PCORI Board approves policy for researchers to share their research data
September 7, 2018 (WASHINGTON, D.C.) – The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors today approved a new policy calling for the researchers PCORI funds to share their data sets and documentation for reanalysis and reuse. The new policy is among the most far-reaching adopted by publicly supported funders of health research.
The policy advances PCORI's commitment to open science by encouraging use of data from the studies it funds to allow other researchers to verify and build on those findings to generate new evidence available to healthcare decision makers. Data sharing can accelerate the discovery of new and better care approaches through additional analyses, reproduction of published findings, and development of avenues for new research.
Under the policy, certain research teams that receive PCORI funding–and particularly those that receive larger PCORI awards–are expected to place the data generated during their studies, as well as the documentation for how the data were produced, into a repository designated by PCORI. These data, including deidentified information collected from study participants, full protocols, meta-data, and statistical analysis plans, can then be made available to other research teams for reanalysis and additional analyses. A distinguishing feature of PCORI's approach is that funding will be provided to research teams to prepare the data and other materials for sharing.
"Through this data sharing policy, we're taking a major step in advancing open science," said PCORI Executive Director Joe Selby, MD, MPH. "By supporting how others may use information generated by the studies we've funded, we're helping to enhance the quality and increase the quantity of evidence for healthcare decision making. We're also reducing redundancy in collecting clinical data sets, which can speed research and the production of more useful evidence."
To protect the privacy of study participants, the new PCORI policy stipulates that all personally-identifiable health information must be deidentified in accordance with HIPAA regulations. Similarly, informed consent obtained from study participants must be sufficiently broad to permit future research by other researchers. Requests to access data and documents in the repository will be reviewed based on the scientific merit of the request and on the qualifications of the requestors.
The data sharing policy is the latest in a series of initiatives that PCORI has undertaken to support the transparency and broader availability of research results. The institute's earlier policy on peer review and public release of research findings ensures that all results from PCORI-funded studies, whether positive or negative, undergo a review and are made publicly available on PCORI's website in a final research report. PCORI also develops brief summaries of all the studies and their findings that are posted as public and professional abstracts on the website. In addition, through its public access policy, PCORI covers the costs for journals to make papers presenting the final results of PCORI-funded studies freely available to the public.
PCORI has invested $2.4 billion to fund more than 440 patient-centered comparative clinical effectiveness research (CER) studies and other projects designed to enhance CER methods and the infrastructure necessary to conduct CER rigorously and efficiently.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information they need to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.