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 Resources

Resources freely available to the research community to improve knowledge of regulatory issues and share best practices.

Clinical Trial Registration & Results Reporting (CTR3)

Resources to help administrators, investigators, and other research staff involved in registration and reporting results for ClinicalTrials.gov.

Community-Engaged Research (CEnR)

Resources to support the involvement of community members and organizations in the research process.

Data & Safety Monitoring

Guidance on data safety and monitoring practices to protect research participants and ensure the integrity of research data.

Emerging Technologies, Ethics, and Research Data

Practical tools to enhance data security reviews and human subjects protections in research involving novel technologies.

International Research

Regulatory topics, education, and resources related to international research at Harvard-affiliated and global research sites.

Investigational Drugs and Devices (IND/IDE)

Guidance on compliance with all applicable regulations in maintaining and conducting research under INDs/IDEs.

Social, Behavioral, and Education Research (SBER)

Dozens of downloadable case studies, resources, and guidance documents.

Quality Assurance/Quality Improvement (QA/QI)

QA/QI practices ensure investigator and institutional compliance with federal and state regulations that oversee human research.

IRB Visiting Program

Attend an Institutional Review Board (IRB) meeting at one of 12 Harvard-affiliated academic healthcare centers.

Regulatory Binder

Downloadable template for tracking documentation of studies involving human subjects.

Human Subjects Training for Community Partners

Required training for community partners and other professionals who conduct research.

IND/IDE Consulting Service

Guidance on complying with Investigational New Drug (IND) and Investigational Device Exemption (IDE) regulations.

QA/QI Consulting Service

QA/QI expertise and support to increase research compliance.

Master Reliance Agreements

Template agreements for reliance at Harvard signatories: Institutional Animal Care and Use, Institutional Biosafety Committee, & Institutional Review Board.

Institutional Animal Care and Use (IACUC)

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Institutional Biosafety Committee (IBC)

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Institutional Review Board (IRB)

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Research Participant Resources

More than two dozen downloadable brochures for research subjects to understand their rights, in 17 languages.

Regulatory Groups

The program convenes a committee and working groups composed of Institutional Review Board (IRB) members, human research protections leadership, compliance officers, and other content experts from Harvard-affiliated institutions and other local affiliates to explore and address issues that pose special challenges, risks, or opportunities to institutions, investigators, and study teams.

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)