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.

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.

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.

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.

Maori responsiveness in health and medical research: clarifying the roles of the researcher and the institution (part 2).

INTRODUCTION: The combination of the Health Research Council's Guidelines for researchers on health research involving Maori and the 1998 revision of the National application form for ethical approval generated an expectation that all research development required consultation with Maori. METHODS AND RESULTS: This paper clarifies issues of consultation for health researchers in two ways. Firstly, the historical development of the focus on the Maori research responsiveness is outlined. Secondly, we argue that research institutions, rather than researchers, need to take a lead role in consulting on research issues with Maori organisations. CONCLUSIONS: Consultation with Maori at the institutional level could help clarify and address key ethical issues in research--while reducing the workload for researchers, Maori organisations, and host institutions alike.

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.