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Harmonized Governance Tools for Data Sharing

Focus Area: Data Transparency

Harmonized Governance Tools for Data Sharing

Access to and sharing of clinical research data are essential for the advancement of science. The past 5 years have seen a marked increase in the call for publicly and privately-funded research data to be openly available. Data sharing allows sponsors and investigators to honor the essential contributions and volunteerism of clinical trial participants, to ensure reproducibility, and to enable the maximal use of data by the research community.

Despite a willingness to share data, contractual agreements for data often pose barriers and delays, ultimately limiting the potential for data sharing. Contractual barriers include the terms of the contracts themselves, as well as the lack of harmonization of data sharing governance processes, which minimizes the interoperability of data. As we move toward a landscape of open science wherein source data, study documents, and published manuscripts will be made publicly available in repositories, the need for harmonized governance tools becomes ever-apparent.

In partnership with the Patient-Centered Outcomes Research Institute (PCORI) Open Science Pilot Project, the MRCT Center is working to plan, develop, demonstrate, and disseminate three governance tools:

  • Data Contributor Agreement (DCA) Template: The DCA template will clarify data contributor responsibilities, institutional safeguards, and requirements for the deposition of data in a data repository.
  • Data Use Agreement (DUA) Template: The DUA template will delineate responsibilities and requirements for requesters of data from data repositories.
  • Data Sharing Template Section for Participants: Clear, plan language informed consent language will enable secondary use of collected science for open science, will explain complex concepts simply, and will commit to participant autonomy and privacy.

Current Status: Active Project

Impact: Development of harmonized governance tools for data sharing will enhance data transparency and collaboration, reduce administrative barriers, and shorten the time to new discovery.


  • To deliver three harmonized governance tools—a DUA, DCA, and data sharing template section for participants—for PCORI’s data sharing effort that will be made publicly available for all PCORI grantees
  • To lower the barriers to data sharing while preserving participant privacy and autonomy
  • To respect the interests of data generators, data users, funders, and patients/participants through multi-stakeholder engagement

Key Milestones:

  • June 2017- Kickoff Meeting with PCORI leadership at MRCT Center
  • July 2017- Teleconference with PCORI and the Inter-University Consortium for Political and Social Research (ICPSR) to discuss deliverables
  • September 2017- Multi-Stakeholder Open Science Pilot Project meeting at PCORI

Related External Links: Patient-Centered Outcomes Research Institute (PCORI)

Project Coordinator: Emily Statham