Helping researchers navigate clinical & translational research regulatory processes. Regulatory Knowledge & Support Program

Program Services

    • IRB Ceded Review Request

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

      The Harvard Catalyst Regulatory Knowledge and Support Program and institutional review boards (IRBs) covering 24 Harvard Catalyst-participating institutions developed the IRB Ceded Review Request form to help facilitate multi-site human studies. The form may be used for any multi-site studies which involve at least one Harvard Catalyst-participating institution.

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    • Regulatory Atlas

      A directory of institutional regulatory offices, forms, policies, and training for research.

      The Regulatory Atlas provides institutional links to regulatory contacts and resources including forms and instructions, policies and procedures, human subjects research training, and information for research participants.

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    • Regulatory Binder

      A template for maintaining regulatory documentation in human subjects research.

      The Regulatory Binder is available to help study sites 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 both biomedical and social-behavioral research and includes regulatory documentation requirements, general guidance for organization and record keeping, and, when applicable, references to federal regulations and Good Clinical Practice guidelines.

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    • IND/IDE Consulting Service

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

      The Harvard Catalyst IND/IDE Consulting Service, composed of volunteer IND/IDE regulatory experts from the Harvard academic, medical, and hospital communities, offers expertise, resources, and shared experiences to assist Sponsor-Investigators in meeting regulatory requirements for their ongoing and/or new clinical and translational projects.

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Program Informational Resources

The Regulatory Knowledge and Support 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.

In particular, 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 & translational (C/T) research at Harvard, but to incorporate each participating entity's best qualities and processes into a comprehensive, cooperative, and integrated system.

The program provides integrated, coordinated, comprehensive 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.

Committee and Subcommittees

In support of these efforts, the Regulatory Knowledge and Support Program has convened the Regulatory Committee comprised of institutional officials, compliance officers, and directors of human research protections from the Harvard Catalyst-participating institutions as well as ex officio members from the Harvard University Provost's Office and Harvard Medical School's Office for Professional Standards and Integrity. The committee serves as the effector arm for a broad array of initiatives and support processes, including issues related to IRBs, HRPPs, research subject advocacy, privacy and data-sharing, education and training, and compliance with regulatory requirements. The Regulatory Committee meets monthly and most decisions are made by consensus. The Committee is responsible for development, approval, and implementation of streamlined processes and, where possible, policies, across Harvard and Harvard-affiliated institutions. Committee members spearhead the implementation of the Committee's recommendations at their home institutions and identify local problems with implementation that require further analysis and solutions.

The program has also convened subcommittees, task forces, and working groups to explore and make recommendations concerning issues that pose special challenges, risks, or opportunities for Harvard Catalyst and its participating institutions. These subcommittees develop aligned policies and procedures, guidance documents, templates, and toolkits covering a diverse set of regulatory topic areas, including: Clinical Research Management, Community Engaged Research, Data Security and Privacy, Regulatory Education, INDs and IDEs, International Research, and Continuous Quality Improvement.