Recently, the NIH Collaboratory Coordinating Center conducted a video interview with Drs. Wendy Weber, Cathy Meyers, and Lesley Curtis to discuss the NIH Collaboratory Data Sharing Policy, including special requirements for the NIH Helping to End Addiction Long-term (HEAL) Initiative projects, and tips for sharing data and resources.
“For all the Demonstration Projects, primary data sets should be made available with the publication of the primary results paper. The Collaboratory policy also recognizes that there are additional considerations that must be incorporated into the policy because data sets are derived from the electronic health records of partnering healthcare systems, and additional precautions might be relevant to making these data sets available.” —Cathy Meyers, MD
The PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) Demonstration Projects are part of the HEAL Initiative to address the national opioid crisis. The special requirements for these pragmatic trials include:
- All publications must be open access so the public has immediate access to the results of the trials.
- The underlying primary data must be shared through a repository, which will be set up for all of the projects funded through the HEAL Initiative.
To support sharing, the NIH Collaboratory Data and Resource Sharing Page on the Living Textbook holds links to datasets and data dictionaries, study tools, ethics and regulatory documentation, computable phenotypes and analytic code, data collection forms, study design papers, main outcomes papers, and other information from the Demonstration Projects that might be useful to others.
Demonstration Projects are given a Data and Resource Sharing Informational Document and an Onboarding Data and Resource Sharing Questionnaire during the onboarding process to assist clinical investigators in planning early for the sharing of these resources,. At closeout, Demonstration Projects are provided a Closeout Data and Resource Sharing Checklist, and investigators from the completed projects use this checklist to provide a final data sharing package.