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 …. (shrink)

Research ethics is high on the agenda of medical ethics and regulatory topics worldwide at the moment. In this field it is thus important to have good textbooks, to educate health care professionals, researchers, ethicists, students, and policy makers about the nature of research ethics, its history and social contexts. Professor Loue's book is thus published in an increasingly competitive marketplace. The book has many merits. It consists of five chapters and two appendices. The first chapter summarises several of the (...) iconic scandals in medical ethics, notably the Tuskegee syphilis study and the Nazi doctors' atrocities. The historical scholarship of this chapter is solid, if not original, and it is useful to have it gathered here in a convenient place. There is a serious debate to be had about the pedagogy and philosophy …. (shrink)