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

Control of data protection
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A.7 Ethical aspects
The responsible data protection commissioner for each study center will ensure that data
collection and handling comply with the data protection concept that has been developed
and in accordance with the Federal Data Protection Act and all other legislation concerning
data protection and confidentiality.
A.7.2.5 Provision of health information to participants
At the end of the visit in the study center or soon after, if desired, participants will receive
the results from the medical examinations conducted at the study center and analyzed
baseline diagnostic results. By reporting standard ranges and giving respective explanations
concerning their individual results, participants will be provided with information that
gives meaning to the examinations. If there is any concern about their health status, participants
will be advised to contact their general practitioner or another physician. Moreover,
participants will be informed and advised to contact a physician in the case of severe findings
which need to be further clarified. No medical diagnosis will be provided. A detailed
feedback at the time of the baseline examination also goes beyond the scope of the study.
On the consent form, participants will advise as to what kind of information they want and
how they want to be informed. New biomarkers implicating a very high risk of a preventable
and serious disease may be found. If such findings become available and are corroborated
in agreement with relevant medical expertise, participants may be contacted and these
findings will be communicated in accordance with an ethics commission. To respect the
“right of nescience,” this will only be done if the participant agreed to be contacted for such
information.
We aim to ensure that subjects understand that study participation does not provide a personal
health check but rather will provide important and valuable information concerning the
etiology of chronic diseases and for future prevention and treatment. Thus, participation will
help enhance other people’s health in the future.
Feedback of incidental findings
Concerning the use of MRI, one important issue warrants specific attention in connection
with the target of asymptomatic voluntary participants, namely incidental findings.
Incidental findings represent an important and very critical issue within the imaging substudy
of the National Cohort and dedicated guidelines will be developed in collaboration
with the pertinent ethics committees. Overall, the guidelines will balance the moral obligation
of reporting findings, anticipated benefits for the participants, and the scientific validity
without intervention in terms of an unbiased assessment. Based on the experience in the
SHIP study 822 , only those incidental findings that are of potential relevance for the participants
are provided to them.
We have already prepared a draft list of serious incidental findings to be provided to the
participants on head, ENT/neck, thorax, heart, abdomen, urogenital system, spine, vascular
system, and musculoskeletal system. This draft will be finalized together with specialists
from the different fields from Germany and the UK.
For further incidental findings, which are not predefined in the list, but are of potential relevance,
we will establish an advisory board consisting of experts of all major, imaging-related
clinical specialties, as well as epidemiologists and ethicists who will meet on a regular basis
to discuss and develop guidelines related to distinct imaging findings on real cases (figure
7.1). Over the course of the preparatory phase, guidelines will be in place to classify imag-
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