COVID-19 Research Resources
A curated list of research resources around guidelines, policies, and procedures related to COVID-19, drawn from Harvard University, affiliated academic healthcare centers, and government funding agencies

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.

    • 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 serves as a resource to the research community to help minimize regulatory burdens while ensuring that research is conducted with the highest standards of scientific design.

Regulatory Groups

The Regulatory Program convenes a committee and working groups composed of human research protections leadership, compliance officers, and other content experts from Harvard Catalyst-participating institutions to explore and address issues that pose special challenges, risks, or opportunities to institutions and investigators.

The Regulatory Committee meets monthly to discuss and share practices and strategies related to human research protections and compliance with regulatory requirements.

Current working groups developing resources and guidance include:

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

Quality Assurance and Quality Improvement Handbook for Human Research

Our QA/QI subcommittee has published a handbook aimed at teaching HRPP professionals how to implement and evaluate QA/QI programs.

Development of a Collaborative Quality Improvement Program

Check out the CQIP poster that was presented in San Diego at PRIM&R 2018!

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