A new article from the NIH Pragmatic Trials Collaboratory outlines stakeholder insights and ethical considerations related to sharing deidentified, participant-level data in pragmatic clinical trials. While there are numerous arguments for and against data sharing in the context of pragmatic trials, the report aims to address the gap in documented stakeholder perspectives.
The article was published this month in Learning Health Systems.
The authors, including members of the NIH Collaboratory’s Ethics and Regulatory Core, recruited stakeholders who represented a range of experiences. They then conducted 40 semistructured interviews focused on ethical considerations. The team identified 5 overarching themes after analyzing the interviews: (1) challenges in sharing data collected under a waiver or alteration of consent; (2) conflicting views regarding patient-subject preferences for data sharing; (3) identification of respect-promoting practices beyond consent; (4) concerns about elevated risks or burdens from sharing data; and (5) diverse views about the likely benefits resulting from sharing data.
A key insight was that a “one size fits all” model for promoting broader sharing of data from pragmatic trials is not feasible, and policies must be sensitive to the unique challenges that pragmatic trials present, such as variation among trials.
“Our data indicate unresolved tensions in how to fulfill this expectation for [pragmatic clinical trials],” the authors wrote. “Future work could inform efforts to tailor data-sharing policy and practice to reflect these and other challenges, including sharing experiences from trials that have successfully navigated these tensions.”
Lead author Stephanie Morain and co-authors Juli Bollinger, Kevin Weinfurt, and Jeremy Sugarman are members of the NIH Collaboratory’s Ethics and Regulatory Core. This work was supported within the NIH Pragmatic Trials Collaboratory by a supplemental grant award from the National Center for Complementary and Integrative Health.