Human Research Protection Program (HRPP)

A Human Research Protection Program (HRPP) is the complete organizational structure an institution operates to protect the rights and welfare of human research participants. It is broader than any single committee: it is the full system of one or more Institutional Review Boards (IRBs), written policies and procedures, an administrative compliance office, researcher and staff training requirements, conflict-of-interest management, and ongoing monitoring of active research — all operating under the institution’s Federalwide Assurance (FWA) filed with HHS’s Office for Human Research Protections (OHRP).

HRPP vs. IRB: program vs. committee

The IRB is the HRPP’s core review body — the committee that reviews and approves, requires modification of, or disapproves individual research protocols and continuing reviews. But the IRB is one functional component of the program, not a synonym for it. A typical HRPP also includes: the administrative office that manages protocol submission workflows, maintains records, and staffs the IRB; the institutional signatory relationship with OHRP through the FWA; researcher training requirements (commonly delivered through the CITI Program); conflict-of-interest disclosure and management processes; and post-approval or “for-cause” monitoring that checks whether approved studies are actually being conducted the way the IRB approved them. An institution can have multiple IRB panels — reviewing different types of research, or organized by campus or department — all operating under a single institutional HRPP.

HRPP vs. AAHRPP: the program vs. its accreditor

Every institution that conducts covered human-subjects research and holds an FWA operates an HRPP by definition — that is simply what “having a compliant program under the Common Rule (45 CFR 46) and applicable FDA human-subjects regulations” means in practice. AAHRPP (the Association for the Accreditation of Human Research Protection Programs) is the independent, non-profit body that voluntarily accredits an institution’s HRPP as a whole, after a self-assessment and peer site visit. AAHRPP accreditation is optional and additive — it is external verification that an already-operating HRPP meets AAHRPP’s published standards; it is not what creates the HRPP or what makes an institution’s human-subjects research legally compliant in the first place.

Who typically runs an HRPP

Administrative responsibility for an HRPP is usually held by a dedicated office — often titled a Human Research Protection Office, IRB Office, or Research Compliance Office — reporting to institutional leadership (e.g. a Vice President for Research or Chief Compliance Officer). The FWA names a Human Protections Administrator as the institution’s designated point of accountability to OHRP, distinct from the IRB Chair, who presides over the review committee itself. The scope of an HRPP’s oversight extends across every human-subjects study the institution conducts or supports, not just a reviewed sample — monitoring program-wide compliance, not only individual-protocol approval, is part of what distinguishes the program from the committee.

Related CASRAI content

For the individual review committee this program centers on, see IRB (Institutional Review Board) and the guide on the IRB/REC approval process. For the accrediting body and how it differs from individual credentials like CIP, see AAHRPP and the guide on IRB certification.