The MRCT Center Individual Return of Results workgroup developed principles that are directly relevant to the return of individual research results to research participants. These principles are summarized in a brief Principles Document.
On December 7, 2016, at the MRCT Center Annual Meeting, we released several principles documents that summarize core principles of major MRCT Center projects:
On December 7, 2016, at the MRCT Center Annual Meeting, we released the MRCT Center 2016 Impact Report.
Transparency has been a special focus of the MRCT Center’s 2016 efforts. We introduced detailed plans for Vivli – an independent Center for Global Clinical Research Data – and we developed a principled framework for the return of individual research results to study participants. The 2016 Impact Report also highlights our work on harmonized core competencies for clinical research professionals, post-trial responsibilities, Bioethics Collaborative, and global regulatory efforts in India and China.
The MRCT Center will hold its 2016 Annual Meeting on December 7, 2016, at Harvard Faculty Club’s Loeb House in Cambridge, Massachusetts.
This meeting will present key deliverables of major projects achieved during 2016 and new projects planned for 2017. This offers Executive and Steering Committee and Working Group members as well as interested stakeholders the opportunity to meet face-to-face with each other and learn about current projects of the MRCT Center.
Key themes of the meeting are: Discussion of the impact of the newly released ICH E17 Guidelines and Data Transparency (sharing data with researchers and individual participants).
A multi-stakeholder work group, led by the MRCT Center, discussed over the last six months issues relevant to returning individual results of clinical trials to participants. We have drafted an initial set of eight principles that are directly relevant to the return of individual results and that are open for comment.
Please see the Return of Individual Results: Principles and Approach document and send comments to MRCT@bwh.harvard.edu by September 1, 2016 with the subject line IRR Principles.
The period for receiving comments is now closed.
Read more about the MRCT Center’s work in returning individual results to participants.
In 2014, the MRCT Center convened a multi-stakeholder workgroup to develop a Guidance Document and Toolkit for returning aggregate results to trial participants. The Guidance Document and Toolkit were released in March 2015 and, since then, modified in response to questions, suggestions, and continued progress in the field.
These documents have been revised, and the latest versions are now available:
