Focus Area: Clinical Trials & Research

Launch of Bioethics Collaborative

The MRCT Center is launching a new initiative–the Bioethics Collaborative.

The MRCT Bioethics Collaborative is a forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development. Our meetings will bring together scholars, executives, and scientists from academia and industry to share, define, study, and propose ethical frameworks for topics including human subject protections, biospecimens, and research integrity. We will look at real-life settings as well as develop approaches to address emerging and unanticipated issues as the pace of research continues to accelerate. The Collaborative will be a neutral forum to provide ethical guidance on global clinical trials concerns.

For more information, or if you are interested in joining the Bioethics Collaborative, please contact Rebecca Li at RLi@bwh.harvard.edu.

Proceedings, Presentations and Annual Report Available from MRCT Center’s 2015 Annual Meeting

The MRCT Center 2015 Annual Meeting was held on 15 December 2015 and was attended by about 70 stakeholders from academia, governmental agencies, pharmaceutical industry, patient advocates, non-profit organizations, institutional review boards and others. The MRCT Center 2015 Annual Progress Report was released at the meeting.

The major themes of the MRCT Center 2015 Annual Meeting included Post-Trial Responsibilities and Data Transparency. The Post-Trial Responsibilities (PTR) Working Group developed an Ethics Framework with two main deliverables: a PTR Guidance Document and a PTR Toolkit. Invited speakers shared their perspectives and suggestions for revisions. The Data Sharing and Data Transparency Initiative’s current progress on developing a blueprint for a new, not-for-profit entity was presented. Invited speakers shared their perspectives on the project vision to date.

Proceedings from this meeting are now available. Presentations from the Post-Trial Responsibilities working group and from the Data Sharing and Data Transparency Initiative are available for sponsors.

MRCT Center and Collaborators Published in Journal of Medical Ethics

A multi-stakeholder team, convened by the MRCT Center, published an article detailing use of a Protocol Ethics Toolkit to facilitate effective recognition, consideration and deliberation of critical clinical ethical issues in clinical trial protocols.

The publication, “Incorporating ethical principles into clinical research protocols: a tool for protocol writers and ethics committees” has just been released by the Journal of Medical Ethics.

To read the article, click here.

To read a related blog posting, click here.

To learn more about the MRCT Center’s work on Protocol Ethics, click here.

Protocol Ethics E-Learning

MRCT Center Transitioned to the Division of Global Health Equity

As of July 1, 2015, the MRCT Center has moved administratively to the Division of Global Health Equity,  under the leadership of Dr. Paul Farmer, at the Brigham and Women’s Hospital (BWH), a Harvard teaching hospital. The Division of Global Health Equity serves as an academic and research home for more than 40 Harvard and BWH faculty who are engaged in teaching, patient care and research around the world and domestically.

The integration of the MRCT Center into the Division offers a community of colleagues and a network of thought leaders globally, as well as infrastructure for program strengthening and expansion. The mission of the MRCT Center will remain unchanged and will be strengthened through this new partnership. The MRCT Center will continue to have a collaborative relationship with Harvard, including the continued involvement of multiple Harvard faculty members and student interns.

In the process of this move, the URL of the MRCT Center’s website changed to: mrctcenter.org, and our email addresses changed to @MRCTcenter.org. Web searches and emails to previous addresses will be redirected. The general email box for the center is admin@MRCTcenter.org. Our full name is now: The MRCT Center of Harvard and Brigham and Women’s Hospital.