The ORI second phase guidance documents are a batch of topic-specific PDFs — covering honest error, admissions, pursuing leads, sub-awardee assurances and institutional assessments — that the US Office of Research Integrity released from September 2025 onward to help Public Health Service (PHS)-funded institutions implement the 2024 Final Rule on research misconduct (42 CFR Part 93) ahead of its January 1, 2026 applicable date. Institutions now need to fold this guidance into formal policy before their next Annual Report cycle.
The Office of Research Integrity (ORI) is the component of the US Department of Health and Human Services (HHS) responsible for overseeing research-misconduct policy and compliance at institutions that receive Public Health Service funding, including funding from the National Institutes of Health (NIH).
- What is ORI’s second phase of guidance documents?
- What do the phased guidance documents cover?
- What must institutions update in Annual Report submissions?
- How does ORI’s jurisdiction fit under federal misconduct rules?
- Common questions on the second-phase guidance
- Implications for research integrity offices
What Is ORI’s Second Phase of Guidance Documents?
ORI began releasing guidance in June 2025 to support institutions implementing the 2024 Final Rule on Public Health Service Policies on Research Misconduct, published in the Federal Register at 42 CFR Part 93. The first tranche — Writing Policies and Procedures, Sample Policies and Procedures, Small Institution Guidance, and Implementation Guidance — gave institutions templates for compliant policy language.
The second phase, announced by ORI on 15 September 2025, is topic-specific rather than template-based. It clarifies how institutions must apply the Final Rule to real proceedings: Honest Error, Admissions, Pursuing Leads, Sub-Awardee Assurances, and Assessments. ORI has continued releasing additional topic guidance in further batches through May 2026, all falling under the same phased rollout of Final Rule guidance.
The Final Rule’s effective date was 1 January 2025 (optional use, by mutual agreement of the parties to a case), and its applicable date was 1 January 2026, after which every PHS-funded institution must use the updated regulation for any new research-misconduct matter.
What Do the Phased Guidance Documents Cover?
Across the rollout, ORI has grouped guidance into consistent topic clusters. The table below maps each release window to its documents and subject matter, based on ORI’s official guidance-documents index.
| Release window | Guidance documents | Institutional focus |
|---|---|---|
| June 2025 (Phase 1) | Writing Policies and Procedures; Sample Policies and Procedures; Small Institution Guidance; Implementation Guidance | Drafting Final Rule-compliant policy language |
| September 2025 (Phase 2) | Honest Error; Admissions; Pursuing Leads; Sub-Awardee Assurances; Assessments | Distinguishing error from misconduct; handling admissions and sub-awardees |
| December 2025 | Institutional Record; Research Records; Multiple Institutions | Compiling the institutional record; multi-site cases |
| March 2026 | Confidentiality; Interviews; Subsequent Use Exception | Disclosure limits, interview conduct, record-sharing exceptions |
| May 2026 | State of Mind; Respondents; Institutional Record Best Practices | Assessing intent; managing multiple respondents; record organisation |
Two details are easy to miss. First, ORI’s own guidance notes that some documents cross-reference other guidance not yet released at the time of publication — institutions should treat the rollout as a living body of interpretation, not a closed set. Second, the Sub-Awardee Assurances Guidance confirms that every recipient of PHS support, including sub-awardees on collaborative grants, must independently establish and maintain an active research-integrity assurance with ORI — a requirement that is easy to overlook on multi-institution NIH research misconduct cases.
What Must Institutions Update in Annual Report Submissions?
Every PHS-funded institution files an Annual Report with ORI: a record of research-misconduct activity from the prior year, combined with an annual assurance that the institution’s policies and procedures comply with 42 CFR Part 93. ORI required institutions to submit an updated assurance reflecting the 2024 Final Rule as part of the 2025 Annual Report, due 30 April 2026 — a deadline that has now passed for most institutions.
That does not close the compliance question. Guidance covering State of Mind, Respondents and Institutional Record Best Practices was not released until May 2026, after the April assurance deadline. Institutions therefore have unfinished work: policies and procedures need to be revised now, in the second half of 2026, so the underlying documents — not just the assurance statement — genuinely reflect the completed guidance set before the 2026 Annual Report is due on 30 April 2027. Practical year-end priorities include:
- Revising written policies to incorporate the Honest Error, State of Mind and Admissions frameworks, so investigative committees apply a consistent intent standard.
- Updating institutional-record procedures against the Institutional Record and Research Records guidance, including retention and compilation practices.
- Confirming that every sub-awardee on active PHS-funded collaborations holds its own current ORI assurance.
- Documenting confidentiality and interview procedures consistent with the March 2026 guidance before any new proceeding opens.
How Does ORI’s Jurisdiction Fit Under Federal Misconduct Rules?
ORI’s authority is defined by 42 CFR Part 93, which applies to institutions receiving PHS funding — chiefly through the NIH, but also the CDC, FDA and other HHS agencies. Research misconduct according to federal regulations is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results, and explicitly excludes honest error or legitimate differences of opinion.
ORI’s own jurisdiction is narrower than institutions sometimes assume: it oversees the institution’s handling of an allegation and can make findings and impose administrative actions, but the initial inquiry and investigation remain the responsibility of the institution itself. This is why the phased guidance — on assessments, interviews, pursuing leads and the institutional record — matters so much: it is ORI’s interpretation of how institutions must run proceedings that ORI does not run directly.
Common Questions on the Second-Phase Guidance
What is ORI’s second phase of guidance documents?
It is a set of topic-specific guidance PDFs — Honest Error, Admissions, Pursuing Leads, Sub-Awardee Assurances and Assessments — that ORI published starting 15 September 2025 to clarify how institutions must apply the 2024 Final Rule (42 CFR Part 93) during actual research-misconduct proceedings.
What is the Office of Research Integrity’s jurisdiction?
ORI oversees research-misconduct policy compliance and case findings at institutions receiving Public Health Service funding, including NIH research misconduct matters. Institutions conduct the actual inquiry and investigation; ORI reviews findings and can take administrative action.
What counts as research misconduct according to federal regulations?
Under 42 CFR Part 93, research misconduct means fabrication, falsification, or plagiarism in proposing, performing or reviewing research, or in reporting results. Honest error and genuine scientific disagreement are expressly excluded from the definition.
When is the next ORI Annual Report due?
Institutions submitted their updated assurance with the 2025 Annual Report by 30 April 2026. The next Annual Report, covering 2026 activity, is due 30 April 2027, giving institutions the remainder of 2026 to align policies with all released guidance.
Implications for Research Integrity Offices
For research integrity officers and research administration offices, the practical task has shifted from watching for new PDFs to closing the gap between assurance language and actual policy text. An assurance filed in April 2026 cannot have anticipated May 2026 guidance on State of Mind and Respondents; institutions that treat the assurance as a one-time filing, rather than a standing commitment to keep procedures current, risk a mismatch that surfaces during ORI compliance review.
The rollout also has downstream implications beyond individual institutions: consistent application of Honest Error and State of Mind standards across hundreds of PHS-funded institutions should, over time, produce more comparable case outcomes and a clearer public record — a goal shared by research-integrity bodies and standards organisations working alongside CASRAI’s originated frameworks for research accountability. Institutions that update procedures methodically now, rather than waiting for the next assurance deadline, will be better positioned when ORI closes remaining cross-references in future releases.
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