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"examining the implementation of the Data Protection Directive 95/46/EC
in relation to medical research and the role of ethics committees"

Germany - RECs and Medical Research

History

Research ethics committees (RECs) were first established in Germany in the early 1970s at some universities and in 1979 the German Medical Association, on the initiative of the German Research Foundation, recommended the introduction of independent RECs. These were then established without any legal standing, rather within a framework of professional self-regulation by the German Medical Association and medical faculties.

In 1985 there was official recognition of RECs through the adoption of a recommendation in the professional guidelines for doctors. Legal recognition came through the enactment of the Medicinal Products Act (MPG) and the 5th amendment to the Drugs Act (AMG) in 1994. These made REC approval compulsory for clinical trials of medicinal products and drugs. A further amendment to the MPG was enacted in August 2004 which implemented the good clinical practice directive 2001/20/EC.

The National Ethics Council was established by the Federal Government in 2001 and it acts as a national forum for discussion of ethical issues. Opinions, recommendations and reports drawn up by the National Ethics Council on a variety of topics are published. The council also works to inform the public about ethical issues. There is a Central Ethics Commission of the German Medical Association, established in 1994, that considers ethical issues and publishes their opinions in professional journals.

Summary of German RECs

Type of REC National Ethics Council Local RECs Local RECs 'Free' RECs
Where situated? Berlin-Brandenburg Academy of Sciences Medical Research Institutes Medical Faculties  
Who applies to them? Federal government or the Bundestag can ask them to formualte opinions and they can also set their own agenda Researchers Researchers Researchers
Formal/Informal Formal Formal Formal Formal
National/Regional National Regional Regional Regional
Laws Involved (see below) Established by Federal Decree
2 May, 2001

Medicinal Products Act (MPG)
Medicinal Drugs Act (AMG) - amended 2004
Transfusion Act 1998

 Medicinal Products Act (MPG)
Medicinal Drugs Act (AMG) - amended 2004
Transfusion Act 1998		 Medicinal Products Act (MPG)
Guidance Involved
Membership requirements 25 members - consisting of prominent representatives from science, medicine, theology, philosophy, sociology, law, ecology and economy Majority have 5 -19 members

Membership consists of mainly medical practitioners with the involvement of a lawyer

Majority have 5 -19 members

Mostly medical practitioners with the involvement of a lawyer

Majority have 5 -19 members

Mostly medical practitioners with the involvement of a lawyer
Responsible/accountable to whom? Federal Chancellor Institute where situated State Chambers of Physicians Institute where situated
Approval or Advisory powers Advisory Approval Approval  

Not submitting research or failing to follow review

Which body, if not the REC itself takes this action, and how do they proceed?

Impact of Directive 2001/20 EC

This has been implemented by the 12th amendment of the Medicinal Drugs Act which came into force in August, 2004. This introduced European regulations on pharmacovigilance and the good clinical practice standards. In addition it stipulates that only the state RECs i.e. not the 'free' RECs, may assess clinical drug trials. Finally in the case of multi-centre trials just 1 REC approval it required.

Legal action that can be taken against RECs

Links section

Laws

Organisations and Ethics Committees

See the REC bibliography section for more links and papers and Data Protection Page