OHRP (Office for Human Research Protections)

The Office for Human Research Protections (OHRP) is the U.S. Department of Health and Human Services (HHS) office responsible for overseeing institutional compliance with the Common Rule (45 CFR 46) in research involving human subjects that HHS conducts or supports. OHRP does not approve, review, or monitor individual studies itself — that is the function of a local or designated Institutional Review Board (IRB). OHRP’s jurisdiction sits one level up: it administers the Federalwide Assurance (FWA) system through which institutions commit to Common Rule compliance, registers the IRBs that carry that commitment out study by study, issues regulatory guidance, and conducts compliance oversight of institutions and IRBs when problems are alleged or suspected.

Where OHRP sits and what it administers

OHRP was created in June 2000, when HHS moved responsibility for human-subjects protections out of the National Institutes of Health — where it had existed since 1972 as the Office for Protection from Research Risks (OPRR) — and elevated it into the Office of the Assistant Secretary for Health within the HHS Office of the Secretary. The reorganization followed a period in which OPRR, as an NIH-housed office, had taken high-profile compliance actions against several major academic medical centers; moving the function to HHS was intended to give it more independence and institutional weight than an intramural NIH office could carry.

OHRP’s regulatory basis is 45 CFR 46: Subpart A (the Common Rule itself), Subparts B–D (additional protections for pregnant women/fetuses/neonates, prisoners, and children), and Subpart E, which requires any IRB reviewing HHS-conducted or HHS-supported human-subjects research to register with OHRP. IRB registration is filed by the institution or organization operating the IRB and is effective for three years before it must be renewed. An IRB must already be registered before OHRP will designate it under an institution’s FWA — registration and the FWA are two separate filings that OHRP requires in sequence, not one combined step.

Compliance oversight: how OHRP investigates

OHRP runs two distinct types of compliance oversight activity, and the distinction matters because it determines what triggered the review:

• Not-for-cause evaluations — proactive reviews conducted in the absence of any specific complaint or allegation. OHRP selects institutions using factors such as the volume of HHS-supported human-subjects research they conduct, prior reporting history, unresolved concerns from an earlier review, geographic distribution, and accreditation status.
• For-cause investigations — reactive reviews opened in response to a substantive written allegation or indication of noncompliance. Allegations can come from research subjects or their families, investigators or study staff, institutional officials, internal whistleblowers, or from OHRP staff themselves noticing a problem described in the scientific literature or the press. HHS regulations also independently require institutions holding an FWA to self-report unanticipated problems involving risk to subjects, serious or continuing noncompliance, and any suspension or termination of IRB approval directly to OHRP — a duty that generates a substantial share of for-cause reviews without any external complainant at all.

After gathering materials — and, where warranted, conducting interviews or an on-site evaluation — OHRP issues a written determination letter to the institution and, where relevant, the IRB. A determination letter states whether OHRP found noncompliance and, if so, what corrective action the institution must take. Outcomes range from a letter stating OHRP is taking no further action, through letters recommending specific improvements to an institution’s human-subjects protection program, to letters requiring corrective action as a condition of keeping the FWA in good standing. OHRP posts finalized, non-privileged determination letters publicly by year on hhs.gov once a review is closed; sections discussing an unresolved concern in an open review are redacted until closure.

Because compliance runs through the FWA rather than through any single protocol, OHRP’s available remedies operate at the institutional level. It can require corrective action; restrict or attach conditions to some or all of the human-subjects research covered by an institution’s FWA, which can force suspension of the affected studies until the restriction is lifted; and, in the small number of cases where subject safety appears to be at immediate risk, require an immediate halt to research activity. In the most serious cases OHRP can recommend to other HHS officials that an institution or investigator be suspended from a project or, ultimately, debarred from federal funding. Because an FWA is institution-wide rather than study-specific, a serious enough finding against one program can put an institution’s entire portfolio of HHS-funded human-subjects research at risk, not just the study that triggered the review — which is the practical reason research institutions treat OHRP correspondence as an institution-level, not a lab-level, event.

Why OHRP oversees institutions, not studies

This institution-level design is the same logic behind the FWA itself: OHRP asks an institution to promise compliance, asks a registered IRB to carry that promise out on individual protocols, and reserves its own direct attention for evaluating whether the institution and its IRB(s) are actually doing what the FWA and Common Rule require — not for second-guessing any single approval decision. A PI whose study is running under proper IRB approval will typically never interact with OHRP directly; their institution’s IRB and human-subjects protection office are the operative points of contact. OHRP becomes visible to individual researchers mainly through institutional policy shaped by its guidance (e.g., continuing-review requirements, unanticipated-problem reporting criteria) or, less commonly, when their study is named within a broader institutional compliance review.

Worked examples

Example 1 — for-cause investigation. A research participant complains directly to OHRP that a study’s consent form omitted a required risk disclosure. OHRP opens a for-cause investigation of the institution holding the FWA, not merely of the single protocol named in the complaint — it can request the institution’s IRB records, minutes, and broader consent-form practices to determine whether the gap was an isolated drafting error or reflects a systemic weakness in the IRB’s review process.

Example 2 — institutional self-report, not-for-cause posture. A university’s human-subjects protection office discovers, through its own audit, that continuing review lapsed on several protocols before their approvals expired. Its FWA obligations require it to report this to OHRP itself, rather than wait to be found. OHRP evaluates the self-report and can close the matter with a determination letter describing required corrective steps (e.g., a revised tracking system) well short of restricting the FWA — self-reporting promptly and fixing the underlying process is treated differently from being caught by an external complaint.

Counter-example

A sponsor runs an early-phase drug trial under an FDA Investigational New Drug (IND) application, with no HHS funding involved anywhere in the study. Oversight of that trial’s IRB and informed-consent process runs through FDA’s own human-subjects regulations (21 CFR Parts 50 and 56), not OHRP — OHRP’s authority under the Common Rule reaches HHS-conducted or HHS-supported research and research otherwise covered by an institution’s FWA, not every clinical study that happens to use an IRB. The two frameworks can still overlap in the same institution: a university that also does HHS-funded human-subjects research separately holds an FWA and answers to OHRP for that work, even while an FDA-regulated trial with no HHS funding at the same institution is overseen only under FDA’s rules.

Related terms

• Common Rule (45 CFR 46) — the regulation OHRP administers and enforces compliance with.
• Federalwide Assurance (FWA) — the institutional compliance filing OHRP approves, and the mechanism through which its enforcement remedies operate.
• IRB (Institutional Review Board) — the body OHRP registers and that carries out protocol-level review on the institution’s behalf.
• Belmont Report — the ethical framework underlying the Common Rule that OHRP was created to help implement and safeguard.