raised by Nietzsche, not even Engelhardt's "principle of permission" can be rationally justified in a strong sense – a problem of transcendental argumentation in morals already realized by I. Kant. Therefore, we propose to abandon the project of providing general justifications for moral judgements and to replace it with a hermeneutical analysis of ethical meanings in real-world situations, starting with the archetypal ethical situation, the encounter with the Other (E. Levinas). (shrink)

Codes are a well known and popular but weak form of ethical regulation in medical practice. There is, however, a lack of research on the relations between moral judgments and ethical Codes, or on the possibility of morally justifying these Codes. Our analysis begins by showing, given the Nuremberg Code, how a typical reference to natural law has historically served as moral justification. We then indicate, following the analyses of H. T. Engelhardt, Jr., and A. MacIntyre, why such general (...) moral justifications of codes must necessarily fail in a society of ‘’moral strangers’ Going beyond Engelhardt we argue, that after the genealogical suspicion in morals raised by Nietzsche, not even Engelhardt's "principle of permission" can be rationally justified in a strong sense – a problem of transcendental argumentation in morals already realized by I. Kant. Therefore, we propose to abandon the project of providing general justifications for moral judgements and to replace it with a hermeneutical analysis of ethical meanings in real-world situations, starting with the archetypal ethical situation, the encounter with the Other (E. Levinas). (shrink)

In research ethics there is a canon regarding what ethical rules ought to be followed by investigators vis-à-vis their treatment of subjects and a canon regarding what fundamental ethical principles apply to the endeavor. What I aim to demonstrate here is that several of the rules find no support in the principles. This leaves anyone who would insist that we not abandon those rules in the difficult position of needing to establish that we are nevertheless justified in believing (...) in the validity of the rules. I conclude by arguing that this is not likely to be accomplished.The rules I call into question are the rules requiring:– that studies be designed in a scientifically valid way– that risks to subjects be minimized– that subjects be afforded post-trial access to experimental interventions– that inducements paid to subjects not be counted as a benefit to them– that inducements paid to subjects not be ‘undue’– that subjects must remain free to withdraw from the study at any time for any reason without penaltyBoth canons, the canon on principles and the canon on rules, are found in the overlap among ethical pronouncements that are themselves canonical: the Nuremberg Code, the Declaration of Helsinki, the Belmont Report, CIOMS's International Ethical Guidelines for Biomedical Research Involving Human Subjects, and NBAC's 2001 report, Ethical Issues in International Research: Clinical Trials in Developing Countries. (shrink)

This paper attempts to provide a broader view into the ethical issues surrounding the field of emergency medicine (EM) research. It starts from defining bioethically relevant features of EM and presents this field in the context of different models of health care provider–patient relationship. The paper also provides a short overview of the “post-Nuremberg” evolution of the main international research ethics guidelines relevant to EM research which demonstrates a tendency of liberalization of research on incapable persons. This tendency culminates (...) with the exceptions to informed consent for EM research which is supposed to be balanced by other research ethics principles, especially a careful rationing of risks and benefits. This finally brings us towards a critical analysis of the minimal risk standard which is one of the main fundamental safeguards in EM research. (shrink)

This volume presents a collection of refereed papers reflecting the state of the art in the area of over-constrained systems. Besides 11 revised full papers, selected from the 24 submissions to the OCS workshop held in conjunction with the First International Conference on Principles and Practice of Constraint Programming, CP '95, held in Marseilles in September 1995, the book includes three comprehensive background papers of central importance for the workshop papers and the whole field. Also included is an introduction (...) by one of the volume editors together with a bibliography listing 243 entries. All in all this is a very useful reference book relevant for all researchers and practitioners interested in hierarchical, partial, and over-constrained systems. (shrink)

The Nuremberg Trials of leading National Socialists established the principle that individuals may be legally punished, even by death, for obeying the laws of their country. Is there then a higher law by which enacted valid positive laws may be judged, so that persons subject to such laws would be duty-bound to defy them? In recent years the theory of natural law has been revived by a number of philosophers and jurists, who however often disagree sharply among themselves about (...) the proper methods for defining and deriving natural law. Howard Kainz surveys the history of natural law from its foreshadowing in ancient Greece down to the most recent controversies. Natural Law both introduces the subject to newcomers and sheds fresh light on such figures as Plato, Aristotle, Hume, Kant, Veatch, McInerny, Grisez, and Finnis. (shrink)

The Nuremberg Code of ethical principles for experiments involving human beings has as its first requirement that “the voluntary consent of the human subject is absolutely essential.” Since the time of the trials that supplied its motivation the principles have been amplified and detail and distinctions have been added. For example, the Declaration of Helsinki, adopted by the World Medical Association in 1964, again laid down general principles related to voluntariness, balance of risk and benefit, and (...) scientific soundness. However, it also noted that the ethical issues with regard to two distinctly different types of human experiment vary. These two types are clinical research and nonclinical biomedical research. In actuality, we may distinguish three types of human biomedical experimentation. Two of these are therapeutic and nontherapeutic experimentation. The first is directed primarily to the benefit of the experimental subjects who are being treated with some new experimental therapy for their ailment. In the second an experiment is designed to increase medical knowledge and uses volunteers who are healthy or whose illness is not related to the experimental study. One key difference between the ethical requirements specified by the Declaration of Helsinki for therapeutic and nontherapeutic experimentation was that the second approach required participation only by volunteers whom we assume are able to and do give their informed consent. However, in the first approach if consent were not obtained, the physician must specify the reasons and present these before an independent committee. (shrink)

This article discusses Lysias’ Against Eratosthenes as an ancient Athenian instance of the superior orders plea, a line of defence made notorious during the Nuremberg trials, which in turn became the cornerstone of modern war crime legislation. Whereas the pre-Nuremberg jurisdiction largely embraced the principle of superior responsibility, whereby a subordinate executing criminal orders was not to be held liable for them, the trials of the Nazi war criminals brought about a complete reversal of this doctrine. While remaining (...) faithful to the spirit of the Nuremberg jurisdiction, the subsequent legislative acts sought to further elaborate its underlying principle of absolute liability, in order to precisely determine the question of guilt and innocence. I argue that despite the close relationship between modern legal systems and Roman law, which fully embraced the doctrine of superior responsibility, it is in the juridical thought of ancient Athens that one finds the archetype of contemporary war crime legislation. (shrink)

The first principle of the Nuremberg Code requires the informed consent of the subject. Proxy consent was not addressed until the Declaration of Helsinki. U.S. policies regarding consent for the participation of children in research would not be finalized for almost two more decades in subpart D of the federal regulations that govern the participation of subjects in research. In October 2000, the Children's Health Act was passed. Title X required the Secretary of the Department of Health and Human (...) Services to conduct a review of the regulations under subpart D and “to consider any modifications necessary to ensure the adequate and appropriate protection of children participating in research, and report the findings of the Secretary to Congress.” In this article, I provide a brief overview of the current informed consent requirements in pediatric research, which include requirements for parental permission and the child's assent. I then examine the moral bases for these requirements; whether the current policies are consistent with these moral foundations; and if not, how the policies ought to be modified. a. (shrink)

At least since the Nuremberg trial of Nazi doctors, it has been impossible to take seriously the idea that freedom of scientific inquiry should be completely unfettered. But even if freedom of scientific inquiry cannot be absolute, how strong a principle is it? What ethical limits should we impose on science?

BackgroundHealthcare ethics is neglected in clinical practice in LMICs such as Nepal. The main objective of this study was to assess the current status of knowledge, attitude and practice of healthcare ethics among resident doctors and ward nurses in a tertiary teaching hospital in Nepal.MethodsThis was a cross sectional study conducted among resident doctors and ward nurses in the largest tertiary care teaching hospital of Nepal during January- February 2016 with a self-administered questionnaire. A Cramer’s V value was assessed to (...) ascertain the strength of the differences in the variables between doctors and nurses. Association of variables were determined by Chi square and statistical significance was considered if p value was less than 0.05.ResultsOur study demonstrated that a significant proportion of the doctors and nurses were unaware of major documents of healthcare ethics: Hippocratic Oath, Nuremberg code and Helsinki Declaration. A high percentage of respondents said that their major source of information on healthcare ethics were lectures, books, and journals. Attitude of doctors and nurses were significantly different in 9 out of 22 questions pertaining to different aspects of healthcare ethics. More nurses had agreement than doctors on the tested statements pertaining to different aspects of healthcare ethics except for need of integration of medical ethics in ungraduate curricula,paternalistic attitude of doctor was disagreed more by doctors. Notably, only few doctors stood in support of physician-assisted dying.ConclusionsSignificant proportion of doctors and nurses were unaware of three major documents on healthcare ethics which are the core principles in clinical practice. Provided that a high percentage of respondents had motivation for learning medical ethics and asked for inclusion of medical ethics in the curriculum, it is imperative to avail information on medical ethics through subscription of journals and books on ethics in medical libraries in addition to lectures and training at workplace on medical ethics which can significantly improve the current paucity of knowledge on medical ethics. (shrink)

The view that research with competent adults requires valid consent to be ethical perhaps finds its clearest expression in the Nuremberg Code, whose famous first principle asserts that “the voluntary consent of the human subject is absolutely essential.” In a similar vein, the United Nations International Covenant on Civil and Political Rights states that “no one shall be subjected without his free consent to medical or scientific experimentation.” Yet although some formulations of the consent principle allow no exceptions, others (...) hold that informed consent is not always strictly necessary for ethical research. The U.S. federal regulations known as the “Common Rule,” which govern research with human subjects, lists several conditions for waiving consent. However, neither guidance documents on the ethics of clinical research nor the literature in bioethics contains a general justification of research without consent. The purpose of this paper is to advance a justificatory framework that will explain why research without consent is permissible in paradigmatic cases and that can be useful in analyzing cases about which there is disagreement. We argue that research without consent can be justified on two grounds: if it stands to infringe no right of the participants and obtaining consent is impracticable, or if the gravity of the rights infringement is minor and outweighed by the expected social value of the research and obtaining consent is impracticable. (shrink)

By focusing on the reasoned debate in the discourse -ethical approach to business ethics, this paper discusses the possibilities and limitations of moral reasoning as well as applied economic and business ethics. Business ethics, it is contended, can be looked at from the standpoint of two criteria: justification and application. These criteria are used to compare three approaches: the Integrative Business Ethics, developed by Swiss philosopher Peter Ulrich, the Cultural Business Ethics of the Nuremberg School in German business ethics, (...) and the concept of “Good Conservation” by Frederick Bird. It is argued that discourse -ethical approaches can be called upon for justifying moral principles. Improving the chances of their application, however, necessitates a good understanding of lifeworlds and culturally developed institutional settings. Bearing this in mind, further research perspectives stressing a linkage between discourse -ethical and critical approaches in social sciences are suggested. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Theory of International Bioethics: Multiculturalism, Postmodernism, and the Bankruptcy of Fundamentalism 1Robert Baker (bio)AbstractThis first of two articles analyzing the justifiability of international bioethical codes and of cross-cultural moral judgments reviews “moral fundamentalism,” the theory that cross-cultural moral judgments and international bioethical codes are justified by certain “basic” or “fundamental” moral principles that are universally accepted in all cultures and eras. Initially propounded by the judges at (...) the 1947 Nuremberg Tribunal, moral fundamentalism has become the received justification of international bioethics, and of cross-temporal and cross-cultural moral judgments. Yet today we are said to live in a multicultural and postmodern world. This article assesses the challenges that multiculturalism and postmodernism pose to fundamentalism and concludes that these challenges render the position philosophically untenable, thereby undermining the received conception of the foundations of international bioethics. The second article, which follows, offers an alternative model—a model of negotiated moral order—as a viable justification for international bioethics and for transcultural and transtemporal moral judgments.Man in the Twentieth Century can not be circumscribed by the standards of any single culture.American Anthropological Association (1948) in a statement officially denouncing the 1948 United Nation’s Declaration of Human Rights.Recently... so-called “liberal” medicine has revived the old rights of a clinic understood in terms of a special contract, a tacit pact made between one man and another. This patient gaze has even been attributed the power of assuming [a role in clinical decision making].Miracles are not so easy to come by....Michel Foucault (1975, p. 5) [End Page 201]An Overview of the AnalysisInternational bioethics originated in the trauma of the Holocaust, specifically, in the 1946–1947 Nuremberg “Doctors Trial” when a tribunal of three American judges convicted Nazi medical researchers of “crimes against humanity.” In justifying their judgment, the Nuremberg Tribunal cited 10 principles for morally permissible research, which, they claimed, were based on “fundamental” principles that civilized societies “all agree” upon and accept as the foundations of their “moral, ethical, and legal” norms. Foremost among the principles was one stating that morally permissible human experiments require the informed voluntary consent of the subject. The Nuremberg judgment soon became associated with the ideal of human rights declared in the 1948 United Nations Charter. These two ideas—fundamental principles of morality and human rights—have been linked in all major formulations of international bioethics promulgated in the past 50 years, including the Council of Europe’s 1997 Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine (Council of Europe 1997; Dommel and Alexander 1997). In this paper, I explore the received justification for international bioethics—the idea that it is grounded in fundamental principles accepted in all societies—tracing it from its initial, almost off-hand, promulgation by the Nuremberg Tribunal, through its more thoughtful development by such bioethicists as Ruth Macklin, to its more complex use by the President’s Advisory Committee on Human Radiation Experiments.After a brief review of the evolution of the received justification, I discuss the viability of this justification in the face of the critique implicit in two important intellectual movements: multiculturalism and postmodernism. In the international context, multiculturalism asserts the claim that there are no common moral principles shared by all cultures. Postmodernism asserts a similar claim against all universal standards, moral and nonmoral. In the 1990s, bioethicists have attempted to respond to these claims in various ways. These responses are documented, analyzed, and then shown to be “bankrupt,” in the sense that they undercut the most important objective of moral fundamentalism: the justification of transcultural moral judgments, such as the condemnation of the Nazi doctors.A second article, which follows the present one in the same issue of the Kennedy Institute of Ethics Journal, revisits the contractarian tradition [End Page 202] of Hobbes and Locke, as it has been reinterpreted by David Gauthier (1986), John Rawls (1971, 1993), and Robert Nozick (1974), to develop the idea of negotiated moral order as the basis of international bioethics. When conceptualized as a negotiated moral order, international bioethics can accept the genuine insights... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:A Theory of International Bioethics: The Negotiable and the Non-NegotiableRobert Baker (bio)AbstractThe preceding article in this issue of the Kennedy Institute of Ethics Journal presents the argument that “moral fundamentalism,” the position that international bioethics rests on “basic” or “fundamental” moral principles that are universally accepted in all eras and cultures, collapses under a variety of multicultural and postmodern critiques. The present article looks to the contractarian tradition (...) of Hobbes and Locke—as reinterpreted by David Gauthier, Robert Nozick, and John Rawls—for an alternative justification for international bioethics. Drawing on the central themes of this tradition, it is argued that international bioethics can be rationally reconstructed as a negotiated moral order that respects culturally and individually defined areas of nonnegotiability. Further, the theory of a negotiated moral order is consistent with traditional ideals about human rights, is flexible enough to absorb the genuine insights of multiculturalism and postmodernism, and yet is strong enough to justify transcultural and transtemporal moral judgments, including the condemnation of the Nazi doctors at Nuremberg. This theory also is consistent with the history of the ethics of human subjects experimentation and offers insights into current controversies such as the controversy over changing the consent rule for experiments in emergency medicine and the controversy over exempting certain clinical trials of inexpensive treatments for preventing the perinatal transmission of AIDS from the ethical standards of the sponsoring country.The Preamble to the Council of Europe’s (1997) Convention on Human Rights and Biomedicine, the most recently ratified code of international bioethics, is noteworthy because it never mentions “principles,” the concept most frequently cited by the fundamentalists as basic to international bioethics. Instead it stresses rights, a concept that has been utterly ignored by the fundamentalist theorists of international bioethics. The Preamble exemplifies a conception of international [End Page 233] bioethics as an ethics of covenants and conventions grounded in human rights. In the full text of the Preamble, the term “rights” appears eight times and the expressions “convention” and “covenant” are used six times; the term “principle” does not appear at all. In this essay, I develop a theoretical framework for international bioethics based on conventions, covenants, and areas of “nonnegotiability”—a concept that serves as a functional analogue to the traditional notion of “human rights.” I also shall argue that, unlike the theory of basic principles central to moral fundamentalism, the theory of negotiated morality appears immune to the multicultural and postmodern critiques of international bioethics that were analyzed in the preceding article in this issue of the Kennedy Institute of Ethics Journal (Baker 1998).Negotiated Moral Order: A Model for International BioethicsReconsidering ContractarianismThe linkage of “conventions” and “covenants” with human rights that is evident in the Council of Europe’s Convention on Human Rights and Biomedicine traces back directly to the moral and political theories of Thomas Hobbes and John Locke. Such philosophers as David Gauthier (1986), Robert Nozick (1974), and John Rawls (1971, 1993) recently have reinvigorated this classic contractarian line of analysis. In this section, I shall reconsider classical contractarian theory from a perspective informed by these more recent analyses.The most riveting feature of all forms of contractarian theory is the metaphor of the contract itself, particularly the legitimating role it accords to assent. Because contractarians look to the assent of those who would be bound by a moral norm as ultimately the sole source of a norm’s legitimacy, the most important corollary of contractarian moral theory is that moral norms are illegitimate insofar as agents either in principle could not, hypothetically would not, or actually will not rationally assent to be bound by them. Contractarians also argue that because legal norms are legitimated by acceptance of the authority of those who promulgate them, the authority of such norms is bounded by the actual or hypothetical assent of the governed. These features of contractarian analysis generate the correlative concepts of human rights and civil rights.Less often remarked, but nonetheless integral to the metaphor of the social contract, is the contractarian recognition that the interests of the [End Page 234] parties who contract to form civil society are naturally in conflict (or, as Hobbes put... (shrink)

Informed consent is one of the foundational ethical and legal requirements of research with human subjects. The Nuremberg Code, the Helsinki Declaration, the Belmont Report, the Common Rule and many other laws and codes require that research subjects make a voluntary, informed choice to participate in research.12345 Informed consent is based on the moral principle of respect for autonomy, which holds that rational individuals have a right to make decisions and take actions that reflect their values and preferences. 6 (...) Whereas most guidelines and codes also require that informed consent be properly documented, informed consent is much more than signing a piece of paper: It is a continuous process of communication between the investigator and the research subject. 7 Because the body of knowledge impacting a study frequently changes, subjects should receive information from investigators after they have enrolled in a study, such as significant new findings that may affect their decision to participate in research or clinically useful tests results. 8910 In large studies, some investigators use newsletters to update subjects on the progress of research and other developments.11Most of the ongoing communications between investigators and subjects involve little more than information sharing, without revisiting the decision to participate in research or signing any additional documents. Sometimes, however, it may be necessary for subjects to reaffirm their decision to participate, to re-consent, or to sign or re-sign a document. 8 Re-consent can be defined as an action in which a subject makes the decision to participate in research once again. Re-consent is different from reaffirming a commitment to participate in a study, because in re-consent one actually reconsiders the information necessary to make decision, whereas in reaffirmation one simply expresses …. (shrink)

Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: research participants are protected and benefited according to the highest ethical standards, while, on the other hand, researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.The balancing of the risk to research participants versus the benefits derived from the research is performed in (...) many counrries by a system for the protection of human research participants that is laid out in national laws and regulations. In the United States, this system is based on principles emanating from the Nuremberg Code, the World Medical Association Declaration of Helsinki,and the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.4 (2004) 411-425 [Access article in PDF] Vulnerability, Vulnerable Populations, and Policy Mary C. Ruof "Special justification is required for inviting vulnerable individuals to serve as research subjects and, if they are selected, the means of protecting their rights and welfare must be strictly applied."Guideline 13: Research Involving Vulnerable Persons International Ethical Guidelines for Biomedical Research Involving Human Subjects Council for International Organizations of (...) Medical Sciences (CIOMS) and World Health Organization (WHO) Geneva, Switzerland, 2002 Within medical research and healthcare certain groups are afforded special protections and services because of their designation as vulnerable. The vulnerable require special justification to participate in human subject research in order to eliminate potential human rights abuses. The Nuremberg Code of 1947 was written in response to the extreme human subject abuses that occurred under the Nazi regime, and, although the intent of the 1947 Code was to protect human rights, rigid voluntary consent requirements deprived some individuals of the right to participate in clinical trials. Recent human research guidelines, such as the CIOMS/WHO guidelines referenced above and the guidelines referenced in Section V of this Scope Note, attempt to balance both protection from abuse in research and access to new, experimental treatments for the vulnerable.Although various protective guidelines stipulate special protections for vulnerable populations, the concept of vulnerability and consequently the criteria designating vulnerable populations remain vague. Precisely who are the vulnerable? The word "vulnerability" stems from the Latin vulnerare, "to wound." (Oxford Encyclopedic English Dictionary 1995). In clinical research, the term [End Page 411] vulnerable generally is applied to individuals who are unable to give informed consent or who are susceptible to coercion. The Common Rule (45 CFR 46, Subpart A) includes as vulnerable research subjects: children, prisoners, pregnant women, and persons who are handicapped, mentally disabled, economically disadvantaged, or educationally disadvantaged. Although the Common Rule specifies certain vulnerable categories, the guidelines were not intended to be exclusive, leaving open the interpretation of vulnerability.In medical research and health policy, vulnerability is an abstract concept that has concrete effects both for those labeled vulnerable and for those not. Clinical researchers, healthcare workers, ethical reviewers, and policymakers must be able to identify vulnerable subjects to establish how healthcare resources will be allocated and who will qualify for special protections and socialized benefits. Attempts to quantify vulnerability in clear, measurable ways have met little if any consensus. As Alexander Morawa (II, 2003, p. 150) states, "There is no single approach to definition of vulnerability. In fact, there is no purposeful categorisation at all."Difficulties in defining vulnerability have prompted discourse surrounding its utility as a qualifying factor in the allocation of health resources and its appropriateness as a guiding principle in bioethics. Some of the authors cited in this Scope Note argue against the labeling and categorization of vulnerable individuals and populations. "Labeling individuals as 'vulnerable' risks viewing vulnerable individuals as 'others' worthy of pity, a view rarely appreciated" (III, Danis and Patrick 2002, p. 320). The categories of vulnerable groups listed under the Common Rule have been the source of controversy, "for example, many find the suggestion that pregnant women are vulnerable to be quite sexist" (IV, DeBruin 2001, p. 7). Instead of creating categories of vulnerable populations, would it not be better to derive an account of just treatment from a just social policy at large that encompasses human vulnerabilities (II, Brock 2002, p. 283).For some of the authors listed here, the concept of vulnerability is essential to bioethics. Robert Goodin (I, 1985, p. 107) writes that the vulnerability of other human beings is the source of our special responsibilities to them. In contrast to the four American principles of biomedical ethics—autonomy, nonmaleficence, beneficence, and justice—the four principles of European bioethics and biolaw include vulnerability along with autonomy, dignity, and integrity. According to, Jacob Dahl Rendtorff and Peter Kemp (I, 2000, p. 274) "the principle of vulnerability is ontologically prior to the other [European] principles, it expresses better than all of the other ethical principles... the finitude of the human condition."Some of the... (shrink)

Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: research participants are protected and benefited according to the highest ethical standards, while, on the other hand, researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.The balancing of the risk to research participants versus the benefits derived from the research is performed in (...) many counrries by a system for the protection of human research participants that is laid out in national laws and regulations. In the United States, this system is based on principles emanating from the Nuremberg Code, the World Medical Association Declaration of Helsinki,and the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (shrink)

After revelations of participation by psychiatrists and psychologists in interrogation of prisoners at Guantánamo Bay and Central Intelligence Agency secret detention centers, the American Psychiatric Association and the American Psychological Association adopted Position Statements absolutely prohibiting their members from participating in torture under any and all circumstances, and, to a limited degree, forbidding involvement in interrogations. Some interrogations utilize very aggressive techniques determined to be torture by many nations and organizations throughout the world. This paper explains why psychiatrists and psychologists (...) involved in coercive interrogations violate the Geneva Conventions and the laws of the United States. Whether done with ignorance of professional ethical obligations or not, these psychiatrists and psychologists have crossed an ethical barrier that may best be averted from re-occurring by teaching medical students and residents in all medical specialties about the ethics principles stemming from the 1946–1947 Nuremberg trials and the Geneva Conventions, together with the Ethics Codes of the World Medical Association and the American Medical Association; and, with regard to psychiatric residents and psychological trainees, by the teaching about The Principles of Medical Ethics With Annotations Especially Applicable to Psychiatry and the Ethical Principles of Psychologists and Code of Conduct, respectively. In this way, all physicians and psychologists will clearly understand that they have an absolute moral obligation to "First, do no harm" to the human beings they professionally encounter. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Negotiating International Bioethics: A Response to Tom Beauchamp and Ruth MacklinRobert Baker (bio)AbstractCan the bioethical theories that have served American bioethics so well, serve international bioethics as well? In two papers in the previous issue of the Kennedy Institute of Ethics Journal, I contend that the form of principlist fundamentalism endorsed by American bioethicists like Tom Beauchamp and Ruth Macklin will not play on an international stage. Deploying techniques (...) of postmodern scholarship, I argue that principlist fundamentalism justifies neither the condemnation of the Nazi doctors at Nuremberg, nor, as the Report of the Advisory Committee on the Human Radiation Experiments (ACHRE) demonstrates, condemnation of Cold War radiation researchers. Principlist fundamentalism thus appears to be philosophically bankrupt. In this issue of the Journal, Beauchamp and Macklin reject this claim, arguing that I have misread the ACHRE report and misunderstood Nazism. They also argue that the form of post-postmodern negotiated human rights theory that I proffer is adequate only insofar as it is itself really fundamentalist; insofar as I take postmodernism seriously, however, I mire international bioethics in relativism. In this response, I reaffirm my anti-fundamentalism, provide further evidence in support of my reading of the ACHRE report, and defend my post-postmodern version of rights theory. I also develop criteria for a minimally adequate theoretical framework for international bioethics.Universal Morality Reconsidered 1Paradoxically, the need for content-full universal moral principles tends to be most deeply felt and most adamantly asserted in the face of striking evidence of their absence. People are inspired to claim that Nazis must accept the universal principle that doing harm is wrong because they are appalled by the horror of the Holocaust. Yet the event itself provides palpable evidence that the Nazis saw no wrong in doing harm. One has the suspicion that claims of universalism [End Page 423] confound philosophical aspirations with empirical observations. This distinction makes a significant difference because empirical claims can be disconfirmed by data, whereas philosophical claims can only be challenged on the level of theory.I am, like Tom Beauchamp and James Childress, a common morality theorist. Thus, I believe, as they do, that ethics “relies heavily on ordinary shared moral beliefs for its content, rather than relying on pure reason, natural law, a special moral sense, and the like” (Beauchamp and Childress 1994, p. 100). For most of human history sexism and slavery were considered moral. They certainly were the norm. Thus, if one looks to common morality as the source of moral content, empirical claims of moral universalism appear suspect. Insofar as one would condemn sexism and slavery, one needs to find some theoretical justification for condemnation that goes beyond a consensus on moral content (hence my embrace of the structural analogue of human rights theory).Beauchamp, however, takes a very different view. He asserts in his critique of my position, that: “it is an institutional fact about the substance of morality (not merely [as Baker claims] the formal features of the concept of morality and not merely my view of it) that it contains fundamental and shared precepts. It is by appeal to this shared moral substance that persons are enabled to make justifiable cross-temporal and cross-cultural judgments” (Beauchamp 1998, p. 395). Beauchamp is thus claiming that it is both an empirical and a conceptual truth there is common core underlying the morality of all societies. He fleshes this claim out in another passage.[T]he term morality refers to norms about right and wrong human conduct that are so widely shared that they form a stable... communal consensus.... These standards sometimes vary from society to society, but embedded in the beliefs of all moral societies are the core dimensions of morality: Persons must keep their promises, must respect the rights of others, must not kill or cause harm to innocent persons, must not abuse children, and the like. All morally committed persons are comfortable with these norms and do not doubt their relevance and importance.(Beauchamp 1998, p. 394)Insofar as Beauchamp is making an empirical claim in this passage, the examples cited are problematic. “Promise keeping,” for example, cannot be a cultural universal because the practice is... (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each (...) school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

Following Alder Hey and the earlier and much more extreme practices at Nuremberg, legislation has been developed governing the practice of medical ethics and research involving human participants more generally. In the medical context, relevant legislation includes GMC guidance, which states that disclosure of identifiable patient information without consent, for research purposes, is not acceptable unless it is justified in the public interest. There is a presumption, in other words, in favour of the view that patient consent ought to (...) be obtained before any piece of research is conducted. The Data Protection Act, furthermore, requires informed consent to be given before any use of identifiable personal data is made for any purpose. Moreover, ensuring that the informed consent of participants is gained is common practice on most research ethics committees. I argue, in this paper, that applying the principle of ‘informed consent’ too mechanistically in the research ethics context risks undermining the very principle it is designed to support – the principle of autonomy. This issue has been much discussed in medical ethics but not so much, so far, in the research ethics context. It will be argued that a more discerning and a less rigid and mechanistic approach, applied by research ethics committees, may help ensure that ethical issues are properly considered. (shrink)

Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed the use of animals (...) in research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries. (shrink)

The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries.Although it has undergone five revisions,1 and most recently incorporated language aimed at addressing concerns over (...) research carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour.In light of the current effort of the World Medical Association to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated.In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups that …. (shrink)

The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries.Although it has undergone five revisions,1 and most recently incorporated language aimed at addressing concerns over (...) research carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour.In light of the current effort of the World Medical Association to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated.In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups that …. (shrink)

The purpose of the article is to study the influence of Nazi experiments on the formation of ideas about the ethos of science in the field of biomedicine. It is shown that the idea of discrediting a value-neutral science was often confronted with the resistance of the scientists themselves, who, in different contexts of condemning Nazi crimes, appealed to the fact that they acted for the good of science, and even of all mankind. The article discusses the strategy of American (...) lawyers adopted at the Nuremberg Trials aimed at demonstrating the perversity of Nazi crimes in the field of biomedicine both ethically and scientifically. In addition, an analysis of individual materials of the Nuremberg process was carried out, which made it possible to give an idea of the scientific and linguistic design of the human body (name correction strategy) as a “correct” scientific object with desired properties. The article considers the influence of the data obtained on Nazi crimes on the formation of the content of the Nuremberg Code and the design of the principle of informed consent in biomedicine. Ethical aspects related to the further use of Nazi scientific data are also considered. In conclusion, the problem of the formation of scientific knowledge in non-violence mode is articulated. (shrink)

This book makes an important contribution to ongoing efforts in the fields of medical law and bioethics to answer the challenges posed by the limitations of the principle of respect for autonomy, especially as these pertain to human research ethics. The principle of respect for autonomy seems to have become firmly embedded in human research ethics since its inclusion in the 1947 Nuremberg Code, which was a response to atrocities committed by Nazi doctors. Nonetheless, there is an increasing awareness (...) of the limitations of the principle of respect for autonomy and the underlying conceptualisations of human autonomy. (shrink)

Many persons who consider the variety of moral and legal problems that arise in respect to war come away convinced that the firmest area for judgment is that of how persons ought to behave in time of war. Such persons feel a confidence about dealing with questions of how war ought to be conducted that is absent when other issues about war are raised. They are, for example, more comfortable with the rules relating to how soldiers ought to behave vis-a-vis (...) enemy soldiers and enemy civilians - the laws of war - than they are with the principles relating to when war is permissible and when it is not. Thus, most commentators and critics are uneasy about the applicability to the American scene of that part of Nuremberg that deals with crimes against peace and crimes against humanity. But they have no comparable uneasiness about insisting that persons who commit war crimes, violations of the laws of war, be held responsible for their actions. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code (1947) and is embodied in various federal human research protection regulations. In a program named "SATURN" (Student Athletic Testing Using Random Notification), each (...) school in the Oregon public-school system may implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

Fifty-nine years ago, Dr Leo Alexander published his now famous report on medicine under the Nazis. In his report he describes the two major crimes of German physicians. The participation of physicians in euthanasia and genocide and the horrible experiments performed on concentration camp prisoners in the name of science. In response to this gross violation of human rights by physicians, the Nuremberg military tribunal, which investigated and prosecuted the perpetrators of the Nazi war crimes, established ten principles (...) of ethical conduct in medical research in 1949. Foremost among them was the need for voluntary consent of the human subject and that the experiment be conducted to avoid all unnecessary physical and mental suffering. Notwithstanding all these important efforts and impressive achievements in understanding the ethical failings of Nazi physicians, the bioethical community has almost completely ignored the moral challenges facing the victims of the atrocities. These dilemmas and their responses have continued relevance for modern medicine. (shrink)

Ethics in research are norms for conduct based on local regulations and universal recommendations such as the Nuremberg Code or the Declaration of Helsinki. However, these documents have a number of shortcomings that thwart the construction of a comprehensive ethical framework to guide research on humans in an effort to make better use of research results and to provide for ethical construction of knowledge. A broader ethical framework is suggested in this article, consistent with Ezekiel J. Emanuel's proposal, specifically (...) one that allows for evaluation, reflection and debate about scientific research on humans, based on eight fundamental principles. (shrink)

Considering the importance of research in the development of nursing, we examine the ethical principles governing nurses' investigative activity, as well as the different codes regulating biomedical investigation with human beings, amongst which are the Nuremberg Code, the Declaration of Human Rights, and the Declaration of Helsinki. From the perspective of the central points of the article reference is made to different codes proposed by international nursing associations, as well as reviewing the Deontological Code of Spanish Nursing. The (...) ethical principles a nurse has to bear in mind in research are analysed, with respect to patients, society and the profession. Finally, we refer to certain ethical aspects to be considered in the elaboration and development of a research project, as well as publication of the results. (shrink)

Beginning with a brief presentation of the historical data and conceptual issues that have led to the emergence of the doctrine of the notion of Transitional Justice, I will describe the orientation adopted in two paradigmatic historical contexts, the Nuremberg trial at the end of the Second World War and the post-apartheid reconciliation process in South Africa. Supported by documents from International Human Rights Law and other international legal sources (Rome Statute) I will then offer a provisional definition of (...) what I call a Critical Transitional Justice. The conclusion highlights how the relationship between retrospective and prospective responsibility today is not exclusionary: as central principles of Critical Transitional Justice, they contribute in conferring normative legitimacy to transformative processes of adapting the international system to compliance to general principles of human rights. (shrink)

There is consensus that children have questionable decisional capacity and, therefore, in general a parent or a guardian must give permission to enroll a child in a research study. Moreover, freedom from duress and coercion, the cardinal rule in research involving adults, is even more important for children. This principle is embodied prominently in the Nuremberg Code and is embodied in various federal human research protection regulations. In a program named "SATURN", each school in the Oregon public-school system may (...) implement a mandatory drug-testing program for high school student athletes. A prospective study to identify drug use among student-athletes, SATURN is designed both to evaluate the influence of random drug testing and to validate the survey data through identification of individuals who do not report drug use. The enrollment of students in the drug-testing study is a requirement for playing a school sport. In addition to the coercive nature of this study design, there were ethically questionable practices in recruitment, informed consent, and confidentiality. This article concerns the question of whether research can be conducted with high school students in conjunction with a mandatory drug-testing program, while adhering to prevailing ethical standards regarding human-subjects research and specifically the participation of children in research. (shrink)

For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social–psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices :168–175, 2001). Institutions such as Institutional Review Boards and Ethics (...) Committees oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki. Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants. The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2 years ago we launched a pilot ethics committee at our technical university and began soliciting our colleagues to submit their studies for review. In the past year, we have become officially recognized as a human subjects ethics committee for our university and we are beginning the process of requiring all studies using human subjects to apply for our approval. In this article, we consider some of the special problems relating to protecting human participants in a technology context, and discuss some of our experiences and insights about reviewing human subjects research at a technical university, concluding: that not less than in medical studies, human participants used in technology research benefit from ethical committees’ reviews, practical requirements for publications, grants, and avoiding legal liability are also served by such committees, and ethics committees in such contexts have many similarities to, but certain other special foci than medical ethics committees. We believe that this experience, and these observations, are helpful for those seeking to establish such committees in technology research contexts, and for framing the particular issues that may arise in such contexts for the benefit of researchers, and nascent committees seeking to establish their own procedures. (shrink)

The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon the (...) increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research. (shrink)

The last half century has been characterized by a growth in the regulation of clinical research nationally and internationally. Each area of research on human subjects has been the subject of a vast academic literature and extensive public policy debate, from issues of informed consent to that of regulatory structures. Professor Bernard Dickens has provided an outstanding contribution to this debate internationally through his many innovative and incisive papers in this area. This paper provides an English lawyer’s perspective upon the (...) increasing regulation of clinical research practices and asks – does regulation equate with effective rights protection? From Nuremberg onwards, there has been concern to ensure that research practices are ethical and in accordance with legal principles. So, for example, there have been statements such as the Declaration of Helsinki, which was initially produced in 1964. In the European context in particular, notably influential statements have been the European Convention on Human Rights, which has been followed by the Council of Europe Convention on Human Rights and Biomedicine and, more recently, a Draft Additional Protocol on medical research. (shrink)