ELSI (Ethical, Legal and Social Issues) / Ethics Coordination (EC)
Clinical studies, registers and cohorts, collect a wealth of quality-assured health data and biosamples. Participants’ consent provided, using this data for secondary research projects efficiently utilizes existing resources and is increasingly encouraged.
Ethics coordination as part of research data infrastructures
We accompany clinical studies and dedicated infrastructures from project planning onwards and are responsible for the integration of infrastructural, ethical and data protection aspects of the processing and use of patient data and biosamples by the research infrastructure into patient documents. We further provide ELSI consultation to ensure that applicable regulatory frameworks allow secondary use of data collected as part of and additional to clinical studies and managed by large national research data infrastructures.
To support Interoperability, consent contents are translated into machine-readable code enabeling the implementation of automated processes, such as bulk consent querying as part of secondary research requests. We further provide Consulting for ethical and regulatory aspects of (emerging) topics in clinical research such as OMICS, record linkage, health insurance data, new legislation, patient involvement, among other.
These topics were adressed as part of the research data infrastructures of the German Centre for Cardiovascular Research (DZHK) and the NUM Clinical Epidemiology and Study Platform (NUKLEUS) of the German Network University Medicine (NUM) in a continuously changing environment over the past 10 years and counting.