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 We conclude that the requirements for animal testing found in the Nuremberg Code were based on scientifically outdated principles, compromised by people with a vested interest in animal experimentation, serve no useful function, increase the cost of drug development, and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 important new work surveys the source and ramifications of the famed Nuremburg Code -- recognized around the world as one of the cornerstones of modern bioethics.

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)

Convinced that armed conflict with the Soviet Union was all but inevitable, that such conflict would involve unconventional atomic, biological, and chemical warfare, and that research with human subjects was essential to respond to the threat, in the early 1950s the U.S. Department of Defense promulgated a policy governing human experimentation based on the Nuremberg Code. Yet the policymaking process focused on the abstract issue of whether human experiments should go forward at all, ignoring the reality of humans (...) subjects research already under way and leaving unanswered ethical questions about how to conduct such research. Documents newly released to the Advisory Committee on Human Radiation Experiments tell the story of the Pentagon policy. (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)

All of us share the same feeling of being torn between two equally impossible attitudes, namely the absurdity of resistance and the abjectness of renunciation, that is to say a feeling of surrender to the course of events and I think that it is true that we are all more or less filled with this feeling or to revert to other terminology which I will borrow from Jacques Ellul, we all have the feeling of being swept away in a haphazard (...) process over which we no longer have any hold. In this respect, I tend to agree with Alain Caillé, that we are at the moment experiencing a shift, a transformation, a revolution - use whichever term you prefer - such as has only happened two or three times in western history and it is true that this great shift is probably comparable, to the Renaissance, say, or the fall of the Roman Empire or possibly the Enlightenment or even the Industrial Revolution in its extent, radicality and also what is enigmatic about it that for those who are experiencing it. There is a radicality in what we are experiencing which is the source of that feeling which sometimes assails us that all resistance would not only be useless but ridiculous. I intend to deconstruct, if I may so express it, this feeling of ridicule which is paralysing us and which indeed paralyses us all the more because it is exploited day after day by talk of flux in which all desires and all ethical or political voluntarism is in general described as some kind of residual archaism. (shrink)

Horst H. Freyhofer. The Nuremberg Medical Trial: The Holocaust and the Origin of the Nuremberg Medical Code. viii + 209 pp., illus., index. New York: Peter Lang, 2004. $35.95 .; Paul Julian Weindling. Nazi Medicine and the Nuremberg Trials: From Medical War Crimes to Informed Consent. xii + 482 pp., illus., index. New York: Palgrave Macmillan, 2004. $80.

Interdisciplinary essays on the ethical issues which encompassed the trials and Code of Nuremberg have been collated from researchers from various countries in fields as diverse as medicine, bioethics, psychoanalysis, history, philosophy, Jewish thought, law, and ethics. The book focuses on five main areas: the juridical originality of the Nuremberg trials; the scientific, epistemological, and psychoanalytic backgrounds of racism and anti-Semitism; the biomedical and bioethical issues of the Nuremberg Code; a post-Nuremberg historical, ethical, and (...) philosophical study of the notion of a 'crime against humanity'; and the Jewish perspective on purity, impurity, race, and the universal ethical expectations of mankind. The goal of the interdisciplinary study is to outline the necessary components of a bridge between science ethics, and ethics and law. (shrink)

Justice at Nuremberg traces the history of the Nuremberg Doctors' Trial held in 1946-47, as seen through the eyes of the Austrian bliogemigrbliogé psychiatrist Leo Alexander. His investigations helped the United States to prosecute twenty German doctors and three administrators for war crimes and crimes against humanity. The legacy of Nuremberg was profound. In the Nuremberg code--a landmark in the history of modern medical ethics--the judges laid down, for the first time, international guidelines for permissible (...) experiments on humans. One of those who helped to formulate the code was Alexander. Justice at Nuremberg provides a detailed insight into the origins of human rights in medical science and into the changing role of international law, ethics and politics. (shrink)

This is the first re-publication and first English translation of regulations concerning Human Experimentation which were binding law prior to and during the Third Reich, 1931 to 1945. The introduction briefly describes the duties of the Reichsgesundheitsamt, which formulated these regulations. It then outlines the basic concept of the Richtlinien for protecting subjects and patients on the one hand and for encouraging New Therapy and Human Experimentation on the other hand. Major issues, like personal responsibility of the physician or researcher, (...) teaching of ethics of research and therapy, and research and therapy on vulnerable populations, are compared with the regulations in the Nuremberg Code and subsequent regulations influenced by the Nuremberg Code. CiteULike Connotea Del.icio.us What's this? (shrink)

This book is a collection of essays which originate from two, mainly European, workshops in 1996 on ethics codes before, and especially after, the appearance of the Nuremberg code in 1947. The book has previously been published in German, and a number of contributions have been translated from the original German and French manuscripts. The majority of the 26 papers cover the development of ethics codes from the Hippocratic oath to the present time, but some papers look at (...) possible codes for new areas such as predictive medicine and resource allocation in health care, …. (shrink)

Since the Nuremberg Code and the first Declaration of Helsinki, globally there has been increasing adoption and adherence to procedures for ensuring that human subjects in research are as well informed as possible of the study’s reasons and risks and voluntarily consent to serving as subject. To do otherwise is essentially viewed as violation of the human research subject’s legal and moral rights. However, with the recent philosophical concerns about responsible robotics, the limits and ambiguities of research-subjects ethical (...) codes become apparent on the matter of constructing automata that maximally resemble human beings (as defined hereunder). In this case, the automata themselves, as products of research and development, are in the very process of their construction subjects of research and development. However, such research faces a paradox: The subjects cannot give their informed consent to this research for their own development, although their consent would be needed for the research. According to ethical codes, this research would be unethical. The article then explores whether the background concepts giving rise to this paradox could be reframed in order to allow such research to proceed ethically. (shrink)

The “Universal Declaration of Human Rights” and the “Geneva Declaration” by the World Medical Association, both in 1948, were preceded by the foundation of the United Nations in New York (1945), the World Medical Association in London (1946) and the World Health Organization in Geneva (1948). After the end of World War II the community of nations strove to achieve and sustain their primary goals of peace and security, as well as their basic premise, namely the health of human beings. (...) All these associations were well aware of the crimes by medicine, in particular by the accused Nazi physicians at the Nuremberg Doctors Trial (1946/47, sentence: August 1947). During the first conference of the World Medical Association (September 1947) issues of medical ethics played a major role: and a new document was drafted concerning the values of the medical profession. After the catastrophe of the War and the criminal activities of scientists, the late 1940s saw increased scrutiny paid to fundamental questions of human rights and medical ethics, which are still highly relevant for today’s medicine and morality. The article focuses on the development of medical ethics and human rights reflected in the statement of important persons, codes and institutions in the field. (shrink)

This book is a collection of essays which originate from two, mainly European, workshops in 1996 on ethics codes before, and especially after, the appearance of the Nuremberg code in 1947. The book has previously been published in German, and a number of contributions have been translated from the original German and French manuscripts. The majority of the 26 papers cover the development of ethics codes from the Hippocratic oath to the present time, but some papers look at (...) possible codes for new areas such as predictive medicine and resource allocation in health care, …. (shrink)

Ethical codes have been widely put in place by professional associations, universities and other organizations. They observe common standards and procedures which are applied and adapted to local or specialist needs. The early codes such as that of Nuremberg exclusively addressed the rights of participants. This article detects a shift in emphasis. The argument relies on a distinction between morality and ethics and it is contended that ethical codes legitimize kinds of practice that are morally unprincipled. In modern formulations (...) of research ethics there is a tendency to abdicate responsibility for the protection of rights and interests and to pass it from researchers to participants or subjects. The concern is rather more for the security of investigators than for that of participants. It is recognized that codes are here to stay but suggestions are made to recover the spirit of Nuremberg. (shrink)

The article presents and analyzes different approaches of U.S. bioethicists in comprehending the Nazi medical crimes after 1945. The account is divided into two sections: one dealing with discussions on research ethics and the Nuremberg Code up until the 1970s and the other ranging from the 1970s to the present and highlighting bioethics' engagement with Nazi analogies. The portrayal of different bioethical scholars, institutions, and documents—most notably Henry K. Beecher, Jay Katz, the Belmont Report, the Hastings Center, Arthur (...) L. Caplan, and Robert M. Veatch—provides a nuanced interpretation of the motives that bioethicists held and the strategies that they applied to establish an understanding of the Nazi medical crimes and their relation to contemporary bioethical issues. In this, the different approaches shared a common goal: To integrate the Nazi medical crimes into an ethical framework by means of selective acknowledgments and representation of their history. (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)

The Mental Incapacity Bill not only paves the way for euthanasia, but invites wholesale abuse and homicide, writes Jacqueline Laing. On 19 October 2004, when the Mental Capacity Bill was at its crucial committee stage, the Law Society issued a statement of ‘strong support’, claiming that it empowers patients and in no way introduces euthanasia. Laing argues that the Bill threatens the incapacitated by granting a raft of new third parties power to require that health professionals withhold ‘treatment’, which, after (...) the controversial decision in Airedale NHS Trust v Bland [1993] AC 789, includes food and fluids delivered both by tube and, in certain cases, by spoon. The Bill further endangers the vulnerable, first, by allowing non-therapeutic research on the non-consenting mentally incapacitated, in breach of the Nuremberg Code and First Declaration of Helsinki, and secondly, by permitting new agents power to undertake on people with learning disabilities certain questionable procedures currently authorised by the High Court, such as non-voluntary sterilisation. (shrink)

El artículo analiza cómo la revista Medicina e Morale ha afrontado en su historia el tema de la ética en la experimentación clínica, que representa una parte muy amplia y compleja de la bioética y también de la deontología médica. Los aspectos que esta temática comprende son ya numerosos y la literatura producida ingentísima. La ética de la experimentación ha recibido particular impulso y atención a continuación de diversas experimentaciones no éticas que han turbado profundamente la opinión pública y hecho (...) necesario una fuerte reconsideración en el ámbito de la investigación clínica. En general, de los años 60's a los años 80's del siglo XX, ha prevalecido en la literatura un intenso empeño e interés en la elaboración de los principios de referencia y en la reflexión teórica relativa a varias cuestiones . De los años 90 en adelante se ha en cambio intensificado -probablemente por las exigencias nacidas en seno de los Comités de ética que precisamente en aquel período han iniciado a difundirse masivamentela elaboración de códigos, reglamentos, líneas-guía que han orientado el desarrollo de la disciplina más en sentido de procedimiento y con un acercamiento ético-deontológico. En particular, Medicina e Morale, ha estado siempre en estas temáticas, desde los inicios de su historia, constituyendo una voz original en el debate, además que un instrumento de difusión de documentos nacionales y sobre todo internacionales. La Revista ha representado, sobre todo en los últimos treinta años, un verdadero punto de referencia a nivel nacional y en algunos casos también internacional, proponiendo a veces orientaciones originales, que han sido luego acogidas en el ámbito de líneas-guía y de normativas.The article deals with how the journal Medicina e Morale has faced ethics in clinical trials, which represents a very large and complex bioethical issue, but also deontological one. This area comprises many questions and the literature is huge. It has risen after unethical clinical trials that have shocked the public and have produced a big rethinking about it. In general, from the '60s to the '80s of the XXth century, an intense commitment and interest have prevailed on the elaboration of the reference principies and on theoretical reflection on various issues, such as informed consent, the ethical significance of clinical research, the protection of vulnerable people, the risk acceptability). Since the '90s onwards the development of codes, regulations, guidelines -that have guided the development of the discipline in a procedural and also deontological sense- has increased, probably due to the large diffusion of ethics committees. Particularly, the journal "Medicina e Morale" has always been present on these issues, since the beginning of its history, creating an original voice in the debate, as well as a dissemination tool of national and especially international documentabon. The journal has been, especially in the last thirty years, a real national, and sometimes international, be nchmark, offering original suggestions which are then accepted in guidelines and regulations. (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)

Following promulgation of the Nuremberg code in 1947, the ethics of research on human subjects has been a challenging and often contentious topic of debate. Escalation in the use of research participants in low-income countries over recent decades , has intensified the debate on the ethics of international research and led to increasing attention both to exploitation of vulnerable subjects and to considerations of how the 10:90 gap in health and medical research could be narrowed. In 2000, prompted (...) by the discussions over several years that led to the US NIH launching a capacity building programme on research ethics for members of research ethics committees in developing countries, we advanced a ‘new look’ for the ethics of international research.1 Since then progress has been made on several fronts.First, our ideas—considered somewhat radical and impractical at the time—have been provocatively addressed by scholars who have either contested them or advanced similar conceptions of what obligations international researchers have to research participants and communities in low income countries before, during and after clinical trials. Second, those researchers who have been sympathetic to our ideas have either endeavoured to put these into practice or have investigated the feasibility of doing so. Third, the intractability of the 10/90 gap and the escalation of interest in global health have sensitised many to the need to amplify the uptake of these ideas in practice.Here, we briefly review the conceptual and practical developments in international research ethics. While much conceptual progress has been made (and the concepts are now appearing …. (shrink)

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. (...) Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. (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)

Several influential ethical guidelines and frameworks endorse the view that research with human participants is ethically acceptable only when it has “social value,” meaning that it generates knowledge which can be used to benefit society. For example, the Nuremberg Code requires that medical experiments on human beings “yield fruitful results for the good of society, unprocurable by other methods or means of study”. The Council for International Organizations of Medical Sciences guidelines hold that “health-related research with humans... must (...) have social value” or the “prospect of generating the knowledge and the means necessary to protect and promote people’s health” (CIOMS... (shrink)

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)

To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.

Classifying research proposals by risk of harm is fundamental to the approval process and the most pivotal risk category in most regulations is that of “minimal risk.” If studies have no more than a minimal risk, for example, a nearly worldwide consensus exists that review boards may sometimes: (1) expedite review, (2) waive or modify some or all elements of informed consent, or (3) enroll vulnerable subjects including healthy children, incapacitated persons and prisoners even if studies do not hold out (...) direct benefits to them. The moral and social purposes behind this threshold are discussed along with relevant views from the National Commission, NBAC, NHRPAC, Grimes v. Kennedy Krieger Institute, The Nuremberg Code, and The WMA's Declaration of Helsinki. Representative policies from Australia, Canada, South Africa, the U.S., and CIOMS are reviewed revealing different understandings of this sorting threshold. Six of nine frequently cited interpretations of “minimal risk” are untenable. The “absolute” interpretation of the “routine examination” standard is defended as best. (shrink)

Animal research has long been a source of biomedical aspirations and moral concern. Examples of both hope and concern are abundant today. In recent months, as is common practice, monkeys have served as test subjects in promising preclinical trials for an Ebola vaccine or treatment 1 , 2 , 3 and in controversial maternal deprivation studies. 4 The unresolved tension between the noble aspirations of animal research and the ethical controversies it often generates motivates the present issue of the Cambridge (...) Quarterly of Healthcare Ethics. As editors of this special section, we hope that these original and timely articles will push the professional discussion of animal research ethics in a positive direction that will benefi t research scientists and others interested in moral problems in animal research. We also look forward to a day when animal research will genuinely meet both appropriate scientifi c and appropriate ethical criteria—criteria that themselves can be improved by critical scrutiny. Animal research—that is, the use of live animals as experimental subjects in biomedical and behavioral fi elds of learning—has been deeply entrenched for well over half a century. One signal development was the enactment in the late 1930s of federal product safety legislation in the United States and other nations that required animal testing of food, drugs, and medical devices prior to use by human subjects or consumers. 5 Another development was the publication of codes of research ethics that called for animal research prior to human research. The Nuremberg Code, published by an American military tribunal in 1947–48 after scrutiny of Nazi medical atrocities, stated that experiments involving the use of human subjects should be " based on the results of animal experimentation. " 6 The Declaration of Helsinki, fi rst published in 1964, reaffi rmed this assumption and added, rather imprecisely, that " the welfare of animals used for research must be respected. " 7 Against the background of such statements, the institutionalization and widespread acceptance of animal research in the twentieth century rested on two basic assumptions, one factual and one moral. The factual assumption was that animal research is suffi ciently reliable as a basis for predicting the effects of drugs, products, and other materials on human beings that animal trials can be expected to yield signifi cant scientifi c conclusions and medical benefi ts to humanity. (shrink)

In 1962, Harvard professor of anesthesiology Henry Beecher wrote to Senator Estes Kefauver about certain additions to the federal Food and Drug Act then being considered. According to The Antibiotic Era, the Maryland congressman Samuel Friedel had introduced language that would require informed consent in clinical research. Beecher joined a number of other distinguished medical scientists warning that such a requirement would “cripple” American medical research. A year before, Beecher had protested the U.S. Army's inclusion of the Nuremberg (...) class='Hi'>Code in its contracts. Beecher's commitment to a medical ethics of virtue rather than one of oversight suggests that he was a far more interesting person than the cardboard cutout so often vaguely referenced in bioethics as an icon of the rights of human subjects. His thinking about research ethics was rooted in his post‐World War II laboratory work with LSD. (shrink)

ABSTRACT A complex problem exists about how to promote the best interests of children as a group through research while protecting the rights and welfare of individual research subjects. The Nuremberg Code forbids studies without consent, eliminating most children as subjects, and the Declaration of Helsinki disallows non-therapeutic research on non-consenting subjects. Both codes are unreasonably restrictive. Another approach is represented by the Council for the International Organizations of Medical Science, the U.S. Federal Research Guidelines, and many other (...) national policies. They allow research ethics committees or institutional review boards to authorize studies with acceptable balances of likely benefits and harms, but neither clarify how to balance them nor explain the meaning of pivotal concepts, like “minimal risk.” Paths to the improvement of balancing or consequentialist approaches include improving standardizing of risk assessment, rejecting crude utilitarianism, identifying and justifying normative or moral judg-ments, and acknowledging extra-regulatory thresholds and deontological or non-negotiable duties to children. (shrink)

Interest in the ethics of research on human subjects, stimulated by atrocious human experimentation during WWII and the resultant Nuremberg Code, has been sustained by examples of unethical research in many countries and by proliferation of codes and guidelines. Such interest has intensified in recent years in association with expanding international collaborative research endeavors. The ongoing controversy in international research ethics takes place at two levels. At the practical level it is about the competing concerns of those predominantly (...) interested in doing research to advance knowledge and those who, while supporting the need for research, are more acutely aware of the potential to exploit vulnerable participants, especially in developing countries. At the level of theory the controversy pits ethical universalism against moral relativism.In her recent review of agreements and controversies in international research ethics, Ruth Macklin has concluded that, despite seeming agreement on several issues, many different viewpoints persist. In her view it is unlikely that these will be resolved easily. (shrink)

There is substantial published evidence showing that countless people enroll each year in ethically deficient clinical trials. Many of the trials are problematic because the quality of the science used to justify their launch may not be sufficiently vetted while many other trials may lack requisite social value. This poses the question: why do people volunteer for them? The answer resides in large part in the fact that informed consent practices have historically masked, rather than disclosed, the information that would (...) alert research candidates to the ethically problematic nature of the trials. The “reasonable person” and “key information” provisions in the revised US Common Rule create the opportunity to correct this historical shortcoming. Two sources are employed to shed light on what the “key information” is that should be disclosed to a “reasonable person”: the original disclosure aims of the Nuremberg Code, as well as an extensive body of meta-research evidence. Those sources jointly support a range of new disclosures in the informed consent process that would unmask the heretofore undisclosed information. The resulting proposed new disclosures pertain to the overall success prospects of clinical trials, the quality of the prior research that both forms the basis of clinical trials and informs assessment of their risks and benefits, the potential social value of clinical trials, and the commercial purposes of clinical trials. (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)

Since the Nuremberg trials (1947–1949), informed consent has become central for ethical practice in patient care and biomedical research. Codes of ethics emanating from the Nuremberg Code (1947) recognize the importance of protecting patients and research subjects from abuses, manipulation and deception. Informed consent empowers individuals to autonomously and voluntarily accept or reject participation in either clinical treatment or research. In some cases, however, the underlying mental or physical condition of the individual may alter his or her (...) cognitive abilities and compromise the informed consent process. This is particularly true in chronic psychiatric conditions such as Treatment-Resistant Depression (TRD), where individuals may fail to respond to traditional antidepressant treatments (e.g., psychotherapy, pharmacotherapy). Moreover, it may raise further concerns for an individual’s motivation to consent and the level of understanding of the treatment or research procedure. This paper focuses on the informed consent process for Vagus Nerve Stimulation (VNS) in the treatment of individuals diagnosed with TRD. Specifically, the paper addresses how depression may affect the decision-making capacity of an individual and the potential ethical and legal impact of failure to appreciate the seven elements of the consenting process (competence, voluntariness, disclosure, recommendation, understanding, decision, and authorization). To ensure the protection of vulnerable individuals with psychiatric disorders such as TRD and promote ethical behavior in biomedical research and patient care while avoiding potential legal pitfalls, we propose a paradigm that requires a stringent evaluation process of decision-making capacity for informed consent. (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)

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)

The Helsinki Declaration, first published in 1964, is the universally accepted standard for ethical behavior in research involving human subjects. The Declaration was formulated in response to the abuses of human subjects by the scientists in Nazi Germany and to update the Nuremberg Code. Amended in 1975, 1983, 1989, 1996, and 2000, the Declaration provides the foundation for the United States federal regulations for research involving human subjects.To conform to standards developed in the Declaration, a researcher must fulfill (...) the following: respect the autonomy of the individual; promote and safeguard the individual’s health; provide informed consent without coercion; take special measures with vulnerable populations; compare new therapies to the best current therapies; have a thorough scientific knowledge of the subject; assess risk versus benefit of the intervention; perform studies that will ultimately benefit the population involved in the research; accurately report their findings; and fully disclose ethical concerns in their research protocols. (shrink)

When Beauchamp and Childress articulated the necessary and sufficient conditions for informed consent, they might have thought that would be the final word on what informed consent is.1 It’s emphasis in the Belmont Report,2 the Nuremberg Code,3 the Helsinki Declaration4 and numerous codes of professional ethics seems more than sufficient for emphasising its importance. Nonetheless, its place as the central issue for medical ethics appears undiminished and Pubmed lists 6192 publications with ‘Informed Consent’ in the title since 1979. (...) One view of this is that medical ethics has channelled too much intellectual effort into consent, perhaps at the expense of other important ethical issues. Papers in this issue of the Journal of Medical Ethics suggest that the discussion of consent continues because of the need to consider what it means in new contexts, how it can be a challenge in some contexts, how it is related to tough theoretical issues about the value of choice and autonomy and how it can blend into other debates. The development of biobanking and the challenges it presents about which variant of consent should apply have been discussed in the JME before. One option is for consent to be ‘broad’, meaning that when consent is given for the collection of tissue the ‘type’ of future secondary uses are specified but not the specific research studies, on the basis that the potential benefits are significant, the risks low and the costs of gaining consent for every use of tissue significant. Hofmann has argued against broad consent on the basis that being ‘informed’ is a crucial aspect of …. (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)

This paper examines the culture, the dynamics and the financial underpinnings that determine how medical research is being conducted on children in the United States. Children have increasingly become the subject of experiments that offer them no potential direct benefit but expose them to risks of harm and pain. A wide range of such experiments will be examined, including a lethal heartburn drug test, the experimental insertion of a pacemaker, an invasive insulin infusion experiment, and a fenfluramine "violence prediction" experiment. (...) Emphasis, however, is given to psychoactive drug tests because of the inherent ethical and diagnostic problems involved in the absence of any objective, verifiable diagnostic tool. Effort is made to provide readers comprehensive reference sources to evidence-based reports about the serious risks these drugs pose for adults and children so that the reader may judge whether the benefits (if any) outweigh the risks for children. The first ethical issue raised by these experiments is: did the severity of illness in these children justify their exposure to short and long-term risks? The ethics of the experiments will be evaluated by referring to existing codes of medical research ethics-the Nuremberg Code, the Declaration of Helsinki, and the federal Code of Regulations. The thirteen cases presented will demonstrate that children are being used in ever more speculative experiments, often in the absence of a therapeutic intent, but a significant chance for causing harm and / or discomfort. Some of the experiments were designed to explore the mechanisms of pathology and pharmacological interventions, or the response of neurological brain receptors to chemical provocation ("challenge"). Others were designed to test the safety or efficacy of new drugs, even to test these drugs on healthy children who were hypothesized to be "at risk." Children and adolescents have been subjected to "forced dose titration" experiments that induced a spectrum of severe adverse effects, including insomnia, extreme restlessness, agitation, (akathisia) and self-injurious behavior. FDA reports show that suicide is a significant issue in psychotropic drug trials-in pediatric trials the problem is even greater. The paper aims to demonstrate how the enactment of the Better Pharmaceuticals for Children Act (incorporated into the Food and Drug Administration Modernization Act, FDAMA), set in motion a radical shift in public policy by providing huge financial incentives to pharmaceutical companies to test new or patented drugs in children. Federal policy shifted from one aimed at protecting children by setting limits on permissible research risks, to a policy aimed at broadening the inclusion of children as test subjects. It will be shown how the FDA and the Department of Health and Human Services lifted regulatory restrictions to permit research involving greater than minimal risk to be conducted on healthy children, claiming that all children are potentially "at risk" of a future condition. Children were in this way deprived of regulatory protections. An argument will be made that the approval of nontherapeutic, harmful experiments-such as exposure of toddlers to lead poison-under the current gate keeping system raises serious doubts about the sustainability of institutional review boards (IRBs) as protectors of human research subjects. Children, who are precluded from exercising the adult human's right to informed consent, are being exploited as commodities for commercial ends. It is the position of the author that nothing less than the enactment of a federal law mandating a radical overhaul of the current research review system, with independent checks and balances, will provide children the legal protections they need. Ten specific recommendations are offered to protect children from harmful experiments. (shrink)

Background The aim of the study is to assess the knowledge, attitudes and practices among healthcare professionals in Barbados in relation to healthcare ethics and law in an attempt to assist in guiding their professional conduct and aid in curriculum development. Methods A self-administered structured questionnaire about knowledge of healthcare ethics, law and the role of an Ethics Committee in the healthcare system was devised, tested and distributed to all levels of staff at the Queen Elizabeth Hospital in Barbados (a (...) tertiary care teaching hospital) during April and May 2003. Results The paper analyses 159 responses from doctors and nurses comprising junior doctors, consultants, staff nurses and sisters-in-charge. The frequency with which the respondents encountered ethical or legal problems varied widely from 'daily' to 'yearly'. 52% of senior medical staff and 20% of senior nursing staff knew little of the law pertinent to their work. 11% of the doctors did not know the contents of the Hippocratic Oath whilst a quarter of nurses did not know the Nurses Code. Nuremberg Code and Helsinki Code were known only to a few individuals. 29% of doctors and 37% of nurses had no knowledge of an existing hospital ethics committee. Physicians had a stronger opinion than nurses regarding practice of ethics such as adherence to patients' wishes, confidentiality, paternalism, consent for procedures and treating violent/non-compliant patients (p = 0.01) Conclusion The study highlights the need to identify professionals in the workforce who appear to be indifferent to ethical and legal issues, to devise means to sensitize them to these issues and appropriately training them. (shrink)

The prelims comprise: Genetics under National Socialism From “Medical War Crimes” to the Nuremberg Code.