Code of Conduct
Our Code of Conduct Rules
Our Code of Conduct ensures that our genetic analyses clearly distinguish themselves from dubious offerings and that our high standards will continue to be maintained in the future.
The DNA Plus Center for Human Genetics is actively ensuring that other genetic analysis providers also adapt this Code of Conduct, thus establishing a new standard of accuracy, reliability and meaningfulness in genetic diagnostics.
Members and partners who voluntarily adapt our Code of Conduct receive the Quality Label for Genetic Diagnostics, which guarantees that this provider adheres to and accepts all important aspects of genetic diagnostics.
Clarifications and information
1) Genetic testing only after informed consent
Genetic analyses may only be carried out with the patient's express written consent. In the written consent, the patient must confirm that he has received extensive information regarding the test. This written consent must be stored for at least 5 years.
2) Compliance with Data Protection Directives
All data protection directives must be adhered to. Analysis results and patient data are to be stored physically locked away and password protected. Only authorized employees who have signed a confidentiality agreement may be granted access to the data. Patient data and analysis results may not be passed on to third parties (such as companies, doctors, insurance companies or employers). Research results obtained with the written consent of the patient may only be used and forwarded to research partners in anonymized form.
3) Information on measurement accuracy
The measurement accuracy of the analytical methods employed must be documented and made publicly available.
4) Information on medical significance
The finding must be scientifically founded and action recommendations compiled and approved by a doctor.
5) Information on the meaningfulness for the customer/patient
Meaningfulness and potential benefits of a genetic analysis must be clarified in advance. The patient must not have unrealistic expectations or misconceptions about the genetic analysis.
6) General information on genetic diagnostics
The patient needs to be fully informed about genes and their impact on health, as well as the possibilities and limitations of genetic analysis.
7) Information on possible consequences of a test
Possible consequences that could arise from a positive or negative result must be discussed. The possibility of a psychological burden, triggered by the analysis result, must be mentioned and discussed.
8) Offer of a detailed genetic consultation BEFORE and AFTER the analysis
The patient must be informed about the various aspects of the disease and the genetic analysis prior to the analysis. After this consultation, the patient must be free to withdraw from the genetic analysis. After the analysis, the patient must be informed extensively and comprehensively about the result and recommended actions. A qualified expert must be available in case of questions.
9) Statement of scientific publications
A list of scientific publications that confirm the validity of the offered gene analysis must be publicly available. Only publications of the scientific "Peer reviewed" literature are accepted.
10) Offering scientifically recognized gene analyses only
The respective genes of the genetic analyses must have been identified as risk factors for a disease in at least two major independent studies.
11) Information on the scientific qualification of employees and consultants
The qualifications of employees and consultants must be scientifically sound and listed publicly.
12)Analyses only by certified laboratories
Analyses may only be carried out by approved laboratories and facilities.
13) Compliance with strict quality assurance measures
Strict quality assurance measures must be complied with during analysis. These must be logged and promptly detect if an analysis were to give incorrect results due to technical problems.
14) Participation in state-approved inter-laboratory comparisons
The accuracy of the analysis and the accuracy of the analysis results must be verified by periodic, state-approved inter-laboratory comparisons. This verification must be performed and logged at least once a year.
15) Review of results by at least two independent experts
The results must be evaluated by at least two independent experts to avoid misinterpretation of results.