Return of Individual Results
Focus Area: Transparency
Participants desire to receive both individual and aggregate research data from clinical studies in which they participated. For return of individual results (including routine results, incidental findings, individual endpoints and study arm information, exploratory findings) standard guidelines and criteria to facilitate this process were lacking.
To address this, the MRCT Center convened a multi-stakeholder group to develop recommendations for returning individual results, with special subgroups dedicated to (1) addressing genomic results and (2) developing a survey to investigate the current status of communication between sponsor, investigator, treating physician, and study participant.
Current status: Dissemination
Impact: Returning individual results honors the essential contributions and voluntarism of study participants in clinical trials, while improving the transparency of those trials.
- Review and revise Principles, Recommendations Document, and Toolkit, as needed, in response to feedback and evolving policy and practice
- Disseminate materials
Key project Milestones:
- December 2015: Launched Return of Individual Results Working Group
- April 2016: Task Force on Communication of Research Results launched to (1) understand current practices in communication of research results to clinical trial participants and (2) develop recommendations to guide communication processes between clinical investigators, primary care physicians, and study participants
- August 2016: “Return of Individual Results: Principles and Approach” available for comments
- December 2016: Draft Recommendations Document, Toolkit and Principles presented at MRCT Center Annual Meeting
- January 2017: Genomics Sub-Group launched to expand on genetic/genomic sections of Individual Return of Results Guidance Document and Use-Case Sub-Group launched to develop simulations to test the workgroup output in real life situations
- February 2017: “Return of Individual Results to Participants: Principles” released
- June 2017: “Return of Individual Results to Participants: Principles” Version 2.1 released
- December 2017: Return of Individual Results to Participants Recommendations Document Version 1.2 and Return of Individual Results to Participants Toolkit Version 1.2 released and “Return of Individual Results to Participants: Principles” Nov 2017 version released
Related external link:
Program Manager: Carmen Aldinger