Respondent Rights During an ORI Research Misconduct Investigation

When a US institution opens a research misconduct proceeding under Public Health Service (PHS) regulations, the person accused — the respondent — is not a passive subject of the process. 42 CFR Part 93, the federal regulation ORI enforces for PHS-funded research, builds a specific set of procedural rights into the institutional inquiry and investigation stages: access to the records and evidence the institution is relying on, a guaranteed opportunity to review and comment on the draft investigation report before it is finalized, and, if the case escalates to ORI or an HHS administrative action, further avenues to respond. This guide covers what those rights actually consist of, where they come from in the regulation, and what a respondent should expect and can reasonably ask for at each stage.

This is a companion to How a Research Misconduct Investigation Actually Works, which walks through the full inquiry-to-investigation-to-ORI-review process. That guide covers the institution’s obligations end to end; this one focuses specifically on what the respondent is entitled to at each step.

Who counts as a “respondent,” and when these rights start

Under 42 CFR Part 93, a respondent is the individual against whom an allegation of research misconduct (fabrication, falsification, or plagiarism in proposing, performing, reviewing, or reporting PHS-supported research) has been made, or who is the subject of an inquiry or investigation. Procedural rights attach at different points:

• Assessment stage — before a formal inquiry opens, the institution is evaluating whether an allegation meets the regulatory definition. The respondent typically has no formal rights yet at this stage; many institutions do not notify the respondent until an inquiry is authorized.
• Inquiry stage — once the Research Integrity Officer (RIO) opens a formal inquiry to determine whether an investigation is warranted, the respondent must be notified in writing and given the substance of the allegation.
• Investigation stage — if the inquiry finds that an investigation is warranted, the respondent’s rights expand substantially: notice of the specific allegations being investigated, sequestration and access provisions for relevant records, and — the centerpiece of this guide — a mandatory opportunity to review and comment on the draft investigation report.
• Post-investigation / ORI review — if the institution refers findings to ORI (or the case otherwise reaches HHS), the respondent has further opportunities to respond, up to and including a hearing before an HHS Administrative Law Judge if a PHS administrative action is proposed.

The regulatory basis: 42 CFR Part 93, Subpart C

The respondent rights described in this guide come from Subpart C of 42 CFR Part 93 (the regulation governing PHS Policies on Research Misconduct, administered by ORI), which sets the minimum requirements every PHS-funded institution’s own research misconduct policy must meet. Institutions can build additional protections into their own policies — many do — but Part 93 sets the federal floor. The most directly relevant provision for the draft-report and comment-period rights covered below is 42 CFR 93.312, which governs the institution’s obligations at the close of an investigation.

Two things worth flagging up front, because they surprise respondents in practice: first, these rights govern the institutional process, not a parallel federal proceeding — ORI does not run the investigation itself in the first instance; the institution does, and Part 93 is what obligates the institution to extend these protections. Second, the regulation sets a floor, not a ceiling — an institution’s own policy, a collective bargaining agreement, or (outside PHS-funded research) a different funder’s or journal’s own process can grant additional rights Part 93 does not itself require.

Record access: sequestration, custody, and what the respondent can see

Before or promptly after a respondent is notified that an inquiry has opened, the institution is required to take custody of — sequester — the research records and evidence relevant to the allegation, specifically to prevent alteration, loss, or destruction while the matter is pending. This sequestration requirement exists for the integrity of the process generally, but it has a direct consequence for the respondent too: it fixes the evidentiary record early, before memories fade or files get reorganized, which cuts both ways — it protects against records being altered, but it also means a respondent who believes exculpatory records exist elsewhere (a collaborator’s notebook, a shared server, an email thread) needs to raise that early, before the sequestered set is treated as complete.

During the investigation itself, 42 CFR 93.312 requires the institution to give the respondent a copy of, or supervised access to, the research records and other evidence that the investigation committee considered or relied on in reaching its findings. This is a substantive right, not a courtesy: a respondent is not expected to comment meaningfully on a draft report’s findings without having actually seen the evidentiary basis for those findings. In practice this usually means the RIO or investigation committee makes the sequestered record set (lab notebooks, data files, correspondence, prior drafts, interview summaries where applicable) available for review, either as copies or under supervised in-person or electronic access, depending on the institution’s own procedures and any data-security constraints on the records themselves.

What this access right does not automatically extend to: internal committee deliberations, draft findings before they’re finalized into the report, or records the committee did not itself rely on. Some institutions voluntarily provide broader access; the regulation’s floor is specifically “considered or relied on.”

Notice requirements the institution owes the respondent

Part 93 requires written notice to the respondent at defined points, not just a single upfront notification:

• Notice that an inquiry has been opened, including the general nature of the allegation, before or at the same time records are sequestered wherever practicable.
• Notice that an investigation has been opened following an inquiry finding that one is warranted, including the specific allegations to be investigated — this matters because an investigation can be, and often is, narrower or differently framed than the original inquiry-stage allegation once the RIO and inquiry committee have looked at it.
• Notice of any new or expanded allegations discovered during the investigation itself, so the respondent is never asked to answer for a finding they were never told was under investigation.
• Notice with the draft investigation report, covered in detail below.

The draft investigation report: mandatory review and the comment period

This is the right most respondents care about most, and the one with the clearest regulatory text behind it. Under 42 CFR 93.312, once the investigation committee has finished its work and produced a draft investigation report, the institution must give the respondent an opportunity to review that draft before it is finalized and before it goes to any institutional deciding official or to ORI. The respondent has 30 days from receiving the draft report to submit comments to the institution.

A few operational points that matter for anyone actually going through this:

• The draft report is meant to be substantively complete — findings, the evidence supporting them, and (typically) a recommended disposition — not a summary. A respondent reviewing a draft that omits the reasoning behind a finding has grounds to ask the institution for the underlying basis, consistent with the record-access right above.
• Comments go into the record, not just into a mailbox. The regulation is about giving the respondent a genuine chance to correct factual errors, challenge the committee’s interpretation of the evidence, or provide context before the finding is locked in — not a symbolic formality. Institutions are expected to actually consider comments received within the window, and many institutional policies require the committee or RIO to document how comments were addressed (accepted, rejected with reasons, or partially incorporated) before the report is finalized.
• The comment period is procedural, not a re-investigation. It is not, by regulation, a new hearing with live testimony or cross-examination — institutions vary in whether their own policies allow a respondent meeting with the committee at this stage, but Part 93’s floor is a written comment opportunity on the draft, not an adversarial hearing.
• Missing the 30-day window has real consequences. If a respondent needs more time — to review a large record set, arrange representation, or gather a response — that needs to be requested from the RIO before the window closes; institutional policies differ on whether and how extensions are granted, and Part 93 itself does not guarantee one.

The institution can also, at its discretion, share relevant portions of the draft report with the complainant and invite comments on the same timeline — see the note on complainant rights below. That is a separate, parallel channel; it does not shorten or dilute the respondent’s own 30-day comment right.

What happens to the respondent’s comments

After the comment period closes, the institution finalizes the investigation report, which becomes the basis for the institution’s own findings and any proposed institutional action, and (where the findings involve PHS-supported research and meet the regulatory threshold) the report the institution submits to ORI. The respondent’s comments themselves — and how the institution addressed them — are typically retained as part of the institutional record and, in many institutional policies, forwarded to ORI along with the final report rather than left behind at the institutional level. This matters because it means a respondent’s written comments don’t simply vanish once the institutional decision is made; they can become part of what ORI itself reviews if the case reaches federal oversight review.

What respondent rights do not cover

It’s worth being precise about the limits, since overstating these rights is as unhelpful as understating them. Part 93’s respondent protections do not, by themselves, guarantee:

• A right to have an attorney present and speaking during institutional interviews or committee proceedings — this is governed by institutional policy, not federal regulation, and varies considerably by institution.
• A right to confront or cross-examine witnesses during the institutional investigation — the process is inquisitorial (committee-driven fact-finding), not adversarial in the courtroom sense, at the institutional stage.
• A right to a public proceeding — the opposite is true; Part 93 requires confidentiality protections for the process itself, which also, in practice, protects the respondent from public disclosure while a matter is pending and not yet substantiated.
• A right to see draft committee deliberations or internal memoranda that were not part of the evidentiary basis for the findings.

Where an institutional proceeding intersects with a separate employment action, tenure process, or licensing board matter, additional due-process rights may come from those other frameworks (a faculty handbook, a collective bargaining agreement, a state licensing statute) rather than from Part 93 itself — Part 93 is the floor for the research-misconduct process specifically, not a substitute for whatever other procedural protections an individual’s employment status separately provides.

A parallel, narrower right: complainant comment on the draft report

Because the two are easy to conflate, it’s worth being explicit: institutions may, but are not required in every circumstance to, share relevant portions of the draft investigation report with the person who raised the original allegation (the complainant) and invite comment on the same general timeline. This is a narrower, discretionary provision compared to the respondent’s own review right, and it is scoped to relevant portions rather than the full draft. See Research Misconduct Whistleblower Protections for the complainant/whistleblower side of the process, including retaliation protections, which is a genuinely separate topic from the respondent rights covered here.

If the case reaches ORI or HHS: further opportunities to respond

Respondent rights don’t end when the institution finalizes its report. If an institution’s substantiated finding is forwarded to ORI, and ORI’s own oversight review leads to a proposed PHS administrative action (such as debarment, supervision requirements, or a correction of the research record), the respondent has additional opportunities in that federal-level process, including the ability to respond to ORI’s findings and, for a proposed administrative action, to request a hearing before an HHS Administrative Law Judge rather than accept the proposed action. See The Consequences of Research Misconduct for what those downstream administrative, funding, and career outcomes actually look like, and How a Research Misconduct Investigation Actually Works for how the institutional and ORI-level stages connect procedurally.

Practical checklist for a respondent

• Get the notice of inquiry or investigation in writing, and confirm exactly which allegations are covered — ask if anything is ambiguous rather than assuming.
• Request access to the sequestered records and evidence the committee is relying on as early as possible, rather than waiting for the draft report to arrive.
• If you believe relevant records exist outside the sequestered set, flag them to the RIO promptly, in writing.
• Calendar the 30-day comment window the moment the draft report is received, and request an extension in writing before the window closes if more time is genuinely needed — don’t assume one will be granted informally.
• Keep a copy of everything submitted, including comments on the draft report — this record can matter again at the ORI review stage.
• Check your own institution’s policy for provisions beyond the Part 93 floor (representation, informal resolution options, internal appeal steps) — these vary by institution and are not uniform across the field.

Frequently asked questions

Does a respondent get to see the evidence against them in an ORI investigation?

Yes, for the institutional investigation stage. Under 42 CFR 93.312, the institution must provide the respondent a copy of, or supervised access to, the research records and other evidence the investigation committee considered or relied on in reaching its findings. This does not automatically extend to internal committee deliberations or records the committee did not rely on.

How long does a respondent have to comment on the draft investigation report?

30 days from receiving the draft report, per 42 CFR 93.312. Extensions are a matter of institutional discretion, not a regulatory guarantee, so a respondent who needs more time should request one in writing before the window closes.

Can a respondent bring a lawyer to interviews or committee meetings during the investigation?

Part 93 itself does not address representation during institutional interviews or proceedings — that’s governed by the institution’s own policy, which varies. Check the specific institution’s research misconduct policy rather than assuming a uniform right.

Does ORI conduct the investigation itself?

No, in the first instance. The institution conducts its own inquiry and investigation under its Part-93-compliant policy; ORI’s role is oversight review of the institution’s findings, particularly for cases involving PHS-supported research where the institution’s finding is substantiated.

What happens to a respondent’s comments on the draft report after the comment period ends?

The institution is expected to consider the comments before finalizing the report, and the comments themselves typically become part of the institutional record — often forwarded to ORI along with the final report if the case reaches federal oversight review, rather than discarded at the institutional level.

Is the research misconduct process confidential?

Yes — Part 93 requires confidentiality protections around the process, which in practice also protects a respondent from public disclosure of an unresolved, unsubstantiated allegation while the matter is pending.

Related CASRAI resources

• How a Research Misconduct Investigation Actually Works — the full inquiry-to-ORI-review process.
• Research Misconduct Whistleblower Protections — the complainant side of the process.
• The Consequences of Research Misconduct — career, funding, and legal outcomes if a finding is substantiated.
• Research Misconduct Case Studies — what real investigations reveal.
• Research misconduct (dictionary)
• ORI (US Office of Research Integrity) (dictionary)
• Research Integrity Officer (RIO) (dictionary)
• Integrity & Compliance pillar