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

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A.7 Ethical aspects
It will take years until (longitudinal) scientific analysis can be carried out. The National Cohort
team will call for proposals, once enough data are available. The first call will be made
public by posting on the webpage and direct distribution to universities, research institutions,
and national and international epidemiologic associations. Any researcher interested
in analyzing the data is then welcome to send a proposal to the National Cohort. Later on,
researchers can apply for access, independent of calls.
The National Cohort participants’ consent includes a question concerning the fact that national
and international universities and research institutions, foundations, and industries
will be able to apply for access to data. Participants can decide during the consent process
whether they agree to this condition. In the information leaflet, participants will be informed
about the possibility of access by additional institutions.
Researchers must be affiliated with an institution that is competent in conducting healthrelated
research. Inexperienced researchers may also be asked to seek the supervision of
a more experienced researcher, affiliated with one of the accepted institutions. For international
projects, collaboration with a German group of scientists as well as full acceptance of
the German ethics rules may be required. No access to data and samples will be given to
insurance companies, employers, the police or other law enforcement agencies and only
limited access to commercial organizations.
review process
Proposals for data use will be reviewed by the “Use and Access Committee” to ensure that
they are in accordance with the participants’ consent and all ethical aspects of the National
Cohort, that they have relevant ethical approval, and that they fit the aims of the National
Cohort.
If necessary, the “Use and Access Committee” reserves the right to ask external experts for
advice on the received proposals. The “Use and Access Committee” will thereafter prioritize
the projects that have been proposed, will give recommendations for those which should be
supported, and advise the Epidemiologic Planning Committee.
The National Cohort e.V. will have the final decision-making authority over access to and
use of data and biosamples and will ensure that the data and samples will be used scientifically
and in the public interest. It will promote the greatest potential benefit for public
health.
Concerning biological samples, an intelligent handling over time of the resources and of the
conducted analyses is necessary to avoid depletion of the stocks in the course of the first
few years. To facilitate the management of the resources, in time and in space, the analyses
may be conducted in a few central laboratories, which will then be in charge of delivering the
results to the teams which have asked for them.
Contract
All users (universities, research institutions, foundations, and industry) must follow the same
ethical standards. Access to data and/or samples will only be conceded under licenses for
scientifically and ethically approved research. Rights to use data and samples will be issued
for specific uses under strict conditions, including compliance with the consent given.
The researcher will need to sign an access agreement contract with the National Cohort e.
V. The contract will cover the aim of the research, the proposed analyses, the timeline, and
the publication of the results. The conditions for data utilization will also be detailed. The
contract will be valid for a defined period of time.
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