sehepunkte 5 (2005), Nr. 7/8

Volker Roelcke / Giovanni Maio (eds.): Twentieth Century Ethics of Human Subjects Research

The book under review is the product of a conference on the "History of Human Experimentation during the Twentieth Century", held at the Institut für Medizin- und Wissenschaftsgeschichte, Universität zu Lübeck, in May 2001. The aim of the conference, according to editor Volker Roelcke's introduction, was "to analyze discussions on the ethics of human experimentation and various attempts to regulate such experiments in the context of different historical traditions of experimental practice" (11). This project is particularly important, he explains, because current debates in the field of bioethics are often grounded in historical understandings that are "deficient, faulty, or misconceived" (12). In so far as our ethical perceptions are informed by our understanding of the history of medical ethics and medical ethical behavior, it behooves us to develop both a more accurate and a more finely nuanced understanding of that history. One imagines that a philosopher might have something similar to say about the typical historian's grasp of moral philosophy. My own experience with bioethicists, however, bears out Professor Roelcke's point that the entire field of bioethics could use a stronger historical grounding.

The papers in this volume represent a step in that direction. They are organized under six headings: a first part on "Norms and Debates: Starting Points"; a second section on "Research Practices, First Decades of the 20th Century"; third, the "BCG Vaccination, the Lübeck Scandal, and the 'Reichsrichtlinien'"; fourth, "Nazi Medicine and the Nuremberg Code"; fifth, "Post-Nuremberg Debates"; and sixth, "Framing Experiments: Politics and Practices". As in any collection of this kind the contributions are unequal in quality and kind. Some more directly address the topic than others; some reflect highly developed areas of research; others are best described as first steps in that direction. Unfortunately, it is also necessary to say that the collection could have used a stronger editorial hand. The translations - all the contributions appear in English or something resembling it - are especially uneven and several passages are very nearly impossible to decipher.

It is not possible here to review all twenty-two contributions to this volume. A number of themes, however, stand out. Evidently no collection of essays on "human subjects research" in the twentieth century can afford to ignore Nazi Germany. The literature on this topic is now quite large - surely the single most important body of historical literature on the history of experimental ethics - and that fact is reflected in the high quality of the contributions by Andreas Frewer, Volker Roelcke, and Paul Weindling.

Andreas Frewer's contribution examines the journal "Ethik" in an attempt to identify the path that led from the journal's "liberal" ethics of the late-1920s to its later support of Nazi ethics. The critical shift, he argues, was the adoption of a "collective morality of the national community" which "was ultimately the cause and internal logic of 'ethics without humanity'" (147). Although Frewer states that this shift does not necessarily prefigure the "extreme radicalization" of National-Socialist medicine, he does maintain that it represented an important shift in the direction of an ethical "slippery slope" in which "the means are legitimated by the ends" (142) Thus, while Frewer is careful to balance continuities and discontinuities in the German medicine of this period, he piece places the greater emphasis on the discontinuities: a fundamental change in the nature of medical ethical thinking.

Volker Roelcke's chapter takes a different tack. Roelcke argues that whether German medical science stood in the mainstream of western medical scientific research (and that depended on the field of speciality), "all the researchers followed the intrinsic logic of their scientific disciplines and used the legally and ethically unrestricted access to human beings created by the context of the political system and the conditions of war" (162). As I understand Roelcke's point, NS scientific research must be seen as "normal" in so far as it simply obeyed the basic imperative of all scientific research, which is the pursuit of a scientifically defined truth. What made NS scientific research so extraordinary was not the science per se, but the conditions in which it was pursued: a rare instance in which researchers could conduct research in complete disregard for all ethical considerations. In this respect, Roelcke's and Frewer's contribution meet up, since they both seem to suggest that the most important determinative factor of NS medicine was not its scientific content but the ethics of the regime and the way in which this ethics created a new research environment in which basic human rights and the dignity of the individual were no longer respected.

Paul Weindling's essay on "the Discourse on Human Experiments at the Nuremberg Medical Trial" suggests yet another approach to these issues. Weindling shows that the trial itself was primarily defined as a murder trial. The "issues of consent and the rights of the experimental subjects," he writes, "arose from discussions among war crimes experts outside the courtroom and prior to trial" (177-178), as well as during the trial. But he argues that the prosecution's focus on the role of the Nazi state obscured the "crucial issues of motivation of the perpetrators", and he concludes that stressing "the role of the state and Nazism in generating the experiments [...] does not allow for the unscrupulous scientist, who opportunistically exploited state power and resources for the pursuit of individual research agendas" (178). The point is well taken, though it is difficult to imagine any convincing account of German medicine during the period of National Socialism that does not give a role to each of these central factors, the state, the imperatives of science, and the individual researcher.

Although these three chapters rank among the stronger contributions to this volume, one of the primary benefits of this collection is its attempt to treat the period of Nazi Germany as just one of several moments in the history of twentieth-century research ethics. A second major theme of this collection is its attentiveness to local conditions and local situations and the sheer diversity of medical ethical thinking and how it has evolved over the course of the twentieth century. Etienne Lepicard's contribution, for instance, details French "Catholic Voices" in the debates over the limits of experimentation. He argues that although those debates reflect the hierarchical nature of the church, the diversity of responses "enables us to collect a multiplicity of Catholic voices when the ethics involved in human experimentation was still in construction and when no official statement had been involved" (47). Similarly, Gerhard Baader's chapter on "Jewish Halachic Medical Ethics and Human Experimentation" shows how this ethics has evolved and responded to new scientific developments as procedures that were once viewed as too risky (and thus unethical) have become standard (and thus ethical). In a chapter comparing the respective responses to Henry K. Beecher's and Maurice Pappworth's pathbreaking exposés of unethical research practices in the United States and Great Britain in the 1960s, Paul Edelson demonstrates that Beecher's criticisms of medical experimental practices was more widely accepted within the medical profession not only because of his more eminent position as a professor at Harvard University, but also because his prescriptive recommendation, his conclusion that the most important "safeguard in experimentation as in therapy is the presence of the skillful, informed intelligent, honest, responsible, compassionate physician" (230) was more in keeping with the medical profession's "culture of honor" than Pappworth's recommendation for a "highly structured and explicit system of control" (229). Finally, in a fascinating but somewhat fragmentary piece on "Human Experimentation in the Czech Republic during the Last Decades", Jiri Simek points out that under the communist regime Czech doctors often enrolled their patients in experimental trials for the simple reason that that was the only way to obtain adequate therapy.

A third theme of this collection is the codification of research ethics. In a piece on "British Research Ethics after the Second World War", Jenny Hazelgrove focusses on the British Postgraduate Medical School, Hammersmith Hospital, in the 1960s to show that Local Research Ethics Committees (LRECs) "did not 'grow naturally' out of [the ethical tradition of the Nuremburg Code], but were the product of a bitter controversy about research ethics within the medical community that began" with the publication of Maurice Pappworth's denunciations of British research practices. Pressure from the outside thus initiated the changes but with the somewhat paradoxical result that "paternalist attitudes" were simply institutionalized within the framework of LRECs. Susan Lederer's piece on the 1964 Declaration of Helsinki describes the "strong American slant" (214) of the declaration and in particular the American role in watering down the provisions against the use of children and confined populations in therapeutic experiments. In the end, Lederer argues, it all came down to money: American doctors and companies paid the bills and they essentially got last say on the content of the Declaration. A last example of this thematic is Giovanni Maio's analysis of "Medical Ethics and Human Experimentation in France after 1945", which stresses the specificity of contemporary French research ethics. Maio stresses in particular the centrality for French research ethics of therapeutic benefit, its emphasis on "freedom and voluntarism" (which precludes the use of confined populations), and the "lesser attention" it pays to the issue of consent (250).

The final major theme of this collection is the definition of a medical experiment (as opposed to any other medical act) and the ethical consequences of such a definition. Christian Bonah's and Philippe Menut's study of the "BCG Vaccination around 1930" describes how Albert Calmette was able to establish the BCG Vaccination (a prophylactic treatment against tuberculosis) as non-experimental even at a point when it might still have been considered to be at an experimental stage. The result was that the vaccine was accepted as a "post-experimental", routine medical treatment, which enabled doctors to avoid giving patients all the relevant data regarding the risks of the treatment. What this paper raises is the question of "how and by whom" an intervention is defined as an experiment. As the authors point out in the conclusion, "the evaluation of 'dangerous experiment' versus 'established treatment' determined to whom was incumbent the charge of proof of safety and efficacy [...] [and] defined as well what information should be given to participants" (125). It is worth emphasizing that such determinations will take place irrespective of the formal regulations regarding experimental practices.

A particularly suggestive article by Nadav Davidovitch takes this point a step further. Her study of the "Image of the Placebo in the Orthodox-Alternative Medicine Debate" traces the place of the placebo as a dividing line between orthodox and alternative medicine from the nineteenth century, when the placebo was picked up by homeopathy as a key methodological device in testing various therapies, to the twentieth century and the emergence of the Random Controlled Trial as a keystone of contemporary scientific medicine. Davidovitch's main point is that what counts as science and not science is historically situated, which means in turn the ethics are also historically situated since the way that ethical issues are framed is closely linked to scientific epistemologies (a point similarly made in Pei P. Koay's study of the Icelandic human genome project). "The current tendency to differentiate between the deceitful 'clinical placebo' and the unbiased 'research placebo'", Davidovich argues, "assists the medical establishment to erect a wall of silence regarding serious ethical drawbacks in contemporary medical research practices". Historical analysis, she further suggests, can help make aware of these and "assist our analysis of ethical issues in present experimental medicine" (305).

This is a hopeful conclusion but the entire thrust of such arguments raises certain questions. If our ethical judgments of science are necessarily shaped by the historical context, is it possible to establish a single ethical reference point from which one could write the history of medical ethics? While the essays in this collection do not offer an answer to this question, they do demonstrate how far the history of medical ethics has come in the last ten or fifteen years. The field remains uneven and in many respects still looks immature compared to more well-established fields of historical research. But there is far more to draw on today than just a decade ago. Still, I was very much struck by the Russian philosopher Boris Yudin's conclusion to his own contribution on "Human experimentation in Russia / the Soviet Union". His article, he writes, "is really more a collection of individual cases, than a connected, integrated story" (109). Much the same could be said of the history of research ethics more generally. What is now needed is someone to pull together the various strands of this story into a single synthetic history.