Human Research Protection Program (HRPP) About Us
Research involving human participants must be conducted in accordance with applicable laws, regulations, guidelines, and ethical principles such as those outlined in the Belmont Report. The Yale Human Research Protection Program (HRPP), which includes the Institutional Review Board (IRB), is responsible for ensuring compliance with these standards and Yale’s institutional policies. Its goal is to: Ensure the rights and welfare of human research participants; Promote excellence in the conduct of research; and Advance scientific knowledge and quality research.
The Yale HRPP was first accredited by Association for the Accreditation of Human Research Protection Programs (AAHRPP) on 12/10/2010, and has maintained its accreditation status since that time. AAHRPP Accreditation indicates that our organization follows “rigorous standards for ethics, quality, and protections for human research” (AAHRPP).
The HRPP assists the University in meeting its legal, regulatory, and ethical obligations and routinely collaborates with other offices across the University, as well as community partners, on various programs and initiatives related to research that foster compliance, quality, efficiency, and the protection of human participants. Examples include the Yale Center for Clinical Investigation (YCCI) led Community Engagement programs such as the Cultural Ambassador Program and YCCI collaborations such as Puerto Rico Science, Technology, and Research Trust (PCCRI) and FDA Clinical Research Diversity Partnership. Other collaboration with YCCI include Quality Assurance Audits and training, including Good Clinical Practice. Former and current IRB members involved with the Yale Interdisciplinary Center for Bioethics also advise the IRB on ethical issues regarding research. One of our IRB Chairs (for the Social, Behavioral, and Education research IRB panel) is the Director of the Center.
In addition to managing the research submitted for IRB review, the HRPP provides educational support to principal investigators and their research staff, provides administrative and regulatory support to 18 Institutional Review Boards (IRB), and works closely with external IRBs when research is ceded to them for IRB review. The HRPP also assists the Radioactive Drug Research Committee (RDRC), Radioactive Investigational Drug Committee (RIDC), and Embryonic Stem Cell Research Oversight Committee (ESCRO).
- Association for the Accreditation of Human Research Protection Programs (AAHRPP).
- Department of Health and Human Services, Code of Federal Regulations, Title 21 (Food and Drugs).
- Department of Health and Human Services, Code of Federal Regulations, 21 CFR 50 (Protection of Human Subjects).
- Department of Health and Human Services, Code of Federal Regulations, 21 CFR 56 (Institutional Review Boards).
- Department of Health and Human Services, Code of Federal Regulations, 45 CFR 46 (Protection of Human Subjects).
- Department of Health and Human Services, International Compilation of Human Research Standards. (2020, January).
- Levine. (2004, May 14). Oral History of the Belmont Report and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
- Levine. (2011, August 16). Research Ethics.
- National Commission. (1979). Belmont Report.
- Resnik. Research Ethics Timeline.