Last updated: November 2026
A research misconduct policy and procedures program is the written process an institution with Public Health Service (PHS) research support uses to assess, inquire into and investigate allegations of fabrication, falsification or plagiarism, as 42 CFR Part 93 requires. Integral Healthcare Solutions (IHS) compares your policy with Part 93, drafts the missing procedures and builds tools that track the time limits. Your institution and its counsel approve every document and run every proceeding.
What is a research misconduct policy and procedures program?
Part 93, Public Health Service Policies on Research Misconduct, governs institutional responses overseen by the Office of Research Integrity (ORI). Section 93.234 defines research misconduct as fabrication, falsification or plagiarism in proposing, performing or reviewing research, or in reporting research results, and adds that it "does not include honest error or differences of opinion." We read 42 CFR Part 93 (eCFR; page opened November 5, 2026).
A finding requires all three of these: a significant departure from accepted practices of the relevant research community; misconduct committed intentionally, knowingly or recklessly; and proof of the allegation by a preponderance of the evidence (93.103). Section 93.227(b) says self-plagiarism and authorship or credit disputes do not meet the definition.
Who needs this program, and what triggers it?
Any institution that applies for or receives PHS research support needs it. Section 93.216 defines an institution broadly, to include colleges and universities, research institutes and independent researchers. Triggers include:
- A first PHS award, or a policy still written to the 2005 text.
- An ORI request for the policy, which ORI says can follow a referred allegation, a missing policy or a routine review.
- A new RIO or deciding official. Section 93.218 bars one individual from serving as both.
What does 42 CFR Part 93 require of an institution?
Institutions applying for or receiving PHS support for biomedical or behavioral research, research training or related activities need compliant procedures and an active ORI assurance (93.102(a), 93.300–93.301). With ORI approval, small institutions may substitute a Small Institution Statement for the policies specified in 93.303. Section 93.300 also requires institutions to:
- respond thoroughly, competently, objectively and fairly to each research misconduct allegation for which the institution is responsible under Part 93, taking precautions against unresolved personal, professional or financial conflicts between those conducting proceedings and complainants, respondents or witnesses (93.300(b));
- take all reasonable and practical steps to protect good faith complainants’, witnesses’ and committee members’ positions and reputations and protect them from retaliation by respondents or other institutional members (93.300(d)).
The Institutional Certifying Official must assure ORI, initially and then annually, that the institution has compliant written policies and complies with them and with the whole part (93.301(b)). The institution must file an annual report with the information ORI specifies (93.302(b)). ORI treats compliance as including providing the policies to ORI and other HHS components on request and making them publicly available (93.302(a)). ORI says institutions file the annual report between January 1 and April 30 and that it may request a policy at any time (ORI, Assurance Program and ORI, Institutional Policy; pages opened November 5, 2026). Verify current reporting instructions with ORI.
Which version of Part 93 applies, and when?
The revised part took effect January 1, 2025, and all its requirements apply on or after January 1, 2026, according to the final rule at 89 FR 76280 (Federal Register, September 17, 2024; page opened November 5, 2026). Under section 93.75, an institution follows the revised part for allegations it receives on or after January 1, 2026. The policies and procedures under 93.300(a) and 93.302(b) had to be implemented and submitted by the ORI-specified deadline for the annual report covering 2025. Earlier allegations follow the 2005 edition, unless the institution and the respondent both elect in writing to follow the revised part.
The preamble says revised policies had to be received by ORI with the annual report covering 2025 on or before April 30, 2026.
What are the stages and time limits in a misconduct proceeding?
Assessment determines whether an inquiry is warranted; inquiry determines whether investigation is warranted (93.306–93.307). The table summarizes selected duties when those stages apply.
| Stage | Section | What the text requires |
|---|---|---|
| Assessment | 93.306 | The Research Integrity Officer (RIO) or another designated official must promptly assess whether the allegation falls within the definition, is within the applicability criteria of section 93.102 and is sufficiently credible and specific that potential evidence may be identified. If all three are met, an inquiry must be conducted. |
| Sequestration | 93.305(a) | The institution must promptly take all reasonable and practical steps to obtain, inventory and securely sequester evidence needed for the proceeding. Copies with substantially equivalent evidentiary value are permitted, including from shared instruments. Whenever possible, obtain evidence before or when notifying the respondent and when additional items become known or relevant to the inquiry or investigation. |
| Inquiry | 93.307 | At or before inquiry initiation, the institution must make a good faith effort to notify the presumed respondent, if any, in writing. It must complete the inquiry within 90 days unless circumstances warrant longer, documenting reasons for exceeding 90 days in the inquiry report. No misconduct findings are made at inquiry. |
| Report to ORI | 93.309(a) | Within 30 days of determining that an investigation is warranted, the institution must provide ORI a copy of the inquiry report, which includes the twelve items the section lists. |
| Investigation | 93.310 | The institution must begin within 30 days after deciding an investigation is warranted and notify ORI on or before the date it begins. Interviews must be recorded and transcribed, and the transcript made available to the interviewee for correction. |
| Completion | 93.311 | Within 180 days of beginning the investigation, complete the investigation, draft-report comment process and ORI transmittal of the institutional record, final report and deciding official’s decision. If unable, request an ORI extension in writing explaining the circumstances or issues warranting more time. A report for an investigation exceeding 180 days must explain the delay. |
| Decision and record | 93.314, 93.315(b), 93.316, 93.318(a) | The deciding official issues a written decision and the institution then transmits the record to ORI, except that if the respondent appeals before transmittal, the institution waits until the appeal concludes (93.315(b)). Securely retain the institutional record and all sequestered evidence, including physical objects, for seven years after the institutional proceeding or any HHS proceeding on the allegation under subparts D and E ends, whichever is later, unless custody transfers to HHS under 93.318(b) or ORI advises otherwise in writing. |
If an institution does not follow the part and its own assurance, ORI may find it noncompliant (93.412) and may require corrective actions or place it on special review status; for a substantial or recurrent failure it may revoke the assurance (93.413(b), (d)).
How does IHS help?
- Gap assessment. IHS reads your policy against sections 93.300 through 93.319 and lists each gap.
- Drafting. IHS drafts the policy and procedures from assessment through appeal and the institutional record, for your counsel and leadership to approve.
- Conflict screen and roles. IHS drafts the conflict screen (93.300(b), 93.305(f)) and role descriptions that keep the RIO and deciding official separate.
- Tracker and letters. IHS builds a one-page tracker for the 90-day, 30-day and 180-day limits and drafts template notices for counsel.
- Evidence mapping and mock review. IHS maps documents and evidence to Part 93, then conducts a mock document review and identifies remaining readiness gaps.
Supply your policy, assurance, committee charters, officials’ names and latest annual report. Counsel reviews every procedure. The institution runs proceedings and files reports; IHS does neither and gives no legal advice.
What should an institution have ready?
- Policy covering applicable institutional duties and definitions, including reasonable and practical reputation protection or restoration efforts when requested and appropriate for persons without a misconduct finding (Part 93, revised rule, 93.304).
- RIO, separate deciding official and Certifying Official roles (Part 93, revised rule, 93.217–93.218, 93.233).
- Conflict screening covering potential, perceived and actual conflicts (Part 93, revised rule, 93.300(b), 93.305(f)).
- Sequestration procedures and documented assessments (Part 93, revised rule, 93.305(a), 93.306(c)).
- Deadline tracker with inquiry-delay documentation and investigation-extension procedures (Part 93, revised rule, 93.307(h), 93.309–93.311).
- Record index and retention schedule using the seven-year trigger and exceptions above (Part 93, revised rule, 93.220(b), 93.318).
If several items are missing, bring the list to the free introductory call.
How does it compare with drafting your own or starting from ORI's sample?
Writing your own policy starts with your institution’s procedures; ORI’s customizable sample supplies a starting document; IHS adds the gap assessment, drafts and tools described above. The institution remains responsible for its adopted procedures. ORI lists the sample in PDF and Word, last edited June 4, 2025 (Sample Policy and Procedures; Guidance Documents; pages opened November 5, 2026). The sample itself was not reviewed.
What does it cost?
ORI does not publish a fee for the assurance or the annual report on the pages we reviewed. IHS scopes each engagement after a free introductory call.
What this is not
- It is not legal advice. IHS is a consulting firm, not a law firm.
- It is not participation in a proceeding. IHS does not investigate or report on an allegation or contact ORI.
- It is not a guarantee that ORI will accept a policy.
Frequently asked questions
What does 42 CFR Part 93 require of an institution?
Covered institutions need compliant procedures and an active ORI assurance; ORI may approve a Small Institution Statement instead of specified policies (93.300–93.303). They must follow their procedures and respond thoroughly, competently, objectively and fairly to each allegation for which they are responsible under Part 93.
What is research misconduct under Part 93?
Research misconduct is fabrication, falsification or plagiarism in proposing, performing or reviewing research or reporting results; it excludes "honest error or differences of opinion" (93.234). Self-plagiarism and authorship or credit disputes are excluded under 93.227(b).
Does the revised Part 93 apply to every allegation?
No. For covered allegations received by the institution on or after January 1, 2026, the revised part applies; earlier allegations follow the 2005 edition unless institution and respondent elect otherwise in writing. Policies had a separate implementation-and-submission deadline tied to the annual report covering 2025 (93.75).
What are the inquiry and investigation time limits?
Inquiries have 90 days from initiation unless circumstances warrant longer, with reasons documented in the report (93.307(h)). Investigations start within 30 days of the decision that an investigation is warranted and must finish all aspects within 180 days of beginning the investigation, including ORI record transmittal, subject to ORI extensions (93.310–93.311).
Can an institution ask ORI for more time?
If an investigation cannot finish within 180 days, the institution must request an ORI extension in writing explaining why; a report for an investigation exceeding 180 days must also explain the delay (93.311). An inquiry exceeding 90 days needs documented reasons, but 93.307(h) does not require an ORI extension request.
Can one person be both the RIO and the deciding official?
No. Section 93.218 says the same individual cannot serve as the Institutional Deciding Official and the Research Integrity Officer.
Can a small institution file a statement instead of a full policy?
With ORI approval, a Small Institution Statement can replace the policies required by 93.300(a), 93.301 and 93.304. The institution must still comply with every other provision and agrees to report all allegations to ORI (93.303).
What does IHS draft, and what does the institution approve?
IHS drafts the gap assessment, policy, procedures, conflict screen, tracker and template letters. The institution and its counsel approve them and run any proceeding. IHS does not contact ORI.