See All Projects

MRCT Bioethics Collaborative

Focus Area: Ethical Frameworks

MRCT Bioethics Collaborative

The MRCT Bioethics Collaborative is a neutral forum to encourage the discussion of bioethical issues among stakeholders in global clinical trials for drug and device development. Our meetings will bring together individuals from academia, industry, patient groups, and government to share, define, study, and propose ethical frameworks for topics including human subject protections, biospecimens, and research integrity. We will examine real-life case studies as we develop approaches to address emerging and unanticipated issues in clinical research.

The consortium will focus primarily on bioethical issues related to aspects of clinical trials; human subjects protections; biospecimens; and research integrity; and will have a particular focus on international settings. The MRCT Bioethics Collaborative will be run as a cooperative endeavor coordinated by the MRCT Center and will meet three times per year.

Topics for discussion will be chosen in advance by a planning committee, and actual cases or scenarios may be circulated prior to the meeting. The meeting itself will follow modified “Chatham House Rules,” in that neither the identity nor the affiliation of any participant will be revealed. A summary of the issues and discussion will be generated for participants after the meeting.  The attendees at the meeting will decide, each time, whether and how the summary will be adapted for broader distribution or publication as either a position paper on a particular issue, an ethical framework, or a case study analysis.

The MRCT Center is grateful to the following sponsors of the MRCT Bioethics Collaborative:

  • Genetech, Inc.
  • Johnson & Johnson
  • Merck & Co., Inc.
  • Pfizer Inc.
  • Sanofi
  • Takeda Pharmaceuticals International, Inc.

Impact:

Discussion forum for pressing ethical issues in multi-regional clinical trials

Objective:

  • Encourage careful discussion and collective understanding of bioethical issues related to global clinical trials
  • Develop approaches to address pressing and emerging bioethical issues

Key Milestones:

  • October 2016: Inaugural meeting, topic: expanded access to investigational products
  • January 2017: Second meeting, topic: early termination of clinical trials
  • May 2017: Third meeting, topic: ethnic and gender diversity in clinical research
  • October 2017: Fourth meeting, topic: recruitment of and fair payment to international research participants

Project Coordinator: Emily Statham