Harmonized Governance Tools for Data Sharing
Focus Area: Current Project
Focus Area: Transparency
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 investigators’ willingness to share data, the data sharing process is often impeded by contractual disagreements and ambiguous standards of data anonymization. Contractual barriers to data sharing, such as restrictive terms of data use and data contribution, as well as inconsistencies in data sharing governance procedures, delay data integration by researchers using previously gathered data (secondary researchers). Ambiguous standards of data anonymization pose additional challenges, as existing policies and guidelines are largely silent on de-identifying data in a manner that preserves scientific utility. As we move toward a landscape wherein source data, study documents, and published manuscripts are made increasingly available, the need for tools that streamline contractual processes, protect participant privacy, and maintain the scientific utility of data continues to grow.
In 2014, the MRCT Center, along with several partners, performed a retrospective analysis of data sharing language in informed consent forms. Subsequently, the MRCT Center published draft Data Contributor Agreement and Informed Consent Form templates. In 2017, the MRCT Center undertook efforts to develop a roadmap for harmonizing standards of data anonymization with the European Medicines Agency (EMA). We continued and expanded in 2017/2018 in partnership with the Patient-Centered Outcomes Research Institute (PCORI). Together with the PCORI Open Science Pilot Project, the MRCT Center developed three harmonized governance tools for data sharing, which will be broadly disseminated:
- 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
- Template Data Contributor Agreement
- Template Data Use Agreement
- Template Data Sharing Section of an Informed Consent Form (ICF)
- Manuscript in preparation
- 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
- November 2017: Workshop with European Medicines Agency on Data Anonymization: A Key Enabler for Healthcare Clinical Data Sharing
- 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 for DCA, DUA, and data sharing section of ICF to PCORI
- November 2018: Released Template Data Contributor Agreement, Template Data Use Agreement, Template Data Sharing Section of an Informed Consent Form (ICF)
Related External Links: Patient-Centered Outcomes Research Institute (PCORI)
Project Leadership: Barbara Bierer (MRCT Center), Jason Gerson (PCORI), Jane Perlmutter (Gemini Group)
Contact Information: firstname.lastname@example.org