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

A.7 Ethical aspects
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A.7 Ethical aspects
The questions of ethics and data protection in the National Cohort have been discussed with
the working group of data protection officers (“Arbeitskreis Wissenschaft der Datenschutzbeauftragten
des Bundes und der Länder”) to develop a concept which is acceptable for
all federal states. The following section describes the current status. Consensus has been
reached for most points; however, some questions are still open and some changes may be
necessary in the final version.
The study protocol for feasibility studies within the framework of the National Cohort has
a similar structure but is simpler. It was first submitted to one ethics committee, which approved
it. This approved protocol has been sent to the other ethics committees involved and
we expect to also receive their approval in January 2011.
A.7.1 Invitation letters and informed consent
A.7.1.1 Information for potential participants
Potential participants will receive, by postal mail, an invitation letter as well as general information
about the National Cohort. The invitation strategy is described in detail in Sect.
A.3.1.4.
The invitation letter will be an official letter signed by the principal investigators and the coordinators
of the clusters. It will contain a brief description of the purpose of the study and
involved institutions and funders and outline the intended research program, including the
time frame. A general information flyer will be sent along with the invitation and will contain
general information about the project and the aim of the study. Furthermore, the invitation
will contain a prepaid postal reply for the participants to make an appointment at the study
center and advice on how to contact the National Cohort team and how to take part in the
study. Letters of support from the Federal Ministry of Research and Education, the Federal
Ministry of Health and local stakeholders are also attached.
Furthermore, participants will receive a detailed study information leaflet. This leaflet contains
detailed information about the project, the aim of the study, funders, organization,
conditions for participation, research program (personal interview, questionnaire, physical
examination, and collection of blood and other biomaterials), risks due to participation (e.g.,
due to collection of blood samples, etc.), voluntariness, right to withdraw, recontact, currently
intended and possible further analyses (including genetic analyses), storage of samples,
communication of personal results, and confidentiality and data protection. We will confirm
that the highest level of data protection will be ensured in accordance with all relevant legislations.
Potential participants for MRI will receive detailed specific information describing
the procedure of feedback in case of incidental findings.
Both documents, the invitation letter and the information leaflet, will be designed with the
greatest possible care since they will be of particular importance for providing the participants
with information and for developing positive attitudes and motivation to participate.
For further information or concerns, a telephone service and a website are provided. Further
questions will be answered personally at the study center.
A.7.1.2 Informed consent
Since it will be impossible to foresee all future research projects, consent will be sought for
the broadest possible range of future medical research proposals, including the use of bio-
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