PHS Research Misconduct — Federal Rules on Fabrication, Falsification, and Plagiarism in Federally Funded Research

Legal Authority

• 42 U.S.C. § 289b — Public Health Service Act § 493B; directs HHS to establish a process for receiving and responding to reports of research misconduct by PHS-funded researchers; authorizes ORI to investigate and impose administrative actions including debarment and retraction requirements
• 42 U.S.C. § 216 — PHS Act § 301; general HHS Secretary rulemaking authority for carrying out Public Health Service functions
• 42 CFR Part 93 — HHS ORI implementing regulation (2005 comprehensive rewrite); defines fabrication, falsification, and plagiarism (FFP); establishes institution-primary/ORI-oversight framework; sets 6-year limitation, preponderance-of-evidence standard, 60-day inquiry and 120-day investigation deadlines, and Departmental Appeals Board appeal pathway

Key Mechanics

42 CFR Part 93 governs research misconduct — defined as fabrication, falsification, or plagiarism (FFP) — in research funded by the National Institutes of Health and other Public Health Service agencies (~$40 billion in annual NIH grants). Misconduct requires: a significant departure from accepted research practices; knowing, intentional, or reckless conduct; and conduct that can be proven by a preponderance of the evidence. Honest error and differences of scientific opinion are excluded. Institutional primacy: every PHS-funded institution must have written misconduct policies, a designated Research Integrity Officer (RIO), and capacity to conduct investigations; the institution investigates first. Process: 60-day inquiry (preliminary fact-finding to determine if the allegation has sufficient substance) → 120-day investigation (full evidentiary process with committee of scientific peers) → institution reports to ORI. ORI oversight: ORI reviews every completed investigation and may make independent findings regardless of the institution's conclusions; ORI may impose supervision of future research, grant debarment (typically 1-5 years), required paper retractions, and prohibition on PHS advisory committee service. Respondent rights: notification of the allegation, opportunity to respond at each stage, review of draft investigation report, and appeal of ORI findings to the HHS Departmental Appeals Board (DAB) within 30 days — the DAB decision is final for administrative purposes. A 6-year limitation period applies, with exceptions for continuing violations and intentional concealment.

Current Rule (2026)

What This Rule Does

When a researcher fabricates data, falsifies results, or steals another scientist's work in a study funded by the National Institutes of Health, the Centers for Disease Control, or another Public Health Service (PHS) agency, 42 CFR Part 93 is the federal regulation that governs what happens next. Part 93 defines what counts as research misconduct, assigns primary investigative responsibility to the institution that received the federal research funds, establishes the Office of Research Integrity (ORI) as the federal oversight body, and sets out the procedural rights of the accused researcher — including the right to appeal ORI findings to a separate Departmental Appeals Board.

Every institution that applies for or receives PHS research funds — universities, medical centers, research hospitals, independent laboratories — must have written research misconduct policies, a designated Research Integrity Officer (RIO), and the institutional capacity to conduct investigations. The institution investigates first; ORI reviews and may make its own independent findings; and a researcher found to have committed research misconduct can be debarred from federal funding, required to retract published papers, and prohibited from serving on PHS advisory committees.

The rule applies to research misconduct in "PHS-supported research" — which includes not just NIH-funded laboratory research but clinical trials, epidemiological studies, biomedical research, and behavioral science funded by any PHS component agency. Roughly $40 billion in annual NIH grants flows through institutions subject to Part 93.

Key Provisions

Definitions (Subpart A — § 93.103)

• Research misconduct means fabrication, falsification, or plagiarism (FFP) in proposing, performing, or reviewing research, or in reporting research results; it does not include honest error or differences of scientific opinion
• Fabrication: making up data or results and recording or reporting them
• Falsification: manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented
• Plagiarism: appropriating another person's ideas, processes, results, or words without giving appropriate credit
• Significant departure: misconduct must represent a significant departure from accepted practices of the relevant research community — minor errors that have no bearing on results do not constitute research misconduct under this definition
• Knowing, intentional, or reckless: the respondent's conduct must have been committed knowingly, intentionally, or with reckless disregard for accepted practices; genuine mistakes and inadvertent errors are outside the rule's scope

Time Limitation and Evidence Standard (§§ 93.104–93.105)

• § 93.104 — Six-year limitation: an allegation of research misconduct must be based on events that occurred within six years of the date the allegation is reported to the institution or ORI; exceptions apply for "continuing violations" (where the misconduct extends into the six-year period) and for situations where the respondent intentionally concealed the misconduct
• § 93.105 — Preponderance of evidence: findings of research misconduct must be supported by a preponderance of the evidence — the standard used in civil proceedings — not the criminal law "beyond a reasonable doubt" standard; the burden of proof lies with ORI or the institution making the allegation

Confidentiality (§ 93.106)

• Institutions and ORI must take reasonable steps to protect the identities of complainants, respondents, and witnesses from disclosure outside the inquiry and investigation — to the extent permitted by law and regulation
• Confidentiality protections apply during the inquiry (preliminary fact-finding) and formal investigation phases; they are not absolute and may give way to disclosure required by law (e.g., subpoena) or necessary to conduct the investigation fairly

Institution Responsibilities (Subpart C — §§ 93.300–93.317)

Every PHS-funded institution must:

• § 93.300 — Adopt written policies: institutions must have a written research misconduct policy that meets Part 93's requirements and applies to all PHS-supported research, including research by faculty, trainees, students, and staff
• § 93.303 — Research Integrity Officer (RIO): designate a RIO responsible for reviewing allegations, conducting inquiries, overseeing investigations, and serving as the institution's point of contact with ORI
• § 93.304 — Allegations: the institution must respond to all allegations of research misconduct in PHS-supported research; it cannot simply dismiss or ignore an allegation without at least an inquiry
• § 93.307 — Inquiry: an inquiry is the initial fact-finding step — the institution must complete it within 60 days of receiving an allegation; the inquiry determines whether the allegation has sufficient substance to warrant a full investigation
• § 93.310 — Investigation: if the inquiry finds the allegation warrants it, the institution must open a formal investigation within 30 days of completing the inquiry; the investigation must be completed within 120 days (with an ORI extension possible); the investigation uses a committee that must include scientific expertise relevant to the research at issue
• § 93.313 — Findings and report: the investigation committee produces a written report including a description of the misconduct alleged, the evidentiary record, findings of fact, findings of whether misconduct occurred, the standards violated, and the degree to which the respondent was responsible; the report must also address institutional practices that contributed to the misconduct
• § 93.317 — Notifying ORI: institutions must notify ORI at several stages — when an investigation is opened, when it is closed, and when final findings are transmitted; ORI uses these notifications to track all active research misconduct cases across PHS-funded institutions

Respondent Rights (§§ 93.108, 93.310)

• The respondent (accused researcher) must be notified of the allegation and given an opportunity to respond at both the inquiry and investigation stages
• The respondent has the right to receive the investigation report before it is finalized, to comment on the draft, and to have those comments considered
• The respondent must be given the opportunity to present evidence and witnesses on their behalf during the investigation
• If ORI makes a finding of research misconduct after reviewing the institution's investigation, the respondent has the right to appeal that finding to the HHS Departmental Appeals Board

ORI Oversight (Subpart D)

• ORI reviews every completed institutional investigation and may accept the institution's findings or conduct its own additional fact-finding
• ORI may make an independent finding of research misconduct even if the institution found none — ORI is not bound by the institution's conclusions
• When ORI finds research misconduct, it imposes remedies — which can include: a period of supervision of the respondent's future PHS-funded research, debarment from eligibility for federal grants (typically 1–5 years), required retraction or correction of published papers, and prohibition on service on PHS advisory committees or peer review panels
• ORI refers cases involving potential criminal fraud (e.g., false statements to the government in grant applications) to the HHS Office of Inspector General and the Department of Justice

Appeal Process (Subpart E)

• A respondent who disagrees with ORI's finding or the proposed remedies may appeal to the Departmental Appeals Board (DAB) within 30 days of receiving ORI's charge letter
• The DAB conducts a hearing with an opportunity to present evidence, examine witnesses, and challenge ORI's findings
• The DAB's decision is final — there is no further administrative appeal; respondents who wish to challenge the DAB's decision must seek judicial review in federal court

How It Affects You

Researchers at PHS-funded institutions: Your institution's research misconduct policy, which must comply with Part 93, governs allegations against you. If a complaint is filed — by a collaborator, a student, a peer reviewer, or an anonymous source — your institution's RIO will conduct a confidential inquiry within 60 days. If the inquiry finds sufficient basis to proceed, a formal investigation follows. You have the right to know the allegation, respond to the evidence, submit your own documentation and witnesses, and review the draft investigation report. ORI typically receives cases only after the institution completes its investigation, but it can open an independent inquiry if it believes the institution's process was deficient. The six-year limitation period means allegations about older work (more than 6 years before the complaint) generally will not proceed — but ongoing concealment of earlier misconduct restarts the clock.

Research institutions and compliance officers: Part 93 compliance requires more than a written policy on the shelf. Your RIO must be trained, empowered, and aware of all incoming allegations. The inquiry timeline (60 days) and investigation timeline (120 days) are firm deadlines; missing them requires ORI notification and justification. Interim measures to protect research subjects, preserve evidence, and prevent destruction of records must be taken as soon as an inquiry opens. Sequester the relevant lab notebooks, data files, and publication drafts before the respondent can access them. Notify ORI when the investigation is opened — not after it concludes — so ORI can track it from the start. Institutions that mishandle misconduct investigations risk losing their ability to receive PHS funding.

Graduate students and postdoctoral fellows: If you witness potential data fabrication or falsification in your lab, you may report it to your institution's RIO (or directly to ORI if you believe the institution will not act impartially). Part 93's confidentiality provisions are designed to protect complainants from retaliation, though the rule does not impose the anti-retaliation protections found in whistleblower statutes. If you are named as a respondent (even as a student trainee whose advisor directed the work), you have full respondent rights — including the right to counsel during the investigation, though the institution is not required to provide counsel at its expense.

ORI and federal agencies: ORI's caseload focuses on PHS-funded research — primarily NIH-funded biomedical and behavioral research. For research funded by NSF, DOE, or other agencies, separate research integrity frameworks apply (NSF's under 45 CFR Part 689; DOE's under internal policy). Cross-agency coordination is required under § 93.107 — if misconduct allegations involve multi-agency research, ORI must coordinate with the other funding agencies.

Statutory Authority

This rule implements:

• 42 U.S.C. § 216 — Public Health Service Act § 301; general rulemaking authority for the HHS Secretary to make and publish rules and regulations necessary to carry out the functions of the Public Health Service
• 42 U.S.C. § 289b — Public Health Service Act § 493B; directs HHS to establish and administer a process for receiving and responding to reports of research misconduct by PHS-funded researchers; requires institutions to report research misconduct to HHS; authorizes ORI to investigate and impose administrative actions

Recent Rulemakings

• 2005 (70 FR 28370): Comprehensive rewrite of PHS research misconduct regulations, replacing a 1989 framework with the current Part 93 structure; established the current FFP definition, the six-year limitation, the preponderance-of-evidence standard, and the Departmental Appeals Board appeal pathway; assigned the regulatory burden to institutions (primary investigators) and ORI (federal oversight)
• No major Part 93 amendments since 2005; ORI has supplemented the regulation with guidance on specific topics (authorship, data management, electronic records) but the regulatory framework has remained stable

Pending Action