Biblioteca Digital

The issue of ethics with respect to medical experimentation in Germany during the 1930s and 1940s was crucial at the Nuremberg trials and related trials of doctors and public health officials. Those involved in horrible crimes attempted to excuse themselves by arguing that there were no explicit rules governing medical research on human beings in Germany during the period and that research practices in Germany were not different from those in allied countries. In this context the Nuremberg code of 1947 is generally regarded as the first document to set out ethical regulations in human experimentation based on informed consent. New research, however, indicates that ethical issues of informed consent in guidelines for human experimentation were recognised as early as the nineteenth century. These guidelines shed light on the still contentious issue of when the concepts of autonomy, informed consent, and therapeutic and non-therapeutic research first emerged. This issue assumes renewed importance in the context of current attempts to assess liability and responsibility for the abuse of people in various experiments conducted since the second world war in the United States, Canada, Russia, and other nations.

The Nuremberg Code drafted at the end of the Doctor’s trial in Nuremberg 1947 has been hailed as a landmark document in medical and research ethics. Close examination of this code reveals that it was based on the Guidelines for Human Experimentation of 1931. The resemblance between these documents is uncanny. It is unfortunate that the authors of the Nuremberg Code passed it off as their original work. There is evidence that the defendants at the trial did request that their actions be judged on the basis of the 1931 Guidelines, in force in Germany. The prosecutors, however, ignored the request and tried the defendants for crimes against humanity, and the judges included the Nuremberg Code as a part of the judgment. Six of ten principles in Nuremberg Code are derived from the 1931 Guidelines, and two of four newly inserted principles are open to misinterpretation. There is little doubt that the Code was prepared after studying the Guidelines, but no reference was made to the Guidelines, for reasons that are not known. Using the Guidelines as a base document without giving due credit is plagiarism; as per our understanding of ethics today, this would be considered unethical. The Nuremberg Code has fallen by the wayside; since unlike the Declaration of Helsinki...

Throughout history, medical practitioners have been admonished to do nothing in treating their patients that might result in harming them. It was not until the 20th century that such teaching was codified in specific legislation. Spurred on by the perversity of Nazi doctors during the Holocaust, world leaders produced the Nuremberg Code in 1947 and the Declaration of Helsinki in 1964. Revelations about other egregious acts in the guise of legitimate medical research led to other measures to prevent such mistreatment. Regulations to ensure physician competency and responsibility have mushroomed in the succeeding years. While such measures were coming into being, some of the greatest advances in medicine were being achieved, not least among them those in cardiovascular surgery. Ironically, much of this valuable research would likely not have been approved under regulatory measures now firmly in place. Given the nature of medical research, more often than not a certain degree of risk in all patients entering such trials may be unavoidable. There is always a balance to be maintained between risk and potential benefit.

Informed consent is an ethical and legal requirement for research involving human participants. It is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision and after studying all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular clinical trial and significance of the research for advancement of medical knowledge and social welfare. The concept of informed consent is embedded in the principles of Nuremberg Code, The Declaration of Helsinki and The Belmont Report. Informed consent is an inevitable requirement prior to every research involving human being as subjects for study. Obtaining consent involves informing the subject about his or her rights, the purpose of the study, procedures to be undertaken, potential risks and benefits of participation, expected duration of study, extent of confidentiality of personal identification and demographic data, so that the participation of subjects in the study is entirely voluntary. This article provides an overview of issues in informed consent: The obligations of investigator, sponsor and Institutional Review Board to protect rights and welfare of human research subjects. It discusses about the basic elements of informed consent and the process to be followed while obtaining informed consent. Some of the circumstances under which informed consent can be waived and ethical challenges faced by physicians in obtaining informed consent from subjects are also highlighted in this article.

Hippocratic Oath is a living document for ethical conduct of the physicians around the world. World Medical Association has been amending the oath as per the contemporary times. Although physicians maintain their ethical standards while treating a patient yet many a times social, administrative and ruling powers either use physicians as their tool of oppression or victimize them for conducting duties as per their oath. The Tuskegee Syphilis Study and Human Radiation Experiments in America, Nazi Experiments in Germany and compulsory sterilization program in India were the studies where States used physicians for the advancement of their rationality or belief. Conversely victimization of physicians in Kosovo, Sri Lanka and incarcerating physicians for treating human immunodeficiency virus/acquired immunodeficiency syndrome patients in some countries is concerning. The Nuremberg code, the Declaration of Geneva, Belmont Report and Declaration of Helsinki are ethical documents while active involvement of Food and Drug Administration through “common rule” resulted in guidelines like International Conference on Harmonization and Good Clinical Practices. Still unethical studies are found in developing countries. Studies such as experimental anticancer drugs in 24 cancer patients without adequate prior animal testing and informed consent in Kerala...

Major pioneering advances of medicine in history tend to manifest in two directions that seem divergent but actually unified with dialectics: one is the important biological principle revealed by in-depth studies from the clinic to the laboratory based on individual cases; the other is the colonial generality displayed by epidemiologic data from large-scale samples. Although advances predominated, we human beings were paying dearly for it due to serious incidents of endangering ourselves and defects of restrictions of laws and ethics. Subsequently, the Nuremberg Code, Declaration of Helsinki and Belmont Report came into light and constrained human experiments and clinical trials. However, the development of such laws and regulations in China is lagging behind and renders China as a breeding ground for gray medicine. There are three lessons we can learn from painful histories and apply to individualized treatment of lung cancer. Firstly, the abuse of Avastin beyond its indications reflected the similar situation of tyrosine kinase inhibitors in lung cancer due to different molecular types and stages of tumors; secondly, the black market of stem cell therapy in China reminds us how to identify the boundaries of clinical trials and clinical treatment...

This paper explores the structure of the major code of ethics regarding human experimentation, the Nuremberg Code. The paper begins with an explanation of the modern ethical standards and how they were established. Following this background is an inquiry into the actual force the Nuremberg Code carries in American courts, and how cultural values are reflected in the courts’ decisions. These ethical codes are then explored through the lens of the AIDS vaccine research being conducted currently in Africa and other third-world countries. This more philosophical part of the paper questions the strength of the Nuremberg Code, and highlights some of its weaknesses with regards to real-life crises. In conclusion, the paper exposes the many conflicting aspects of this ethical debate between human autonomy and medical emergency and reveals that while perhaps there is no “right†answer at this time, the debate itself is a valuable check on our ambitions.

The purpose of this chapter is to provide a context for thinking about the role of ethics in quantitative methodology.We begin by reviewing the sweep of events that led to the creation and expansion of legal and professional rules for the protection of research subjects and society against unethical research. The risk–benefit approach has served as an instrument of prior control by institutional review boards. After discussing the nature of that approach,we sketch a model of the costs and utilities of the “doing” and “not doing” of research.We illustrate some implications of the expanded model for particular data analytic and reporting practices.We then outline a 5 × 5 matrix of general ethical standards crossed with general data analytic and reporting standards to encourage thinking about opportunities to address quantitative methodological problems in ways that may have mutual ethical and substantive rewards. Finally,we discuss such an opportunity in the context of problems associated with risk statistics that tend to exaggerate the absolute effects of therapeutic interventions in randomized trials.

Research in human beings is an important chapter of medical ethics. In recent years, investigation has been taken over by profit driven corporations that must guarantee the medical and commercial application of results. This new model of investigation has generated conflicts of interest in doctor-patient, researcher-subject relationship. The inevitable debate and media reaction has led. These trials of controversial design to regions of the globe where the vulnerability of the populations continues to allow their undertaking. This article includes a historical perspective on experimentation in human beings and the conditions that led to its regulation: the Nuremberg CODE, followed by the Helsinky Declaration in its different versions, and the Belmont Report, that defend the subject according to the ethic of principles used in western medicine. There is then a review of the attempts to change international regulation to reintroduce clinical trials with placebo--which since 1996 is only permitted where there are no therapeutic or diagnostic methods--on populations that would otherwise have no access to treatment. This then leads on to the issue of double standards in medical investigation defended by many investigators and some official entities. The article concludes that it may be prudent to allow local ethical commissions to approve deviation from the established norm if such is necessary to resolve urgent questions of health in the country...

Australian National University and Leiden University; Paper presented at the Transmission of academic values in Asian Studies workshop, 25 & 26 June 2009, Canberra, ANU

O objectivo do presente texto é apresentar a história do consentimento informado, discutir a sua utilidade, e distinguir o que é direito de todos os cidadãos do que é obrigação dos profissionais. Discute-se o significado do consentimento informado em diversos códices (Código de Nuremberg, Declaração da Promoção dos Direitos dos Doentes na Europa, Declaração de Helsínquia, Código de Ética da Associação Americana de Psicologia e da Associação Britânica de Psicologia, e na Lei Portuguesa). Defende-se a importância do respeito por esta figura embora referindo a necessidade de aperfeiçoar a sua aplicação. ------ ABSTRACT ------ The aims of the present study are to describe and to discuss the informed consent in health research in general and, more specifically, in health psychology. We salient a distinction between human rights and ethical obligation, that is present in different codices. We discuss the meaning of informed consent in different codices (Nuremberg Code, Declaration on the Promotion of Patients' Rights in Europe, Declaration of Helsinki, Code of Conduct of the American Psychological Association and British Psychological Society, and the Portuguese Law). We defend the importance of the idea of informed consent and the respect for it for the practice of health psychology.

This article analyzes historical background leading to first world and regional regulations on medical and bioethical ethics, since Nuremberg Code, until UNESCO, UNO, Church Magistery, Ciom and Helsinki declarations, as well as the Belmont Code and the Medical Ethics Federal Code in the USA. In Colombia those codes have translated into the 83 Law of Medical Ethics under Health Ministry Resolution 8430 of 1993, and Enactment 156, pending sanction. National and international codes are founded on three basic principles: respect, benefice, and justice. Criticism on Helsinki declaration is reviewed, primarily in reference to placebos based controls, and informed consent, with a word of advice on negative effects of social and economic condition of medical profession on observance of code of ethics in medicine practice.; Se analizan los antecedentes históricos que llevaron a las primeras legislaciones regionales y mundiales sobre ética médica y Bioética, desde el Código de Nuremberg hasta las declaraciones de la Unesco, de las Naciones Unidas, de   L Magisterio de la Iglesia, del Cioms y de Helsinki; en los Estados Unidos, el Código de Belmont y el Código Federal de Ética Médica. En Colombia, esos códigos se han traducido en la Ley 83 de Ética Médica...

Today's researchers are obligated to conduct their studies ethically. However, it often seems a daunting task to become familiar with the important ethical codes required to do so. The purpose of this article is to examine the content of those ethical documents most relevant to the biomedical researcher. Documents examined include the Nuremberg Code, the Declaration of Helsinki, Henry Beecher's landmark paper, the Belmont Report, the U.S. Common Rule, the Guideline for Good Clinical Practice, and the National Bioethics Advisory Commission's report on research protections for the mentally ill.

Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the ‘Ethical Guidelines for Biomedical Research on Human Subjects’ in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity...

Este artigo tem por objetivo relacionar as normas éticas sobre pesquisas com seres humanos com o Código Civil brasileiro, lei que trata de diversos aspectos relacionados à proteção da pessoa humana. Em geral, os pesquisadores da área médica desconhecem a legislação civil, não se dando conta das consequências jurídicas dos erros causados pelas pesquisas realizadas. Apresenta-se, no início, um resumo da disciplina ética sobre pesquisas com seres humanos, com o Código de Nuremberg e a Declaração de Helsinque, além da disciplina infralegal no Brasil, realizada pelo Conselho Nacional de Saúde. Em seguida, com o intuito de demonstrar a inexistência de um vazio legislativo nessa matéria, analisaram-se os aspectos do Código Civil relativos às pesquisas com seres humanos, como a personalidade jurídica, a capacidade de agir, os direitos da personalidade e a responsabilidade civil.; This study seeks to relate the ethical norms for research on human subjects with Brazilian Civil Code, a law that considers many aspects of protection for individuals. In general, medical researchers are unaware of civil legislation and do not realize the legal consequences of any errors caused by their research. First, a summary of the ethical aspect of research on human subjects is presented...

Health research sets out to acquire not only theoretical knowledge but also benefits for many people and often society as a whole, and is therefore justified. The quandary, though, is how such an important, shared purpose can be pursued with full protection of individuals and communities, in particular those with vulnerabilities. Abuses in the field surfaced in the early 1800s, and by the 1890s, anti-vivisectionists were calling for laws to protect children because of the increasing numbers of institutionalised children being subjected to unethical research. When read together, the Nuremberg Code and the Universal Declaration of Human Rights can be interpreted as establishing a basis for underpinning the principles of free and informed consent and avoiding harms and exploitation in scientific experiments involving human participants. The Declaration of Helsinki has been recognised as one of the most authoritative statements on ethical standards for human research in the world.