Research into the human genome and novel diagnostic procedures for the first time offer the possibility to diagnose genetic disposition of diseases before their onset.
The Deutsche Forschungsgemeinschaft Senate Commission on Genetic Research looked into this aspect of human genome research and now addresses the public with the statement "Human Genome Research and Predictive Genetic Diagnosis: Possibilities - Limitations - Consequences." In this statement, the commission deals with a variety of ethical, legal, and social questions arising from handling this novel genetic knowledge.
Research into the human genome is of particular importance for understanding disease causes, the assessment of disease risks, and for the development of novel therapies. The predictive genetic diagnosis that results from human genome research differs from diagnostic procedures commonly used in medicine for clarifying manifest diseases. Such predictive tests will not be capable of decide if a disease will actually become manifest or if so at which time - many years or even decades can lie between the test result and the first signs of a disease.
Moreover, to date, causal treatments for the majority of genetic diseases are not yet available. Rapid developments predominantly in chip technology are making it possible to develop novel and relatively easy test systems for the simultaneous detection of many genes. This would enable tests to be performed on a large scale although there might not be any medical reason to do so. For society and for the individual these developments will have considerable consequences. Apart from diagnosis and therapy of genetic diseases, there will be far- reaching consequences for insurance matters and the employment market.
The Senate Commission recommends that handling of predictive genetic diagnosis be restricted rigidly to health matters such that tests can be performed only with a medically justified goal of establishing a disease risk. This means that such tests must not be available freely and that they can be performed only if there is a corresponding medical justification. A genetic test can be performed only after individuals under study have given their free and informed consent. It is important here to note that there are not only a "Right to know" but also a "Right not to know" and that it is necessary to respect both. Exceptions from this should be the forensic usage of genetic tests. The Commission also recommends that predictive genetic tests should not be performed with children and adolescents if the test aims to detect diseases that might occur in adulthood and if there is no way for preventive measures or treatment.
Special legal stipulations regulating the extent of obligations of employees to tolerate performance of genetic tests currently do not exist in Germany. The Senate Commission recommends that predictive genetic tests be carried out in connection with the work place only if it is concerned with a certain foreseeable manifestation of a genetic disease or if the consequences of such disease becoming manifest with a high probability would put third parties at considerable risks. In view of further advancing medical-diagnostic possibilities the committee recommends that suitable concrete protective criteria be worked out.
There are no legal problems with predictive genetic diagnosis as far as compulsory legal health and social insurances are concerned, which do not require any medical examinations or a duty to disclose information on behalf of the insurance holder. The situation is different with respect to private insurance laws. In this case, applicants are obliged to disclose information about existing diseases, those that will become manifest with certainty of those that might probably become manifest. However, genetic analyses performed before the conclusion of a contract are a considerable infringement of general personal rights of the applicant. Results of such analyses might have considerable negative effects on applicants and their families also beyond the scope of the insurance contact. The Commission, therefore, recommends that such tests must not serve as a prerequisite for the conclusion of insurance contracts.
Editorial offices: the statement "Human Genome Research and Predictive Genetic Diagnosis: Possibilities - Limitations - Consequences" can be obtained by contacting the Press Office of the Deutsche Forschungsgemeinschaft, Kennedyallee 40, 52175 Bonn. Tel. 0228-885-2210 and Fax 0228-885-2180. The statement can be downloaded also through the internet from the following URL:www.dfg.de/english/press/hgenom_en.rtf