Scientific Concept of the National Cohort (status ... - Nationale Kohorte

A.7
A.7 Ethical aspects
logical/genetic markers measured in blood samples and other biomaterials, with full respect
of current laws and regulations for human data protection. It will be endeavored to ensure
that participants understand what they are consenting to. This will be done by training the
National Cohort personnel well in communicating the information and assessing the participants’
understanding and to give further advice and clarification if necessary.
Participants will be requested to give written consent:
� That they have read and understood the information leaflet and that they had the possibility
to ask further questions and that the appropriate answers were understood.
� To participate in the entire research program (personal interview, questionnaire, medical
examination, and collection of blood and other biomaterials).
� To be recontacted (via mail, telephone, or internet) and reinterviewed (and thus reidentified)
at regular intervals during the follow-up period to provide information about
changes in lifestyle or other risk factors and incident diseases and to be invited to
repeated examinations.
� That personal identifying data will be recorded strictly separated from study data and
biosamples and will only be used for the purpose of recontacting. Home and work
address will be used to generate scientific data concerning environmental exposures
such as outdoor air quality, noise, etc. These data will only be analyzed in coded form.
� That their data and biosamples will be stored in the long-term for future research, including
tests of new methods or extension of the initial research proposals due to new
techniques or increased knowledge/new insights that had not been defined or were
unknown at the time of recruitment. A new request of consent will not be necessary in
such a case.
� That their data and biosamples can be used to analyze genetic risk factors for chronic
diseases.
� That for future scientific analyses there may be collaborations with universities and
research institutes (national and international). After ethical approval, coded data for
medical research could also be transferred to foundations and industries, for projects
that may or may not, be based on cost sharing.
� That they will communicate the name and address of their general practitioner or
treating physician/clinic and that they allow the National Cohort e.V. to check their
health status from secondary data (e.g., from medical files and registries). Participants
will release their present and future physicians from maintaining confidentiality,
including the permission to get the information on cause of death and information on
diseases from disease and death registries.
� That information needed for the study can be transferred and scientifically used in
coded form from social insurance carriers and health insurance (Institute for Employment
Research, statutory health insurance). For this, participants will communicate
the name of their health insurance, their health insurance number, and their social
security number.
� That participation will not serve as a substitute for an individual health check, but that
there will be communication of the most important findings (at baseline and later on)
with the advice to contact a physician in case of any concern about their health status.
Participants can choose what kind of information they will receive. They will have the
right to refuse to receive any information about their health status.
� That the National Cohort e. V. will be the legal owner of the data and samples and that
participants transfer property rights on the data and samples to the National Cohort e. V.
� That participation is voluntary and that they have the right to withdraw at any time
during the study with different options of withdrawal. Otherwise, the consent form will
retain validity throughout the lifetime of the National Cohort.
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