CASRAI Dictionary

Tag: 42 CFR Part 93

  • Duke Research Misconduct Policy vs MIT, Stanford

    Duke, MIT and Stanford each operationalise the same federal research-misconduct standard through different institutional machinery. Duke routes allegations to a Misconduct Review Officer and a 24-hour Integrity Line; MIT centralises review under its Vice President for Research; Stanford assigns first-line assessment to school deans under a Research Policy Handbook chapter revised effective 1 January 2026. All three exist to satisfy one governing rule: the Public Health Service Policy on Research Misconduct.

    The federal policy on research misconduct — codified at 42 C.F.R. Part 93 and enforced by the HHS Office of Research Integrity (ORI) — defines research misconduct as fabrication, falsification, or plagiarism (FFP) in proposing, performing, or reviewing research, or in reporting research results. Every US university that accepts Public Health Service funding, including Duke, MIT and Stanford, must maintain an institutional policy that meets this baseline, then layers its own governance, reporting channels, and disciplinary structure on top.

    How does Duke’s research misconduct policy define and handle allegations?

    Duke’s research misconduct policy is set out in the Duke University Policy and Procedures Governing Misconduct in Research, part of the Faculty Handbook and last updated in May 2023. Allegations are directed to a designated Misconduct Review Officer (MRO), or to a department chair, division chief, or dean, who must promptly forward the matter to the MRO.

    Duke also operates an Integrity Line — a 24-hour, anonymous telephone hotline (1-800-826-8109) — so that reporters can raise concerns without disclosing their identity. This dual-channel design (a named institutional officer plus an anonymous hotline) reflects a broader reform effort: Duke’s policy was revised to extend coverage beyond faculty to research staff, alongside wider research-integrity reforms following a 2019 case in which the university agreed to a $112.5 million False Claims Act settlement over fabricated data in federally funded pulmonary research, as reported by Science. That episode is a documented driver of the university folding staff explicitly into the policy’s scope, according to case-study materials prepared for the Council on Governmental Relations (COGR).

    How does MIT structure its research misconduct procedures?

    MIT’s framework sits in MIT Policies and Procedures §10.1, “Procedures for Dealing with Misconduct in Research and Scholarship,” last updated 10 December 2025. Oversight is centralised: every allegation, wherever it is first raised, must be conveyed promptly to the Vice President for Research (VPR), MIT’s designated Research Integrity Officer.

    MIT’s definition tracks the federal FFP triad — fabrication (making up data), falsification (manipulating materials or altering results), and plagiarism (appropriating another’s ideas or words without credit) — but adds a fourth category not found in the core PHS definition: deliberate interference, meaning intentionally causing material harm to another’s research, such as damaging equipment or deleting data. MIT’s policy also explicitly excludes self-plagiarism (text recycling) and authorship or credit disputes among former collaborators from the definition of misconduct, mirroring longstanding ORI guidance on plagiarism.

    What changed in Stanford’s research misconduct policy for 2026?

    Stanford’s governing chapter, Research Policy Handbook (RPH) 1.7, “Research Misconduct: Policy on Allegations, Investigations, and Reporting,” dates originally to 3 February 1983 but carries a current version effective 1 January 2026. The update aligns Stanford’s procedures with the 2024 Final Rule amending 42 C.F.R. Part 93 — the same federal regulation that governs Duke and MIT.

    Two provisions distinguish Stanford’s approach. First, the “Six-Year Rule” (42 C.F.R. §93.104): research misconduct allegations are only actionable if the conduct occurred within six years of the date Stanford or a federal agency received the allegation, subject to a “subsequent use” exception (if the respondent later cited or republished the disputed material) and a “public health and safety” exception. Second, first-line responsibility sits with the school dean, who must assess an allegation and, if it meets the definition, immediately open an inquiry and notify the Dean of Research — a more devolved structure than MIT’s single VPR intake point.

    How do Duke, MIT and Stanford compare side by side?

    The table below sets the three institutional policies against each other and against the federal baseline they all must satisfy.

    Institution Governing document First-line authority Reporting channel Misconduct definition
    Duke University Policy and Procedures Governing Misconduct in Research (Faculty Handbook, updated May 2023) Misconduct Review Officer MRO, department chair/dean, or anonymous Integrity Line FFP, per 42 C.F.R. Part 93; covers faculty and staff
    MIT MIT Policies and Procedures §10.1 (updated 10 Dec 2025) Vice President for Research Report to VPR, typically via supervisor or department head FFP plus deliberate interference; excludes self-plagiarism and authorship disputes
    Stanford University Research Policy Handbook 1.7 (current version 1 Jan 2026; original 1983) School dean, then Dean of Research Report to school dean for initial assessment FFP per 42 C.F.R. Part 93 (2024 Final Rule); six-year time limitation
    Federal baseline PHS Policy on Research Misconduct, 42 C.F.R. Part 93 HHS Office of Research Integrity (ORI) Institutional report to ORI after a finding Fabrication, falsification, or plagiarism (FFP)

    All three institutions converge on the same two-stage process required by federal policy:

    • An inquiry — a preliminary assessment of whether an allegation has substance and warrants formal review.
    • An investigation — a full evidentiary examination that produces findings reported to ORI when federal funding is involved.

    Common questions on federal and institutional research misconduct policy

    What is the US federal research misconduct policy?

    The US federal research misconduct policy is the Public Health Service Policy on Research Misconduct, codified at 42 C.F.R. Part 93 and enforced by ORI. It applies to fabrication, falsification, and plagiarism in proposing, performing, reviewing, or reporting PHS-supported research, and requires every recipient institution to maintain a compliant local policy.

    What is 42 CFR Part 93 research misconduct?

    42 C.F.R. Part 93 is the federal regulation setting the definitions, procedural standards, and reporting obligations that PHS-funded institutions — including Duke, MIT, and Stanford — must follow. A 2024 Final Rule to Part 93 took effect on 1 January 2026, updating provisions including the definition of plagiarism that institutions must now apply.

    What are the three types of research misconduct?

    The three federally recognised types are fabrication (inventing data or results), falsification (manipulating materials, equipment, or data so the research record is inaccurate), and plagiarism (using another’s ideas, processes, or words without credit). Honest error and legitimate differences of scientific opinion are explicitly excluded.

    What constitutes research misconduct according to federal regulations?

    A federal finding requires three elements together: a significant departure from accepted research practices, conduct committed intentionally, knowingly, or recklessly, and an allegation proven by a preponderance of the evidence. All three tests must be met before ORI or an institution can record a formal finding of misconduct.

    What this means for research administrators

    For research administrators, compliance officers, and institutional leaders, the practical lesson is that federal alignment does not mean procedural uniformity. Duke, MIT, and Stanford each satisfy 42 C.F.R. Part 93, yet route allegations through different first-line authorities — an MRO, a VPR, and a school dean respectively — and set different scope boundaries around staff coverage, deliberate interference, and time limitations. Institutions benchmarking their own research administration policy against peer practice should treat the federal rule as the floor, not the template, and expect further local revisions as the 2024 Final Rule to Part 93 continues to work through university policy cycles into 2026 and beyond.

    Given that Stanford’s update took effect only this year and MIT revised its procedures in December 2025, institutional research misconduct policies are clearly still catching up to the federal 2024 Final Rule — administrators reviewing their own institution’s policy should confirm which version of 42 C.F.R. Part 93 it currently cites before assuming compliance.

  • Research Misconduct Federal Funding: Grant Risk

    When an allegation of research misconduct is opened against a federally funded project, the grant does not simply continue as normal. The funding agency can defer draw-downs, restrict how funds are spent, or suspend the award outright, while the awardee institution — not the agency — conducts the inquiry and investigation under research misconduct federal funding rules that require prompt notification, safeguarding of funds, and, if misconduct is confirmed, cost recovery or debarment.

    Research misconduct is fabrication, falsification, or plagiarism in proposing, performing, or reviewing federally funded research, or in reporting its results — a definition set by the Office of Science and Technology Policy’s 2000 Federal Policy on Research Misconduct (65 Fed. Reg. 76,260) and applied by every major federal research funder.

    What Is Research Misconduct Under Federal Policy?

    Federal research misconduct policy applies a single, government-wide standard: fabrication, falsification, or plagiarism (FFP) committed in proposing, performing, or reviewing federally funded research, or in reporting its results. Under the OSTP Federal Policy on Research Misconduct, a finding requires proof that the conduct represents “a significant departure from accepted practices,” was committed “intentionally, or knowingly, or recklessly,” and is established “by a preponderance of the evidence” — a civil, not criminal, standard.

    Honest error and legitimate differences of scientific opinion are explicitly excluded. The policy also does not cover authorship disputes, harassment, or general grant-management violations, which fall under separate institutional or agency processes.

    • Fabrication — making up data or results and recording or reporting them.
    • Falsification — manipulating materials, equipment, or data so the research record is not accurately represented.
    • Plagiarism — appropriating another person’s ideas, processes, results, or words without credit.

    What Happens to Grant Funds During an Investigation?

    A grant under a misconduct inquiry does not automatically stop, but the funding agency retains authority to take interim administrative actions to protect federal funds while the institution investigates. These typically include deferring decisions on continued funding, restricting the purposes for which existing funds may be spent, requiring special award certifications, or — where the risk is severe — suspending the active award pending outcome.

    Responsibility for the investigation sits primarily with the recipient institution, not the funder. Under Public Health Service (PHS) rules governing NIH-funded research (42 CFR Part 93), and the parallel National Science Foundation framework (45 CFR Part 689), the institution runs its own inquiry and investigation while the agency monitors, can intervene, and controls the purse strings throughout.

    Investigation stage Typical fund status Who acts
    Institutional assessment / inquiry Funds usually continue; agency may be informed Research Integrity Officer (RIO)
    Formal investigation opened Agency may defer, restrict, or condition funding Institution investigates; ORI or NSF OIG notified
    Investigation concluded, misconduct found Suspension, termination, or debarment possible Agency Inspector General / Deciding Official

    Who Must Notify the Funding Agency, and When?

    Every institution receiving PHS or NSF funding is required, as a condition of its funding assurance, to notify the relevant federal office once a formal investigation is opened. For NIH and other Public Health Service awards, that notice goes to HHS’s Office of Research Integrity (ORI); for NSF awards, it goes to the NSF Office of Inspector General (OIG).

    Notification cannot wait for the case to close. If the institution determines during an inquiry or investigation that public health or safety is at risk, that federal interests or resources are threatened, that research activities should be suspended, or that there is a reasonable indication of a possible civil or criminal law violation, it must notify the agency immediately — not at the standard reporting milestones.

    • Immediate notice — health/safety risk, threat to federal resources, or suspected civil/criminal violation.
    • Formal notice at investigation opening — required under the institution’s PHS or NSF assurance.
    • Closing report — the full institutional record, transmitted to ORI or NSF OIG after a final misconduct determination and any institutional appeal.

    What Are the Consequences If Misconduct Is Confirmed?

    If an investigation substantiates research misconduct, the funding agency can impose administrative sanctions independent of, and in addition to, any action the institution itself takes. Under ORI’s guidance on federal policy, “the Federal Government can debar researchers who commit misconduct from receiving Federal funds for a specified period of time,” and institutions commonly pursue their own parallel actions such as termination of employment or mandated supervision of future work.

    Available federal administrative actions include:

    • Correction of the published research record and retraction of affected papers.
    • Letters of reprimand or special certification requirements on future awards.
    • Suspension or termination of the active award, with recovery of misspent federal funds.
    • Suspension or debarment from federal funding, published on the General Services Administration’s SAM.gov exclusions list.
    • Referral to the Department of Justice where civil or criminal fraud is suspected.

    Cost recovery is a distinct lever from debarment: an institution can be required to repay funds tied to fabricated or falsified data even where an individual researcher, not the institution, is the primary respondent.

    How Does the 2024 Final Rule Change the Process?

    The compliance landscape shifted materially with HHS’s Final Rule updating 42 CFR Part 93, published in the Federal Register on 17 September 2024 and formally titled “Public Health Service Policies on Research Misconduct.” The rule took effect 1 January 2025, but institutions were required to apply its new procedural requirements to any allegation received on or after 1 January 2026, with updated institutional policies due to ORI no later than the annual report covering 2025 (filed by 30 April 2026).

    The Final Rule extends two of the timelines research administrators rely on most:

    • Inquiry period: extended from 60 days under the 2005 regulation to 90 days.
    • Investigation period: extended from 120 days under the 2005 regulation to 180 days.

    It also formalises a new pre-inquiry “institutional assessment” stage (§93.306), in which the Research Integrity Officer must document whether an allegation falls within the misconduct definition and PHS jurisdiction before an inquiry is opened — with no fixed time limit for this new stage. The rule further clarifies confidentiality obligations, allowing institutions to disclose respondent identities to journals, co-authors, and collaborating institutions where there is a legitimate need to know, and expands provisions covering multiple respondents and multi-institution proceedings.

    Frequently Asked Questions

    Does the Funding Agency Investigate Misconduct Directly, or Does the Institution?

    The institution conducts the initial inquiry and investigation, not the federal funding agency. Agencies such as ORI or the NSF OIG monitor the case, can intervene if the institution is unable or unwilling to act, and retain authority over the grant throughout.

    What Standard of Proof Applies to a Misconduct Finding?

    A finding requires proof “by a preponderance of the evidence” — more likely than not — not the criminal “beyond a reasonable doubt” standard. The conduct must also be shown to have been committed intentionally, knowingly, or recklessly, and to represent a significant departure from accepted research practice.

    What Is the First Phase of a Research Misconduct Response?

    The process begins with an institutional assessment or inquiry — a preliminary review to decide whether an allegation has enough substance to warrant a full investigation. Under the 2024 Final Rule, this assessment stage is now formally documented before any inquiry clock starts running.

    To Whom Does the Federal Research Misconduct Policy Apply?

    The policy applies to anyone proposing, performing, or reviewing federally funded research — including applicants, grant recipients, subrecipients, project participants, and peer reviewers — at any institution receiving Public Health Service or comparable federal research funding.

    Implications for Research Administrators

    The practical exposure is threefold: a live award can be frozen or restricted mid-project, cost recovery can claw back funds already spent, and delayed or incomplete notification to the funder is a compliance failure in its own right, separate from the underlying allegation. Research integrity offices should treat the 2026 compliance deadline as a trigger to audit their policies against the extended 90/180-day timelines and the new institutional-assessment stage — a policy still reflecting the 2005 regulation’s 60/120-day clock no longer matches what ORI expects in an institutional record.

    The Final Rule’s added reporting elements — sequestration inventories, interview transcripts, and multi-institution coordination — point toward longer, more paperwork-intensive proceedings even as deadlines extend. For anyone administering federally funded research, what happens to the grant while a case runs is as important as the underlying definition of misconduct itself.

  • ORI Research Misconduct Case Summaries Database: What It Publishes and Removes

    The ORI Case Summaries database is the U.S. Office of Research Integrity’s public register of confirmed research misconduct findings involving Public Health Service-funded research. Each entry names the respondent, describes the fabrication, falsification, or plagiarism found, and lists the administrative sanctions imposed — but, unlike a permanent archive, a case is removed from the live list once its sanction period expires.

    The ORI research misconduct case summaries register is the closest thing the U.S. federal research-integrity system has to a public “misconduct docket.” For research administrators, publishers, and compliance officers, understanding exactly what it discloses — and, just as importantly, what it stops disclosing over time — is essential to using it correctly as a due-diligence tool.

    The Office of Research Integrity (ORI) is the HHS component that oversees research integrity for Public Health Service-supported research, a remit that in practice covers the great majority of federally funded biomedical science, including nearly all NIH-funded work.

    What is the ORI Case Summaries database?

    The ORI Case Summaries database is a page maintained at ori.hhs.gov listing individuals against whom ORI has made a formal finding of research misconduct and imposed an administrative action. It is not a docket of allegations or open investigations — a case only appears once an inquiry and full investigation have concluded and ORI has accepted the finding.

    Research misconduct itself is narrowly defined under 42 CFR Part 93 as fabrication, falsification, or plagiarism (FFP) in proposing, performing, or reviewing research, or in reporting research results. Disputes about interpretation, authorship credit, or research design are explicitly excluded from this definition, which is why the register is narrower than the broader universe of retracted papers.

    ORI itself, established in 1992 within HHS, does not conduct most investigations directly. Institutions receiving PHS funds are required to investigate allegations under their own procedures and report outcomes to ORI, which then reviews the institutional finding before a case summary is published.

    What information is disclosed in each case summary?

    Each published case summary follows a broadly consistent disclosure pattern, even though length and detail vary case by case. This consistency is what makes the register usable as a structured compliance-checking resource rather than a set of one-off press notices.

    • Respondent identity — the named individual found to have committed misconduct, plus their institution at the time of the conduct.
    • Nature of the misconduct — which category of fabrication, falsification, or plagiarism was found, and in what context (grant application, published paper, data submitted to PHS).
    • Affected research — the specific publications, images, datasets, or grant materials implicated, often naming the journal or funding mechanism.
    • Administrative actions — the sanctions ORI imposed, which can include debarment from receiving federal funds, exclusion from PHS advisory or peer-review service, and supervision or certification requirements for any future PHS-supported research.
    • Corrective steps — where applicable, a note that the respondent must request retraction or correction of the affected literature.

    What the summaries generally do not disclose is the full institutional investigation report, interview transcripts, or the raw evidentiary record — those remain with the institution and are only obtainable, if at all, through a separate public-records request.

    How long do case summaries stay public?

    This is the detail most guidance on the ORI register omits, and it materially changes how the database should be used. ORI’s own case summary page states that the list only includes respondents who currently have an administrative action in effect — once a debarment, supervision period, or certification requirement expires, the case summary is removed from the live online list.

    In practice, this means the ori.hhs.gov register functions as an active-sanctions list, not a permanent misconduct archive. A researcher sanctioned for three years in 2020 will typically no longer appear on the current page by 2026, even though the underlying finding was never reversed. Older findings persist instead in ORI’s historical newsletters and in contemporaneous Federal Register and NIH Guide for Grants and Contracts notices, which are not removed once published.

    For anyone conducting due diligence — a journal editor vetting a submission, a hiring institution, or a funder — checking the live case summaries page alone is not sufficient to establish that a researcher has a clean misconduct history; the historical notice archive must also be checked.

    How does it compare with other misconduct registers?

    Research administrators often conflate the ORI register with other misconduct- and retraction-tracking resources. They serve different purposes and, critically, have very different persistence rules.

    Register Scope Named respondent? Persistence
    ORI Case Summaries (ori.hhs.gov) PHS/NIH-funded research with a confirmed misconduct finding and an active sanction Yes Removed once the sanction period expires
    ORI historical notices (NIH Guide / Federal Register) Same findings, at time of original publication Yes Permanent archival record
    Retraction Watch Database Retracted or corrected papers from any funder, any cause (misconduct, error, or dispute) Sometimes, via linked retraction notice Permanent
    Institutional investigation reports Single institution, single case Varies by institution’s public-records policy Retained per institutional records policy, rarely public by default

    The practical takeaway: the ORI register and the Retraction Watch Database answer different questions. ORI tells you whether someone is currently under federal sanction; Retraction Watch tells you whether a specific paper has been retracted or corrected, regardless of whether any individual was ever sanctioned by ORI.

    Common questions about ORI case summaries

    Are researchers named in ORI case summaries?

    Yes. Once ORI has finalised a finding of research misconduct and imposed an administrative action, the respondent’s name and affiliated institution are published in the case summary. This differs from the confidentiality that generally applies while an inquiry or investigation is still open and unresolved.

    What happens to a case summary once the sanction ends?

    The entry is removed from the live online list at ori.hhs.gov once the administrative action — debarment, supervision, or certification requirement — expires. The finding itself is not reversed; it persists instead in ORI’s historical newsletters and Federal Register notices, which remain permanently accessible.

    Where else are ORI misconduct findings published besides the website?

    Beyond the case summaries page, ORI findings have historically been announced through the NIH Guide for Grants and Contracts, the ORI Newsletter, and Federal Register notices. These channels provide an archival record that outlasts the rolling, sanctions-only website list.

    What this means for research administrators and publishers

    For institutional research integrity officers, the practical implication is clear: the ORI Case Summaries page is a screening tool for active sanctions, not a comprehensive misconduct history check. A clean search result today does not confirm a researcher has never been found to have committed misconduct — only that no sanction is currently in force.

    A 2024 modernisation of the underlying regulations at 42 CFR Part 93, with a 1 January 2026 effective date, updated investigation and reporting procedures between institutions and ORI, but did not change this fundamental “currently sanctioned” design of the public case summary list. Institutions building author-vetting, hiring, or peer-reviewer-screening workflows should pair a live ORI search with a check of ORI’s historical notice archive and, where the concern involves a specific publication, the Retraction Watch Database.

    As research-integrity oversight continues to modernise, the case for a permanent, jointly maintained misconduct record — rather than a rolling active-sanctions list — is likely to grow, particularly as funders and publishers increasingly expect due diligence to extend beyond an individual’s current sanction status.

    For related definitions and standards context, see the CASRAI Dictionary and the broader research administration resource hub.

  • Research Misconduct Policy: Lehigh’s 2026 Update Sets the Pace for Peer Institutions

    A research misconduct policy is the institutional and federal framework that defines fabrication, falsification, and plagiarism (FFP) in research, and sets out how allegations are reported, investigated, and adjudicated. Lehigh University’s new research misconduct policy took effect on 1 January 2026, and it is not an isolated update: dozens of US research universities revised their policies for the same date, all responding to the first substantial rewrite of the federal research misconduct rule in two decades.

    Research misconduct policy in the United States is not institutional discretion. Any university receiving Public Health Service (PHS) funding — the great majority of federally funded research institutions — must maintain a policy satisfying 42 CFR Part 93, administered by the HHS Office of Research Integrity (ORI). When that regulation changes, every covered institution’s policy changes with it. That happened in 2024, and 1 January 2026 is when the consequences arrived on campus.

    What does Lehigh’s new research misconduct policy change?

    Lehigh’s Office of Research Integrity finalised its revised policy on 19 December 2025, in a notice from Naomi E. Coll, Director of Research Policy and Compliance, confirming that the policy would take effect on 1 January 2026. The document sets out how the university assesses, inquires into, and investigates allegations of research misconduct against academic, scientific, and professional staff, students, and contractors, regardless of funding source.

    What distinguishes Lehigh’s process is its provenance rather than its content: the policy was drafted by a faculty working group with one representative from each college, presented to the Faculty Senate in November 2025, and opened to a university-wide online public comment period before finalisation. That sequence — draft, Senate review, public comment, publication — is now a template other institutions are following as they race the same federal deadline.

    What is the federal research misconduct policy institutions must follow?

    The federal research misconduct policy originates with the Office of Science and Technology Policy’s 2000 Federal Policy on Research Misconduct and is codified for PHS-funded research at 42 CFR Part 93. It defines research misconduct as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results — honest error and honest differences of opinion are explicitly excluded.

    A formal finding requires three elements together: a significant departure from accepted practices of the relevant research community, conduct that was intentional, knowing, or reckless, and proof by a preponderance of the evidence. Non-PHS agencies apply parallel rules — the National Science Foundation administers its own version at 45 CFR Part 689 — so multi-funder institutions must reconcile more than one regulatory text in a single policy.

    What changed in the 2024 ORI Final Rule (42 CFR Part 93)?

    ORI published its final rule in the Federal Register on 17 September 2024 — the first substantive revision to the 2005 regulation. The rule became legally effective on 1 January 2025, but institutions only had to apply it to allegations received on or after 1 January 2026, which is why the current wave of policy rewrites is landing now rather than a year ago.

    • Defined intent standard: “Intentionally,” “knowingly,” and “recklessly” — previously undefined terms central to any finding — now carry fixed regulatory definitions.
    • New “institutional record” definition: the rule specifies, for the first time, exactly which documents (inquiry and investigation reports, sequestered evidence indexes, appeal records) must be compiled and preserved.
    • Seven-year retention rule: institutions must secure the institutional record and all sequestered evidence for seven years after the proceeding — or any related HHS proceeding — concludes, whichever is later.
    • Longer inquiry window: the initial inquiry phase is extended from 60 to 90 days, giving Research Integrity Officers more time before deciding whether a full investigation is warranted.

    ORI has confirmed it will not require institutions to submit revised policies until the annual report covering 2025 is filed, due by 30 April 2026 — but the policies themselves, and the procedures behind them, must already be in force for any allegation received from 1 January 2026 onward.

    Which other universities are revising policies for 2026?

    Lehigh is one of a cohort. Institutional policy pages and faculty handbooks show a cluster of revisions timed to the same compliance date, though each institution has followed its own governance path to get there.

    Institution Policy action Date Notes
    Lehigh University New research misconduct policy finalised Effective 1 Jan 2026 Faculty working group, Senate review, public comment
    Columbia University Revised policy approved by University Senate Approved 12 Dec 2025; effective 1 Jan 2026 Realigns definitions with the PHS Final Rule
    Auburn University Policy on Research Misconduct republished 21 Nov 2025 Updated allegation-resolution framework
    Ohio State University Research Misconduct policy revised March 2025 Among the earliest movers ahead of the deadline
    Wayne State University Interim Research Misconduct Policy (26-01) Interim, 2025–26 cycle Document numbering signals the 2026 compliance cycle
    Duke University Misconduct in Research policy (established) Bound to 42 CFR Part 93 / 45 CFR Part 689 Long-cited model policy; must reflect the revised rule by the deadline

    The pattern is consistent: governance bodies — Faculty Senate, University Senate, or equivalent — are being used explicitly to legitimise the revision, not just administrative sign-off. That marks a shift from prior cycles, where research misconduct policy updates were typically handled as compliance housekeeping rather than faculty-governance business.

    Common questions on research misconduct policy

    What are the three forms of research misconduct under US federal policy?

    US federal policy recognises three forms of research misconduct: fabrication (making up data or results), falsification (manipulating materials, equipment, or data so the research record is inaccurate), and plagiarism (appropriating another person’s ideas, processes, results, or words without credit). This “FFP” definition has applied since the 2000 OSTP policy and is unchanged by the 2026 rule.

    What is considered research misconduct in the US?

    Conduct only counts as research misconduct if it is a significant departure from accepted practices of the relevant research community, committed intentionally, knowingly, or recklessly, and proven by a preponderance of the evidence. Honest error, differences of scientific opinion, and most authorship disputes are explicitly excluded from the definition.

    What is 42 CFR Part 93?

    42 CFR Part 93 is the codified federal regulation — the Public Health Service Policies on Research Misconduct — that sets binding rules for how PHS-funded institutions must respond to allegations. Its 2024 revision, effective for allegations from 1 January 2026, is the first major overhaul since 2005 and drives the current round of university policy rewrites.

    What does the federal research misconduct policy cover?

    The federal research misconduct policy covers federally funded research and funding proposals across all fields — including medicine, social sciences, engineering, and statistics — conducted at universities, federal laboratories, and other funded research institutions. It governs the inquiry, investigation, and adjudication phases but does not supersede separate rules on human-subjects protection, animal welfare, or financial conflicts of interest.

    What this means for research administrators

    The consequences of research misconduct under the federal framework range from correction of the research record and letters of reprimand to suspension of funding, debarment from future federal awards, and referral for civil or criminal fraud proceedings. For research administrators, the sharper immediate risk is procedural: if an institution’s inquiry, evidentiary, or retention procedures do not match the 2026 rule, findings made under a defective process are vulnerable on appeal.

    Three takeaways follow. First, Research Integrity Officers should confirm their policy explicitly defines “intentionally,” “knowingly,” and “recklessly” in the regulatory terms now fixed by the final rule, rather than leaving them undefined as most pre-2026 policies did. Second, retention schedules need extending to the mandated seven years and mapped against the newly defined “institutional record.” Third, institutions routing revisions through faculty governance — as Lehigh, Columbia, and Auburn have done — are building a stronger due-process record that may matter if a finding is later contested.

    The compliance clock does not stop at 1 January. ORI’s own review of revised policies, via the annual report covering 2025, falls due on 30 April 2026 — a second checkpoint on which institutions treated this as a genuine revision to research administration practice, and which merely updated a document to survive it.

  • Federal Research Misconduct Policy: 42 CFR Part 93 Baseline

    The federal research misconduct policy is a uniform definition of fabrication, falsification, and plagiarism (FFP) that the Office of Science and Technology Policy set in 2000, which federal funding agencies implement through their own regulations — most consequentially, for the health sciences, via 42 CFR Part 93. That regulation sets a compliance floor; institutional policies at universities such as Duke and Lehigh sit on top of it, and in places go further than it requires.

    Federal research misconduct policy is not a single statute. It is the 2000 Office of Science and Technology Policy (OSTP) statement of principles, translated agency-by-agency into binding regulation — 42 CFR Part 93 for the Public Health Service, 45 CFR Part 689 for NSF, and comparable rules at NASA, DOD, USDA and EPA. This article explains the federal baseline, the 2024 final rule that reshaped 42 CFR Part 93 from 1 January 2026, and how far real institutional policies diverge from — or exceed — that floor.

    What is the federal research misconduct policy?

    The Federal Policy on Research Misconduct was finalised by OSTP and published in the Federal Register on 6 December 2000 (65 FR 76260), following a National Science and Technology Council (NSTC) initiative begun in 1996. It applies to research funded by, conducted by, or proposed to federal agencies, and it exists to give every agency a shared definition so that a finding at one institution means the same thing across the federal system.

    The policy defines research misconduct as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. It explicitly excludes honest error and honest differences of opinion. A finding requires all three of the following elements:

    • A significant departure from accepted practices of the relevant research community;
    • The conduct was committed intentionally, knowingly, or recklessly; and
    • The allegation is proven by a preponderance of the evidence — the same civil standard used in most federal administrative proceedings, not the higher “clear and convincing” bar.

    OSTP’s policy does not itself create rights or obligations. It only takes legal effect once each funding agency implements it through regulation or administrative mechanism, which is why the practical compliance burden for most US research institutions runs through agency-specific rules rather than the OSTP text itself.

    What does 42 CFR Part 93 require of institutions?

    42 CFR Part 93 is the Public Health Service’s codification of the federal policy, administered by the HHS Office of Research Integrity (ORI). It governs misconduct allegations involving PHS support — chiefly NIH, CDC, FDA and AHRQ funding — and is the regulation most research-intensive US universities build their institutional policy around, since it covers the largest share of federally sponsored biomedical and behavioural research.

    Under 42 CFR Part 93, PHS-funded institutions must maintain written procedures and carry out three organisationally separated phases when an allegation surfaces:

    1. Inquiry — an initial assessment of whether the allegation has substance and warrants a full investigation.
    2. Investigation — formal development of a factual record, leading to a recommended finding.
    3. Adjudication — a separate institutional official reviews the investigation record and recommendation and decides on findings and corrective action, with any appeal handled independently of the inquiry and investigation stages.

    Institutions must notify ORI when an inquiry proceeds to investigation and forward the full evidentiary record, investigative report, and the subject’s written response on completion. ORI can then impose administrative actions — including debarment listed on the GSA’s List of Parties Excluded from Federal Procurement and Nonprocurement Programs — independent of any institutional employment action.

    What changed under the rule taking effect in 2026?

    HHS finalised amendments to 42 CFR Part 93 in 2024, and institutional compliance became mandatory from 1 January 2026 — the most consequential revision since the regulation was first adopted in 2005. PHS-funded institutions had to update written policies, notification procedures, and recordkeeping to match the amended rule by that date.

    Because that deadline has only just passed, institutions are in an early implementation window: some have already published revised policy text referencing the amended regulation by name, while others are still finalising internal approval. Research administrators reviewing an institutional policy today should check its printed effective date rather than assume it reflects the amended rule by default.

    How do institutional policies compare: Duke, Lehigh and beyond?

    42 CFR Part 93 sets a floor, not a ceiling. Institutions retain — and routinely exercise — authority to adopt policies broader in scope or more explicit in remedy than the federal minimum requires. Two cases show the range:

    • Duke University revised its Policy and Procedures Governing Misconduct in Research to track the amended 42 CFR Part 93 for the January 2026 compliance date, retaining the federal FFP definition and the inquiry–investigation–adjudication structure while specifying Duke-level committee composition and timelines the federal rule leaves to institutional discretion.
    • Lehigh University applies its research misconduct policy to all research activity conducted at the university, regardless of funding source — a materially broader scope than 42 CFR Part 93, which by statute only reaches PHS-supported work. Lehigh’s policy also commits explicitly to restoring the reputation of respondents investigated but not found to have committed misconduct, a safeguard the federal text encourages generally but does not mandate.

    This divergence is structural, not accidental. Different sponsors administer separate, non-identical regulations — 45 CFR Part 689 (NSF), 14 CFR Part 1275 (NASA), DOD Instruction 3210.7, USDA’s 2 CFR Part 422, EPA Order 3120.5, ONR Instruction 5041.2B, alongside 42 CFR Part 93 (PHS). A university with grants from several agencies has an incentive to write one all-funder policy meeting the strictest applicable standard, rather than run separate tracks — the consolidation behind policies like Lehigh’s.

    Dimension 42 CFR Part 93 (federal floor) Typical institutional policy
    Scope of covered research PHS-supported research only Often all institutional research, any funder (e.g. Lehigh)
    Standard of proof Preponderance of evidence (mandatory floor) May apply the same or a higher internal standard, but must still report to the agency at preponderance
    Phases Inquiry, investigation, adjudication Same phases, often with added pre-inquiry assessment step
    Reputational remedy for cleared respondents Encouraged in principle Sometimes made an explicit, named commitment (e.g. Lehigh)
    Agency notification Mandatory to ORI at defined trigger points Same, plus internal governance and public-records handling

    For research administrators managing multi-sponsor portfolios, the task is not choosing between federal and institutional rules — it is writing an institutional policy broad enough to satisfy the strictest applicable federal regulation while staying consistent for cases with no federal funding at all.

    Answer-first Q&A on federal research misconduct policy

    What is the federal policy for research misconduct?

    It is the 2000 OSTP-issued definition of fabrication, falsification, and plagiarism, adopted uniformly across federal research agencies and then implemented through agency-specific regulations. For Public Health Service-funded work, that implementation is 42 CFR Part 93, administered by HHS’s Office of Research Integrity.

    What constitutes research misconduct according to federal regulations?

    Research misconduct requires all three of: a significant departure from accepted research-community practice, conduct that was intentional, knowing, or reckless, and proof by a preponderance of the evidence. Honest error and genuine differences of scientific opinion are explicitly excluded from the definition.

    What are the three types of research misconduct?

    Federal policy recognises three forms, commonly abbreviated FFP: fabrication (making up data or results), falsification (manipulating materials or altering results so the record is inaccurate), and plagiarism (using another person’s ideas, results, or words without appropriate credit).

    What does fabrication involve according to the US federal research misconduct policy?

    Fabrication is defined as making up data or results and recording or reporting them as if genuinely obtained — distinct from falsification, which alters or omits real data, and plagiarism, which misattributes another researcher’s genuine work. Inquiry committees must identify which category an allegation falls into before an investigation can proceed.

    Where federal rules end and institutional policy begins also matters for adjacent governance questions, including authorship disputes, which the federal policy excludes from its scope unless plagiarism is involved, leaving institutions to set their own authorship-dispute procedures separately from misconduct proceedings.

    Institutions that have not yet formally re-issued their policy against the amended 42 CFR Part 93 text should treat the 1 January 2026 compliance date as already binding, not upcoming, and audit committee composition, notification templates and recordkeeping against the amended rule rather than the pre-2024 version still circulating in older policy PDFs.

  • ORI Research Misconduct Policy: 2026 Annual Assurance Renewal Explained

    The ORI research misconduct policy that governs Public Health Service (PHS)-funded research changed materially for 2026, and the annual paperwork cycle that keeps an institution’s assurance active has not paused to accommodate the transition. Every institution that holds a PHS assurance under 42 CFR Part 93 — whether or not it has an open case — must file its Annual Report on Possible Research Misconduct between 1 January and 30 April 2026, and for the first time that filing sits alongside a revised regulatory framework institutions are expected to have already adopted.

    This is a mechanics piece, not a restatement of the Final Rule’s substance. It sets out exactly what the U.S. Department of Health and Human Services’ Office of Research Integrity (ORI) expects institutions to submit for the 2026 assurance renewal cycle, which form to use, and where the transition from the 2005 regulation creates procedural traps for research integrity officers (RIOs) and sponsored-programs staff.

    What changed: the Final Rule and the 2026 effective date

    ORI’s revised Public Health Service Policies on Research Misconduct — published in the Federal Register on 17 September 2024 and codified at 42 CFR Part 93 — took effect on 1 January 2026. It is the first substantive rewrite of the misconduct regulation since 2005, and it introduces more than twenty-five newly defined terms, including “institutional record,” “administrative record,” “intentionally,” and “recklessly,” aimed at tightening consistency across institutional proceedings.

    The core three-part definition of research misconduct is unchanged: fabrication, falsification, or plagiarism (FFP) that represents a significant departure from accepted practices of the relevant research community, committed intentionally, knowingly, or recklessly, and proven by a preponderance of the evidence. What has changed is procedural detail — respondent comment rights on draft investigation reports, record-retention protocols, and interim-action notification triggers are now spelled out in greater depth.

    Critically, the Final Rule is not retroactive. Allegations received before 1 January 2026 continue to be handled under the 2005 version of Part 93 unless the institution and the respondent agree in writing to proceed under the new rule. Institutions running dual-track proceedings across the transition need to document, case by case, which regulatory version applies.

    Who must file an assurance renewal, and via which form

    Any institution that receives PHS-supported research funds — including awards from NIH, CDC, FDA, HRSA, and other PHS agencies — must maintain an active research misconduct assurance with ORI. Once an assurance is established, the institution is obligated to file annually, regardless of whether it received any misconduct allegations that year.

    • Form: Annual Report on Possible Research Misconduct, Form PHS-6349, submitted through ORI’s online Annual Report system (ARPRM).
    • Filing window: 1 January through 30 April each calendar year, covering the prior calendar year’s activity.
    • 2026 deadline: 30 April 2026, covering the reporting period 1 January–31 December 2025.
    • No-activity institutions: institutions with no PHS-supported research or no allegations in the reporting period may still owe a report; small or inactive institutions should confirm with ORI’s Assurance Program whether a Small Institution or no-activity statement applies to their circumstances.
    • Access: ORI’s Annual Report system now requires two-factor authentication (2FA) — institutions should confirm their registered email with the Assurance Program ([email protected]) well before the deadline to avoid last-minute access issues.

    The 2026 assurance renewal checklist

    Beyond the Form PHS-6349 filing itself, 2026 is unusual because institutions are also expected to have brought their internal policies and procedures into alignment with the new 42 CFR Part 93 requirements. ORI published a Sample Policies and Procedures document in June 2025 specifically to help research integrity officers, compliance staff, and institutional counsel update their templates ahead of the 1 January 2026 effective date.

    Item 2005 rule (pre-2026 cases) 2026 Final Rule
    Effective date 16 June 2005 1 January 2026
    Defined terms in 42 CFR Part 93 Baseline set 25+ additional defined terms
    Applies to allegations received Before 1 Jan 2026 (default) From 1 Jan 2026 onward, or earlier by written agreement
    Annual Report on Possible Research Misconduct Form PHS-6349, Jan–Apr window Unchanged: Form PHS-6349, Jan–Apr window
    Institutional policy alignment N/A Sample Policies and Procedures released June 2025

    Institutions preparing their 2026 renewal should treat the filing as a two-part exercise: (1) submit Form PHS-6349 through ARPRM by 30 April 2026 for the 2025 reporting year, and (2) confirm that the policies and procedures referenced in that assurance actually reflect the post-1-January-2026 regulatory text, not the 2005 language many institutional websites still carry. ORI’s own research administration compliance guidance and case-summary archive remain useful references for RIOs benchmarking their inquiry and investigation timelines against the 60-day inquiry and 120-day investigation targets that persist in the revised rule.

    Frequently asked questions

    What is the deadline for the ORI 2026 annual assurance renewal?

    Institutions holding a PHS research misconduct assurance must file the Annual Report on Possible Research Misconduct (Form PHS-6349) between 1 January and 30 April 2026, covering research misconduct activity from the 2025 calendar year, via ORI’s online ARPRM system.

    Which institutions must maintain an ORI research misconduct assurance?

    Any institution receiving Public Health Service-supported research funds — from NIH, CDC, FDA, or other PHS agencies — must hold an active assurance under 42 CFR Part 93 and file annually, even in years with no reported allegations.

    Does the new ORI Final Rule apply retroactively to open cases?

    No. Allegations received before 1 January 2026 are handled under the 2005 version of 42 CFR Part 93 by default, unless the institution and respondent agree in writing to proceed under the revised rule instead.

    What form and system do institutions use to submit their annual report?

    Institutions submit Form PHS-6349 through ORI’s Annual Report on Possible Research Misconduct system (ARPRM), which now requires two-factor authentication tied to the institution’s registered email address.

    Implications for research administrators

    The overlap between the Final Rule’s 1 January 2026 effective date and the routine 30 April annual report deadline compresses an already tight compliance calendar. Research integrity officers now need to reconcile three separate obligations in the same window: filing the standard annual report, confirming that institutional policies match the revised regulatory text, and correctly classifying any pending allegation as either a 2005-rule case or a 2026-rule case for procedural purposes.

    ORI’s most recent published Annual Report, covering 2024 activity, recorded 713 allegations of possible research misconduct and 117 new cases opened that year, with 38 cases carried over from prior years — a caseload that gives some sense of scale for institutions weighing how much internal capacity to dedicate to inquiry and investigation infrastructure under the tightened procedural clock.

    • Audit institutional policy language against ORI’s June 2025 Sample Policies and Procedures document before certifying compliance in the 2026 assurance filing.
    • Tag open cases by intake date to determine which regulatory version (2005 or 2026) governs each proceeding.
    • Confirm ARPRM account access and two-factor authentication setup well ahead of the 30 April deadline — do not wait for filing week.
    • Brief institutional review boards and legal counsel on the expanded defined terms, particularly “recklessly” and “intentionally,” which affect how misconduct findings are documented.

    Looking ahead

    The 2026 cycle is likely to be the messiest transition year institutions face under 42 CFR Part 93 for some time: two regulatory regimes running in parallel, a compressed policy-update timeline, and an unchanged annual filing deadline that does not care which rule applies to a given case. Institutions that treat the 30 April 2026 Form PHS-6349 submission purely as a data return — rather than as an opportunity to verify their underlying policies actually match the current regulation — risk finding gaps only when ORI reviews a proceeding. Research administrators tracking related standards work, including contributor-role and authorship frameworks referenced in misconduct findings, can cross-reference CASRAI’s CRediT contributor role and authorship resources when documenting responsibility in a research record.

  • What the ORI 2024 Final Rule Means for Research Administrators in 2026

    Two decades after its last comprehensive revision, the ORI research misconduct policy that governs how US institutions handle allegations against Public Health Service (PHS)-funded researchers has been rewritten. The Department of Health and Human Services’ Office of Research Integrity (ORI) finalised sweeping changes to 42 CFR Part 93 in September 2024, and the compliance clock is now running out for research administrators. For any allegation an institution receives on or after 1 January 2026, the new rule — not the 2005 version still in force today — governs the entire process, from first inquiry to final institutional finding.

    For research integrity officers (RIOs), sponsored programmes staff, and institutional counsel, this is not a distant regulatory footnote. It is an operational deadline that requires revised bylaws, retrained committees, and updated PHS assurances before the new year turns. Institutions that received PHS funding any time in the last twenty years will recognise the stakes: 42 CFR Part 93 is the backbone of every federally compliant misconduct policy at universities, medical centres, and research institutes across the country, and non-compliance can jeopardise an institution’s standing to receive further PHS awards.

    This piece sets out, in plain language, what changed, when it takes effect, and what research administrators need to have in place before the applicability date arrives.

    Why ORI Rewrote Its Research Misconduct Policy

    The federal research misconduct regulations at 42 CFR Part 93 had not been substantively updated since 2005. In the intervening years, research practice changed considerably: the 2008 NIH Public Access Policy, the 2023 NIH Data Management and Sharing Policy, the migration of research records to cloud storage, and the emergence of artificial intelligence tools capable of detecting image manipulation and data falsification all outpaced a regulation written for a largely paper-based research environment. ORI’s final rule, published in the Federal Register in September 2024, is the agency’s attempt to modernise federal research misconduct policy for that reality.

    Crucially, the amended rule does not retroactively apply to open cases. Institutions must continue to apply the 2005 version of 42 CFR Part 93 to any allegation received before 1 January 2026, unless the respondent and the institution jointly elect in writing to proceed under the new rule instead. This creates a transitional period in which RIOs may be running two parallel sets of procedures — a detail that governance documents and training materials need to reflect clearly.

    Revised Inquiry and Investigation Timelines

    The most immediately practical change for administrators is timing. Under the current regulation, institutions have 60 days to complete an inquiry and roughly 120 days to complete an investigation once a formal case is opened. The final rule extends both phases: the inquiry period is lengthened to 90 days, and the investigation period to 180 days, giving RIOs and investigation committees materially more runway to conduct a thorough, defensible review before a finding is reached.

    The final rule also formalises procedural protections around the investigation report. Respondents must be given an opportunity to review the draft investigation report and to submit written comments — generally within 30 days of receipt — before the institution finalises its findings. Notably, ORI declined to adopt a provision from its proposed rule that would have barred institutions from determining “honest error” at the inquiry stage; that flexibility survives into the final text, giving institutions more room to close weak allegations early without triggering a full investigation.

    These extended timelines should be reflected in every institutional misconduct policy, in RIO case-tracking templates, and in any communications sent to complainants and respondents about expected case duration.

    Updated Definitions and New Assurance Requirements

    The revised PHS research misconduct regulations introduce more than 25 defined terms that did not previously exist in the regulatory text, including “institutional record,” “administrative record,” “intentionally,” and “recklessly.” Institutional record is now explicitly defined as the records an institution actually compiled or generated during a misconduct proceeding — excluding materials it never considered or relied upon — which narrows disputes over what must be produced during appeals or ORI oversight review.

    The definition of plagiarism has also been sharpened to explicitly exclude self-plagiarism (text recycling) and authorship disputes from the scope of research misconduct, redirecting those matters to separate institutional processes such as publication ethics review or authorship-contribution reconciliation. This is a useful distinction for institutions that already document individual contributor roles using frameworks such as the CRediT taxonomy — CASRAI originated the CRediT contributor role taxonomy in 2014, and the standard is now stewarded by NISO as ANSI/NISO Z39.104-2022 — since clear contribution records can help RIOs quickly separate a genuine authorship dispute from a fabrication or plagiarism allegation.

    On the assurance side, institutions must update their PHS Research Integrity Assurance and supporting policies and procedures to align with the final rule, and reflect that update in the annual report covering 2025 activity, due to ORI on or before 30 April 2026. ORI has also expanded and clarified its jurisdictional reach — the office of research integrity jurisdiction now extends more explicitly to applicants, subawardees, and PHS-supported research regardless of the specific funding mechanism, closing gaps that previously left some collaborative and subcontracted research outside clear oversight.

    What This Means for Research Administrators

    The practical to-do list for institutions receiving PHS funding is substantial:

    • Revise institutional policy documents to reflect the 90-day inquiry and 180-day investigation windows, the new defined terms, and the narrowed plagiarism definition.
    • Update the PHS Research Integrity Assurance on file with ORI and prepare to certify compliance in the annual report due by 30 April 2026.
    • Train RIOs, deciding officials, and investigation committee members on the revised definitions of intent, recklessness, and institutional record, since these terms carry direct evidentiary consequences.
    • Build a transitional protocol for distinguishing cases governed by the 2005 rule from those governed by the 2026 rule, including the joint-election mechanism for respondents who prefer the new procedures.
    • Coordinate with sponsored programmes and general counsel on subrecipient and subaward language, given the clarified jurisdictional scope over collaborative research.
    • Monitor ORI’s phased guidance releases, which began appearing in December 2025 and are continuing through 2026, for topic-specific implementation detail beyond the regulatory text itself.

    Professional associations that support research administrators — including NCURA and ARMA — have flagged the final rule as a priority training topic for 2026, and institutions should expect sample policy language and compliance checklists to continue circulating through those channels and through compliance-focused organisations such as CITI Program.

    A Modernised Baseline, Not a Finished Job

    The final rule brings 42 CFR Part 93 into closer alignment with how research is actually produced, stored, and scrutinised in 2026 — but it does not settle every open question. Guidance documents are still arriving in phases, institutions are still building parallel procedures for the transitional period, and the practical burden of proof around “intentionally” and “recklessly” will only be tested as new cases move through the revised process. For research administrators, the sensible posture is to treat 1 January 2026 not as a finish line but as the date from which institutional practice will be judged against a materially more detailed, and more demanding, federal standard.