Data Protection

The protection of personal data, particularly when linked to medical results, is especially important in research studies and is subject to legal requirements. The handling of personal data, study results and biomaterials complies with the requirements of the State Data Protection Act. Access to all study databases is secured and requires password authentication. Before the start of the study, the study protocol was reviewed and approved by the independent Ethics Committee of the Medical Association of Rhineland-Palatinate and the Data Protection Officer of the University Medical Center Mainz. The ethical principles of the Declaration of Helsinki as well as the guidelines for Good Clinical Practice (GCP) and Good Epidemiological Practice (GEP) are observed. All study staff are subject to medical confidentiality and/or confidentiality obligations under Article 42 EGStB (German Act on the Formal Obligation of Persons Who Are Not Civil Servants) and have provided written confirmation of their obligation to maintain data confidentiality. The data protection concept was reviewed by the State Commissioner for Data Protection of Rhineland-Palatinate. Any publication of scientific results will be presented in a way that does not allow individual participants to be identified.

Handling of Study Data

The study data are analysed at the University Medical Center of Johannes Gutenberg University Mainz. Under the data protection concept, each participant is assigned a study identification number by the study centre. The data collected as part of the study are stored under this study identification number separately from personal data. The link between the study identification number and the individual participant is known only to the study management and to designated staff specifically responsible for supporting study participants. As part of the analysis of the study data, pseudonymised examination results and biomaterials are shared with academic collaborating organisations that perform, among other things, laboratory analyses, questionnaire analyses and quality control of individual examinations. Pseudonymised means that third parties are unable to link study results to an individual participant. Personal data, such as name, initials, address or date of birth, are not shared. The results of external analyses are entered into the central study database. The study management decides whether pseudonymised study results from the study database may be shared with collaborating organisations.

Consent

Participants receive detailed information about the study in a personal consultation and are asked to provide consent for various aspects of the study:

  • Consent to the sharing of contact details with the GHS Information Office
  • Consent to participate in the study
  • Consent to genetic analyses to identify genetic risk factors for cardiovascular disease
  • Consent to the sharing of biomaterials
  • Consent to genetic analyses of susceptibility to chemotherapy
  • Refusal to provide consent