Educating Children and Families about Medical Research
Watch Sophie’s Science Project, an engaging and lively animation video for children and families that explores the ins and outs of participating in research and outlines the informed consent process.
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.
ETech Consulting Service
Consulting service offering information technology (IT) expertise & guidance.
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.
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.
Human Subjects Training for Community Partners
Required training for community partners and other professionals who conduct research.
Affiliate Resource and Contact Directory
Resources and contacts at Harvard-affiliated academic healthcare centers.
Digital Accessibility: Utilizing Third-Party Devices or Software
Questions to consider when evaluating third-party devices & software for research.
Video Series: Participant Data
Videos for potential research participants on sharing their data in a research study.
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)