Ethics Committees in Central and Eastern Europe
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, firstname.lastname@example.org, 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 …