The research exemption implemented in the new EU General Data Protection Regulation (EU-GDPR) gives member states leeway in determining whether patient consent is required for secondary data use in medical research. However, even though broad consent has become common in data-rich medical research in many EU countries, giving up consent altogether is likely to be controversial. The aim of this study was to examine whether abolishing consent for secondary data use would be acceptable to patients. A questionnaire study was conducted among 700 outpatients of a northern German university hospital to assess their attitude towards use of clinical data for scientific research without consent. There was both strong willingness to give broad consent for secondary data use (468 of 503 responders, 93.0%) and strong approval of abolishing patient consent (n = 381, 75.7%) among study participants. The willingness to give consent was moderately associated with approval of the respective stipulations by the EU-GDPR. In research settings where broad consent is widely accepted (e.g. university hospitals), abolishing consent for secondary research use of clinical data will likely be acceptable to a large majority of patients.      «

The research exemption implemented in the new EU General Data Protection Regulation (EU-GDPR) gives member states leeway in determining whether patient consent is required for secondary data use in medical research. However, even though broad consent has become common in data-rich medical research in many EU countries, giving up consent altogether is likely to be controversial. The aim of this study was to examine whether abolishing consent for secondary data use would be acceptable to patients....     »