Doctors involved in vital clinical research have warned that the Department of Health’s interpretation of the new European data protection rules could force them out of research because of a requirement to obtain explicit consent before processing a patient’s data. Explicit consent means the patient must give an express statement of consent. Anyone processing patient data in this respect must have some sort of mechanism in place by May 1 that addresses explicit consent. Reconsenting is ‘a major issue’ when drawing on biobanks for research purposes, the review says. Explicit consent will be particularly problematic for research involving patients who lack the capacity to consent.

Source: Irish Examiner April 08, 2019 04:07 UTC