Voluntary Exclusion Agreements in ORI Cases

Not every research misconduct case under Public Health Service (PHS) research-misconduct regulations ends with the U.S. Office of Research Integrity (ORI) issuing a formal finding. A significant number close through a voluntary exclusion agreement (VEA) — a negotiated settlement in which the respondent accepts specific administrative restrictions without ORI, or in some cases the institution, ever completing a formal finding of research misconduct. This guide explains what a voluntary exclusion agreement actually is, the regulatory provision that authorizes it, what it typically requires, and how it differs from the fully adjudicated path covered in CASRAI’s companion guides on the investigation process and respondent rights.

What is a voluntary exclusion agreement?

A voluntary exclusion agreement is a settlement between a respondent (and often their institution) and the U.S. Department of Health and Human Services (HHS), acting through ORI, that closes a research misconduct matter by agreement rather than through a completed inquiry, investigation, and formal finding. The respondent agrees to specific restrictions — most commonly a period of exclusion from federally funded research activity — in exchange for HHS closing the case on negotiated terms.

The defining feature, and the one this guide is built around, is that a VEA does not require ORI to have made, or to ever make, a formal finding of research misconduct. The case can be settled at essentially any stage — during an institutional inquiry, during an ORI review, or after a finding has already been proposed — and the settlement itself becomes the public record of the outcome instead of a Federal Register notice describing a finding.

The regulatory basis: 42 CFR 93.409

The authority for this mechanism sits in 42 CFR § 93.409, “Settlement of research misconduct proceedings,” part of the PHS research-misconduct regulation ORI administers. The rule is short and direct on the point that matters most for this topic:

93.409(a) — HHS may settle a research misconduct proceeding at any time it determines that settlement is in the best interests of the federal government and the public health or welfare.
93.409(b) — Settlement agreements are publicly available, regardless of whether ORI made a finding of research misconduct. This is the specific regulatory text that makes a settlement-without-a-finding an officially recognized outcome, not an informal workaround.
93.409(c) — A settlement agreement precludes the respondent from later contesting any ORI findings of research misconduct, HHS administrative actions, or ORI’s jurisdiction over the proceeding. Signing closes off the appeal and hearing rights that would otherwise apply under 42 CFR Part 93’s respondent-rights provisions.

Separately, 42 CFR § 93.408 sets out the mitigating and aggravating factors ORI and HHS weigh when an administrative action is imposed following a finding — the same factors inform what terms HHS is willing to accept in a negotiated settlement, even though 93.408 itself governs post-finding actions rather than settlements directly.

What a voluntary exclusion agreement typically requires

Terms vary case by case, but ORI’s published guidance and its public settlement record describe a recurring structure:

A defined exclusion period — commonly around three years — during which the respondent agrees not to contract or subcontract with any U.S. government agency and is excluded from participating in “covered transactions” under the government-wide debarment and suspension regulations (the same nonprocurement debarment framework behind SAM.gov’s exclusion screening).
Exclusion from PHS advisory and peer-review service — the respondent typically agrees not to serve on PHS advisory committees, review panels, or in a consulting capacity to PHS for the exclusion period.
A supervision period after exclusion ends — a further period, sometimes longer than the exclusion itself, during which any PHS-supported research the respondent is involved in must proceed under a supervision plan.
ORI approval of a supervision plan — before resuming PHS-supported research, the respondent’s institution typically must submit a plan describing the oversight arrangements to ORI for review and approval.

Institutions considering closing a case this way are expected to coordinate with ORI before finalizing it — PHS regulations require notifying ORI in advance when an institution intends to close a research misconduct proceeding, at any stage, on the basis of an admission or a settlement, rather than presenting ORI with a fait accompli.

How this differs from a formal ORI finding

It helps to place a VEA next to the fully adjudicated alternative. CASRAI’s guide to how a research misconduct investigation actually works walks through that full path: institutional assessment, a formal inquiry, a formal investigation, a draft report the respondent has a mandatory opportunity to comment on, referral to ORI, and — if ORI concurs — a published PHS finding of research misconduct plus whatever HHS administrative action follows. Recent litigation illustrates just how far that fully contested path can run: in Frech v. HHS, a formal ORI finding made in 2023 was still being challenged in federal court more than two years later before a district court upheld both the finding and the resulting debarment in December 2025.

A voluntary exclusion agreement sidesteps that entire trajectory. Key differences:

No formal finding required. Under 93.409(b), the settlement is valid whether or not ORI ever makes a finding — the case can close on negotiated terms before the investigation reaches a conclusion on the merits.
No admission of guilt is required by the regulation itself, though individual settlement agreements can and do vary in what they state about the underlying conduct; read the specific agreement rather than assuming a uniform admission or non-admission clause across cases.
No further right to contest. A respondent who pursues the full investigation path retains appeal and hearing rights at each stage (see CASRAI’s guide to respondent rights during an ORI investigation). Signing a settlement under 93.409(c) waives those rights going forward for the matters the settlement covers.
Faster resolution. A contested finding-and-administrative-action path can run for years, as the Frech case shows. A settlement can close the case in a fraction of that time, which is a large part of why HHS considers it “in the best interests of the federal government and the public health or welfare” in appropriate cases.

Why an institution or respondent might choose settlement

From HHS’s side, 93.409(a) frames the decision as a public-interest judgment: settling can conserve investigative resources, secure prompt protective restrictions on a respondent’s federal research activity without years of contested proceedings, and produce a public record even where the evidentiary record might not have supported a formal finding to the standard ORI would need to defend on appeal.

From a respondent’s side, a VEA trades the right to contest for certainty and speed — accepting defined restrictions now rather than facing an open-ended investigation, a possible formal finding, and the debarment, correction, and reputational consequences a contested finding can carry (see CASRAI’s guide on the consequences of research misconduct). For an institution, a settled case also closes out its own institutional inquiry and investigation obligations under Subpart C of 42 CFR Part 93 without needing to complete every procedural step of a full investigation to conclusion.

What a voluntary exclusion agreement does not do

A VEA is a narrow instrument. It resolves the specific PHS research-misconduct proceeding it names and the administrative terms both sides agreed to — nothing more:

It does not resolve separate institutional employment or disciplinary action; an institution can still terminate, demote, or otherwise discipline a respondent independently of what ORI’s proceeding covers.
It does not resolve separate federal exposure, such as False Claims Act liability tied to the same underlying data if federal funds were fraudulently obtained or expended, or criminal referral in the rare cases that rise to that level.
It does not undo journal-level consequences (retraction, correction, or an expression of concern) — those are editorial decisions made independently under frameworks like COPE’s guidelines, regardless of how the PHS proceeding is resolved.
It does not necessarily determine which jurisdiction’s process governs other aspects of the same underlying conduct if multiple funders or institutions were involved.

Finding real examples

ORI’s own public case-summary register (ori.hhs.gov/case_summary) lists administrative actions, including those arising from voluntary exclusion agreements, alongside those arising from formal findings. One structural limitation worth knowing before treating that register as a complete archive: it lists only cases with a currently active administrative action, organized by the year the case closed — older cases whose sanction period has already run drop off the public list. It is a real, useful primary source for reviewing actual settlement terms, but not a complete historical record of every VEA ORI has ever concluded.

Frequently asked questions

Does a voluntary exclusion agreement mean the respondent admitted to research misconduct?

Not necessarily, and not uniformly. The regulation authorizing settlement (42 CFR 93.409) does not itself require an admission, and settlement terms vary by case — some respondents settle without admitting wrongdoing, while others’ agreements do reference an admission. The specific published agreement, not a general assumption, is the source to check for a given case.

Can ORI still publish something about a case that settles without a finding?

Yes. 93.409(b) makes settlement agreements publicly available specifically “regardless of whether ORI made a finding of research misconduct” — the settlement itself, not a finding notice, becomes the public record.

Is a voluntary exclusion agreement the same thing as debarment?

Related but not identical. A VEA is the negotiated settlement; excluding the respondent from covered federal transactions for a defined period is typically one of its terms, functioning similarly to a debarment action but arising from agreement rather than a debarring official’s unilateral administrative action following a finding, which is the path described in CASRAI’s guide to OIG exclusion-list screening for a related but distinct HHS exclusion authority.

Can a respondent back out of a voluntary exclusion agreement after signing?

93.409(c) specifically precludes a respondent from later contesting the ORI findings, HHS administrative actions, or ORI’s jurisdiction covered by the settlement — signing forecloses the appeal and hearing avenues that remain open to a respondent who does not settle.

Voluntary Exclusion Agreements: Settling an ORI Misconduct Case Without a Formal Finding