Better insights into the link between genetic predispositions and diseases have resulted in a rapid increase in genetic testing methods. The planned law on genetic testing is aimed to meet the considerable need for regulations in this area.
Against this background, the Senate Commission on Genetic Research of the Deutsche Forschungsgemeinschaft (DFG) has formulated a new statement on predictive genetic diagnostics. It takes the place of the statement "Humangenomforschung und prädiktive genetische Diagnostik: Möglichkeiten - Grenzen - Konsequenzen", issued in 1999, and reaches beyond the latter's content.
The key recommendations of the new statement are summarised in six items preceding the text proper. In addition to the demand to provide sustained funding for this area, the recommendations refer to the physician's proviso and quality assurance, genetic probes and data banks as well as labour and insurance law.
The DFG proposes that the right to conduct predictive genetic tests be reserved for doctors. It states that predictive genetic diagnostics always has to be linked to qualified genetic counselling both ahead of the test and when the test result is on hand. Referring responsibilities to the professional physician protects the autonomy of the patient while simultaneously ensuring that an adequate indication is formulated, appropriate quality standards are observed and the requirements of professional discretion and data protection are upheld. The DFG holds that genetic diagnostics oriented on primarily commercial aspects ought to be banned.
Regarding genetic sample and data banks, the DFG is of the opinion that procuring, storing and processing samples and data has to go hand in hand with a reliable protection of the respective donors from any abusive use. In addition, the donor has to give his self-determined consent to the use of his samples and data. In these conditions, the DFG also holds that a donation of samples or data with a right of usufruct formulated in broad terms and without being tied to any concrete research projects is ethically and legally justified. The emphasis has to be on striking an appropriate balance between the legal protection of the donor's personality and the protection of confidence for the researcher.
In the field of labour and insurance law, the DFG suggests that predictive genetic tests only be carried out in connection with an employment relationship if the tests serve the protection of the employee and a predictable emergence of a genetic disease is at issue that is immediately related to the employment relationship. Furthermore, it should be possible to conduct these tests if the consequences of such a genetically conditioned disease probably occurring would put other people at a considerable risk.
The DFG holds the opinion that predictive genetic tests should not be made a general condition for effecting insurances.
Predictive genetic diagnostics affects central principles of our legal foundations and our self-understanding. The handling of results from genetic tests has to ensure that the right to individual self-determination is upheld provided that it does not infringe upon the rights and interests of other persons. The right to know and the right not to know are of crucial importance in this context. It is up to the legislator to make appropriate provisions to ensure that informed decisions are made.
In no circumstances may genetic tests contribute to certain groups of persons being segregated or discriminated against owing to their predispositions.
Prädiktive genetische Diagnostik:
Wissenschaftliche Grundlagen, praktische Umsetzung und soziale Implementierung
Stellungnahme der Senatskommission für Grundsatzfragen der Genforschung der Deutschen Forschungsgemeinschaft
March 2003, 63 pages.
The German text can be called up on the Internet at http://www.dfg.de/aktuelles_presse/reden_stellungnahmen/2003/download/praediktive_genetische_diagnostik.pdf
An English translation will be available shortly.
For more details, please contact:
Professor Dr. Bärbel Friedrich, Chairwoman of the Senate Commission on Genetic Research, Humboldt University, Berlin.
Tel: 49-302-093-8100,
E-mail:baerbel.friedrich@rz.hu-berlin.de; or
Dr. Annette Schmidtmann, DFG Programme Director.
Tel: 49-228-885-2243,
E-mail: annette.schmidtmann@dfg.de