The policy lays out the expectation that our awardees will make the data from their PCORI-funded research projects available to third-party requestors. Very importantly, it provides funding to our awardees for their time and effort in preparing the data to be shared. It includes details about what data awardees will place into a repository and when those data would be available to those who request it. It also describes the data request process and the criteria that will be used to assess the scientific merit of the requests.
The sharing of clinical research data is a complex issue, and we arrived at this policy through careful deliberation, substantial professional and public input, and a commitment to learning by listening and learning by doing. This included obtaining public comment on the draft policy, convening and consulting an expert advisory group experienced with data sharing issues, conducting a pilot project that brought together data repository organizations with our awardees to assess technical and operational challenges related to implementing the policy, and speaking with other funders and regulatory agencies about their experiences in developing data sharing guidance and policies.
The sharing of clinical research data is a complex issue, and we arrived at this policy through careful deliberation, substantial professional and public input, and a commitment to learning by listening and learning by doing.
We’re confident that the result is a carefully considered policy that seeks to maximize the utility and usability of data collected in research projects that we fund. Our intent is to encourage scientifically rigorous secondary use of clinical research data to foster scientific advances that will ultimately improve clinical care and patient outcomes.
In developing this policy, we have paid close attention to data privacy and human subject protections concerns. The data required to be shared via this policy must be deidentified in accordance with federal HIPAA regulations. It will include only data from participants whose informed consent allows data to be used for secondary research by researchers not affiliated with the awardee’s institution. The policy also has clear prohibitions against using the data to reidentify individuals and redistributing the data to people who haven’t been approved to use the data.
We know this is not a simple thing. So, we plan to implement the specific requirements of this policy in stages. Since 2015, our funding announcements and contracts for funded research have included a general expectation that awardees must develop a data management and data sharing plan and be prepared to share research project data. Accordingly, we will seek our awardees’ compliance with the new policy upon a research project’s completion of our peer review and public release process. We will hold town hall webinars for current awardees and applicants to provide additional information and answer questions about the policy and provide other resources, such as FAQs, on our website. And we plan to work directly with individual awardees to facilitate compliance with this policy.
As noted in the 2015 Institute of Medicine report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk, responsible sharing of clinical research data is in the public interest. It maximizes contributions made by clinical research participants to scientific knowledge that benefits future patients and society as a whole. We are very pleased, therefore, to do our part as a funder to foster open science and scientific advances that will ultimately improve patient care and outcomes.