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Ethics challenges in sharing data from pragmatic clinical trials.

Publication ,  Journal Article
Morain, SR; Bollinger, J; Weinfurt, K; Sugarman, J
Published in: Clin Trials
December 2022

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 health record and potential implications of such limits for meeting obligations inherent to Certificates of Confidentiality. These challenges raise questions about the extent to which traditional research ethics governance structures are capable of guiding decisions about pragmatic clinical trial data sharing. This article identifies and examines these ethical challenges for pragmatic clinical trial data sharing. We suggest several areas for future empirical scholarship, including the need to identify patient and public attitudes regarding pragmatic clinical trial data sharing as well as to assess the demand for pragmatic clinical trial data and the correspondingly likely benefit of such sharing. Further conceptual work is also needed to explore how requirements to respect patient-subjects about whom data are shared in the context of pragmatic clinical trials should be understood, particularly in the absence of informed consent for initial research activities, and the appropriate balance between promoting the generation of socially valuable knowledge and respecting autonomy.

Duke Scholars

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Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

December 2022

Volume

19

Issue

6

Start / End Page

681 / 689

Location

England

Related Subject Headings

  • Statistics & Probability
  • Research Personnel
  • Informed Consent
  • Information Dissemination
  • Humans
  • Ethics, Research
  • Electronic Health Records
  • 5203 Clinical and health psychology
  • 4905 Statistics
  • 3202 Clinical sciences
 

Citation

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Morain, S. R., Bollinger, J., Weinfurt, K., & Sugarman, J. (2022). Ethics challenges in sharing data from pragmatic clinical trials. Clin Trials, 19(6), 681–689. https://doi.org/10.1177/17407745221110881
Morain, Stephanie R., Juli Bollinger, Kevin Weinfurt, and Jeremy Sugarman. “Ethics challenges in sharing data from pragmatic clinical trials.Clin Trials 19, no. 6 (December 2022): 681–89. https://doi.org/10.1177/17407745221110881.
Morain SR, Bollinger J, Weinfurt K, Sugarman J. Ethics challenges in sharing data from pragmatic clinical trials. Clin Trials. 2022 Dec;19(6):681–9.
Morain, Stephanie R., et al. “Ethics challenges in sharing data from pragmatic clinical trials.Clin Trials, vol. 19, no. 6, Dec. 2022, pp. 681–89. Pubmed, doi:10.1177/17407745221110881.
Morain SR, Bollinger J, Weinfurt K, Sugarman J. Ethics challenges in sharing data from pragmatic clinical trials. Clin Trials. 2022 Dec;19(6):681–689.
Journal cover image

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

December 2022

Volume

19

Issue

6

Start / End Page

681 / 689

Location

England

Related Subject Headings

  • Statistics & Probability
  • Research Personnel
  • Informed Consent
  • Information Dissemination
  • Humans
  • Ethics, Research
  • Electronic Health Records
  • 5203 Clinical and health psychology
  • 4905 Statistics
  • 3202 Clinical sciences