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Established in 2008, the Regulatory Foundations, Ethics, and Law program works to reduce administrative and regulatory burdens and improve processes in the conduct and oversight of clinical and translational research. Since 2013 the program has collaborated with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School to promote the ethical conduct of research.

In addition to an extensive library of supportive tools, guidance, training, and other resources, a major achievement of the program has been advancing reliant models of review and oversight, most notably through the development of a master institutional review board (IRB) reliance agreement that streamlined the review of collaborative research across Harvard University and its affiliates.

This agreement was expanded regionally and was foundational to the SMART IRB Agreement, a national IRB reliance network which has nearly 1000 participating institutions across the country. The program spearheaded similar models of reliant review for research involving animals and for protocols requiring oversight by a biosafety committee.

The program works with its regulatory committee and topic-focused subcommittees or working groups from across Harvard, its affiliates, and other CTSAs to identify problems, develop solutions, and share best practices that may be implemented locally and adapted nationally. Areas of focus have included: social, behavioral, and education research; community-engaged research; international research; data safety and emerging technologies; quality assurance and improvement; investigational drugs and devices; and research participant protections and advocacy.

The Regulatory Foundations, Ethics, and Law program is led by faculty director Barbara E. Bierer, MD, professor of medicine at Brigham and Women’s Hospital and faculty director of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital, and director of regulatory affairs operations Aaron Kirby, MSc, along with the core staff who support and contribute to the success of the program. In addition to supporting the Harvard Catalyst community, program leadership and staff lead and contribute to the national SMART IRB platform, supporting IRB reliance and advancing collaborative research across the nation.

Read more about the history of the Regulatory Foundations, Ethics, and Law program in this news article.