Eurecnet - National Information: Germany

National Information: Germany

Short description of RECs system:

Germany has a total of 53 research ethics committees, 33 attached to Faculties of Medicine/Universities, 17 attached to Medical Associations ("Ärztekammern") in the States and 3 attached to States governments. These RECs are the only legally competent ethics committees to asssess all kind of biomedical research including drug research. The legal competence of the 3 RECs attached to States governments is restricted to drug research and to research on medicinal devices. These RECs are established in conformity with States law. The Federal Republic has no competence for that establishment.

Around 55% of all projects in the field of biomedical research are drug research, whereas around 45 are attributed to other types of biomedical research. Different legal regulations are in force for both of these groups.

By the 12^th Novel of the Federal Drug Law ("Bundesarzneimittelgesetz") for the implementation of EU-Directive 2001/20/EC (4^th of August 2004) was introduced that a drug trial may only be begun with the favourable opinion of a REC established in conformity with States law ("Landesrecht") and with the approval given by the competent Federal authorithy.

By the "Law for the Amendment of Provisions concerning Regulations in the Drug Field" (Gesetz zur Änderung arzneimittelrechtlicher Vorschriften), entered into force in 2009, RECs are entitled to withdraw a favourable opinion. They are not obliged to perform any kind of active monitoring. The same regulation is given by the revised "Law on Medicinal Devices" (Medizinproduktegesetz). This law prescribes in conformity with the drug law that for the assessment of research projects on medicinal devices only RECs are admitted which are established in accordance with the States law (Landesrecht). Free or commercial RECs are no more legally competent for the assessment of any kind of research. In addition to both Federal laws there are legally binding decrees for the procedure of RECs assessing drug trials and trials on medicinal devices. The competent REC for the assessment of these trials and to issue the "single opinion" is defined by States law in multicentric trials as well as in monocentric trials. In multicentric trials RECs which are not entitled to issue the "single opinion", are charged to assess the qualification of the researchers and the suitability of the study site. This assessment is included in the "single opinion":
For studies performed by an investigator attached to a university, the REC of the Faculty of Medicine or of that University is entitled to assess the research. For studies carried out by an investigator outside a university, the REC of the regional Medical Association ("Ärztekammer") is legally competent. In the States Berlin, Bremen and Sachsen-Anhalt RECs are attached to the Government with the only competence to assess clinical drug trials and trials on medicinal devices.
There is no specific legislation concerning biomedical research which is not covered by the Federal Drug Law and by the Federal Law on Medicinal Devices, until now Germany has no legislation on biomedical research as a whole. Medical researchers are obliged by the code of deontology ("Ärztliche Berufsordnung"), which, in the German States is a legally binding instrument, and / or by the "Intramural Right" of Universities to submit any biomedical research project to the REC of the Medical Association or of the University/Faculty of Medicine (legal competence of the REC as described earlier). In this field of research the decision of the REC is an advice, but not a allowance or a prohibition – in contrast to drug research and research on medicinal devices. There is no central REC for the review of individual biomedical research projects.

National Level

a.) The National Council for Ethics: http://www.ethikrat.org/ ("Deutscher Ethikrat"), as established by legislation of the "Deutscher Bundestag" on April 26, 2007 may give recommendations which are not binding.

b.) There is a the Central Ethics Committee of the German Medical Association ("Zentrale Ethikkommission zur Wahrung ethischer Grundsätze in der Medizin und ihren Grenzgebieten bei der Bundesärztekammer [ZEKO]") which gives opinions on general ethical issues and which may give advice to the Ethics Committees of the Medical Associations at their request. This advice is not binding on these committees.

Networking between RECs

In 1980 a group of German academics interested in research ethics formed a working group to discuss emerging issues of clinical research and the ethical review process. This working group initiated a forum for exchange of information and harmonization for the work of ethics committees, as established by the Faculties of Medicine and the Medical Associations in the German States ("Bundesländer") since the late seventies - "Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland" ("Permanent Working Party of Research Ethics Committees in Germany"): https://www.akek.de. Up to now, there is no National Ethics Committee for medical research in Germany, therefore this group is accepted as an important consultancy for the public, governments and parliaments.

The Working Party organizes semiannual meetings to enhance the cooperation between the RECs. At these meetings issues of scientific, legal and ethical interest are discussed with experts coming from the membership or coming from outside. Examples are research in emergency situations, research on persons not able to consent, deep brain stimulation. In addition practical questions are discussed with the aim to propose a uniform procedure. It must be recognized that the German RECs are independent and decide to follow or not those proposals. The Working Party prepares training for REC members, specifically for persons invited to become a REC member. Training is performed on a national and on a regional level.

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