Data Access and Data Sharing Policy: Public Comment (2017)

PCORI was established in 2010 as a funder of clinical comparative effectiveness research (CER). PCORI was created to support clinical trials and observational studies that address critical knowledge gaps in clinical care and practice by providing high-integrity, evidence-based information to patients, clinicians, and the broader healthcare community.

As a funder with a commitment to open science, PCORI has already implemented key data sharing initiatives to promote access to research findings. These findings include adoption of PCORI's Process for Peer Review of Primary Research and Public Release of Research Findings and PCORI’s policy on Public Access to Journal Articles Presenting Findings from PCORI-Funded Research.

We also believe that it is important for our funded researchers to share the data from their PCORI-funded studies. Open scientific inquiry requires that researchers systematically create and preserve research project data and data documentation (e.g. study protocol, metadata, and analytic code).

To that end, in consultation with an expert advisory group, PCORI developed a draft Policy for Data Access and Data Sharing and we sought input from various stakeholder groups. The deadline for submitting comments was Monday, January 23, 2017, at 5:00 p.m. (ET).

View/Download the Final Policy

View/Download the Draft Policy View Submitted Comments

More About the Draft Policy

The intent of this initial draft policy is to set forth expectations and guidelines for PCORI research awardees for management of their data in order to do the following: (1) facilitate reproduction of original analyses to increase the integrity of PCORI-funded research findings; and (2) promote data sharing to enable conduct of additional analyses using data from PCORI-funded studies, thereby augmenting the knowledge generated from the original studies.

Along with similar efforts underway by peer funding institutions including the National Institutes of Health (NIH), which recently solicited information about approaches for measuring and assessing value of biomedical data repositories, PCORI hopes to play a part in promoting the benefits of data sharing, while being mindful of the numerous practicalities and challenges related to its implementation.

Posting this draft policy for public comment provides us with an opportunity to hear from various stakeholders—researchers, patients and their caregivers, and clinicians, among others—about the strengths and limitations of the initial draft.

We have embraced a “learning by doing” approach to our work on data sharing. The public comment period for this draft policy is one example of this approach. Another is a pilot project we are conducting in which we are bringing together some of our research awardees with select data repositories, with the goal of having their study data and data documentation deposited in one of these repositories. 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/effort that is needed for PCORI research awardees to prepare their data for sharing, and the costs associated with data sharing. Taken together, these activities will inform what we hope is a thoughtful, considered approach to data sharing.

View Submitted Comments

Policy Regarding Use and Disclosure of Public Comments
Members of the public can decide whether to provide personal identifying information during any public comment period. Any comments you provide to PCORI, including but not limited to any documents or other materials and any identifying information submitted with your comments, are collected voluntarily and may be disclosed by PCORI on this website, elsewhere on the Internet, in any other public forum, or in other PCORI materials. By providing public comments, you are consenting to their disclosure, use, and consideration by PCORI. PCORI makes comments available as submitted and does not independently verify any aspect of comment (e.g., content, organization affiliation or stakeholder designation). Read more about PCORI's Privacy Policy and Terms of Use.

Posted: November 1, 2016; Updated: September 7, 2018