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Ethics challenges in sharing data from pragmatic clinical trials.

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Sharing de-identified clinical trials data is increasing, but pragmatic clinical trials face unique ethical hurdles. These include informed consent issues and risks to patients and health systems, requiring new governance approaches.

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Area of Science:

  • Bioethics
  • Clinical Trials
  • Health Informatics

Background:

  • Broad sharing of de-identified participant-level clinical trials data is increasingly mandated by sponsors and journals.
  • Pragmatic clinical trials (PCTs) present distinct ethical challenges for data sharing compared to traditional trials.

Purpose of the Study:

  • To identify and examine the ethical challenges specific to sharing data from pragmatic clinical trials.
  • To evaluate the adequacy of current research ethics governance for PCT data sharing decisions.

Main Methods:

  • The study involves a conceptual examination of ethical issues in PCT data sharing.
  • It reviews existing literature and ethical frameworks related to clinical trial data sharing and informed consent.

Main Results:

  • Ethical challenges include waivers/alterations of informed consent, risks to individuals and health systems, use of electronic health record data, and limitations in controlling sensitive data.
  • Traditional ethics governance structures may be insufficient for guiding PCT data sharing.

Conclusions:

  • Further empirical research is needed on public attitudes and the demand/benefit of PCT data sharing.
  • Conceptual work is required to define respect for patient-subjects when informed consent is altered and to balance knowledge generation with autonomy.