Beyond Nazi War Crimes Experiments: The Voluntary Consent Requirement of the Nuremberg Code at 70.

The year 2017 marks both the 70th anniversary of the Nuremberg Code and the first major revisions of federal research regulations in almost 3 decades. I suggest that the informed consent provisions of the federal research regulations continue to follow the requirements of the Nuremberg Code. However, modifications are needed to the informed consent (and institutional review board) provisions to make the revised federal regulations more effective in promoting a genuine conversation between the researcher and the research subject. This conversation must take seriously both the therapeutic illusion and the desire of both the researcher and the research subject not to engage in sharing uncertainty.

Research ethics on the agenda - the debates preceding the establishment of the ethics committees. / Forskningsetikk på dagsordenen ­ debattene bak de etiske komiteene.

BACKGROUND This article examines two factors that helped to trigger and drive forward the debate about research ethics committees (now the Regional Committees for Medical and Health Research Ethics) in Norway in the 1970s: the revision of the Declaration of Helsinki by a Scandinavian working group, and the unfolding of the so-called Gro case in the Norwegian national media.METHOD We have used existing literature in the form of books and articles on the history of research ethics from the University Library of the University of Oslo, the National Library of Norway, the History of Science, Technology and Medicine database, and Retriever. We have manually reviewed issues of the Dagbladet daily newspaper from 1974, and relevant volumes of the Journal of the Norwegian Medical Association from the 1960s and 1970s. Finally, we have used the archives of the Norwegian Association of Higher Education Institutions, and the Faculty of Social Sciences at the University of Oslo.RESULTS The World Medical Association's revision of the Declaration of Helsinki in 1975 stipulated the use of independent ethics committees for the assessment and supervision of research projects. The Gro case, which concerned the testing of behavioural therapeutic treatment on a young girl resident in an institution and the ensuing public debate, led to a demand from the public for closer monitoring and ethical regulation of research activity.INTERPRETATION Both of the events mentioned were used actively in the argumentation and preparatory work for the establishment of research ethics committees.

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.

[About the genesis of the first Polish local research ethics committee]. / Wokól utworzenia pierwszej polskiej komisji bioetycznej.

From the moment in which the development of medicine became necessary experimental research involving human subjects, the question arose about the ethical limits and limitations of the experiment. The turning point was the year 1947. The Nuremberg Code was formulated after the disclosure of pseudo-medical experiments involving human subjects during the Second World War. In 1964, the medical world accepted the Declaration of Helsinki, which, however, did not prevent abuses and it became necessary to appoint independent ethics committees supervising and enforcing the application of ethics in biomedical experiments. In Poland in the 60's and 70's started a discussion on the ethical rules related to conduct of research involving humans. The initiators of the appointment of bioethics committees were professors of medicine, inspiring experiences of their Western colleagues. It was difficult for reasons of political ideologies to convince the authorities to use the best of western solutions. This paper attempts to describe the circumstances connected with the appointment in 1979 at the Medical University of Gdansk, the first Polish bioethics committee.

Avicenna's doctrine and institutional review board in international bio-medical research.

Avicenna, an outstanding Persian physician and philosopher (980 AD-1037 AD), established a clinical treaty, or doctrine, without which medical experimentation would not have progressed. This doctrine emphasizes the ultimate divine power of God or a higher being over healing and mandates the patients' well-being as the crucial aspect in all medical care and experiments. The Institutional Review Board, as the ethical body that oversees clinical research, is in line with this doctrine. However, the lack of a homogenous and internationally recognized code of ethics, the decentralized work of ethics oversight committees, the improper implementation of established ethical standards and a shortage of scientific auditing capacities have raised concerns over the possible exploitation of vulnerable populations.

The establishment of ethical committees for medical research.

BACKGROUND: In this article we will describe the process that preceded the establishment of regional committees for medical research ethics in 1985. We will also take a look at the difficult initial period experienced by the committees in the eastern and southern regions. MATERIAL AND METHODS: We have examined the material that has been submitted to the National Archives by the Research Council of Norway, the Ministry of Social Affairs and the Ministry of Education and Research, as well as the records of the Regional Committees for Medical and Health Research Ethics South-East. RESULTS: From the early 1970s the Norwegian Medical Association played a key role, for example by launching the proposal for "nationally dispersed committees" in 1977. There was widespread consensus that such committees were desirable, but everybody assumed that they would be funded by somebody else. As a result, the simplest model was chosen. The full set of regional committees was not established until 1987, and even more time passed before they were granted the funding that could ensure appropriate processing of cases. This was only achieved after the adoption of the Research Ethics Act in 2006. INTERPRETATION: Unsolved financial issues were the key reason why this process was so prolonged. The organisational model proposed by the Norwegian Medical Association in 1977 is fairly similar to the one that the Health Research Act brought into place in 2009.

Clinical research: protection of the "vulnerable"?

In this age of evidence-based medicine, clinical research is critical for developing new therapeutics and determining the best way to use these therapies. To perform appropriate clinical research, researchers must adhere to ethical standards. These standards have developed in large part as a response to egregious violations of ethically appropriate behavior. In this respect certain populations have been identified as at risk of being treated inappropriately in medical research. Current ethical guidelines prohibit or severely limit what types of research can be performed involving these "vulnerable" populations. Although this might protect these populations, the lack of research on them might actually do harm in limiting their access to life-saving therapies. We explore the historical underpinnings of protecting the vulnerable populations and whether a newer ethical paradigm that would allow for protected research on these populations should be adopted by society.

Creating a 'Father Confessor': the origins of research ethics committees in UK military medical research, 1950-1970. Part I, context and causes.

Part I provides the historiographical context and examines the causes which led to the creation of the first independent research ethics committee (REC) at Porton Down, Britain's biological and chemical warfare establishment, in operation since the First World War. The papers in part I and part II argue that the introduction of RECs in the UK stemmed from concerns about legal liability and research ethics among scientists responsible for human experiments, and from the desire of the UK military medical establishment to create an external organisation which would function both as an ' internal space ' for ethical debate and as an ' external body ' to share moral and legal responsibility. The paper asks: What factors were responsible for causing military scientists and government officials to contemplate the introduction of formalised structures for ethical review within the UK military? It argues that Porton may have been exempt from public scrutiny, but it was not above the law of the land. By the mid-1960s evidence of serious ill effects among staff members and service personnel involved in tests could no longer be ignored. Whereas the security of the British realm had previously trumped almost any other argument in contentious debates about chemical warfare, the role of medical ethics suddenly moved to the forefront of Porton's deliberations, so much so that tests with incapacitants were temporarily suspended in 1965. It was this crisis, examined in detail in part II, which functioned as a catalyst for the creation of the Applied Biology Committee as the responsible body, and first point of call, for authorising human experiments at Porton Down.

Bioethics in the Oversight of Clinical Research: Institutional Review Boards and Data and Safety Monitoring Boards.

This article describes oversight mechanisms for clinical research that have developed substantially over the last few decades, including institutional review boards and data safety and monitoring boards. LeRoy Walters and others in the 1970s in the US thoughtfully described the importance of fundamental ethical principles and the application of bioethics to clinical research. Dr. Walters's important essay and work with the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research helped identify and explain ethical principles that guide research. These principles, subsequently enunciated by the Commission in the Belmont Report, remain central to our understanding of the ethics of clinical research and are the foundation of our regulations. In this article, I review some history, successes, and challenges of IRBs and DSMBs to exemplify the significance of understanding and applying ethical principles to the design and conduct of clinical research, and to honor Dr. Walters's contributions.

Under the shelter of ethics.

Problems of ethics committees in post-communist Russia are briefly discussed. The first ethics committees were established in 1980s upon the initiative of international pharmaceutical companies involved in clinical trials. Generally, such committees exist at hospitals conducting these trials and at research institutions dealing with human experimentation. They are bureaucratic structures heavily dependent on hospital or institution administration. Publication of research results in international periodicals is the main reason for their existence. An officially recognized National Ethics Committee is non-existent although there are several competing ethics committees at a national level (at the Ministry of Health, Academy of Sciences, Academy of Medical Sciences, Russian Medical association etc.). There is no federal legislation on the structure and status of ethics committees.

[Bioethics in clinical practice]. / La bioética en la práctica clínica.

Bioethics has grown exponentially in recent decades. Its most important schools include principlism, casuistry, virtue ethics and the ethics of care. These schools are not exclusive. Within bioethics, clinical ethics addresses the inherent clinical practice ethical problems, problems which are many and very varied. Bioethics training is essential for clinicians to address these bioethics' problems. But even the professionals are trained, there are problems that cannot be solved individually and require advisory groups in clinical ethics: clinical ethics committees. These committees are also responsible for education in bioethics in health institutions. Clinical bioethics is a practical discipline, oriented to address specific problems, so its development is necessary to improve the decision making in such complex problems, inevitable problems in healthcare.

La bioética ha tenido un desarrollo exponencial en las últimas décadas. Entre sus escuelas más importantes destacan el principialismo, el casuismo, la ética de la virtud y la ética del cuidado, las cuales no son mutuamente excluyentes. Dentro de la bioética, la ética clínica aborda los problemas éticos de la práctica clínica, problemas que son numerosos y muy variados. La formación en bioética es fundamental para que los clínicos aborden adecuadamente estos problemas. Pero aunque los profesionales estén formados, existen problemas que precisan del concurso de grupos asesores en ética clínica: los comités de ética para la asistencia sanitaria. Estos comités son además los responsables de la formación en bioética en las instituciones sanitarias. La bioética clínica es una disciplina práctica, orientada a dar respuesta a problemas concretos, por lo que su desarrollo es necesario para mejorar la toma de decisiones ante estos complejos problemas, inevitables en la asistencia sanitaria.

Moral reasoning and the review of research involving human subjects.

The model of moral reasoning used in Institutional Review Board review fails to uphold ethical ideals for research participants for it does not adequately acknowledge the particular context of research or of subjects, including their gender, their socioeconomic status, and the communities in which they lead their lives. The ethical review of research needs to take seriously the particularities of the research context as well as the situations of potential participants. A variety of conclusions are drawn for changes to the system for ethical review. Most significant is a call for effective consultation with the various communities affected by research and greater reliance on subject representatives. Also proposed is national review for selected research.

Ethics committees in Germany.

Because its chemical industry led the world a century ago, the need for control over research on humans was recognized first in Germany. Yet effective control, in the form of ethics committees, came later than in some other countries. This paper reviews the history and present status of German ethics committees.

Institutional review boards: what's old? What's new? What needs to change?

SUMMARY: Institutional review boards have come under fire for being burdened with work, causing delays in the progress of human subject research without improvements in the protection of human subjects. Over the years, there have been increases in the numbers of clinical trials, the use of multisite studies, and the amount of bureaucracy, but there have been no changes to the system to accommodate these advancements. Proposed changes include the use of a centralized institutional review board for multisite studies and harmonization of reporting requirements among agencies. The purposes of this article are to review the history, structure, and purpose of the institutional review board, to assess the criticisms of the current system, and to discuss solutions for improvement.

Research ethics and Institutional Review Boards. The influence of moral constraints on emotion research.

Researchers in the twenty-first century face a set of challenges unknown to researchers a half century ago--the need to justify the moral acceptability of their research methods through formal review processes. However, the role that moral constraints play in the development and demise of scientific theories has largely gone unappreciated. The rise of Institutional Review Boards (IRB) in the 1960s compounded the impact of moral constraints on scientific research and on the theories that develop out of such highly monitored research. To demonstrate the effects of moral constraints on scientific theory and research, this paper offers a history and analysis of the interaction between evolving moral standards and twentieth century emotion theory. Recommendations regarding IRB reform are also reviewed. The paper concludes by arguing that, while appropriate IRB reform is important, it cannot eliminate the need for careful reflection on the broader forces that shape scientific practice and understanding.

Institutionalisation of Bulgarian ethics committees: history and current status.

This paper provides an overview of the institutionalisation of the ethics review process in Bulgaria in accordance with the worldwide trend in establishment of ethics committees. Historical and current politico-legal changes influencing the work of ethics committees are analysed. The paper focuses on ethics committees which review biomedical research involving humans, with an emphasis on their composition, functions, training of members, and decision-making processes. Recent positive changes addressing insufficient training of ethics committees'members are highlighted. Recommendations are made for enhancement of the ethics review process and improved transparency.

The institutional review board.

Several ethical transgressions involving human subjects in scientific research during the last century have led to guidelines for acceptable research conduct and oversight. Thoughtful examination of these events yielded ethical documents whose principles eventually became codified into federal regulations governing research. These regulations specify the composition and function of the institutional review board (IRB), as well as the criteria by which the IRB judges the acceptability of proposed research. Continuous advances in medicine and technology generate the need to test new and potentially viable interventions for safety and efficacy. These advances in medical science rely heavily on the altruism and sometimes heroism of individuals who put their own well being at risk for the benefit of others by participating in clinical research experiments. It is therefore necessary for researchers to understand the function of the IRB and ethics review committees from which approval is required before research in human subjects may begin. Understanding the function of the IRB requires an appreciation for the rules by which it is governed, as well as the history and circumstances that influenced the creation of those rules. Researchers who appreciate the IRB's purpose will be better equipped to navigate the labyrinth of research guidelines and regulations.