English summary of a report presenting description and analysis of the legal conditions for care providers to perform the processing of personal data required to calculate whether patient populations are large enough prior to initiate a clinical research study.
The Committee for Technological Innovation and Ethics propose that sample size calculations prior to clinical research is laid down in law as a permitted purpose for processing personal data. A description and analysis of the legal conditions is presented in the report, especially regarding the General Data Protection Regulation. The Committee’s proposals aim to contribute to greater clarity, facilitate clinical research planning and improve legal certainty. Another important aim is to protect people’s right to privacy.
The report (in Swedish) was presented to the Swedish government September 2nd, 2020.