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).

Why we have Human Research Protection Programs

A number of historical events paved the way for the establishment of an ethical framework that guides research involving human participants today (Levine, 2004; Levine 2010; Resnik). In 1974, the National Research Act was passed, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research within the U.S. Department of Health and Human Services (DHHS), renamed later to the Office of Human Research Protections (OHRP) within DHHS. Published in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, the Belmont Report identified the basic ethical principles for the conduct of research involving human participants (Levine, 2004; Levine, 2011; National Commission, 1979).

Respect for Persons requires that potential research participants have the freedom to make voluntary decisions regarding whether or not to participate in research without coercion, undue influence, or exploitation;
Beneficence requires that the proposed research must have a favorable risk/benefit ratio, be designed to maximize benefits and minimize harms, and have scientific merit thus requiring an assessment of, among other things, study design, inclusion/exclusion criteria, and methods to ensure that diverse population groups are included in the overall study design as appropriate; and
Justice requires the equitable selection of research participants in research so that the benefits and burdens are shared equitably and population groups are not excluded and/or exploited in research.

In addition to the Belmont Report, regulations were passed shortly thereafter requiring researchers to obtain voluntary informed consent from participants taking part in studies. They also required studies using human subjects be reviewed by Institutional Review Boards (IRB’s), which have the authority to approve disapprove, or require a change in research that is submitted to the IRB for review. The IRB’s review and approval of a study (and ongoing monitoring until the study is complete) is intended to ensure the ethical protection of human research participants and compliance with applicable human research standards (21 CFR 56.109; 45 CFR 46.109).

In the United States, the core regulations are set forth in the Code of Federal Regulations (CFR) Title 45 (Public Welfare), Part 46 (Protection of Human Subjects). The Food and Drug Administration issued CFR Title 21 (Food and Drugs), Parts 50 (Protection of Human Subjects) and 56 (Institutional Review Boards). Additional laws, regulations, guidelines, and standards also have been established over time, including local requirements (e.g., state laws, etc.) related to human research protection and related issues. According to HHS, there are currently “over 1,000 laws, regulations, and guidelines (collectively referred to as “standards”) that govern human subject protections in 133 countries, as well as standards from a number of international and regional organizations. (HHS, The International Compilation of Human Research Standards, 2020).