Save

The Institutionalization of Research Ethics Committees in Germany – International Integration or in the Shadow of Nuremberg?

In: European Journal for the History of Medicine and Health
Author:
Matthis Krischel Dr.; Department of the History, Philosophy and Ethics of Medicine, Centre for Health and Society, Medical Faculty, Heinrich Heine University, 40225 Düsseldorf, Germany, matthis.krischel@hhu.de

Search for other papers by Matthis Krischel in
Current site
Google Scholar
PubMed
Close
Free access

Abstract

Although already established in West Germany since the 1970s, with the introduction of research ethics committees (rec s) into the Tokyo revision of the Declaration of Helsinki, they gained in importance. From 1985, a duty to consult rec s in human subject research was written into West German physicians’ codes of conduct. In East Germany (“Deutsche Demokratische Republik”, ddr), a central rec was set up in 1981 within the ddr Ministry of Health, and after German reunification, a duty to consult rec s was introduced in the federal Medical Products Act (Arzneimittelgesetz). Since 2001, European regulations were incorporated into national laws which applied in Germany as in other member states. Regarding the institution and legal history of rec s in Germany, this contribution seeks to answer three questions: (1) Were rec s developed in response to a specifically German experience of medical crimes and the abuse of human research subjects, or were they part of an internationalization of medical research ethics and international integration of German research? (2) Was the setting up of rec s in Germany a more top-down, centralized process or a more bottom-up, grassroots undertaking, and what does this tell us about the status that biomedical researchers gave to the ethics of human subject research in that period? And (3) who has traditionally held authority over human subject research in Germany and who holds it today?

1 Introduction

The Nuremberg Code, handed down by the judges of the Nuremberg Medical Trail in 1946/1947, is often described as the point of origin for biomedical research ethics, including the protection of human research subjects. While this perspective overlooks the existence of regulations in Prussia since 1900 and Germany since 1931 (to name just two examples), the Nuremberg Principles and the subsequent Declaration of Helsinki (1964) form important bases of internationally recognized research ethics. Since the second iteration of the Declaration of Helsinki in 1975, research ethics committees (rec s) have to be consulted by investigators if they work with human subjects.

From the 1970s, the (West) German Research Foundation (Deutsche Forschungsgemeinschaft, dfg) asked for rec s to be established locally in some externally funded biomedical research centers – in Ulm, for example, in 1971 and in Göttingen in 1973. In 1979, the German Medical Faculty Association (Medizinischer Fakultätentag) called for the formation of such boards in all German faculties of medicine. Subsequently, the federally organized German state medical associations (Landesärztekammern) established their own rec s in almost all West German federal states.1 On the local and regional level, the rise of multiple rec s seems like an institutional success story, but nevertheless, it took until 1994 for the German Medical Products Act (Gesetz über den Verkehr mit Arzneimitteln, Arzneimittelgesetz, amg) to integrate rec s into the legal framework for research. Several other laws also require approval by ethics committees for the trials they regulate, including the Medical Devices Act (Gesetz über Medizinprodukte, Medizinproduktegesetz) and other laws addressing research on human subjects.2

In East Germany, a Working Group on Ethics in Medical Research was formed within the Ministry of Health in the early 1980s. The local “ethics groups” and “ethics committees” that followed in the second half of the decade had limited authority and continued to yield to the directives of the Ministry of Health. After German re-unification in 1990, the West German model was adopted throughout Germany.3

In this contribution, I will trace the institutionalization and development of rec s in Germany since the 1970s. I will ask three questions: (1) Were rec s developed in response to a specifically German experience of medical crimes and the abuse of human research subjects, or were they part of an internationalization of medical research ethics and international integration of German research? (2) Was the setting up of rec s in Germany a more top-down, centralized process or a more bottom-up, grassroots undertaking, and what does this tell us about the status that biomedical researchers gave to the ethics of human subject research in that period? And (3) who traditionally held authority over questions of ethics and ultimately the legitimacy of biomedical research involving human subjects in Germany, and who holds this authority today?

In order to answer these questions, I will first trace the development of research ethics from the Nuremberg Doctors’ Trial in 1946/1947 to the Declaration of Helsinki (1964) and its first revision in Tokyo (1975). Then I will describe the genesis of rec s in West Germany (and, in a more cursory way, those of East Germany), giving special attention to their legal status in both professional and regulatory law. In this context, professional law refers to physicians’ professional codes of behavior, as laid out in the codes of conduct (Berufsordnungen) of state medical associations (Landesärztekammern). Regulatory law refers to civil and criminal law that are not the domain of physicians and their organizations, but of the individual German states or of German national law.4

The 1994 revision of the amg, passed just four years after German reunification, is an important milestone in this history, because it marks a legal requirement to consult ethics commissions constituted according to state laws. After briefly describing the status of rec s in Germany today, I will discuss the factors that led to this status, including the experience of Nazi medical experimentation without the consent of research subjects and the Nuremberg Doctors’ Trial, but also pre-1933 German regulations of human subject research, the international bioethical discourse since the 1960s, and European regulations of clinical trials. This will be followed by a conclusion, offering answers to the three research questions formulated above.

While ethics institutions in Germany today have an associated standardized terminology, this was not the case throughout the second half of the twentieth century. Today, research ethics commissions (Forschungsethikkommission, Ethikkommissionen) are distinguished from clinical ethics committees. The latter are established to offer guidance to physicians, nurses and others in clinical settings.5 In addition, there are several policy advisory bodies, including the Central Ethics Commission at the German Medical Association (Zentrale Kommission zur Wahrung ethischer Grundsätze in der Medizin und ihren Grenzgebieten, Zentrale Ethikkommission bei der Bundesärztekammer)6 and the German Ethics Council (Deutscher Ethikrat).7

2 The Nuremberg Doctors’ Trial, the Nuremberg Code, and the Declaration of Helsinki

The Nuremberg Doctors’ Trial, which was held from 1946 to 1947, charged 23 defendants – 20 physicians and three bureaucrats – with war crimes and crimes against humanity. ‘Euthanasia’ murders of patients with disabilities and psychiatric or neurological conditions and experiments on human subjects in concentration camps were among the most widely debated charges brought in the trial. Victims of those experiments included, among others, Jews, political prisoners, homosexual men, and (mostly Russian) prisoners of war.8 More than 15,000 human research subjects were forced to participate in experiments. Some were murdered according to study protocols or died during the experiments. Those who survived often suffered life-long psychic and somatic health consequences.9

Together with the verdicts handed down at the trial, the judges delivered the Nuremberg Code, comprised of ten points to protect human research subjects in the future and to frame how ethical human subject research should be carried out. The code emphasized the voluntary, informed consent of participants, the minimization of the possibilities of injury, disability or death, and the competence and qualifications of the experimenter.10

It was soon debated that changes in the biomedical-science discourse as well as in the public discourse about research ethics necessitated a more pragmatic set of rules governing human subject research than the Nuremberg Code. This included a strong distinction between experimental therapy on the one hand and human experimentation without a curative approach on the other, as well as an integration of double-blind studies into the ethical framework. Among the medical men discussing these points were the German internist Paul Martini in the late 1940s11 and the American pioneer of bioethics Henry Beecher in the 1950s and 1960s (see below).

The Nuremberg Code, together with other documents, such as Germany’s 1931 Regulations on New Therapy and Human Experimentation12 (see below), and the interests of research-oriented physicians and the pharmaceutical industry contributed to the formulation of the Declaration of Helsinki by the World Medical Association (wma) in 1964. The interim period saw “international negotiations about the essential divide between an internal professional moral code and external legal control over the rules and principles that differentiate licit and illicit clinical research practices”.13 This became explicit, for instance, in the early 1950s in the struggle for dominance over questions concerning medical ethics between the wma and the Medico-Juridical Commission of Monaco that represented military and civil physicians as well as jurists.14 The wma – an organization representing physicians – advocated that medical doctors, not jurists, should govern the ethics and ultimately the permissibility of human subject research by closely associating human subject protection with medical professionalism and medical professional ethics. It was the wma that would largely gain the upper hand in this struggle.

Connections between the Nuremberg Code and the Declaration of Helsinki (1964) have been well established. While there is, almost curiously, no direct mention of the Nuremberg Code in the Declaration of Helsinki, consultation and discussion of the older document was certainly instrumental in the creation of the newer one.15 The drafts of one of its principal authors, Antonio Spinelli from Italy, drew heavily from the Nuremberg Code and Hugh Clegg, another principal author, had reported from the Nuremberg Doctors’ Trial for the British Medical Journal.16 Numerous interests influenced the eventual publication of the Declaration of Helsinki in 1964, which contained less of a “language of rights and legal liability in clinical trials” and more of a “protective system emphasizing patient health and welfare.”17 The Declaration helped to confirm the position of the ethics of human subject research as part of physicians’ professional domain.

It was with the first revision of the Declaration – the Tokyo revision from 1975 – that independent, external committees to review human subject research were introduced.18

3 The Development of rec s in West Germany

Pioneers of rec s in Germany attribute their rise directly to the 1975 revision of the World Medical Association’s Declaration of Helsinki.19 It states:

The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration, comment and guidance.20

While the German Medical Association (Bundesärztekammer, bäk) had been among the signatories of the 1975 revision, it was not until 1985 that the bäk included a duty to consult rec s in its model code of conduct (Musterberufsordnung), which was subsequently adopted into the state medical associations’ binding codes of conduct. The model code of conduct states:

Physicians who participate in clinical research on human subjects or research on vital human gametes or living embryonic tissue or epidemiological research involving personal data shall consult a research ethics committee established at a medical association or medical faculty in order to be advised on questions of professional ethical and professional legal questions concerning their undertaking. The advice is to be based on the World Medical Association’s Declaration of Helsinki (1964) in its revised version of Tokyo (1975).21

In 1988, the phrasing “shall consult” was changed to “must consult,” and this was subsequently adopted by the different state medical associations by 1990. Physicians in Germany face professional legal consequences for any violation of the code of conduct.22 These could range up to losing the license to practice medicine in Germany.

The formulation has varied slightly in different versions of the model code of conduct. The latest version (2018) states that physicians “must” obtain advice “from an Ethics Committee established at the responsible Chamber of Physicians, or from another independent, interdisciplinary Ethics Committee set up according to state law”.23

An infrastructure of rec s was established in West Germany before their consultation became a mandatory requirement. The first two committees were founded even before the 1975 revision of the Declaration of Helsinki. Taking its cues from the American debate started by the publication of Henry Beecher’s Ethics and Clinical Research (1966),24 the German Research Foundation (dfg) – an institution that dispenses public funds to research institutions – had asked for two rec s to be established: one at Ulm University and another at the University of Göttingen. Ulm had received funding for a Collaborative Research Center (Sonderforschungsbereich, sfb) on cell physiology which included human experimentation of a hematological nature. Göttingen received funding for an sfb on cardiology. In response to the dfg’s requirement that beneficiary research centers develop models to ensure ethical conduct of research in accordance with the Declaration of Helsinki, both developed rec s; Ulm in 1971 and Göttingen in 1973.25 It has been suggested that one of the motivating factors behind their establishment was for researchers to gain experience regarding this novel instrument of ethics review boards.26 After evaluating these experiences, the dfg wrote to the deans of West Germany’s medical faculties in 1979 and suggested that all faculties set up rec s.27 Following a symposium at the University of Münster in 1980 that brought together experts from clinical medicine, law, ethics and the history of medicine,28 the Association of Medical Ethics Committees in Germany was founded in 1983. The association survives to the present day (2021) and represents the overwhelming majority of rec s in Germany.29

By 1985, there were at least 30 rec s associated with universities and state medical associations in West Germany, meeting the requirements of the model professional code of conduct. At the same time, six sfb s still had their own review boards. Most rec s at that time had between five and seven members and were dominated by medical doctors. Almost all included a jurist, while only a minority included a theologian or philosopher.30

As a reaction to the growing demands of ethics approval, a small number of privately operated rec s were formed in the 1980s. Two of the more prominent examples were Freiburg Ethics Commission International (Freiburger Ethik-Kommission International, feki) and Ulm Independent Ethics Commission Swabia (Ulmer Unabhängige Ethikkomission Schwaben).31 Some large pharmaceutical companies, including Boehringer (Mannheim), Beiersdorf (Hamburg) and Schering (Berlin) established their own rec s.32 In the 1990s, a privately operated Ethics Commission Rhein-Main was founded.33

In 1989, an article had already appeared in the Journal of the German Medical Association critiquing “commercial ethics commissions”.34 This triggered a reply by the head of feki – which had not directly been named in the article.35 In 1994 the president of the German Medical Association spoke out directly against private rec s, arguing they could not effectively protect “human subjects, physicians and the public from the consequences of ethically and legally precarious research”.36

Perhaps one of the most striking examples of the limits of private rec s in Germany involved feki. Founded in 1980 in the south-west German university city of Freiburg, feki – which was not associated with the University of Freiburg – also operated subsidiaries in nearby Switzerland. In the 1990s, the commission gave ethical approval for the Swiss contract research company VanTx to recruit hundreds of participants for Phase 1 drug trials in Eastern Europe and transfer them to Switzerland. Human subjects did not receive adequate information before traveling to Switzerland, consent forms were provided in languages that many of the subjects could not read. In the course of an investigation initiated by the Swiss drug administration, it was discovered that the ceo of VanTx also served as head of one of feki’s Swiss subsidiaries, constituting a clear conflict of interest.37

From the 1990s onwards, private rec s drew increasing criticism from the medical profession and regulations on clinical trials increasingly required the consultation of state-regulated rec s. The 1994 revision of the Medical Products Act states that “a clinical trial of medical products in human subjects […] can only commence when an independent ethics commission, constituted according to state law, has approved it”.38 This gave power to the states to formulate laws describing which rec s they recognized, and this led to the current situation in which research ethics commissions exist within state medical associations, within medical faculties and within state bureaucracies. Since 2005, rec s can be recognized by states according to explicit requirements formulated by the amg (see below).

The case of private, “independent” rec s in Germany contrasts starkly with the situation in the United States. As Sarah Babb shows, for-profit irb s have increasingly taken over in the U.S. since the 1990s. Among the reasons, she identifies over-work of volunteer members caused by “more intensive procedural and record keeping requirements”, a lack of public funding for rec s at medical schools, and the economies of scale imposed by large review boards which, among other things, results in shorter turnaround times on reviews.39 In Germany, physicians and their organizations were strongly opposed to private rec s, perhaps in part because of fear of external oversight on biomedical research, or in part because they feared that private rec s would do inadequate work, potentially resulting in medical scandals and shaken public confidence in biomedical research. In part their opposition may also have been due to the fact that medics continued to see human research subject protection as part of their professional ethos.

The 1994 revision of the Medicinal Products Act is especially relevant for rec s in Germany, because it moves the duty to consult rec s from professional law (medical associations’ codes of conduct) to the domain of regulatory law. Since the 2004 revision, the amg also explicitly refers to European Directive 2001/20/eg, which deals with ethics committees and which aims to harmonize good clinical practice in the conduct of clinical trials across all European Union member states.40 While this European regulation has created a degree of harmonization within the European Union, structures and institutionalization of rec s remain distinct in different member states.41

4 The Development of rec s in East Germany

Medicine in the “German Democratic Republic” (“Deutsche Demokratische Republik”, ddr) was organized more centrally than in West Germany. By the 1970s, East Germany had taken an active role in the deliberations of the Council for International Organizations of Medical Sciences, an institution established jointly by the World Health Organization (who) and the United Nations Educational, Scientific and Cultural Organization (unesco). At a meeting in Manila in 1981, it proposed a set of International Guidelines for Biomedical Research involving Human Subjects and published these guidelines the following year.42 Subsequently, the Working Group on Ethics in Medical Research that was formed at the Council for Medical Sciences (Rat für Mediznischen Wissenschaften) of the ddr Ministry of Health in 1982 has come to be regarded as the first central rec in East Germany. It was led by the professor of clinical and experimental tumor biology and director of the Central Institute for Cancer Research Stephan Tanneberger.43 While medical ethics in East Germany was generally strongly influenced by Marxist-Leninist philosophy and integration into the Eastern bloc, there were no clear models to be found in the field of research ethics. For this reason, ddr authorities looked to the American and West German discourses (respectively, the Belmont Report of 1978,44 and written recommendations for the foundation of rec s at medical faculties in 1979).45 Interdisciplinary approaches to questions of medical ethics more generally had been discussed in East Germany before. For this reason, the West German approach of including physicians, jurists, philosophers, and theologians into rec s was received favorably. An annotated bibliography in six volumes, including 500 titles in German, English, French and Russian, was published by the working group, with the first volume containing the texts of various medico-ethical codices, including the Prussian Directives (see below), the Nuremberg Code, and the 1964 and 1975 versions of the Declaration of Helsinki.

The working group had 16 members, including philosophers and jurists, and met two or three times per year. Their deliberations were understood as a source of advice and orientation, but their recommendations were not legally binding.46

A 1980 review of publications in the journal Das deutsche Gesundheitswesen, the official journal of the Society for Clinical Medicine in the ddr (Gesellschaft für klinische Medizin der ddr), revealed that 23 studies, including a total of 2,241 participants, were deemed ethically problematic, because patient information had not been documented, or risk-benefit analysis had not been conducted.47 This approach parallels that of Henry Beecher, who had pioneered the investigation of these kinds of ethical problems in the U.S. context in 1966.48

In 1988 the working group published recommendations regarding the preservation of ethical principles in new medical procedures. These, too, were not legally binding, but made clear what was expected of medical researchers and served as guidelines for research planning and funding, publications, and travel – all areas, that were centrally administered in East Germany.49 The recommendations contain ten points. Point 8 includes the following guidance:

A precise study protocol must be defended in front of a competent committee before starting the investigation. This defense must also address ethical aspects. Particularly in cases of high-risk investigation, a statement must be obtained from the Council for Medical Science at the Ministry of Health.50

In order to create an infrastructure that could prepare this approval, Central Research Councils for medical and biomedical research – mid-level bureaucratic structures established to ensure the influence of the East German state party on science and education – were authorized from 1987 onwards to act as decentralized rec s. Individual members of these councils received training in research ethics and led local deliberations, but ultimate authority remained with the central Working Group at the ddr Ministry of Health.

During the 1970s and 1980s it was not uncommon for West German pharmaceutical companies to “outsource” clinical trials to East Germany. The authors of a recent study conclude that, while ethical standards and subject protection were lacking from today’s perspective, trial participants were not systematically worse protected in the ddr than they would have been in West Germany. At the same time, the studies were paid for with West German money, making them very attractive for the East German administration, and making approval processes quicker and smoother than they might have been in the West.51

After the peaceful revolution in East Germany in 1989 and German reunification a year later, West German laws and regulations applied in all of Germany. Five states were formed on the territory of the former ddr that joined the eleven West German states to form the Federal Republic of Germany in its current form. Each of the five new states subsequently formed a state medical association. rec s were set up within the new medical associations, as well as at medical faculties in the five new Eastern states.

5 The Status of rec s in Germany Today

The current version of the amg (2005) explicitly states that only public sector ethics committees instituted according to state law may approve clinical trials. In addition, they must be registered with the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and meet certain requirements including:

  1. scientific expertise of commission members and external experts,
  2. interdisciplinary composition of the ethics committee, with the participation of at least one jurist, one person with scientific or professional experience in the field of ethics in medicine, one person with experience in the field of experimental design and statistics, three physicians who possess experience in clinical medicine, including one specialist in clinical pharmacology or in pharmacology and toxicology, as well as one layperson,
  3. representation of persons of male and female gender, with the aim of equal participation,
  4. regulations on the un-remunerated nature of membership, confidentiality, and conflicts of interest, among other things, and
  5. sufficient resources to operate in a professional and timely manner.

Pediatric clinical trials must also include an outsider with expertise on medical, ethical, and psychosocial aspects of children’s health, if the committee does not have a member with this expertise.52 In its current form, the amg is closely modeled on European Directive 2001/20/eg (see below).

The Association of Medical Ethics Committees in Germany today serves as a forum for the individual committees that constitute its members, provides educational materials, and suggests a model charter for ethics committees in order to meet legal requirements according to the amg.53

As of 2021, only three German states have established state rec s: Berlin, Bremen, and Saxony-Anhalt. According to the amg, the other states have delegated tasks to ethics committees at universities or state medical associations.54 Currently, the Association of Medical Ethics Committees in Germany has 52 members. In addition to the state rec s there are 14 rec s at state medical associations, and 36 rec s at medical faculties, universities, and medical universities.55

rec s in Germany begin their deliberation on application, with rec s at medical faculties and universities addressing the needs of researchers associated with universities, and rec s at state medical associations and within state bureaucracies addressing those of researchers outside universities. In trials run in accordance with the Medicinal Products Act or the Medicinal Devices Act, the sponsor – often a pharmaceutical cooperation – must seek approval from the rec responsible for the clinical study leader (Prüfarzt). The central criteria employed by ethics committees are scientific quality, legal permissibility, and ethical maintainability.56

6 Factors Contributing to the Constitution and Acceptance of rec s in Germany

Different factors contributed to the constitution and acceptance of rec s in Germany from the 1970s. These include – to some degree – historical references to Nazi medical experimentation and their legal and ethical reflection in the Nuremberg Doctors’ Trial, but also references to research ethics guidelines formulated in Prussia in 1900 and in Germany in 1931, as well as to international bioethical discourses since the 1960s. After 2000, European Union regulations play an increasingly important role.

6.1 Nuremberg Doctors’ Trial

In the German historiography, the Nuremberg Doctors’ Trial and the Nuremberg Code are often referenced as a central event and document in the development of ethics in human subject research and contributing factors to the Declaration of Helsinki.57 The tension between a medical researcher’s role as “healer” and as life-science researcher is inherent to modern medicine, with a gray area existing between the two – for instance in cases where a physician employs experimental therapy in order to cure an individual patient without (primarily) aiming to increase scientific knowledge. This distinction was emphasized more in the Declaration of Helsinki than in the Nuremberg Code.58 While rights for research subjects were strengthened, at the same time physicians were given more leeway to use experimental therapies in accordance with their clinical experience.

Many aspects of the Nuremberg Code have been identified as remaining central to the ethics of human subject research today. These include informed consent, voluntary participation in research, the scientific validity of studies, a positive risk-benefit analysis, and the preclusion of serious harm to study participants. Other aspects – in addition to the distinction between therapeutic and non-therapeutic research – have been revised. This includes the ban on research using less than fully competent research subjects, because it has been shown that this precluded research on diseases affecting vulnerable groups like children or people with psychiatric diseases. Since the adoption of the Declaration of Helsinki and the subsequent establishment of rec s in Germany, medical ethicists and jurists have mostly referred to the Declaration of Helsinki and only rarely to the Nuremberg Code when formulating decisions in the context of research ethics.59

6.2 Prussian Directives of 1900 and German Guidelines of 1931

Other important contributions to the discourse on the ethics of human subject research in the German context are the Prussian Directives for the Directors of Hospitals and other Medical Institutions (Anweisung an die Vorsteher der Kliniken, Polikliniken und sonstigen Krankenanstalten, 1900)60 and the German Guidelines for New Therapy and Human Experimentation (Richtlinien für neuartige Heilbehandlungen und für die Vornahme wissenschaftlicher Versuche am Menschen, 1931).61 These two ethical codes, of course, pre-date Nazi medical crimes and were understood to be non-legally binding (in the sense of regulatory law).62 Ultimately, they proved futile inasmuch as they did nothing to prevent Nazi medical crimes. Nonetheless, the two codes illustrate that a discourse on human subject research was already established in Germany in the nineteenth and throughout the first decades of the twentieth century.63

The Prussian Directives were formed after a scandal involving the Breslau dermatologist Albert Neisser, who had conducted venereological research on underage girls. After a media campaign and legal trial against Neisser, it was judged that he had failed to obtain explicit consent from his research subjects. After deliberations with medical and legal authorities, the Prussian governments subsequently published the Directives in 1900. They stated:

[…] that medical interventions for purposes other than diagnosis, therapy, and immunization are absolutely prohibited, even if all other legal and ethical requirements for performing such interventions are fulfilled if: (1) the person in question is a minor or is not fully competent on other grounds; (2) the person concerned has not declared unequivocally that he consents to the intervention; (3) the declaration has not been made on the basis of a proper explanation of the adverse consequences that might result from the intervention.64

For the purposes of diagnosis, therapy, and immunization programs, other guidelines had been issued earlier.65

The 1931 Guidelines show that the discourse on human experimentation further evolved during the Weimar Republic. It distinguished between therapeutic (“new therapy”) and non-therapeutic research (“human experimentation”) and imposed stricter requirements for non-therapeutic research, which was “under no circumstances permissible without consent” – a distinction later introduced into the international discourse by the Declaration of Helsinki.66 The Guidelines also explicitly required a risk-benefit analysis according to medical ethics and medical science, specific protection for research subjects younger than 18 years of age, and a trial protocol that would include documentation of informed consent.

Upon their release, the Guidelines were widely disseminated in the medical press. While they continued to be referred to after 1933, it is unclear how widespread their application was in human subject research during that time. As Volker Roelcke has shown, the guidelines were again referred to by German medical scientists after 1945 to illustrate the existence of ethical standards for human subject research and to highlight the extraordinary nature of the medical crimes perpetrated by the Nuremberg Doctors’ Trial defendants. At the same time, Paul Martini, professor of internal medicine and president of the German Association for Internal Medicine, discussed how the Guidelines might be harmonized with the emerging “gold standard” of double-blind clinical trials.67 This illustrates an understanding that ethical standards and codes to protect human research subjects must evolve together with biomedical standards of how to conduct research.

Today, the Association of Medical Ethics Committees in Germany traces the development of ethics in medical research back to the Prussian and German regulations of 1900 and 1931,68 as do some early exponents of rec s in West Germany69 and many historians of medicine. The regulations were also included in the annotated bibliography published by the East German Working Group.

While neither the regulations from 1900 nor 1931 recognized the need for institutional review boards, much of their content is similar to later regulations. This may help to explain why rules concerning human subject research were broadly accepted in Germany from the 1970s.

6.3 International Bioethical Discourse Since the 1960s

The international discourse on human subject research greatly influenced the German discourse on this topic. This is more evident for West Germany but is true also for East Germany. The Journal of the (West) German Medical Association published an article in 1981 that referred to the United States as a “pioneer and in some respects also role model” for research ethics committees in West Germany, specifically naming the Institutional Clinical Center Review of the National Institutes of Health and the Institutional Review Board of Georgetown Hospital as models.70 Early members of rec s and of the Association of Medical Ethics Committees in (West) Germany likewise refer the United States as a model during the early years.71 Regulation and organization of U.S. American irb s was discussed in considerable detail at meetings of the Association.72

Henry Beecher’s publication on Ethics and Clinical Research (1966) and the Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1978) have been described as central for the development of rec s in West Germany.73 They were also included in the official East German annotated bibliography published by the Working Group on Medical Ethics. The Working Group was also influenced by West German institutions and practices related to research ethics, which meant that the East German institution was – indirectly – modeled after U.S. American irb s. The German Medical Association describes the Declaration of Helsinki as the “benchmark for clinical trials on human beings and has been influential in the formation of German drug law”.74

Beecher himself was critical of the limits placed on human subject research by the Nuremberg Code, for reasons similar to those of Martini a decade earlier. This led to Beecher’s contribution to the debate, aimed at formulating “more workable guidelines for clinical research,”75 which is what the Declaration of Helsinki would ultimately become. Notably, the Declaration included a “differentiation between ‘clinical research combined with professional care’ and ‘non-therapeutic clinical research’,”76 a distinction quite similar to that made between “innovative therapy” and “scientific experimentation” in the 1931 German Guidelines.

These examples show that, at least since the 1970s, the international – specifically the anglophone – bioethical discourse was highly influential in Germany.

6.4 European Directive 2001/20/eg

While rec s were already well established in Germany in 2001, their central position in European Directive 2001/20/eg made their role even more vital and led to the amg stipulating specific requirements for them. The directive was passed by the European Parliament and the European Council in 2001 and amended four years later by directive 2005/28/eg. Its aim is to inform and promote the harmonization of laws and administrative regulations regarding good clinical practice in the European Union, including rules on the application for clinical trials, and the conduct, recording, reporting and analysis thereof.77 In the directive, an ethics committee is defined as:

an independent body in a Member State, consisting of healthcare professionals and non-medical members, whose responsibility it is to protect the rights, safety and wellbeing of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, expressing an opinion on the trial protocol, the suitability of the investigators and the adequacy of facilities, and on the methods and documents to be used to inform trial subjects and obtain their informed consent.

The work of rec s in Germany today is informed by those aspects that the directive asks the ethics committees to consider. Among them are a risk-benefit analysis, the suitability of the investigator and staff, the adequacy and completeness of information materials given to participants, the recruitment of participants, and provisions for indemnity and insurance in case the trial causes harm to a study participant.78

7 Conclusion

Having given this overview of the development of regulations concerning human subject research in Germany, I want to return to the three questions posed in the Introduction.

While the experience of Nazi medical crimes, including experimentation on human subjects in concentration camps, played in important role in the German discourse on research ethics, it is by no means the only important factor that led to the adoption and recognition of rec s. Both West and East Germany looked to the international bioethical discourse from the 1960s onwards. After an experimental period of rec s within externally funded research centers in the 1970s, the first regular boards established within medical faculties and state medical associations in West Germany were modeled on U.S. American examples. It is significant to note that during this period, the duty to consult ethics committees was a requirement in professional law, regulating physicians as members of a profession and of a state medical association, not in regulatory law. This step into regulatory law would be taken only with the revision of the amg in 1994. This is relevant because it shows that human subject protection was understood to be part of medical professionalism and professional ethics, not something to be governed by jurists and the state. The East German Working group also took its cues from the international, including anglophone, bioethical discourse, as well from practices that had been established in West Germany in the 1980s.

Since 2001, European regulations have also played in increasingly important role. This further illustrates the importance of international and European integration in the implementation of clinical trials in Germany today.

It has been argued that while much attention was paid in Germany to the Nuremberg Doctors’ Trial and the Nuremberg Code in the immediate aftermath of the war, their lasting effects were more indirect. While neither the trial nor the code were often referred to initially in the United States post-war debates about human research subject consent, by the mid-1950s the Nuremberg Code was being referred to as “ten commandments of human medical research” concerning healthy volunteers, framing it as an ethical principle rather than as a legal requirement.79 Alexander Capron has identified the period from the publication of the Nuremberg Code to the scandal surrounding the reports of the Tuskegee syphilis study as an “ethical lacuna” in the American discourse on research with human subjects – one punctuated by the publication of Beecher’s “Ethics and Clinical Research”.80 While ultimately inadequate to prevent problematic research practices after 1947, the Nuremberg Code has been identified as “influential in the fields of medical politics, ethics and law”.81 It directly influenced the Declaration of Helsinki, and is referred to in the Belmont Report which describes the Nuremberg Code as “the prototype of many later codes intended to assure that research involving human subjects would be carried out in an ethical manner,” naming the Helsinki Declaration of 1964 and its revision, among others, in a footnote.82 In this way, the international integration of German research ethics is into a framework that was itself constructed in the aftermath of the Nuremberg Code.

Regarding the ways in which rec s were set up and regulated in West and East Germany and the post-1990 reunited Germany, there was a clear distinction between a more de-centralized West German system a more centralized East German system. From the beginning in West Germany, ethics committees were set up in individual research centers, in local medical faculties, and at the state level in medical associations and within bureaucracies of individual federal states. This follows the early U.S. American model, which has been described as an “ethics of place” in which ethical expertise is present in individual locations that perform and regulate biomedical research.83 A decade later, East Germany set up a central Working Group within the national Ministry of Health. While until the end of the 1980s, some efforts were made to create a more decentralized infrastructure, authority ultimately remained with the Working Group and under the strict control of the East German state party until the end of the ddr in 1990.

The shift from professional to regulatory law marked by the 1994 amg can be understood as a step towards centralization in the regulation of rec s in the re-united Germany, as a federal law regulated requirements for rec s for the first time. Around the same time, commercial rec s and those within pharmaceutical companies almost completely disappeared. This was in large part, because they did not meet new legal requirements, but also because they were criticized strongly and openly by the German Medical Association. European Directive 2001/20/eg is even more centralized, giving guidelines from the European Union that led to concrete changes in the German amg regarding requirement for ethics committees.

Any analysis of the institutionalization of rec s in Germany makes clear the centrality of the medical profession in this process. This may in part be due to the fact that human subject protection is understood to be part of the professional duties of physicians, but it may also be explained by the perceived need to safeguard biomedical research against too much “outside” interference. Volker Roelcke has argued that the “regulation of medical research is essential to enable the progress of medical science,”84 i.e., to continue biomedical research without scandals. In that sense, rec s in Germany today continue to serve medical researchers and administrators in making ethical decisions. Noortje Jacobs has described, moreover, that rec s also secure public funds and support by aligning “‘ethical conduct’ in the creation of medical knowledge with adherence to proper ‘scientific method’.”85

Forty-nine out of fifty-two review boards exist within medical faculties and state medical associations; only three out of the 16 German states (Länder) maintain rec s within the state bureaucracy: in Berlin, within the State Office for Health and Social Affairs (Landesamt für Gesundheit und Soziales), and in Saxony-Anhalt, within the State Office for Consumer Protection (Landesamt für Verbraucherschutz). The rec of the state of Bremen is hosted by the department of pharmacology at Bremen Hospital. This illustrates that while formally, authority over human subject research has shifted from the domain of medical professionalism to the domain of regulatory law, in practice, the medical profession still fundamentally maintains the process of ethics approval.

One of the effects of this shift towards regulatory law can be an “ethics creep,”86 such as has been described in the Canadian and U.S. American contexts,87 in which requirements for irb approval have become the norm in the social sciences and the humanities. This has been largely absent in Germany. While some rec s exist outside the medical context, for instance in psychology,88 social science research and oral history are often still conducted without seeking ethics approval.

Today, Germany has a large number of rec s institutionalized at the local level, but regulated to a common standard. With many having far more members than the seven persons required by law, there are a relatively large number of representatives of different academic disciplines (and laypeople) who participate in deliberations and receive continuing education on research ethics. As most German medical faculties include a department for the history of medicine and medical ethics,89 many rec s include at least one professional bioethicist who can fulfill a “pedagogical role”90 and transfer academic experience to practice and practical experience to teaching and research on meta-ethics. This contributes to a healthy public discourse on the ethical aspects of clinical trials, and to a wide acceptance of rec s in Germany today.

Acknowledgments

I would like to thank the editors of this special issue, Helena Tinnerholm Ljungberg and Noortje Jacobs, as well as the anonymous peer reviewers for their valuable feedback. Any remaining inconsistencies or errors are mine. I would also like to acknowledge the visiting postdoctoral fellowship at the Institute for the Medical Humanities (today, the Institute for Bioethics and Health Humanities) at the University of Texas Medical Branch at Galveston, which I held from March to May 2018, which gave me the opportunity to develop some of the material that contributed to this article.

1

Sebastian Klammt, Andreas Büttner and Emil Reisinger, “Klinische Prüfung von Arzneimitteln in ddr und brd: Unterschiedliche Rechtsrahmen,” Dtsch Arztebl, 111 (2014), A-2008 / B-1710 / C-1636; Joachim Czawalinna, Ethik-Kommissionen: Forschungslegitimation durch Verfahren (Frankfurt am Main, 1987); Erwin Deutsch, “Die rechtlichen Grundlagen und Funktionen der Ethik-Kommissionen,” in Die Ethik-Kommission in der Medizin: Problemgeschichte, Aufgabenstellung, Arbeitsweise, Rechtsstellung und Organisationsformen Medizinischer Ethik-Kommissionen, ed. Richard Toellner (Stuttgart–New York, 1990), 67–77; Richard Toellner, “Problemgeschichte: Entstehung der Ethik-Kommissionen,” in idem, Die Ethik-Kommission in der Medizin, 3–18.

2

Elmar Doppelfeld, “Ethikkommission,” in Handbuch Ethik und Recht der Forschung am Menschen, ed. Christian Lenk, Gunnar Duttge and Heiner Fangerau (Berlin–Heidelberg, 2014), 141–144.

3

Harmut Bettin, “Eine ag Ethik in der ddr als erste zentrale deutsche Ethikkomission. Zum Umgang mit ethischen Frageb bei der Forschung am Menschen,” Zeitschtschrift für medizinische Ethik, 56 (2010), 235–250.

4

Hans-Peter Ries, Karl-Heinz Schnieder, Björn Papendorf, Ralf Großbölting and Sebastian Berg, “Ärztliches Standesrecht,” in Arztrecht, ed. eidem (Heidelberg, 2017), 85–108.

5

Andrea Dörries, Gerald Neitzke, Alfred Simon and Jochen Vollmann, eds., Klinische Ethikberatung: Ein Praxisbuch für Krankenhäuser und Einrichtungen der Altenpflege(Stuttgart, 2010); Andreas Frewer, Florian Bruns and Arnd T. May, eds., Ethikberatung in der Medizin (Berlin–Heidelberg, 2012); Norbert Steinkamp and Bert Gordijn, Ethik in Klinik und Pflegeeinrichtung (Munich, 2010).

6

Zentrale Ethikkomission, www.zentrale-ethikkommission.de, last accessed 18 April 2021.

7

Deutscher Ethikrat, www.ethikrat.org, last accessed 18 April 2021.

8

Friedrich Moll, Matthis Krischel and Heiner Fangerau, “Nazi Medical Crimes and the Nuremberg Doctors’ Trial,” in Skeletons in the Closet: Indignities and Injustices in Medicine, ed. American Urological Association (Linthicum, MD, 2012), 79–83.

9

Paul Weindling, Anna von Villiez, Aleksandra Loewenau and Nichola Farron, “The victims of unethical human experiments and coerced research under National Socialism,” Endeavour, 4 (2016), 1–6.

10

Moll, Krischel and Fangerau, “Nazi Medical Crimes,” 79–83.

11

Volker Roelcke, “The Use and Abuse of Medical Research Ethics: The German Richtlinien/ guidelines for human subject research as an instrument for the protection of research subjects – and of medical science, ca. 1931–61/64,” in From Clinic to Concentration Camp: Reassessing Nazi Medical and Racial Research, 1933–1945, ed. Paul Weindling (London, 2017), 33–56.

12

On the role of the 1931 Guidelines immediately after the war in Germany, cf. Roelcke, “Use and Abuse of Medical Research Ethics.”

13

Christian Bonah and Florian Schmaltz, “From Nuremberg to Helsinki: The Preparation of the Declaration of Helsinki in the Light of the Prosecution of Medical War Crimes at the Struthof Medical Trials, France, 1952–4,” in Ethical Research: The Declaration of Helsinki, and the Past, Present, and Future of Human Experimentation, ed. Ulf Schmidt, Andreas Frewer and Dominique Sprumont (Oxford, 2020), 69–100, 90.

14

Ulf Schmidt, “In the Absence of Alternatives: The Origins and Success of the Declaration of Helsinki, 1947–82,” in Schmidt, Frewer and Sprumont, Ethical Research, 101–130, 103.

15

Sharon Perley, Sev S. Fluss, Zbigniew Bankowski and Françoise Simon, “The Nuremberg Code: An International Overview,” in The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation, ed. George Annas and Michael Grodin (Oxford, 1992), 149–173.

16

Schmidt, “In the Absence of Alternatives,” 106–107.

17

Ibid., 111.

18

Urban Wiesing and Hans-Joerg Ehni, “Die Deklaration von Helsinki des Weltärztebundes – Ethische Grundsätze für die Forschung am Menschen,” in Lenk, Duttge and Fangerau, Handbuch Ethik und Recht der Forschung am Menschen, 517–524.

19

Deutsch, “Die rechtlichen Grundlagen und Funktionen der Ethik-Kommissionen”; Robert Carlson, Kenneth Boyd and David Webb, “The revision of the Declaration of Helsinki: past, present and future,” British Journal of Clinical Pharmacology, 6 (2004), 695–713.

20

Declaration of Helsinki 1975, www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/doh-oct1975, last accessed 18 April 2021.

21

Deutsche Ärztekammer, “Berufsordnung für die deutschen Ärzte,” Dtsch Arztebl, 82 (1985), A-3371–5.

22

Deutsch, “Die rechtlichen Grundlagen und Funktionen der Ethik-Kommissionen,” 70.

23

(Model) Professional Code *for Physicians in Germany- mbo-ä 1997 – **The Resolutions of the 121st German Medical Assembly 2018 in Erfurtas amended by a Resolution of the Executive Board of the German Medical Association on 14/12/2018, www.bundesaerztekammer.de/fileadmin/user_upload/downloads/pdf-Ordner/MBO/MBO-AE_EN_2018.pdf, last accessed 18 April 2021.

24

Henry Beecher, “Ethics and Clinical Research,” N Engl J Med, 274 (1966), 1354–1360.

25

Hans-Dieter Lippert, “Ethikkommissionen: wie sie wurden was sie sind,” MedR, 26 (2008), 654–656.

26

Erwin Deutsch, “Entstehung und Funktion der Ethikkommissionen in Europa,” Medizinrecht, 26 (2008), 650–654.

27

Fritz Walter Fischer, “Ethik-Kommissionen. Bedeutung – politisches Umfeld – transkultureller Vergleich aus der Sicht der Deutschen Forschungsgemeinschaft,” in Toellner, Die Ethik-Kommission in der Medizin, 149–156; for a case study on the foundation of the Erlangen-Nuremberg rec, cf. Andreas Frewer, “Zur Frühgeschichte der Ethik-Kommission an der Universität Erlangen-Nürnberg,” in 200 Jahre Universitätsklinikum Erlangen, 1815–2015, ed. Karl-Heinz Leven, Andreas Plöger, et al. (Cologne, 2016), 332–335.

28

Universität Münster (Westfalen) Ethik-Kommission, Symposium Medizinische Ethik-Kommissionen. Aspekte und Aufgaben, 19.11. 1980 (Münster, 1981).

29

Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e.V., www.akek.de, last accessed 18 April 2021.

30

Czawalinna, Ethik-Kommissionen, 120–132.

31

“Ethik-Kommissionen: Konkurrenzkampf,” Dtsch Arztebl, 51/52 (1989), A-3937–8.

32

Czawalinna, Ethik-Kommissionen, 121.

33

S. Dauth, “Freie Ethikkomission registiert,” Dtsch Arztebl, 11 (1996), A-658.

34

Elisabeth Pflanz, “Die dornenvolle Arbeit von Ethik-Kommissionen,” Dtsch Arztebl, 27 (1989), A-4990–1.

35

G. Pfeiffer, “Unrichtig,” Dtsch Arztebl, 33 (1989), A-2257.

36

S. Dauth, “Ethikkomissionen. Regelung à la Pfeiffer,” Dtsch Arztebl, 24 (1994), A-1669.

37

Schmidt, Frewer and Sprumont, “Introduction: The limits of altruism,” in eidem, Ethical Research, 1–45, 7.

38

Fünftes Gesetz zur Änderung des Arzneimittelgesetzes. Vom 09. August 1994, www.bgbl.de/xaver/bgbl/start.xav?start=%2F%2F*%5B%40attr_id%3D%27bgbl194s2071.pdf%27%5D#__bgbl__%2F%2F*%5B%40attr_id%3D%27bgbl194s2071.pdf%27%5D__1617024801037 (my translation), last accessed 18 April 2021.

39

Sarah Babb, “The Privatization of Human Research Ethics: An American Story,” European Journal for the History of Medicine and Health, current issue.

40

Sebastian Graf von Kielmansegg, Norbert Benda, Guido Grass and Thomas Sudhop, “Die Rolle von Ethikkommissionen bei der Bewertung klinischer Arzneimittelprüfungen,” Bundesgesundheitsbl, 62 (2019), 706–712.

41

Adam Hedgecoe, Fatima Carvalho, Peter Lobmayer and Frederik Rakar, “Research ethics committees in Europe: implementing the directive, respecting diversity,” J Med Ethics, 32 (2006), 483–486.

42

Klammt et al., “Klinische Prüfung von Arzneimitteln.”

44

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research (dhew Publications, Bethesda, MD, 1978).

45

Cf. Deutsch, “Die rechtlichen Grundlagen und Funktionen der Ethik-Kommissionen.”

46

Bettin, “Eine ag Ethik in der ddr.”

47

Stephan Tanneberger, “Zu einigen Problemen der Ethik in der medizinischen Forschung,” in Ethik in der Medizin, ed. Ernst Luther (Berlin, 1986), 52–58.

48

Beecher, “Ethics and Clinical Research.”

49

Bettin, “Eine ag Ethik in der ddr.”

50

Stephan Tanneberger, “Empfehlungen zur Wahrung ethischer Grundsätze bei der Erprobung neuer medizinischer Verfahren und Maßnahmen,” Zeitschrift für Klinische Medizin, 6 (1988), 437–438.

51

Volker Hess, Laura Hottenrott and Peter Steinkamp, “Testen im Osten – ddr-Arzneimittelstudien im Auftrag westlicher Pharmafirmen. ddr-Arzneimittelstudien im Auftrag westlicher Pharmaindustrie, 1964–1990” (Berlin, 2016).

52

Section 40. General conditions for clinical trials, www.gesetze-im-internet.de/englisch_amg/englisch_amg.html#p0984, last accessed 18 April 2021.

53

Standorte der Ethik-Kommissionen, www.akek.de/ethik-kommissionen/#/cats_mitglieder/all, last accessed 18 April 2021.

54

Kielmansegg et al., “Die Rolle von Ethikkommissionen,” 706–712.

55

One rec is counted in two categories; it is associated with Medical Association of Westphalia-Lippe and the University of Münster.

56

Doppelfeld, “Ethikkommission.”

57

For example, Walter Bruchhausen and Heinz Schott, Geschichte, Theorie und Ethik der Medizin (Göttingen, 2008), 210; Wolfgang Eckart, Geschichte, Theorie und Ethik der Medizin (Berlin–Heidelberg, 2017), 268–270, 359–362.

58

Todd L. Krause and William Winslade, “Fünfzig Jahre Nürnberger Kodex,” in Ethik und Medizin 1947–1997. Was leistet die Kodifizierung von Ethik? ed. Ulrich Tröhler and Stella Reiter-Theil (Göttingen, 1997), 189–219.

59

Erwin Deutsch, “Der Nürnberger Kodex. Das Strafverfahren gegen Mediziner, die zehn Prinzipien von Nürnberg und die bleibende Bedeutung des Nürnberger Kodex,” in Tröhler and Reiter-Theil, Ethik und Medizin 1947–1997, 103–114.

60

Preussisches Ministerium fuer Religion, Unterricht und Medizin (1900) Instruktionen fuer die Direktoren der Krankenanstalten und andere medizinische Einrichtungen. Centralblatt der gesamten Unterrichtsverwaltung in Preussen (2000), 188–189 (Engl. transl.: Annas and Grodin, Nazi Doctors and the Nuremberg Code, 124); also cf. Nicolas Pethes, Birgit Griesecke, Marcus Krause and Katja Sabisch, Menschenversuche. Eine Anthologie 1750–2000 (Frankfurt, 2008).

61

Jochen Vollmann and Rolf Winau, “Nuremberg Doctors’ Trial – Informed consent in human experimentation before the Nuremberg Code,” British Med. J., 313 (1996), 1445–1447.

62

Cf. Roelcke, “Use and Abuse of Medical Research Ethics.”

63

Barbara Elkeles, Der moralische Diskurs über das medizinische Menschenexperiment im 19. Jahrhundert (Stuttgart–Jena–New York, 1996).

64

Translation from Annas and Grodin, Nazi Doctors and the Nuremberg Code, 127.

65

Friedrich Moll, Matthis Krischel and Heiner Fangerau, “Albert Neisser and the First Prussian Directive on Informed Consent,” in American Urological Association, Skeletons in the Closet, 73–77.

66

Vollmann and Wenau, “Nuremberg Doctors Trial.”

67

Roelcke, “Use and Abuse of Medical Research Ethics.”

68

Geschichte der Forschungsethik, www.akek.de/geschichte-der-forschungsethik, last accessed 19 April 2021.

69

Heinz Losse, “Ethische Problemen der medizinischen Forschung am Menschen,” in Toellner, Die Ethik-Kommission in der Medizin, 19–29.

70

Pflanz, “Die dornenvolle Arbeit von Ethik-Kommissionen,” A-1990–1.

71

Richard Toellner, “The Historical Precondition for the Origin of Medical Ethics Committees in West Germany,” Metamedicine, 2 (1981), 275–282; Erwin Deutsch, Das Recht der klinischen Forschung am Menschen (Frankfurt, 1979).

72

Hans Martin Sass, “Ethik-Kommissionen und andere Beratungsformen in den USA,” in Toellner, Die Ethik-Kommission in der Medizin, 121–139.

73

Geschichte der Forschungsethik, www.akek.de/geschichte-der-forschungsethik, last accessed 19 April 2021.

74

World Medical Association(wma), <www.bundesaerztekammer.de/weitere-sprachen/english/cooperation/world-medical-association-wma>, last accessed 18 April 2021.

75

Susan E. Lederer, “‘Ethics and Clinical Research’ in Biographical Perspective,” Perspectives in Biology and Medicine, 59 (2016), 18–36.

76

Perley et al., “The Nuremberg Code.”

77

Stéphanie Dagron, “Die Regulierung der klinischen Forschung in der Europäischen Union,” in Lenk, Duttge and Fangerau, Handbuch Ethik und Recht der Forschung am Menschen, 525–530.

78

Directive 2001/20/ec of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32001L0020&from=DE, last accessed 18 April 2021.

79

Leonard Glantz, “The Influence of the Nuremberg Code on U.S. Statutes and Regulations,” in Annas and Grodin, Nazi Doctors and the Nuremberg Code, 183–200.

80

Alexander M. Capron, “Henry Knowles Beecher, Jay Katz, and the Transformation of Research with Human Beings,” Perspectives in Biology and Medicine, 59 (2016), 55–77.

81

Ulf Schmidt, “The Nuremberg Doctors’ Trial and the Nuremberg Code,” in History and Theory of Human Experimentation. The Declaration of Helsinki and Modern Medical Ethics, eds. Ulf Schmidt and Andreas Frewer (Stuttgart, 2007), 71–116, 108.

82

The National Commission, Belmont Report, 1.

83

Laura Stark, Behind Closed Doors: irbs and the Making of Ethical Research (Chicago, IL, 2012).

84

Roelcke, “Use and Abuse of Medical Research Ethics,” 46–47.

85

Noortje Jacobs, “A Moral Obligation to Proper Experimentation: Research Ethics as Epistemic Filter in the Aftermath of World War ii,” Isis, 111 (2020), 759–780, https://doi.org/10.1086/712205.

86

Kevin D. Haggerty, “Ethics Creep: Governing Social Science Research in the Name of Ethics,” Qualitative Sociology, 27 (2004), 391–414.

87

Zachary M. Schrag, Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965–2009 (Baltimore, MD, 2010).

88

Ethikkomission, www.psych.uni-goettingen.de/ethikkommission, last accessed 5 August 2021.

89

Ylva Söderfeldt and Matthis Krischel, “Feeling Great? Practice, Institutionalization and Disciplinary Context of History of Medicine in Germany,” in Communicating the History of Medicine: Perspectives on Audiences and Impact, ed. Solveig Jülich and Sven Widmalm (Manchester, 2020), 43–65.

90

Hedgecoe et al., “Research ethics committees in Europe,” 485.

Content Metrics

All Time Past 365 days Past 30 Days
Abstract Views 676 222 2
Full Text Views 90 33 22
PDF Views & Downloads 165 46 22