Playing by the rules: Impact of the new General Data Protection Regulation on retrospective studies: A researcher’s experience 

Playing by the rules: Impact of the new General Data Protection Regulation on retrospective studies: A researcher’s experience 
M H van der Ree, R A Scholte, P G Postema, J R de Groot
European Heart Journal, 21 June 2019; 40(24) pp 1900–1902
Excerpt
…Despite the retrospective nature of the study, informed consent is required for the reuse of care data in the context of scientific research. For participants of the PREDICT-AF study, consent for the reuse of care data was available as part of the informed consent form of this prospective study. For the control cohort, however, no such consent was available. This was our first barrier: only a physician who is directly involved in the patient’s medical care, and not an investigator, is allowed to approach potential study participants and ask for informed consent. This physician is also allowed to ask for the patient’s permission for another person to approach him or her and ask for consent. As the control patients of our retrospective study were no longer under the treatment of the two hospitals that performed the PREDICT-AF study, this implied approaching approximately 50 referring cardiologists of the control patients and ask for their cooperation. These cardiologists would then have to personally ask their patients permission to be approached by the investigator, who could then ask for informed consent. This procedure put some serious constraints on the timelines of our envisioned data collection…

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