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, and exploratory findings) standard guidelines and criteria to facilitate this process were lacking.
To address returning individual results, 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. The group considered different data types that may be returned in a research study and recommended which data types to return, at a minimum (see graphic below).
For return of aggregate results, the MRCT Center had previously provided guidance.
Current status: Dissemination and Communication
Impact: Returning individual results honors the essential contributions and voluntarism of study participants in clinical trials, while improving the transparency of those trials.
- Return of Individual Results to Participant: Principles
- Return of Individual Results to Participant Recommendations Document
- Return of Individual Results to Participants Toolkit
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; results from Task Force on Communication of Research Results survey were presented at MRCT Center Annual Meeting.
Related external link:
Project Leadership: Barbara Bierer (MRCT Center), Debra Mathews (Johns Hopkins), David Pulford (GSK), Sandra Prucka (Eli Lilly)
Program Manager: Carmen Aldinger