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Bioethics Collaborative

Focus Area: Ethics, Conduct, and Oversight

Bioethics Collaborative

The MRCT Center Bioethics Collaborative is a neutral forum to foster the discussion of bioethical issues among stakeholders involved in global clinical trials for drug and device development. Meetings  bring together individuals from academia, industry, patient groups, ethics committees, and government to share, define, study, and propose ethical frameworks to address issues arising in the context of the design, conduct, and oversight of multi-national clinical trials. The MRCT Center runs the Bioethics Collaborative as a cooperative endeavor that meets three times per year.

A planning committee chooses discussion topics in advance. The MRCT Center then prepares a case statement of the topic to be discussed and circulates the case statement, relevant examples and readings prior to the meetings. The meetings themselves follow modified “Chatham House Rules,” by commentary will not be attributed to any individual, not to their institutional affiliation. After the meetings, the MRCT Center generates a summary of the issues and discussion for participants.  At each meeting, the attendees decide whether and how the summary will be adapted for broader distribution or publication.

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

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

Current status: Active

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 emerging bioethical issues

Key Milestones:

Project Coordinator: Emily Statham