CASRAI Dictionary

Tag: ori research misconduct policy

  • 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.

  • Research Misconduct Allegation Phases (3 Stages)

    A research misconduct allegation moves through three formal stages — inquiry, investigation and adjudication — each with a distinct purpose, evidentiary threshold and, under the US federal model, a defined deadline. The inquiry screens whether a full investigation is warranted; the investigation builds a factual record; adjudication delivers the finding and any sanctions. This article walks through each phase in order, then contrasts the US federal timetable with the more variable UK institutional model.

    Research misconduct is formally defined, under the US Public Health Service policy (42 C.F.R. Part 93), as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results — a definition that explicitly excludes honest error and legitimate differences of scientific opinion.

    What Is a Research Misconduct Allegation?

    A research misconduct allegation is a formal statement, made by a complainant to a designated institutional official — typically a Research Integrity Officer (RIO) — that a named respondent has fabricated, falsified or plagiarised research. The allegation triggers a duty on the institution to make a preliminary assessment before any formal phase begins. This assessment is not itself one of the three formal phases; it simply determines whether the allegation, if true, would fall within the scope of research misconduct.

    Phase One: The Inquiry

    The inquiry is a preliminary, confidential fact-check, not a determination of guilt. Its sole question is whether the allegation has enough substance to warrant a full investigation.

    • A small committee or designated official gathers documents and research records.
    • The respondent and complainant may be interviewed informally.
    • A written inquiry report records the findings and a recommendation on whether to proceed.

    Under 42 C.F.R. §93.307(g), US institutions receiving Public Health Service funding must complete the inquiry within 60 calendar days of initiation unless the delay is documented and justified. If the inquiry finds no substance to the allegation, the matter closes at this point; the majority of allegations do not proceed past inquiry.

    Phase Two: The Investigation

    If the inquiry concludes an investigation is warranted, the process becomes formal. The respondent is notified in writing, and under federal guidance the institution must notify the Office of Research Integrity (ORI) within 30 days of that determination.

    The investigation committee, typically composed of subject-matter experts without conflicts of interest, must establish three things:

    1. Whether there was a significant departure from accepted practices in the relevant field.
    2. Whether the conduct was committed intentionally, knowingly, or recklessly.
    3. Whether the allegation is proven by a preponderance of the evidence — the standard set out in 42 C.F.R. §93.106, a lower bar than criminal “beyond reasonable doubt.”

    US institutions are expected to complete the investigation within 120 days of initiation, covering evidence review, interviews, drafting the report, and giving the respondent an opportunity to comment, per 42 C.F.R. §93.311. Extensions are routinely requested and granted where cases are complex.

    Phase Three: Adjudication

    Adjudication is the decision phase. An institutional Deciding Official — someone who played no role in the inquiry or investigation — reviews the investigation report, the respondent’s comments, and any procedural objections, then issues a final institutional finding.

    Where federal funding is involved, ORI conducts its own oversight review of the institution’s finding before any Public Health Service administrative action is imposed. According to ORI’s own published process, a respondent facing formal action retains the right to request a hearing before an Administrative Law Judge before sanctions take effect. Possible outcomes range from correction of the research record to debarment from federal funding and referral for further action.

    How Do UK and US Procedures Compare?

    The US model is unusual in having a single statutory timetable enforced through 42 C.F.R. Part 93. The UK has no equivalent statutory regulator; instead, individual institutions run their own codes of practice, informed by non-binding sector guidance.

    Feature United States (PHS-funded research) United Kingdom
    Governing instrument 42 C.F.R. Part 93 Institutional codes of practice, informed by UKRIO and UKRI guidance
    Federal/national oversight body Office of Research Integrity (ORI) None statutory; UK Research Integrity Office (UKRIO) is advisory
    Inquiry deadline 60 calendar days Not centrally mandated; varies by institution
    Investigation deadline 120 calendar days Not centrally mandated; varies by institution
    Final appeal route Hearing before an Administrative Law Judge Institutional appeal stage (naming varies, e.g. “Stage 3”)

    UKRI’s April 2025 guidance for research organisations describes an assessment stage that “refers to the process of reviewing the nature of an allegation of research misconduct” and establishing scope — functionally equivalent to the US inquiry, but without a fixed clock. UK institutional codes, such as those published by the University of Surrey and University of Staffordshire, typically layer a similar inquiry-investigation-decision logic across numbered stages, though the labelling and timeframes differ institution to institution. This is separate from journal-level handling: COPE’s flowcharts guide editors on suspected misconduct in submitted or published papers, and a publisher may pause or flag a work while the institutional process above runs in parallel.

    Answer-First Questions About Misconduct Allegations

    What are the phases of a research misconduct allegation?

    The formal process runs through three phases: an inquiry that screens whether an allegation has substance, an investigation that establishes the facts against a defined evidentiary standard, and adjudication, where a Deciding Official issues the final finding and any sanctions.

    What is the first phase in response to a research misconduct allegation?

    The first formal phase is the inquiry — a confidential, preliminary review of documents and testimony conducted to determine whether the allegation warrants a full investigation. It is not a determination of wrongdoing and, under US federal policy, must normally conclude within 60 days.

    Who investigates allegations of research misconduct?

    The employing or funded institution conducts the inquiry and investigation, typically through a Research Integrity Officer and an appointed committee of subject experts. For US federally funded research, the Office of Research Integrity then reviews the institution’s finding before any federal sanction is applied.

    What is a research misconduct allegation?

    A research misconduct allegation is a formal claim that a named individual has fabricated, falsified, or plagiarised research. It excludes honest error or genuine scientific disagreement, and it obliges the receiving institution to make a documented preliminary assessment before any formal phase begins.

    Implications and Next Steps

    For research administrators, the practical lesson is procedural discipline: documenting the preliminary assessment, meeting inquiry and investigation deadlines where they apply, and keeping the Deciding Official separate from earlier stages protects the institution against later appeal. For researchers named as respondents, understanding which phase they are in — and what standard of proof applies — clarifies what rights and evidence obligations attach at each step.

    As UK institutions continue to align local codes with UKRI’s 2025 guidance, expect greater convergence in stage naming, though a single UK statutory deadline regime, of the kind ORI enforces in the US, remains absent. Institutional research administration teams should treat the inquiry-investigation-adjudication sequence as the baseline procedural map, then check their own code of practice for the specific labels and timeframes that apply locally.

  • Sanctions for Research Misconduct: Debarment, Funding Bans and Criminal Prosecution Compared

    Sanctions for research misconduct fall into three distinct enforcement tracks: institutional and federal debarment (led in the United States by the Office of Research Integrity), funder-imposed bans such as those applied by UKRI and Wellcome, and, in rare cases, criminal prosecution for fraud involving public funds. Each track has its own decision-maker, standard of proof, and range of outcomes, and the three are frequently confused in general explainers.

    Research misconduct is formally defined under US federal regulation as fabrication, falsification, or plagiarism (“FFP”) committed in proposing, performing, or reviewing research, or in reporting research results (45 CFR § 93.103). No equivalent single statutory definition exists in the United Kingdom, where funders and employers apply their own policies against the same broad FFP framework.

    What sanctions exist for research misconduct?

    Three separate mechanisms can be triggered by a single proven case of research misconduct, and they are not mutually exclusive. An institution can dismiss a researcher, a federal or national funder can bar them from future awards, and — only in the most serious cases involving fraud against public money — a prosecutor can bring criminal charges.

    The table below compares the three tracks as they currently operate.

    Enforcement track Who imposes it Typical sanction range Standard of proof
    Federal debarment (US) HHS Office of Research Integrity / federal agency Supervision or funding restriction (commonly around three years) up to lifetime exclusion from federal funds Preponderance of the evidence
    Funder sanctions (UK) UKRI, Wellcome, NIHR and other funders individually Grant termination, repayment demands, time-limited bar on future applications Funder’s own investigation findings
    Criminal prosecution National courts (e.g. US Department of Justice) Fines, restitution, imprisonment Beyond reasonable doubt

    Institutional actions — reprimand, retraction requests, termination of employment — typically happen first and independently of whether a funder or prosecutor later gets involved.

    How does ORI debarment work in the United States?

    ORI oversees misconduct findings in Public Health Service–funded research under 42 CFR Part 93, and can recommend administrative actions ranging from a certification requirement to full debarment. Debarment itself is executed through the government-wide exclusion mechanism at 2 CFR Part 180, which bars a researcher from receiving any federal award, not only from the agency that funded the original research.

    Debarment periods are not fixed by statute. ORI case records and published analyses of federal misconduct findings indicate that a supervised-research period or funding restriction of around three years is the most common outcome, with longer bars — up to a lifetime exclusion — reserved for the most serious or repeated cases. The National Institutes of Health can additionally exclude a debarred individual from serving on grant review panels.

    • Certification of research integrity for a fixed period
    • Supervision requirements on future federally funded work
    • Time-limited exclusion from federal funding and review committees
    • Lifetime debarment in the most severe or repeat cases

    How do UKRI and UK funders sanction research misconduct?

    The UK has no single federal debarment register equivalent to the US system. Instead, individual funders investigate and sanction cases against their own grant conditions, and institutions handle the underlying employment consequences separately.

    Wellcome’s grant conditions state that where an organisation upholds a research misconduct allegation, sanctions “may vary in length, depending on the severity of the misconduct” — which can include grant termination, repayment demands, and a time-limited bar on future applications to that funder. UKRI applies a comparable case-by-case approach across its research councils rather than a single published tariff, and the UK Research Integrity Office supports institutions in running consistent, fair investigation processes rather than issuing sanctions itself. Plagiarism findings that concern disputed authorship credit are frequently resolved at institutional level even before a funder becomes involved.

    Because UK sanctions are funder-specific rather than government-wide, a researcher barred by one funder is not automatically barred by another — a structural difference from the US debarment model that institutional research administration offices need to track carefully when advising on eligibility.

    When does research misconduct lead to criminal prosecution?

    Criminal prosecution is rare and reserved for cases where misconduct overlaps with fraud against public funds, false statements to a federal agency, or theft — not for FFP findings alone. The evidentiary bar is far higher than for an administrative debarment finding, which is one reason so few cases reach a courtroom.

    Two US cases illustrate the outer edge of this track. In 2005, University of Vermont researcher Eric Poehlman became the first American scientist sentenced to prison over research misconduct-related fraud, receiving one year and a day and an order to repay roughly $180,000 after fabricating data in federal grant applications. In 2015, former Iowa State University researcher Dong-Pyou Han was sentenced to 57 months in federal prison for making false statements in NIH-funded HIV vaccine research — one of the longest custodial sentences on record for research fraud in the US.

    No comparable UK criminal prosecutions for research misconduct itself exist on the public record; related conduct there is more commonly pursued, if at all, under general fraud law rather than a research-specific statute.

    Frequently asked questions about sanctions for research misconduct

    What are the penalties for research misconduct?

    Penalties include institutional actions (reprimand, retraction, termination), funder sanctions (grant termination, repayment, time-limited application bans), and federal debarment from all future government funding. Criminal penalties — fines and imprisonment — apply only in rare cases involving fraud against public money.

    What is the most severe sanction for research misconduct?

    The most severe administrative sanction is lifetime federal debarment, which permanently excludes a researcher from receiving any US government funding or serving on review panels. Where fraud against public funds is proven, imprisonment is the most severe outcome overall, though it is far less common than debarment.

    Can you go to jail for research misconduct?

    Yes, but only in cases that cross into criminal fraud, such as fabricating data to obtain federal grant money. Documented examples include Eric Poehlman (one year and a day, 2005) and Dong-Pyou Han (57 months, 2015), both convicted over federally funded research fraud rather than FFP findings alone.

    What are the three types of research misconduct?

    Under the US federal definition, the three types are fabrication (inventing data), falsification (manipulating data, materials, or processes), and plagiarism (appropriating others’ ideas or words without credit) — collectively known as FFP under 45 CFR § 93.103.

    What these sanctions mean for institutions and researchers

    The practical implication for research administrators is that a single misconduct finding can trigger overlapping consequences on different timelines: an institution may act within weeks, a funder’s sanction may follow months later, and a criminal referral — where warranted — can take years to resolve. Advising researchers or institutional leadership requires tracking all three tracks separately rather than assuming one outcome implies another.

    For publishers and standards bodies, the growing use of AI-assisted fabrication and image manipulation is pushing debarment and funder-sanction frameworks to adapt faster than criminal law can follow, since prosecution requires proof of intent to defraud rather than mere data manipulation. Institutions should expect funders on both sides of the Atlantic to keep tightening administrative sanctions — debarment periods and funder bans — well ahead of any corresponding shift in criminal enforcement.

  • 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.