See All Projects

Harmonized Governance Tools for Data Sharing

Focus Area: Transparency

Harmonized Governance Tools for Data Sharing

Access to and sharing of clinical research data are essential for the advancement of science. Over the last 5 years, the movement towards publicly and privately-funded research data to be openly available has markedly increased. 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, that challenge the ability of data to be utilized and integrated. As we move toward a landscape of open science wherein source data, study documents, and published manuscripts will be made available in repositories, the need for harmonized governance tools becomes ever-apparent.

In 2014, the MRCT Center, with partners, performed a retrospective analysis of data sharing language in informed consent forms and subsequently published draft Data Contributor Agreement and Informed Consent templates. This was followed in 2017 by a partnership with the Patient-Centered Outcomes Research Institute (PCORI) Open Science Pilot Project, during which the MRCT Center developed and will disseminate three governance tools:

  • Data Contributor Agreement (DCA) Template: The DCA template clarifies data contributor responsibilities, institutional safeguards, and requirements for the deposition of data in a data repository.
  • Data Use Agreement (DUA) Template: The DUA template delineates responsibilities and requirements for requesters of data from data repositories.
  • Data Sharing Template Section for Participants: Clear, health literate informed consent language enables participants to understand secondary use of collected data elements for open science, explaining complex concepts simply. Clear communication helps to promote participant autonomy.

Current Status: Active Project

Impact: Development of harmonized governance tools for data sharing enhances data transparency and collaboration, reduces administrative barriers, and shortens the time to new discovery.


  • To deliver three harmonized governance tools—a DUA, DCA, and data sharing template section for participants
  • 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:

  • May 2014: Retrospective analysis of data sharing language in informed consent forms completed
  • September 2014: Drafts of the DUA template and informed consent language completed
  • March 2015: Revised drafts of DUA templates and informed consent forms (for studies with external sponsors and studies without external sponsors released)
  • 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
  • February 2018: MRCT Center delivers template DCA, DUA, and data sharing section of an ICF to PCORI for distribution amongst PCORI grantees
  • July 2018: Submitted final document templates to PCORI

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

Project Coordinator: Emily Statham