Ethics challenges in sharing data from pragmatic clinical trials.

ABSTRACT: Numerous arguments have been advanced for broadly sharing de-identified, participant-level clinical trials data, and trial sponsors and journals are increasingly requiring it. However, data sharing in pragmatic clinical trials presents ethical challenges related to the use of waivers or alterations of informed consent for some pragmatic clinical trials and corresponding limitations of informed consent to guide sharing decisions; the potential for data sharing in pragmatic clinical trials to present risks not only for individual patient-subjects, but also for health systems and the clinicians within them; sharing of data from electronic health records instead of data newly collected for research purposes; and researchers' limited capacity to control sensitive data within an electronic healt

SUBMITTER: Morain SR 

PROVIDER: S-EPMC10267884 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature