A Brief History of Biomedical Research Ethics in Iran: Conflict of Paradigms.

During the past two decades, Iran has experienced a noteworthy growth in its biomedical research sector. At the same time, ethical concerns and debates resulting from this burgeoning enterprise has led to increasing attention paid to biomedical ethics. In Iran, Biomedical research ethics and research oversight passed through major periods during the past decades, separated by a paradigm shift. Period 1, starting from the early 1970s, is characterized by research paternalism and complete reliance on researchers as virtuous and caring physicians. This approach was in concordance with the paternalistic clinical practice of physicians outside of research settings during the same period. Period 2, starting from the late 1990s, was partly due to revealing of ethical flaws that occurred in biomedical research in Iran. The regulatory and funding bodies concluded that it was not sufficient to rely solely on the personal and professional virtues of researchers to safeguard human subjects' rights and welfare. The necessity for independent oversight, emphasized by international declarations, became obvious and undeniable. This paradigm shift led to the establishment of research ethics committees throughout the country, the establishment of academic research centers focusing on medical ethics (MEHR) and the compilation of the first set of national ethical guidelines on biomedical research-one of the first and most important projects conducted by and in the MEHR. Although not yet arrived, 'period 3' is on its way. It is predictable from the obvious trends toward performance of high-quality clinical research and the appearance of a highly educated new generation, especially among women.

Ética na Pesquisa Histórica em Enfermagem e Saúde: Perspectiva à Integridade Científica / Ethics in Historical Research in Nursing and Health: Perspective to Scientific Integrity

Ética em Pesquisa em História da Enfermagem comporta o processo historiográfico, a comunicação do conhecimento produzido e os limites dessa comunicação. Pensar em ética na pesquisa histórica comporta também a realização de estudos cujos benefícios possam ser revertidos para a sociedade, em termos sociais ou acadêmicos.

Bioética: afinal, o que é isto? / Bioethics: after all, what is this?

JUSTIFICATIVA E OBJETIVOS: A Bioética tem se estruturado como discurso em resposta às novas questões éticas levantadas pelas ciências da saúde e da vida - mormente aquelas relativas ao desenvolvimento tecnocientífico dos últimos 100 anos -, permitindo a reflexão sobre valores e conceitos - por exemplo, vida,finitude e sofrimento. Com base nessas breves considerações, o objetivo deste artigo - um ensaio crítico-reflexivo - é apresentar uma contextualização teórica sobre a Bioética, enfocando suas origens e seus principais problemas. CONTÉUDO: A ponderação sobre temas atinentes à Bioética remete a algumas das questões mais candentes da atualidade: o aborto,a eutanásia e os problemas morais atinentes ao início e ao fim da vida; a (bio)ética em pesquisa, envolvendo seres humanos e/ou animais, a bioética nas questões relativas à saúde pública, destacando-se suas interfaces com a Estratégia Saúde da Família e os atuais debates sobre a alocação de recursos, bem como a bioética e as questões referentes à preocupação com o meio ambiente e sua preservação. CONCLUSÃO: Em decorrência de sua amplitude e da natureza crítica das reflexões elaboradas no bojo da disciplina, propõe-se que a Bioética seja incluída definitivamente na educação superior das diferentes áreas do conhecimento, contribuindo com a formação de cidadãos, profissionais e pesquisadores comprometidos com ações eticamente defensáveis no cotidiano de suas práticas.

BACKGROUND AND OBJECTIVES: Bioethics has been structured as a discourse in response to new ethical issues raised by thes ciences of health and life - especially those relating to technoscientific development in the last century - allowing for reflection on values and concepts - for example, life, finiteness, and suffering. Based on these brief considerations, the aim of this paper - a critical and reflective essay - is to present a theoretical contextualization on Bioethics, focusing on its origins and main problems. CONTENTS: The reflection on issues related to bioethics refers to some of the most burning issues of our time: abortion, euthanasia and the moral issues pertaining to the beginning and end of life; (bio) ethics in research - involving human beings and / or animals - bioethics issues relating to public health - highlighting its interfaces with the Family Health Strategy, and the current debates about the allocation of resources - as well as bioethics and issues of concern with the environment and its preservation. CONCLUSION: Due to its extent and critical nature of thinking developed in the wake of the discipline, the proposal is that bioethics is definitely included in graduation courses in different areas of knowledge, contributing to the formation of citizens, professionals, and researchers committed to an ethical practice defensible in their every day practice.

With the best intentions: lead research and the challenge to public health.

In 2001, Maryland's court of appeals was asked to decide whether researchers at Johns Hopkins University had engaged in unethical research on children. During the 1990s, Johns Hopkins's Kennedy Krieger Institute had studied 108 African American children, aged 6 months to 6 years, to find an inexpensive and "practical" means to ameliorate lead poisoning. We have outlined the arguments in the case and the conundrum faced by public health researchers as they confront new threats to our health from environmental and industrial insults. We examined the case in light of contemporary public health ideology, which prioritizes harm reduction over the historical goals of prevention. As new synthetic toxins-such as bisphenyl A, polychlorinated biphenyls, other chlorinated hydrocarbons, tobacco, vinyl, and asbestos-are discovered to be biologically disruptive and disease producing at low levels, lead provides a window into the troubling dilemmas public health will have to confront in the future.

Ética de la Investigación científica: la fiebre amarilla, la Comisión Reed y el origen del consentimiento informado / Ethics in scientific research: yellow fever, the Reed Commission and the origin of informed consent

Durante el siglo XIX las investigaciones en infectología y microbiología, confirmaron la teoría "contagionista" de la enfermedad, descartando la teoría miasmática, fomentando el desarrollo de técnicas para aislar los microorganismos causantes de las infecciones y descubriendo los mecanismos de trasmisión de la enfermedad. Ante la dificultad de tener modelos animales para varios grupos de enfermedades, la experimentación en seres humanos se hizo necesaria, incluyendo la autoinoculación de los investigadores. La historia de las investigaciones sobre la fiebre amarilla en Cuba es una experiencia paradigmática y fundamental de la salud pública y ejemplo del triunfo del planteamiento de la infectología. Sin embargo, las circunstancias subyacentes a los triunfos científicos sobre la peste americana relatan una historia menos conocida, caracterizada por el sacrificio y el heroísmo, de la cual surgen los fundamentos de la ética en la investigación científica y el origen del moderno consentimiento informado. Mucho antes del Código de Nuremberg, las investigaciones de Walter Reed y las teorías de Carlos Finlay interactuaron para establecer un hito histórico que derivó en el triunfo de la medicina científica, y en el origen de la documentación y formalización estricta del respeto a la integridad de los voluntarios que participan en la investigación.

During the Nineteenth Century, research on infectious diseases and microbiology confirmed the disease´s contagionist theory, thus ruling out the miasma theory and promoting the development of techniques to isolate the microorganisms that cause infections and the discovery of mechanisms for the disease´s transmission. Given the difficulty for having animal models for several disease groups, experimentation with humans, including the researchers´ selfinoculation, became necessary. The history of yellow fever research in Cuba is a Public Health´s fundamental and paradigmatic experience and an example of the approach to infectious diseases´ triumph. However, the circumstances underlying the scientific triumphs in the fight against the American Plague tell a less known story, marked by sacrifice and heroism, which generated the foundations for Scientific Research Ethics and the origin of modern Informed Consent. Long before the Nuremberg Code, Walter Reed´s research and Carlos Finlay´s theories interacted to establish a milestone that led to the triumph of scientific medicine and to the origin of respect for strict documentation related to the integrity of volunteers involved in research.

Breve história da ética em pesquisa / A brief history of ethics in research

A resenha histórica da pesquisa envolvendo seres humanos reside mais no desenvolvimento de conceitos do que na cronologia de eventos. Também não é possível falar em progresso, uma vez que não há um caminho traçado em direção a uma meta e as mudanças ocorrem de forma fluida, com avanços e retrocessos. Este artigo situa o surgimento da ética na pesquisa como resultado da divulgação de condutas impróprias na prática científica. Atualiza o funcionamento dos Comitês de Ética em Pesquisa envolvendo seres humanos e a regulamentação pertinente no Brasil e exalta a necessidade fundamental do controle social sobre a atividade científica

A historical review of research involving human beings lies more in the development of concepts than in the chronology of events. Nor is it possible to speak of progress, since there is not a path towards a goal and changes occur smoothly, with advances and setbacks. This article situates the emergence of research ethics as a result of the disclosure of misconduct in scientific practice. It updates the functioning of Ethics Committees in Research involving human beings and relevant regulations in Brazil and celebrates the fundamental need for social control of scientific activity

On first looking into Kutcher's "Contested Medicine": ethical tensions in clinical research.

Contested Medicine examines the experiments done at the University of Cincinnati by Eugene Saenger and his colleagues during the 1960s, a time of great fear that the Cold War between the United States and the Soviet Union would become a hot war using nuclear weapons. These studies were to provide the Department of Defense information relevant to the consequences of exposure of military personnel to ionizing radiation in such circumstances. Kutcher, a radiation physicist turned historian of science, is especially well prepared to put these studies into the context of the evolving bioethics of the time. He reviews the essential ethical reviews, beginning with the Nuremberg Code and extending to those of the Advisory Committee on Human Radiation Experiments appointed by President Clinton. These evolving ethical standards provide a cautionary note to today's methods of clinical experimentation in search of proper evidence-based medicine. There has been an ascendance of the priority of patient rights over societal good except in increasingly limited special circumstances. Some of what was considered good and necessary science in the 1960s and 1970s is no longer considered proper. Similarly, future ethical norms may well find current trial methodology to be flawed.

A medical journal editor's role in exposing an unethical research study.

The involvement of Dr. Richard Mattingly, Editor of Obstetrics & Gynecology between 1972 and 1985, in the publication of an article on carcinoma in situ (CIS) of the cervix, facilitated exposure of an unethical study into the natural history of CIS of the cervix (now termed cervical intraepithelial neoplasia 3) by Dr. Herbert Green. The object of Dr. Green's study was to verify his premise that CIS was not a precursor of invasive cancer, and he published his "atypical viewpoint" that CIS was a benign disorder in international medical journals and the lay press. Alarmed by the number of women developing cancer and frustrated by the failure of the hospital authorities to deal with the problem, Dr. Bill McIndoe began presenting his interpretation of Dr. Green's study at international scientific meetings. Dr. Mattingly was aware of both Dr. Green's previous publications and the difficulties facing Dr. McIndoe, and he encouraged Dr. McIndoe to publish his data in Obstetrics & Gynecology. The correspondence between Dr. Mattingly, a senior U.S. academic and journal editor wishing to publish important scientific data, and Dr. McIndoe, an unknown antipodean clinician intent on revealing an unethical experiment, provides important lessons for all who practice medicine, in particular those in positions of responsibility.

Experimentação animal: ética e legislação brasileira / Animal experimentation: ethics and the Brazilian legislation

Este artigo trata da experimentação animal sob os pontos de vista da ética e da política, fazendo uma abordagem histórica do tema no cenário legislativo brasileiro. Os animais de laboratório desempenharam um papel decisivo para o desenvolvimento da ciência e continuam tendo um papel essencial na pesquisa biomédica, no entanto, sua utilização sempre despertou manifestação de diferentes naturezas. Apesar de as primeiras incursões na pesquisa experimental terem sido iniciadas há, pelo menos, quatro séculos, é incipiente o estabelecimento de normas que regulamentem a utilização de animais na América Latina. No Brasil, embora não haja uma lei específica em relação a essa utilização, algumas iniciativas já foram tomadas. As discussões sobre este tema continuam ocorrendo, contudo, a demora para definir uma lei que regulamente o uso de animais em pesquisa tem dificultado a padronização de procedimentos necessários à sistematização dos conhecimentos desenvolvidos no País.

This article covers animal experimentation under the viewpoint of ethics and politics, and does a historical review of the theme in the Brazilian legislative scenario. Laboratory animals play a decisive role in the development of science and continue to have an essential role in biomedical research. However, their use always provoked manifestations of different natures. Even though the first incursions in experimental research began at least four centuries ago, the establishment of norms that regulate the use of animals in Latin America is incipient. In Brazil, although a specific law regarding this use does not exist, some initiatives have already been taken. The discussions on this theme continue to happen, however the delay to define a law that regulates the use of animals in research has hindered the standardization of procedures that are necessary to the systematization of the knowledge produced in the country.

[Research developments in neurostimulation after 1945: historical and ethical aspects of medical manipulations of the human brain]. / Uber Forschungsentwicklungen der Neurostimulation nach 1945: Historische und ethische Aspekte medizinischer Manipulationen am menschlichen Gehirn.

For nearly fifteen years, the impact of modern neuroscience has become a central focus of public debate, not just following the Decade of the Brain in the United States. Newly developed options for manipulating the central nervous system (CNS) are not only of primary medical concern but have come to be regarded as extremely questionable in recent bioethical discourse. This article provides an in-depth comparison between modern neuromanipulative approaches from "Deep Brain Stimulation" (DBS) with methods from earlier historical periods. After World War II, electrophysiological stimulation was developed, which changed the functional capacity of the human brain. It is argued that many contemporary debates questioning neuroethical applications are flawed in significant respects: A unique neuroethical position can neither be upheld philosophically nor with regard to consumer-oriented clinical practice. By drawing on individual case examples from the contemporary and recent history of neuroscience, some related problem fields and consequences are mapped out and discussed. They show an increasingly blurred conceptual boundary furnished by the complex relations between clinical research, physiological restitution, and functional enhancement inherent in modern biomedicine.

Ética em pesquisa: temas globais / Research ethics: global issues

O texto aborda a ética em pesquisa desde seu debate inicial, a partir dos crimes de guerra nazistas, passando pela Resolução 196, do Conselho Federal de Medicina (CFM), pela proteção às populações vulneráveis até a controvérsia sobre pagamento e ressarcimento pela participação em uma pesquisa.

As depressing as it was predictable? Lung cancer, clinical trials, and the Medical Research Council in postwar Britain.

In recent years lung cancer specialists have complained that due to stigma resulting from the association of the disease with smoking, theirs is a neglected field. This paper demonstrates that in the 1950s and 1960s, when the British Medical Research Council (MRC) started to organize clinical trials for various forms of cancer, this was not the case. Rather, the organizers of these trials saw lung cancer as a particularly promising object of research, for much was known about the disease. The cancer trials were part of a strategy to use the Randomized Controlled Trial (RCT) technology to cement the role of the MRC as the dominant body overseeing medical research in Britain. The organization of the trials, however, turned out to be very difficult, due to ethical problems and the dominance of one form of therapy, surgery. The trial results were deeply disappointing. I argue that these frustrating results contributed to the notion of hopelessness that has come to surround lung cancer, and to the shift of focus from cure to prevention that was triggered by epidemiologic studies identifying tobacco smoke as the main cause of the disease. The paper deals with an important episode in the history of clinical cancer research in postwar Britain, illustrating the ethical and practical problems faced by the organizers.

Gonorrhea and the beginnings of clinical research ethics.

Research on ocular inflammation associated with gonorrhea began in conjunction with the entry of trachoma into Europe during the Napoleonic wars. The initial questions involved the cause of the contagiousness of gonorrhea and how the contagion spreads from the genitalia to other sites. Because efforts to infect animals with gonorrheal matter were unsuccessful, all experiments were conducted on human subjects. Once these two causes of blindness were tentatively differentiated, attempts to restore vision in an eye that had been blinded by a trachomatous membrane over the cornea by instilling gonorrheal pus began to be practiced. In 1841, Joseph Piringer described his use of this method to determine infectiousness decades before the discovery of pathogenic bacteria, as well as ethical concerns about the associated endangerment of patients. Beginning in the 1880s, research focused on the identification of the gonococcus and assessment of its pathogenicity. The ethical dilemma of inducing a disease with an unpredictable outcome persisted until the 1940s, when gonorrhea could be reliably cured by penicillin.