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

Program Services

    • IRB Visiting Program

      Learn about the IRB review process and identify best practices and innovative processes in the review of clinical and translational research.

    • SMART IRB Reliance Request

      Request single or consolidated IRB review for a multisite study.

      Use this form for any multisite 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.

    • Human Subjects Training for Community Partners

      This document assists with the required training of community partners and/or lay individuals engaged in the conduct of research.

      In addition to focusing on ethical conduct related to working with research participants, this training helps educate community partners on their roles and ethical responsibilities during the research project.

    • 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.

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.

Ethical Payment to Research Participants

Researchers at Harvard Catalyst and the Petrie Flom Center share a practical framework to reduce uncertainty around payment to research participants. See also: Payment Guidance for IRBs/Investigators