Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Program Services

    • IRB Ceded Review Request

      Request single or consolidated IRB review for a multi-site study.

      Use this form for any multi-site studies which involve at least one Harvard Catalyst-participating institution.

    • Regulatory Binder

      A template for maintaining regulatory documentation in human subjects research.

      Achieve and maintain regulatory compliance and adhere to high standards of practice in the conduct of research involving human subjects. This template binder can be used for biomedical and social-behavioral research.

    • IND/IDE Consulting Service

      Consultation for investigators and IRBs on issues relating to IND/IDE studies.

      Volunteer IND/IDE regulatory experts from the Harvard academic, medical, and hospital communities offer expertise, resources, and shared experiences to assist Sponsor-Investigators in meeting regulatory requirements for ongoing or new clinical and translational projects.

    • QA/QI Consulting Service

      Consultation for institution officials, IRBs, or committees to develop Quality Assurance/Quality Improvement activities.

      Volunteer QA/QI regulatory experts from the Harvard academic, medical, and hospital communities offer expertise, resources, and shared experiences to assist other institutions in establishing or strengthening QA/QI activities or programs.

Got questions on regulatory issues? Watch this video to find answers.

The Regulatory Foundations, Ethics, and Law Program minimizes the regulatory burdens for investigators and promotes cooperation and interoperability by coordinating the diverse processes of inter-institutional research, including human subjects protections, patient privacy, quality improvement, contracting, and support for FDA-regulated research.

Specifically, the program:

  • Develops regulatory cooperation, institutional harmonization, and simplification where appropriate
  • Reduces barriers for data sharing and HIPAA compliance
  • Redefines a robust Research Subject Advocate Program

The goal is not to create a new, centralized, single system for regulatory review of clinical and translational (C/T) research at Harvard University, but to incorporate each participating entity's best qualities and processes into a comprehensive, cooperative, and integrated system.

The program provides resources and services to the C/T research community, ensuring that all research is conducted with the highest standards of scientific design and guaranteeing participant safety, a high level of research ethics and integrity, and compliance with regulatory requirements.

In support of these aims, the program has launched a visitation program for local IRB members to observe the deliberations of another IRB. This program is intended to help identify best practices and innovative processes in the review of clinical and translational research. (Request schedule and more information.)

Partnership with Harvard Law School

The Ethics and Law Initiative aims to develop innovative, practical solutions to stubborn and complex ethical and legal quandaries that hinder clinical and translational research. For more information, please visit The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics or contact us.

HMS article on streamlined IRB review process

Boston Marathon bombing victims participate in a three-year hearing study, thanks to the Harvard Catalyst IRB Ceded Review Request System.

National Award Received

Learn why the work on the Reliance Agreement by Harvard Catalyst's Regulatory Foundations, Ethics, and Law Program was recognized as a Best Practice in Human Research.