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.

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.

How We Work

  • Identify Initiatives
    Local stakeholders (investigators, IRBs, research administrators, community members) identify opportunities — and challenges — for collaboration.
  • Form Working Groups
    Drawing from local expertise across our institutions and communities, working groups drive the development of new initiatives.
  • Pilot Solutions
    Following an iterative development cycle, working groups incorporate key stakeholder input through built-in feedback processes.
  • Implement Locally
    Working groups and stakeholders spearhead implementation at Harvard Catalyst's participating institutions, with an eye toward broad adoption.
  • Support Broad Adoption
    Resources and offerings are made available locally, regionally, and nationally, as appropriate and feasible.

Regulatory Committee and Subcommittees

The Regulatory Committee is comprised of institutional officials, compliance officers, and directors of human research protections from Harvard Catalyst-participating institutions as well as ex officio members from Harvard University Provost's Office and Harvard Medical School's Office for Professional Standards and Integrity. The committee meets monthly and 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. Committee members spearhead the implementation of recommendations at their home institutions and identify any issues with implementation that may require further analysis and solutions.

The program has also convened subcommittees, task forces, working groups, and advisory bodies to explore and make recommendations concerning issues that pose special challenges, risks, or opportunities for Harvard Catalyst and its participating institutions. These currently include:

  • Clinical Trials Registration & Results Reporting (CTR3)
  • Collaborative Quality Improvement Program (CQIP)
  • Informed Consent in Research
  • Emerging Technologies, Ethics, and Research Data (E-Tech)
  • Quality Assurance/Quality Improvement (QAQI)
  • Research Subject Advocacy (RSA) Program
  • Social Behavioral and Economic Research (SBER)

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