CASRAI Dictionary

Tag: office of research integrity jurisdiction

  • ORI Second Phase Guidance Documents: 2026 Update for US Institutions

    The ORI second phase guidance documents are a batch of topic-specific PDFs — covering honest error, admissions, pursuing leads, sub-awardee assurances and institutional assessments — that the US Office of Research Integrity released from September 2025 onward to help Public Health Service (PHS)-funded institutions implement the 2024 Final Rule on research misconduct (42 CFR Part 93) ahead of its January 1, 2026 applicable date. Institutions now need to fold this guidance into formal policy before their next Annual Report cycle.

    The Office of Research Integrity (ORI) is the component of the US Department of Health and Human Services (HHS) responsible for overseeing research-misconduct policy and compliance at institutions that receive Public Health Service funding, including funding from the National Institutes of Health (NIH).

    What Is ORI’s Second Phase of Guidance Documents?

    ORI began releasing guidance in June 2025 to support institutions implementing the 2024 Final Rule on Public Health Service Policies on Research Misconduct, published in the Federal Register at 42 CFR Part 93. The first tranche — Writing Policies and Procedures, Sample Policies and Procedures, Small Institution Guidance, and Implementation Guidance — gave institutions templates for compliant policy language.

    The second phase, announced by ORI on 15 September 2025, is topic-specific rather than template-based. It clarifies how institutions must apply the Final Rule to real proceedings: Honest Error, Admissions, Pursuing Leads, Sub-Awardee Assurances, and Assessments. ORI has continued releasing additional topic guidance in further batches through May 2026, all falling under the same phased rollout of Final Rule guidance.

    The Final Rule’s effective date was 1 January 2025 (optional use, by mutual agreement of the parties to a case), and its applicable date was 1 January 2026, after which every PHS-funded institution must use the updated regulation for any new research-misconduct matter.

    What Do the Phased Guidance Documents Cover?

    Across the rollout, ORI has grouped guidance into consistent topic clusters. The table below maps each release window to its documents and subject matter, based on ORI’s official guidance-documents index.

    Release window Guidance documents Institutional focus
    June 2025 (Phase 1) Writing Policies and Procedures; Sample Policies and Procedures; Small Institution Guidance; Implementation Guidance Drafting Final Rule-compliant policy language
    September 2025 (Phase 2) Honest Error; Admissions; Pursuing Leads; Sub-Awardee Assurances; Assessments Distinguishing error from misconduct; handling admissions and sub-awardees
    December 2025 Institutional Record; Research Records; Multiple Institutions Compiling the institutional record; multi-site cases
    March 2026 Confidentiality; Interviews; Subsequent Use Exception Disclosure limits, interview conduct, record-sharing exceptions
    May 2026 State of Mind; Respondents; Institutional Record Best Practices Assessing intent; managing multiple respondents; record organisation

    Two details are easy to miss. First, ORI’s own guidance notes that some documents cross-reference other guidance not yet released at the time of publication — institutions should treat the rollout as a living body of interpretation, not a closed set. Second, the Sub-Awardee Assurances Guidance confirms that every recipient of PHS support, including sub-awardees on collaborative grants, must independently establish and maintain an active research-integrity assurance with ORI — a requirement that is easy to overlook on multi-institution NIH research misconduct cases.

    What Must Institutions Update in Annual Report Submissions?

    Every PHS-funded institution files an Annual Report with ORI: a record of research-misconduct activity from the prior year, combined with an annual assurance that the institution’s policies and procedures comply with 42 CFR Part 93. ORI required institutions to submit an updated assurance reflecting the 2024 Final Rule as part of the 2025 Annual Report, due 30 April 2026 — a deadline that has now passed for most institutions.

    That does not close the compliance question. Guidance covering State of Mind, Respondents and Institutional Record Best Practices was not released until May 2026, after the April assurance deadline. Institutions therefore have unfinished work: policies and procedures need to be revised now, in the second half of 2026, so the underlying documents — not just the assurance statement — genuinely reflect the completed guidance set before the 2026 Annual Report is due on 30 April 2027. Practical year-end priorities include:

    • Revising written policies to incorporate the Honest Error, State of Mind and Admissions frameworks, so investigative committees apply a consistent intent standard.
    • Updating institutional-record procedures against the Institutional Record and Research Records guidance, including retention and compilation practices.
    • Confirming that every sub-awardee on active PHS-funded collaborations holds its own current ORI assurance.
    • Documenting confidentiality and interview procedures consistent with the March 2026 guidance before any new proceeding opens.

    How Does ORI’s Jurisdiction Fit Under Federal Misconduct Rules?

    ORI’s authority is defined by 42 CFR Part 93, which applies to institutions receiving PHS funding — chiefly through the NIH, but also the CDC, FDA and other HHS agencies. Research misconduct according to federal regulations is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results, and explicitly excludes honest error or legitimate differences of opinion.

    ORI’s own jurisdiction is narrower than institutions sometimes assume: it oversees the institution’s handling of an allegation and can make findings and impose administrative actions, but the initial inquiry and investigation remain the responsibility of the institution itself. This is why the phased guidance — on assessments, interviews, pursuing leads and the institutional record — matters so much: it is ORI’s interpretation of how institutions must run proceedings that ORI does not run directly.

    Common Questions on the Second-Phase Guidance

    What is ORI’s second phase of guidance documents?

    It is a set of topic-specific guidance PDFs — Honest Error, Admissions, Pursuing Leads, Sub-Awardee Assurances and Assessments — that ORI published starting 15 September 2025 to clarify how institutions must apply the 2024 Final Rule (42 CFR Part 93) during actual research-misconduct proceedings.

    What is the Office of Research Integrity’s jurisdiction?

    ORI oversees research-misconduct policy compliance and case findings at institutions receiving Public Health Service funding, including NIH research misconduct matters. Institutions conduct the actual inquiry and investigation; ORI reviews findings and can take administrative action.

    What counts as research misconduct according to federal regulations?

    Under 42 CFR Part 93, research misconduct means fabrication, falsification, or plagiarism in proposing, performing or reviewing research, or in reporting results. Honest error and genuine scientific disagreement are expressly excluded from the definition.

    When is the next ORI Annual Report due?

    Institutions submitted their updated assurance with the 2025 Annual Report by 30 April 2026. The next Annual Report, covering 2026 activity, is due 30 April 2027, giving institutions the remainder of 2026 to align policies with all released guidance.

    Implications for Research Integrity Offices

    For research integrity officers and research administration offices, the practical task has shifted from watching for new PDFs to closing the gap between assurance language and actual policy text. An assurance filed in April 2026 cannot have anticipated May 2026 guidance on State of Mind and Respondents; institutions that treat the assurance as a one-time filing, rather than a standing commitment to keep procedures current, risk a mismatch that surfaces during ORI compliance review.

    The rollout also has downstream implications beyond individual institutions: consistent application of Honest Error and State of Mind standards across hundreds of PHS-funded institutions should, over time, produce more comparable case outcomes and a clearer public record — a goal shared by research-integrity bodies and standards organisations working alongside CASRAI’s originated frameworks for research accountability. Institutions that update procedures methodically now, rather than waiting for the next assurance deadline, will be better positioned when ORI closes remaining cross-references in future releases.

  • Office of Research Integrity Jurisdiction: What It Covers and What It Doesn’t

    Office of Research Integrity jurisdiction is limited to research misconduct — fabrication, falsification, or plagiarism (FFP) — occurring in research funded, applied for, or otherwise supported by the US Public Health Service (PHS). ORI has no authority over non-PHS-funded research, no authority over federally funded research from other agencies such as the National Science Foundation, and no authority over conduct issues that fall outside the FFP definition, such as authorship disputes or data-management lapses. Institutions that treat ORI as a general research-ethics regulator routinely misroute allegations and miss the deadlines that actually apply.

    The Office of Research Integrity (ORI) is the unit within the US Department of Health and Human Services that oversees and directs PHS research integrity activity, operating under the regulatory authority of 42 CFR Part 93.

    ORI’s jurisdiction is not discretionary policy — it is set out in federal regulation. 42 CFR Part 93, the PHS Policies on Research Misconduct, defines the scope of ORI’s oversight and binds every institution that accepts PHS funding to specific reporting and inquiry obligations. ORI itself states plainly that it “has jurisdiction over a narrowly defined subset of activities that can occur in a research setting,” a limitation the agency emphasises precisely because institutions frequently assume otherwise.

    The regulation carves out one further exception within HHS itself: the Food and Drug Administration’s own regulatory research-integrity activities are excluded from ORI’s remit and handled separately. ORI’s authority, in other words, is bounded twice over — first by funding source, then by conduct type.

    Which research does ORI’s jurisdiction actually cover?

    ORI’s jurisdiction attaches to research connected to the Public Health Service, which includes the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, and other PHS agencies. Coverage is broader than a simple “funded by NIH” test.

    • Awarded PHS support — grants, cooperative agreements, and contracts funded by any PHS agency.
    • Pending applications — misconduct in an application for PHS funding falls within scope even if the award is never made or is later withdrawn.
    • Related infrastructure — PHS-supported tissue banks, data repositories, and dissemination of PHS-funded research results.
    • All personnel on the project — postdoctoral fellows, residents, students, technicians, and other staff working on PHS-supported research, not only the principal investigator.

    Institutions receiving PHS funds must maintain a standing “assurance” on file with ORI, committing them to the inquiry-then-investigation procedure the regulation requires before any finding reaches ORI’s own oversight review.

    What behaviours and cases fall outside ORI’s jurisdiction?

    ORI’s jurisdiction is confined to fabrication, falsification, and plagiarism (FFP) — it does not extend to research misconduct definitions institutions may apply internally for other misconduct behaviours. This distinction is where most misrouted allegations originate.

    • Honest error and scientific disagreement — 42 CFR Part 93 explicitly excludes good-faith mistakes and legitimate differences of interpretation from the misconduct definition.
    • Authorship disputes — disagreements over credit or contributor order are not FFP and sit outside ORI’s authority, even when raised alongside a misconduct complaint.
    • Civil or criminal fraud — matters properly regulated by civil or criminal statute are outside ORI’s jurisdiction; where ORI suspects such a violation it is required to refer the matter to the Department of Justice or the HHS Office of Inspector General rather than adjudicate it.
    • Non-PHS-funded research at the same institution — an institution can hold PHS funding for one project and non-federal funding for another; only the PHS-connected project is within ORI’s reach, even under a shared institutional policy.
    • Other conduct concerns — sexual harassment, financial conflicts of interest, data-management failures, and animal- or human-subjects protection breaches are governed by separate federal offices, not ORI.

    Where an institutional investigation mixes PHS and non-PHS issues, ORI’s own findings are confined strictly to the PHS-connected conduct; non-PHS material may inform an institution’s broader case but cannot form part of ORI’s official misconduct finding.

    Who has jurisdiction when ORI does not?

    A federal funding source other than PHS does not mean a misconduct allegation goes unregulated — it means a different federal office holds jurisdiction, each operating its own version of the government-wide 2000 Federal Policy on Research Misconduct issued by the White House Office of Science and Technology Policy (OSTP). The core FFP definition is shared across agencies; the enforcement office is not.

    Funding source / context Body with jurisdiction Governing framework
    PHS agencies (NIH, CDC, and others) Office of Research Integrity (ORI), HHS 42 CFR Part 93
    National Science Foundation grants NSF Office of Inspector General 45 CFR Part 689
    FDA-regulated research integrity matters FDA (separate from ORI) FDA regulatory authority
    Privately funded, non-federal research (US) No federal misconduct regulator Institutional policy only
    UK-based research (any funder) Institution, under UKRI grant terms; UKRIO advises UKRI Guidance for Research Organisations (April 2025); no statutory regulator

    The UK offers a useful contrast on the secondary keyword institutions often search alongside ORI’s scope. The UK Research Integrity Office is an independent charity, not a regulator: it offers advice and a model investigation procedure but cannot compel an institutional outcome or issue binding findings, unlike ORI’s statutory oversight-review power over PHS-connected cases.

    Answer-first: common questions on ORI’s jurisdiction

    What is the Office of Research Integrity’s jurisdiction?

    ORI’s jurisdiction covers fabrication, falsification, and plagiarism occurring in research funded, applied for, or otherwise supported by the Public Health Service. It does not cover non-PHS-funded research, non-FFP conduct, or civil and criminal fraud, which are referred to other federal bodies.

    What does the Office of Research Integrity do?

    ORI oversees and directs PHS research integrity activity on behalf of the HHS Secretary, conducts oversight review of institutional misconduct findings, maintains institutional assurances, and can refer confirmed PHS-connected findings to the HHS Departmental Appeals Board for administrative action.

    Does ORI actually investigate misconduct cases itself?

    No — under 42 CFR Part 93, the institution conducts the inquiry and investigation first. ORI’s role is oversight review of the institution’s process and findings, not first-instance fact-finding, except in limited circumstances such as PHS intramural research.

    Is NIH research misconduct the same as ORI jurisdiction?

    NIH research misconduct allegations fall within ORI’s jurisdiction because NIH is a PHS agency, so NIH-funded FFP cases follow the same 42 CFR Part 93 process as any other PHS-supported research, including the institutional assurance and inquiry requirements described above.

    What this means for institutions

    Research integrity officers who assume ORI will take every complaint create two predictable failure modes: misallocated urgency on cases ORI will never touch, and missed referrals to the office that actually has authority.

    • Confirm the funding source before assuming ORI applies. A single lab can run PHS and non-PHS projects side by side; the applicable regulator depends on the project, not the institution.
    • Screen for FFP before filing with ORI. Authorship, data-sharing, and conflict-of-interest complaints need an internal or funder-specific pathway, not an ORI referral.
    • Keep the institutional assurance current. ORI’s inquiry-then-investigation sequence only runs correctly if the institution’s own procedure matches 42 CFR Part 93’s requirements.
    • Escalate suspected fraud separately. Civil or criminal fraud indicators should go to the HHS Office of Inspector General or the Department of Justice in parallel with, not instead of, any ORI-connected process.

    As with contributor-role standards — where CASRAI originated the CRediT taxonomy in 2014 and the standard is now stewarded by NISO as ANSI/NISO Z39.104-2022 — research integrity oversight is a reminder that adjacent bodies rarely share jurisdiction by default. The practical safeguard is the same in both cases: verify which body actually holds authority over the specific case in front of you before assuming coverage.