MRCT Bioethics Collaborative
Focus Area: Ethical Frameworks
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 bring together individuals from academia, industry, patient groups, 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, and circulating any relevant cases and/or readings prior to the meeting. The meeting itself follows modified “Chatham House Rules,” in which neither the identity nor the affiliation of any participant will be revealed. After the meeting, 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:
- Genetech, Inc.
- Johnson & Johnson
- Merck & Co., Inc.
- Pfizer Inc.
- Takeda Pharmaceuticals International, Inc.
Current status: Active
Discussion forum for pressing ethical issues in multi-regional clinical trials
- Encourage careful discussion and collective understanding of bioethical issues related to global clinical trials
- Develop approaches to address emerging bioethical issues
- October 2016: Inaugural meeting: Expanded access to investigational products
- January 2017: Second meeting: Early termination of clinical trials
- May 2017: Third meeting: Ethnic and gender diversity in clinical research
- October 2017: Fourth meeting: Fair payment to and recruitment of international research participants
- December 2017: Released Expanded Access: A Practical Approach for Sponsors, Physicians and Institutional Review Boards
- January 2018: Fifth meeting: Enabling informed selection of clinical trials: institution, provider, and participant responsibilities: Summary notes available
- April 2018: Sixth meeting: The Return of Individual Results to Research Participants and Axes of Communication
Project Coordinator: Emily Statham