See All Projects

Return of Individual Results

Focus Area: Data Transparency

Return of Individual Results

Patients 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 are lacking.

The MRCT Center previously developed guidelines for the return of aggregate results to research study participants; this project focuses on returning individual results to study participants

Current status: Active work group

Impact:

Returning individual results honors the essential contributions and voluntarism of study participants in clinical trials, while improving the transparency of those trials.

Objectives:

  1. Determine types of data to return and to whom
  2. Develop principles and methodology best suited for return of individual research results
  3. Define methods to facilitate disclosure and communication of results to individuals
  4. Identify best practices to manage disclosure to and follow-up with individuals
  5. Develop a framework to manage return of results in the global context of clinical research trials

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” was 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 / 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

Related external link:

SACHRP Recommendation: Return of Individual Results and Special Consideration of Issues Arising from Amendments of HIPAA and CLIA.

Program Manager: Carmen Aldinger