Focus Area: Ethical Frameworks
Presently, data sharing language in informed consent forms is inconsistent and often confusing. As a result, participants are left unaware of the purposes, risks, and benefits of data sharing. Plain-language definitions of key data sharing terms are needed in order to increase participant understanding of data sharing, decrease participant confusion, and respect participant autonomy.
In addition to developing harmonized, standardized terminology for data sharing, the MRCT Center seeks to design participant educational tools and resources that respect health literacy principles and enhance participant comprehension of data sharing.
Current Status: Drafts of key deliverables complete; development of participant educational tools and resources in progress
The research community will have access to informed consent language and educational resources to explain data sharing and transparency.
- Perform a retrospective analysis of data sharing language in informed consent forms
- Draft appropriate informed consent forms (ICF) that would enable broader data sharing
- Develop educational tools and resources for participants that respect health literacy principles and enhance comprehension of data sharing
- 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 template and informed consent forms (for studies with external sponsors and studies without external sponsors released)
- June 2017- MRCT Center receives grant from Patient-Centered Outcomes Research Institute (PCORI) to develop standard, patient-centric language on data sharing for Informed Consent Forms as part of the Open Science Pilot Project
- February 2018 – MRCT Center delivers template Data Contributor Agreement (DCA), Data Use Agreement (DUA), and Data Sharing Section of an Informed Consent Form (ICF) to PCORI for distribution amongst awardees
Project Coordinator: Emily Statham