Ulf Schmidt, Andreas Frewer (eds), History and theory of human experimentation: the Declaration of Helsinki and modern medical ethics, History and Philosophy of Medicine, vol. 2, Stuttgart, Franz Steiner, 2007, pp. 370, €54.00 (hardback, 978-3-515-08862-6).

Abstract

Although the Declaration of Helsinki (1964) of the World Medical Association (WMA) is internationally recognized as a code of ethics for medical research on human subjects, its origins and the circumstances of its various revisions (Tokyo 1975, Venice 1983, Hong Kong 1989, Somerset West 1996, Edinburgh 2000, Seoul 2008) have received relatively little historical attention. The present volume therefore constitutes a welcome addition to the literature on this important “living document”. Several contributions to this volume provide historical background, especially Ulf Schmidt’s essay on the Nuremberg Doctors’ Trial and the Nuremberg Code as the most influential precursor document for the principles contained in the Helsinki Declaration, or discuss from various perspectives the issues that have shaped the different versions of the WMA document. Compared with the stringency of the rules for voluntary informed consent and the strength of the protection for human subjects in the Nuremberg Code (1947), the Declaration of Helsinki reflected the start of a “watering down process”, as the editors observe (p. 15), which has made allowances for the practical needs of medical researchers and which has continued to the present day. As Susan Lederer’s discussion of the origins of the 1964 version makes clear, American pharmaceutical interests and financial power prevailed over attempts within the WMA to ban experimentation on children in institutions and on so-called captive subjects (inmates of mental asylums, prisons and reformatories). These groups of human subjects were too important for the testing of new vaccines and for drug development. While the insertion of the requirement for independent review of research projects through ethics committees in the Tokyo version of 1975 (discussed by one of its authors, Povl Riis) could be seen as a step that increased safeguards for subjects, the controversies surrounding the Declaration’s revision in 2000 illustrated again the conflicts between research interests and wishes to strengthen protections for vulnerable subjects. The debates about the key issues then, the use of placebo controls even when a standard therapy exists for comparison, and the guaranteeing of post-trial access of the participants to the best treatment identified by the study, are analysed from different viewpoints. Kati Myllymaki, as a member of the WMA’s committee of “three wise women” in charge of this revision, provides an insider’s recollections; Robert Carlson, Kenneth Boyd and David Webb examine the complex process of re-drafting the Declaration in 2000 through the relevant archive materials of the WMA; and David Willcox reviews the comments in the medical and general press that accompanied this revision process. Although I found these essays the most interesting in this collection, I missed a more thorough ethical and historical discussion of the relevant trials in developing countries that formed the background to these debates and of the attempts, since then, to provide guidelines for human subject research in those countries, such as the report of the relevant Working Party of the Nuffield Council on Bioethics in 2002. One might also wish for a clearer assessment of the intentions and effects of the WMA’s Notes of Clarification on the Declaration’s controversial paragraphs 29 (placebos) and 30 (post-trial access), that were issued in 2002 and 2004, respectively. On the other hand, readers interested in the legal and ethical significance of the Helsinki Declaration are well served by Dominique Sprumont, Sara Girardin and Trudo Lemmens’ discussion of how its principles have influenced United States, Canadian, European Union, Swiss, German, French, and UK legislation (tellingly, most legal references are made to the 1996 rather than the controversial 2000 version of the Declaration), and by Ulrich Trohler’s documentation of the plethora of bioethics codes, including codes on human experimentation, that have been issued since the 1980s. Moreover, contributions by Ulf Schmidt (on the nerve gas experiments at Porton Down in the 1950s) and by Andreas Frewer (referring to his research on forced labourers at the Gottingen university clinics during National Socialism) remind us of the important practical dimensions, in the form of facilitating compensation claims of victims, that historical research in this area may have. An appendix including an English translation of the German Reich Guidelines for New Therapy and Human Experimentation of 1931 and reprints of the Nuremberg Code (1947), of the 1964, 1975 and 2000/2004 versions of the Helsinki Declaration and of the 1997 Council of Europe Convention on Human Rights and Biomedicine further enhances the usefulness of this volume.