At PCORI, we try to ensure transparency in everything we do. It’s part of our commitment to the patients, caregivers, researchers, clinicians, and other healthcare stakeholders we serve. This transparency includes our efforts to support open science, making scientific research—including the data and results it generates—widely accessible to the public. Two examples are our process for peer-review and public release of the findings of those studies and funding public access to journal articles that present key results. Our latest initiative in this area is our developing policy for sharing the data generated by our funded studies.
We drafted this policy last year as a way to advance scientific knowledge beyond the immediate impact of our funded studies. In this post, we provide updates about the progress we’re making in finalizing and eventually implementing this policy.
As with all of our work, we knew stakeholder input would improve the draft policy. We sought public comments through our website last winter. We received 32 responses from stakeholders including patients, clinicians, and researchers, as well as representatives of health systems, patient advocacy organizations, and other professional organizations. Those comments can be found here.
Four Key Themes Emerged
The comments told us about strengths and limitations of the draft. There were some areas of consensus, but also a number of open issues that PCORI will need to contend with as we work to finalize the draft policy. Important considerations that came up included (a) what restrictions on data use the policy should articulate, (b) what qualifications and documentation the policy should require of people who request the data, (c) how the policy should approach informed-consent issues, and (d) how the policy should handle data from electronic health records and other observational data sources.
To help inform next steps, we reconvened an expert group in spring. The group, which also provided early guidance on the draft policy, includes leading specialists on the technical, governance, and ethical aspects of sharing data from clinical research studies. The expert group considered the public comments and provided recommendations about the four issues.
As with all of our work, we knew stakeholder input would improve the draft policy.
Later in the spring, PCORI staff presented a summary of the public comments and expert-group recommendations to the Research Transformation Committee, the subcommittee of our Board of Governors responsible for overseeing PCORI’s open science activities. PCORI obtained the committee’s input on options for refining the policy to address the issues raised by our stakeholders. One point that became clear was that in certain circumstances, PCORI awardees may need an exemption from part or all of the policy’s data-sharing requirements because of human-subject-protection considerations, applicable laws or institutional policies, or intellectual property restrictions.
We are now conducting a pilot project in which we are bringing together several research awardees and two data-repository organizations. The goal is having the awardees’ deposit their study data and data documentation in one of the repositories. The two data-repository organizations are the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University and the Inter-University Consortium for Political and Social Research at the University of Michigan.
Through this pilot, we hope to learn about the features and capabilities of repositories that are most critical for depositing and sharing clinical data, the time and effort that PCORI research awardees need to prepare their data for sharing, the costs of data sharing, and appropriate governance models.
Taken together, these activities will inform what we hope will be a thoughtful, considered approach to data sharing in our final policy, which we expect to release later this year. To provide suggestions about the policy, or for more information, please contact email@example.com.
Katherine Jackstadt, MS, is also a co-author of this blog post.