Biomedical Research in Germany

Abstract

Biomedical research with human volunteers, human tissue, or identifiable human data must follow ethical, legal, and regulatory standards. In Germany, biomedical research is regulated by federal and state laws as well as by the Code of Deontology (the professional code, vide infra). Ethics committees (institutional review boards) have been established in Germany since 1973 to safeguard the well-being and rights of human subjects involved in biomedical research. According to the Code of Deontology, investigators are obliged to seek the advice/vote of their local ethics committee before starting biomedical research. The Code of Deontology does not state that approval by the ethics committee is required, but in practice it is interpreted as requiring a positive vote before the study can begin. Under German federal law, clinical trials with drugs or medical devices must have a favorable opinion (i.e., approval) of the ethics committee before the trial starts. Thus, German physicians engaged in research must adhere both to the Code of Deontology, which governs their activities as physician investigators, and federal and state laws that govern the conduct of clinical trials with drugs or medical devices in Germany. Germany consists of 16 federal states (Bundeslander). By law every state has a state medical association (Landesarztekammer), acting as an organization under public law; the largest state has 2 such associations. The Federal Medical Association (Bundesarztekammer) is the umbrella institution of all 17 state medical associations but does not act as an organization under public law. Among other responsibilities, the Federal Medical Association works to provide consistency among the 17 state medical associations. For example, basic principles describing how to act as a physician are outlined in the Code of Deontology. The Bundesarztekammer has harmonized the Code of Deontology among the different state medical associations and released a general example (Table 1, Ref. 1). Every state medical association has enacted this code with minor modifications. It is only when the Code of Deontology is enacted by the state medical association that it becomes binding law (Table 1, Ref. 2). Every physician is required to be a member of the respective state medical association in which he or she is working. All physicians are obliged to follow the Code of Deontology (Table 1, Ref. 2), which starts with the vow, “When I become a member of the medical profession I vow that I will act in favor of humanity. I will act as a physician with respect to conscientiousness and dignity.” Article 15 of the Code of Deontology outlines some ethical principles of medical research. Section 1 states that physicians must submit a research proposal for all studies involving human subjects or human tissues to their respective ethics committee and seek their advice/votes before starting the project. Section 3 states that institutional affiliations and interactions between the physician/investigator and the sponsor should be declared when the results are published. Section 4 states that the physicians should abide by the ethical principles for medical research involving human subjects as outlined in the Declaration of Helsinki established by the World Medical Association (Table 1, Ref. 3). In addition to the Code of Deontology there exist several Federal Laws and Regulations that address research with drugs (Table 1, Ref. 4), medical devices (Table 1, Ref. 5), and radiation exposure in medical research (Table 1, Ref. 6). Through these laws the Federal government defines the role of the ethics committee for the latter clinical trials. For example, the Ordinance for Good Clinical Practice (Table 1, Ref. 7) defines the complete material submitted by the sponsor to the ethics committee as well as the procedure for the committee performing the ethics review. The federal medicinal and medical device laws mandate that