Relevant German Laws on Human Experimentation
Special regulations concerning the law consist in Germany only in terms of specific kinds of medical research. The most notable aspects in this context are the testing of medicinal products and medical devices, which comply to the Pharmaceutical Act and respectively the Medical Devices Act and its legal positive norms. In both laws there are special provisions found for research in minors. Not regulated in a special way of law are the trials concerning the new operation methods but also mere diagnosis studies. Besides, special regulations in law limit the constitution as well as the criminal law and civil law, particularly with its provisions concerning the protection of physical integrity and self-determination. In the context of research involving minors, the regulations of the family law are a major issue. Thus the § 1627 Civil Code regulates that the exercise of the parental care has to take place for the good of the child. It is discussed whether and to which extent against the backdrop of it the parents can give substitutional consent to participate in a medical experiment.
The following German laws and ordinances contain the pertinent provisions on human experimentation (German versions only):
Gesetz über den Verkehr mit Arzneimitteln - Arzneimittelgesetz - AMG [Pharmaceutical Act], especially §§ 40-42a. Online Version
Gesetz über Medizinprodukte - Medizinproduktegesetz - MPG [Medical Devices Act], especially §§ 20-21. Online Version
Gesetz zum Schutz vor der schädlichen Wirkung ionisierender Strahlung - Strahlenschutzgesetz - StrlSchG [Radiation Protection Law], especially §§ 31-37, 295. Online Version
Verordnung zum Schutz vor der schädlichen Wirkung ionisierender Strahlung - Strahlenschutzverordnung - StrlSchV [Radiation Protection Ordinance], especially §§ 133-138. Online Version
More details concerning the legal situation in respect of research involving minors cf. Michael 2004 and Magnus 2006; in 2007 Sprecher presented a survey with regard to comparative law (Germany, Switzerland, European and international law):
Michael, Nadja (2004): Forschung an Minderjährigen. Verfassungsrechtliche Grenzen. [Research involving minors. Limits of constitutional law.] Berlin: Springer (Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim 19. [Publications of the institute for German, European and international medical law, public health law and bioethics of the universities of Heidelberg and Mannheim 19.]).
Magnus, Dorothea (2006): Medizinische Forschung an Kindern. Rechtliche, ethische und rechtsvergleichende Aspekte der Arzneimittelforschung an Kindern. [Medical research involving children. Legal, ethical and other aspects with regard to comparative law in medicinal product research in children.] Tübingen: Mohr Siebeck (Studien zum ausländischen und internationalen Privatrecht 170[Surveys about foreign and international private law 170.]).
Sprecher, Franziska (2007): Medizinische Forschung mit Kindern und Jugendlichen nach schweizerischem, deutschem, europäischem und internationalem Recht. [Medical research involving children and adolescents on the strength of Swiss, German, European and international law.] Berlin: Springer (Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim 29[Publications of the institute for German, European and international medical law, public health law and bioethics of the universities of Heidelberg and Mannheim 29.]).