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

A.7
A.7 Ethical aspects
pants, travel accident insurance may be required. A special insurance will cover participants
who receive a DXA or MRI examination.
A.7.2 Procedures for ethical clearance of National Cohort proposals
A.7.2.1 regulatory framework
The National Cohort will be conducted in accordance with all relevant legislation, including
the Federal Data Protection Act, the Data Protection Acts of the German States (which are
comparable to the Federal Data Protection Act), the German Constitution, the registration
laws of the Federal States, and the Cancer Registries Law. Overall, according to §1 of the
German Constitution, human dignity will be protected. The right of self-determination, and
the right to life and physical integrity are regulated in §2, German Constitution. Since, for
example, the collection of blood samples may affect physical integrity, participants must
give their written consent to the study.
In the following, the term “personal data” includes names, addresses, and other contact
data as well as all medical study data that are collected during the study. In order to better
protect the privacy of study participants, personal data will be split up into the two parts
“personal identifying data” (name, contact data) and “study data” (only medical data).
For recruitment, the responsible registry office will provide the study centers with randomly
selected registration data. According to the respective registry law of the Federal States 1 ,
personal data can be transferred from the registry office to an official office (university, research
institute) if these institutions need these data to fulfill their functions. According to
§14, Federal Data Protection Act, the mentioned institutions are allowed to store, alter, and
use personal data if this is necessary to fulfill their functions.
Personal data must be deleted once no longer needed to fulfill the specific functions (§20,
Federal Data Protection Act). Within the scope of the National Cohort, study data will be
kept for the long-term, because it is anticipated to be of scientific value for a long time. Personal
identifying data will be deleted after the end of the study, after withdrawal and when
no further direct contact to the participants or reidentification of individuals is needed. During
the follow-up period, direct contact to the participants will be necessary, e.g., to update
information on health status and relevant exposures. Due to the study design, it is planned
to use personal identifying data for at least 20–30 years.
According to §3a, Federal Data Protection Act, personal data must be anonymized or coded
(pseudonymized). Personal identifying data will be stored strictly separated from study data
with additional restrictions for access. Only few staff members will have access to personal
identifying data. All National Cohort staff members with direct contact to participants or personal
identifying data will be committed to follow data secrecy according to §5, Data Protection
Act and will be made aware of §203 Criminal Code in the case of breach of duty. Within
the scope of the National Cohort, exclusively coded scientific study data will be transferred
from the study centers to the integration centers for centralized recording.
The access to and use of secondary data will be conducted in accordance with §287, Social
Security Code V, and §75, Social Security Code X.
According to §1, Cancer Registries Law, cancer registries must provide coded data for
scientific research. According to §8, Cancer Registries Law, in which measures concerning
1 § 24 Schleswig-Holstein; § 25 Berlin; Art. 28 Bavaria; § 28 Brandenburg; § 29 Baden-Wuerttemberg, Lower
Saxony, Saxony, Saxony-Anhalt; § 30 Bremen; § 31 Hamburg, Mecklenburg-Western Pomerania, Rhineland-
Palatinate, North Rhine-Westphalia, Saarland
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