The consent working group focuses on the design of the consent declaration signed by patients to allow healthcare data to be used in future medical research.

Goals and tasks

A key objective of the Medical Informatics Initiative is to ensure routinely captured patient data are available for research and to improve medical care. Scientific use is only permissible where the patient has given their explicit consent. In particular, the structure and wording of patient information and any declaration of consent must take into account that the concrete purpose of future research is not known at the time the data are captured.

The consent working group is currently identifying the legal parameters for the design of corresponding information and consent forms, and is developing solutions and template documents for discussion and agreement amongst project participants and relevant stakeholders.

Results

Standardised template document (version 1.0), comprising preamble, declaration of consent and patient information; preliminary work performed by the working group and finalisation by the writing group.

>> Template text for patient consent forms

Working group chairpersons:

Dr Sven Zenker (University of Bonn)
Prof. Daniel Strech (Hannover Medical School)