Policy Engagement

The MRCT Center works to improve the integrity, safety, and rigor of global clinical research by shaping policies that foster ethical, responsible, and accessible research practices. Contributing to policy engagement and public dissemination by submitting public commentary on regulatory proposals, draft guidance, and policies ensures that evolving frameworks, guidelines, and rules reflect the needs of research participants, sponsors, investigators, and the broader scientific community. Our ongoing engagement demonstrates our dedication to strengthening research integrity through thoughtful feedback on evolving regulations, promoting participant protection and ethical considerations, and encouraging innovation and practical implementation. Our submissions address a wide range of critical topics, shaping policies and practices that impact sponsors, researchers, and participants in the U.S. and worldwide. These contributions help ensure that research remains rigorous, responsible, and accessible.

OBJECTIVES

Enhance research integrity by providing thoughtful comments on evolving federal regulations to ensure clinical research remains ethical, transparent, and responsible.
Promote participant protection by advocating for global policies and practices that prioritize the rights, safety, and inclusion of research participants.
Encourage ethical innovation by supporting regulatory frameworks that foster advancement while maintaining rigorous ethical and practical standards.
Foster stakeholder engagement by bridging the needs of sponsors, researchers, and participants, contributing to policy writing and regulatory discussions that shape effective, transparent, and patient-centered research.

KeY MILESTONES

Public comments submitted to federal and international agencies

project Leadership & sTAFF

Barbara E. Bierer, MD, Professor of Medicine, Harvard Medical School and Faculty Director, MRCT Center
Julia S. Etkin, MBE Candidate, Research Assistant II, MRCT Center