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Edited by J Glasa for the Council of Europe. IMEB Foundation and Charis a.s.: order from the Institute of Medical Ethics and Bioethics Foundation, Limbova 12, 83303 Bratislava, Slovak Republic,, 2001, US$7.00 (within Europe), US$9 (elsewhere) (includes postage), pp 266. ISBN 80-88743-40-0
The growth of research ethics committees worldwide is now fairly rapid and new “markets” for research ethics are opening all the time. The market metaphor is appropriate, since a good deal of the impetus for research ethics review comes from the development of new pharmaceutical products, the globalisation of pharmaceutical research, development and marketing, and the internationalisation of regulatory standards for pharmaceutical R&D. The need for independent ethical review of research protocols by a committee drawing on a range of professional and lay expertise is established as a moral, a quality-management and a regulatory requirement in many jurisdictions, and internationally in the Declaration of Helsinki, the Council of Europe’s Biomedicine Convention, and the International Committee on Harmonisation’s Tripartite Guideline on Good Clinical Practice.
Central and Eastern Europe have for many years been sites of pharmaceutical R&D, but this has intensified in the aftermath of the revolutions of 1989 and since that time. These revolutions and this intensification have been followed by liberalised markets in health goods and health care, the opening of the state and university sectors to public-private collaborations and private enterprise, creating a fertile context for clinical trials. In addition, the widespread official or unofficial privatisation of health care has created a new set of ethical problems for health care workers, and the beginnings of clinical ethics committees and education programmes. In many cases these beginnings this builds on foundations laid down in the 1960s and later after, but the creation of new nation states (or reinvention of old ones) and the changes in political culture, have made important differences to the scope and significance of ethical reflection on health care and biomedical research.
This useful volume summarises the experience of many states in Central and Eastern Europe, together with comparative material from some Western states, including the UK, the USA, Germany, and the Netherlands. The volume includes helpful material on the role of the Council of Europe and the Biomedicine Convention, the international and national regulations defining research and clinical ethics committees, and the special local issues relevant in each of the countries. It is based on a conference held in Bratislava in late 2000 under the auspices of the Council of Europe’s Demo droit Ethical Review of Biomedical Research Activity (DEBRA) programme, designed to facilitate the development of research ethics committees in Europe.
In addition to the useful comparative material, a few papers describe historical factors relevant to the development of ethical review in particular countries. For example, several papers describe the changing nature of university bioethics under the various changes in government over the past 30 years, and several papers describe the changing involvement of the pharmaceutical industry in their countries—including the role of “home” companies as well as multinational firms. A few papers raise philosophical questions about research, research ethics, and research ethics review—the quality of these is good, and they raise some interesting questions which are not often discussed, for example, should ethics committees pronounce on the substantive ethics of a research programme, or only on the actual work planned in this application? For instance, research into the supposed genetic basis of homosexuality, and what the relationship is between ethical review and political culture (does review depend on some form of “pragmatic tolerance” in society and its institutions)? The strong and longstanding philosophical traditions in Central and Eastern Europe are not widely known in the West, and deserve to be better understood. Too much work in research ethics assumes that the US/UK model is the ideal to be exported. On the evidence of this volume, the potential for a more reflective research ethics lies as much in Eastern Europe as in the USA or the UK, however different the state of institutional development may be.
This book will be useful to researchers planning projects in the various states in Central and Easter Europe, to scholars of research ethics and its regulations, and to those working in, or otherwise interested in, the development of health care in the region.
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