Open for Comment: PCORI's Draft Policy on Data Access and Data Sharing
We at PCORI are committed to disseminating the results of our funded research so that they may be widely taken up in practice. This availability of our findings to researchers, as well as patients, caregivers, and the broader healthcare community, is essential to improving patient outcomes.
As a research funder with a commitment to such “open science,” we have already implemented two initiatives to promote widespread access to study results. Today, we are releasing a draft policy on a third: Data Access and Data Sharing. We invite your comments on this important initiative.
Access to Study Findings
Our previous open science initiatives include adoption of a process for peer-reviewing primary research and releasing findings to the public. A related policy ensures public access to journal articles that present key findings from our funded research. (See Expanding Public Access to PCORI's Research Results.)
We hold that our funded researchers should not only share their findings but also be willing to share their data. Open scientific inquiry requires that researchers systematically create and preserve research project data and data documentation, including study protocol, metadata, and analytic code. Researchers should also digitally deposit data in a location where the information will be easy to find and access. That way, other researchers can use the data to reproduce results or build on them.
Our Draft Policy
The draft policy for Data Access and Data Sharing that we are releasing today for public comment sets forth expectations and guidelines for PCORI-funded researchers. The guidelines on managing data aim to both facilitate reproduction of original analyses—to ensure the integrity of PCORI-funded findings—and promote data sharing to enable additional analyses—to augment the findings of the original studies.
Our draft policy includes funding for all large PCORI studies to document their data and deposit them into a repository. We will also require all other studies to prepare to share their data, with the expectation that funding will be provided by PCORI if a need for data sharing arises.
The draft policy was developed by PCORI staff, with input from an expert advisory panel and our Research Transformation Committee, which consists of members of our Board of Governors.
We invite input from all our various stakeholders—researchers, patients and their caregivers, clinicians, and others—about the strengths and limitations of the initial draft. The public comment period will end on Monday, January 23, 2017.*
We encourage you to review and comment on this draft policy. Your feedback on this important matter is most welcome!
*Update (December 13, 2016): The comment period deadline has been extended, from Thursday, December 15, 2016.