It regulates the handling of examinations of the properties of human chromosomes or DNA or genes, insofar as they are inherited or were acquired before birth. However, it also applies to the investigation of gene products if the aim of the investigation involves gaining knowledge about a genetic makeup.
Specifically, this means that this law is used for epigenetic investigations, DNA adducts and SOD profiles.
Although the legislature does not expressly name these, it also makes its intention with epigenetics clear and thus these parameters are subject to the GenDG.
The doctor's reservation applies to all genetic diagnostics and especially to epigenetic parameters (see above) and requirements. In the case of predictive examinations, the requesting doctor must even have a special qualification, e.g. can be acquired in special courses of the medical associations and the KVen.
No analysis without the patient's declaration of consent. A mandatory requirement for any genetic diagnostic examination in the laboratory is the patient's declaration of consent, signed by the doctor and patient, stating about
- the subject or scope of the investigation,
- Consent for sampling and examination,
- Acknowledgment of the test result or destruction of the same and the decision about the whereabouts of the sample after the analysis.
Before the declaration of consent, the "responsible" doctor, i.e. the doctor primarily commissioning the patient, must provide information about the nature, scope and scope of the examination and document it. Use the corresponding form (consent form). You can also request it in the laboratory. In the case of persons unable to consent (children, incapacitation), the legal representative signs.
If the declaration of consent is not available, the analysis may not even be carried out by the laboratory; it is not permissible to do the analysis and only withhold the result.
If there is no other instruction / consent from the patient, the sample must be discarded immediately after completion of the analysis.
If the sample is still available on the basis of an instruction issued by the patient, additional requests for further genetic diagnostic examinations may only be carried out if the patient's written consent is sufficient for this. Otherwise new consent is required.
The patient can withdraw from his declaration of consent at any time, also by telephone, but only to the responsible doctor. This must then be documented accordingly.
Results that have not yet been communicated must then be destroyed immediately.
Results that have already been communicated, however, are not discarded, but blocked.
The laboratory may only communicate the result of a genetic diagnostic test to the doctor commissioning the contract, but not to the patient or to any other person! It may only be passed on to third parties (including other doctors) by the responsible doctor and only with the patient's written consent.
The results must be automatically destroyed after 10 years, unless the patient requests a longer retention period or a blocking of the results. The blocking results in an extension of the storage by 10 years from this point in time.
All examinations for which the patient's declaration of consent is required according to the GenDG are marked with a "§" in the analysis directory, as well as on the order form.