United States Court of Appeals 

For the First Circuit 

No. 15-1897 

PIERO ANVERSA and ANNAROSA LERI, 

Plaintiffs, Appellants, 

v. 

PARTNERS HEALTHCARE SYSTEM, INC., ET AL., 

Defendants, Appellees. 

APPEAL FROM THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF MASSACHUSETTS 

[Hon. Denise J. Casper, U.S. District Judge] 

Before 

Thompson, Selya and Kayatta, 

Circuit Judges. 

 Tracy A. Miner, with whom Megan A. Siddall and Demeo LLP were 

on brief, for appellants. 

 Roberto M. Braceras, with whom Jennifer L. Chunias and Goodwin 

Procter LLP were on brief, for appellees Harvard Medical School 

and Gretchen Brodnicki. 

 Geoffrey M. Raux, with whom Michael J. Tuteur and Foley & 

Lardner LLP were on brief, for remaining appellees. 

 

August 30, 2016 
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SELYA, Circuit Judge. There is a time for every action, 

cf. Ecclesiastes 3:1 ("To every thing there is a season, and a 

time to every purpose . . . ."), including the bringing of suit. 

This case breathes life into that axiom. 

The context is the high-stakes world of academic medical 

research. The questions before us have their genesis in 

allegations that the plaintiffs (prominent medical researchers) 

used manipulated research data in articles reporting on studies 

supported by government funds. Responding to those allegations, 

the institutional defendants (including a medical school and a 

teaching hospital) triggered a unique federal statutory and 

regulatory scheme. Things did not go smoothly and, after some 

time elapsed, the plaintiffs repaired to the federal courts in 

search of relief (without awaiting the outcome of the 

administrative proceedings). 

Concluding that the suit was premature because the 

plaintiffs had not exhausted their administrative remedies, the 

district court dismissed the action. See Anversa v. Partners 

Healthcare Sys., Inc., 116 F. Supp. 3d 22, 34-35 (D. Mass. 2015). 

The plaintiffs appeal. Their appeal raises novel questions at the 

federal appellate level concerning the interrelationship between 

the statutory and regulatory scheme and state-law causes of action 

touching upon its implementation. Answering those questions, we 

affirm the district court's application of the doctrine of 
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administrative exhaustion but modify the judgment to ensure that 

the suit receives a full airing at the appropriate time. 

I. STATUTORY AND REGULATORY FRAMEWORK

We begin with a description of the unique and highly 

detailed statutory and regulatory scheme that underlies this 

appeal. The federal government provides substantial funding for 

path breaking medical research. Fearful that these funds could be 

misused by researchers who might fabricate, falsify, or otherwise 

doctor research outcomes, Congress envisioned a need to establish 

procedures to address complaints of research misconduct. To this 

end, Congress created the Office of Research Integrity (ORI) within 

the Department of Health and Human Services (HHS), see 42 U.S.C. 

§ 289b(a)(1), and tasked ORI with responsibility for carrying out 

regulations to be promulgated by the Secretary of HHS (the 

Secretary) for the investigation of research misconduct 

allegations, see id. § 289b(a)(2), (b)-(e). 

Among other things, the statute obligates the Secretary 

to promulgate regulations that define "research misconduct," id. 

§ 289b(a)(3)(A); to ensure that institutions receiving funds have 

a compliant "administrative process to review reports of research 

misconduct," id. § 289b(b)(1); and to create a process for ORI 

itself to receive allegations of and reports about research 

misconduct, to carry out its own investigations as needed, and to 

take necessary remedial action, see id. § 289b(c). Relatedly, 
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Congress tasked the Secretary with fashioning regulations that 

would facilitate ORI's oversight of institutional compliance with 

the research misconduct regulations. See id. § 289b(d). Congress 

also authorized the Secretary to appoint ORI's director, who must 

"be experienced and specially trained in the conduct of research, 

and have experience in the conduct of investigations of research 

misconduct." Id. § 289b(a)(2). 

The Secretary has responded to this statutory mandate by 

promulgating an elaborate regulatory mosaic. In that mosaic, 

"research misconduct" is defined as "fabrication, falsification, 

or plagiarism in proposing, performing, or reviewing research, or 

in reporting research results." 42 C.F.R. § 93.103. Establishing 

research misconduct requires a showing, by a preponderance of the 

evidence, of "a significant departure from accepted practices of 

the relevant research community" that is "committed intentionally, 

knowingly, or recklessly." Id. § 93.104. 

These standards inform a protocol which, mirroring 

congressional intent, creates a two-level process for review of 

research misconduct allegations. The first level occurs at the 

funded institution. An inquiry "is warranted" when the institution 

is made aware of "sufficiently credible and specific" allegations 

of research misconduct. Id. § 93.307(a)(3). Such an inquiry 

comprises "an initial review of the evidence to determine whether 

to conduct an investigation." Id. § 93.307(c). The institution 
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generally "must complete the inquiry within 60 calendar days of 

its initiation unless circumstances clearly warrant a longer 

period," and it must document the reasons for any delays in 

completing the inquiry. Id. § 93.307(g). The inquiry culminates 

in a written report — a report on which the target of the inquiry 

(the respondent) has the opportunity to comment. See id. 

§ 93.307(e)-(f). 

If the inquiry finds a "reasonable basis for concluding" 

that some research misconduct involving federal funds has taken 

place, id. § 93.307(d)(1), and that particularized allegations of 

research misconduct "may have substance," id. § 93.307(d)(2), the 

institution must notify ORI of the inquiry results within 30 days, 

sending along a copy of the inquiry report, see id. § 93.309(a). 

It must also give the respondent notice of the allegations that 

the investigation will explore. See id. § 93.310(c). 

From that point forward, the institution is obliged to 

conduct a "thorough and sufficiently documented" investigation, 

which "includes examination of all research records and evidence 

relevant to reaching a decision on the merits of the allegations." 

Id. § 93.310(e). The institution is expected to interview all 

relevant witnesses, see id. § 93.310(g), and to "[p]ursue 

diligently all significant issues and leads discovered that are 

determined relevant to the investigation . . . and continue the 

investigation to completion," id. § 93.310(h). As with the earlier 
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inquiry, the investigation culminates in a written report, on which 

the respondent has the opportunity to comment. See id. 

§§ 93.312(a), 93.313(g). This phase of the regulatory framework 

has its own temporal limitation: it provides that "[a]n institution 

must complete all aspects of an investigation within 120 days," 

id. § 93.311(a), unless it requests and receives an extension from 

ORI, see id. § 93.311(b). Regardless of whether the investigation 

concludes that research misconduct occurred, the report, its 

findings and conclusions, all the relevant evidence, and any 

information about actions taken or pending by the institution must 

be forwarded to ORI. See id. § 93.315. 

Once ORI receives the investigation report and the 

related materials, it conducts its own assessment of the 

allegations. ORI has the authority to obtain additional input 

from virtually any source, supplement the evidence, and develop 

its own analysis. See id. § 93.403(d)-(e). Moreover, ORI may 

make independent findings as to whether research misconduct was 

committed and if so, by whom. See id. § 93.403(f). It also may 

recommend appropriate administrative action, which can range from 

the relatively mild (say, a letter of reprimand) to the relatively 

severe (say, debarment from eligibility to receive federal 

research funding). See id. § 93.407(a). 

Even beyond the notice requirements, opportunities for 

comment, and time limits described above, the regulatory framework 
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contains protections for researchers facing investigation. For 

example, the regulations offer assurances of confidentiality, 

limiting disclosure of information about an ongoing proceeding "to 

the extent possible, to those who need to know." Id. § 93.108(a). 

So, too, the regulations require institutions to "[t]ake 

reasonable steps to ensure an impartial and unbiased investigation 

to the maximum extent practicable." Id. § 93.310(f). In this 

regard, institutions must ensure that those participating in the 

investigation have the "appropriate scientific expertise" and are 

not affected by "personal, professional, or financial conflicts of 

interest." Id. 

Should ORI find research misconduct, a respondent has 

access to an additional safety valve: a right to appeal that 

finding and any resulting administrative action to an 

administrative law judge (ALJ). See id. § 93.500(b). The ALJ's 

review of both ORI's finding and its proposed administrative action 

is de novo. See id. § 93.517(b). Withal, the ALJ "does not review 

the institution's procedures or misconduct findings." Id. When 

issued, the ALJ's decision serves as a recommendation to the 

Assistant Secretary for Health in HHS, who may affirm, modify, or 

reject it entirely. See id. § 93.523(b). In making those 

determinations, the Assistant Secretary uses familiar standards of 

review, such as whether particular findings are clearly erroneous 

or whether the decision (or any part of it) is arbitrary or 
- 8 - 

capricious. See id. The Assistant Secretary's decision 

constitutes final agency action for most purposes,1 subject to 

review in the federal courts under the Administrative Procedure 

Act (APA). See 5 U.S.C. § 701-706. 

Three other features of this statutory/regulatory scheme 

deserve mention. First, although ORI examines the institution's 

handiwork in determining whether to carry out its own 

investigation, see 42 C.F.R. § 93.403(c), there is no formal 

process for a respondent to prefer charges that an institution has 

violated the regulations in the course of either the inquiry or 

the first-tier investigation. The regulations do, however, 

provide a process by which ORI may, on its own initiative, probe 

an institution's compliance with the regulations and take 

appropriate enforcement action. See id. §§ 93.412-.413. 

Second, it is manifest that neither the statute nor the 

regulations contemplate enforcement by private parties. Instead, 

enforcement is left to the Secretary, acting through ORI and the 

Assistant Secretary for Health. 

Finally, the statute itself contains no explicit 

exhaustion requirement. While the district court found an 

 

 1 We say "for most purposes" because a recommendation for 

debarment or suspension from receiving federal research funds only 

becomes final after ratification by a different official. See 42 

C.F.R. § 93.523(c). 
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exhaustion requirement to be implicit in the statutory scheme, see 

Anversa, 116 F. Supp. 3d at 31-32, it is unnecessary (for reasons 

to which we shortly shall return) for us to pass upon this aspect 

of the district court's decision — and we do not do so. Instead, 

we resolve this appeal on the basis of the district court's 

alternate holding (its administrative exhaustion ruling). 

II. FACTUAL OVERVIEW

The raw facts, outlined in the complaint, are 

essentially undisputed for present purposes. The plaintiffs are 

two high-profile medical researchers, Dr. Piero Anversa and Dr. 

Annarosa Leri. At the time of the underlying events, both of them 

held faculty appointments at Harvard Medical School (Harvard).2 

In addition to their teaching roles, both plaintiffs were 

intimately involved with a cardiac stem cell research laboratory 

at Brigham and Women's Hospital (the Brigham): Dr. Anversa led the 

lab, and Dr. Leri toiled as a principal investigator there. The 

Brigham, it should be noted, is not only a Harvard teaching 

hospital but also a founding member of the Partners HealthCare 

System (Partners). 

In 2012, questions arose about the authenticity of data 

that appeared in an article co-authored by the plaintiffs and other 

 

 2 At oral argument in this court, plaintiffs' counsel reported 

that both of her clients have left Harvard and are now working in 

Switzerland. 
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scientists, including a researcher at Lawrence Livermore National 

Laboratory (LLNL). Shortly after the publication of this paper in 

the journal "Circulation," the LLNL researcher reported to the 

plaintiffs that discrepancies existed between the data LLNL had 

provided and the data presented in the paper. Dr. Anversa asserts 

that he repeatedly asked the Brigham lab member who received the 

LLNL data if the presentation in the paper was accurate and 

received assurances that everything was in order. But LLNL 

persisted; it reported the discrepancies to Gretchen Brodnicki, 

Harvard's Dean for Faculty and Research Integrity. 

On January 10, 2013, Dean Brodnicki informed the 

plaintiffs that Harvard and the Brigham were going to begin a joint 

inquiry into allegations of research misconduct. These 

allegations related not only to the "Circulation" paper but also 

to an article co-authored by the plaintiffs and other collaborators 

that had appeared in another journal, "The Lancet," in 2011. 

The inquiry took substantially longer than the 60 days 

allotted in the regulations. One reason was that (as Dean 

Brodnicki told the plaintiffs in March of 2013) the inquiry was 

expanded to encompass yet another allegation relating to an 

unpublished manuscript submitted in 2013 to "The Lancet" and the 

journal "Science." The inquiry panel did not submit a draft report 

to the plaintiffs for their comments until January 8, 2014. The 

final panel inquiry report was issued on February 28, 2014. The 
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plaintiffs allege that the report recommended retraction of the 

2011 "Lancet" and 2012 "Circulation" papers, that the lab be 

evaluated for its appropriateness as a training ground for budding 

researchers, and that the inquiry proceed to a full-blown 

investigation. The plaintiffs further allege that "[t]he inquiry 

panel found no evidence that [the plaintiffs] ever participated in 

falsifying or fabricating research data or results, or that they 

even knew of any research misconduct at the time it occurred," but 

nonetheless recommended proceeding to an investigation "on the 

theory that Dr. Anversa should be held responsible for arguably 

negligent failure to investigate" research misconduct. 

Simultaneous with their receipt of the final panel 

inquiry report, the plaintiffs were notified that Harvard and the 

Brigham intended to commence an investigation. The three 

scientists who composed the inquiry panel were appointed to serve 

on the investigation panel, and a fourth member was added a few 

weeks later. On three separate occasions — twice in 2014 and once 

in 2015 (after suit had been commenced) — the investigation was 

expanded to include additional research papers beyond those 

identified in the panel inquiry report. Betimes, Harvard and the 

Brigham have sought — and ORI has granted — multiple extensions to 

the 120-day investigatory period.3

 

 3 At oral argument in this court, counsel for Harvard reported 

that the deadline for completing the investigation authorized by 
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III. TRAVEL OF THE CASE 

In December of 2014 — while the investigation was still 

in progress — the plaintiffs sued Partners, the Brigham, Harvard, 

Dean Brodnicki, and Dr. Elizabeth Nabel (the Brigham's president). 

Their complaint limned claims under Massachusetts law for tortious 

interference with business relations, invasion of privacy, and 

unfair and deceptive business practices. The complaint also 

charged Partners, the Brigham, and Harvard with breach of contract 

based on a claim that the ORI regulations are incorporated into 

their employment contracts with those institutions. 

The plaintiffs alleged that both the completed inquiry 

and the ongoing investigation failed to comply with pertinent 

regulations. Specifically, they alleged that the inquiry panel 

applied the wrong standard in recommending an investigation and 

that its report was riddled with other errors. See id. 

§ 93.104(b). They also ascribed a host of failings to the 

investigation panel, claiming (for example) that some of its 

members lacked the requisite scientific expertise and that some 

were either biased due to their participation in the flawed inquiry 

or labored under conflicts of interest. See id. § 93.310(f). The 

plaintiffs further lamented that both the inquiry and the 

 

the most recent ORI extension is November 1, 2016. The 

investigation panel, we were told, is in the process of drafting 

its report. 
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investigation have been subject to egregious and unwarranted 

delays. See id. §§ 93.307(g), .311(b). Finally, the plaintiffs 

alleged that Dr. Steven Gygi (a member of both the inquiry and 

investigation panels), Dean Brodnicki, and Dr. Nabel separately 

transgressed confidentiality obligations imposed by the 

regulations.4 See id. § 93.108. 

The plaintiffs seek money damages and unspecified 

declaratory relief. With respect to damages, they say that the 

manifold failures that occurred during the inquiry and the 

investigation caused them harm. They claim, for instance, that 

they missed out on a number of promising employment and other 

professional opportunities, and lost a lucrative offer for the 

purchase of Dr. Anversa's company. They also claim that Dr. Leri's 

promotion to a full professorship at Harvard was delayed and that 

they have suffered reputational injury. 

The defendants moved to dismiss. See Fed. R. Civ. P. 

12(b)(1), (6). They contended, inter alia, that the plaintiffs 

should be required to exhaust administrative remedies before 

bringing suit. The district court agreed and dismissed the 

complaint without prejudice. See Anversa, 116 F. Supp. 3d at 35. 

The court held that the statutory scheme governing research 

 

 4 The plaintiffs allege that Dr. Gygi resigned from the 

investigation panel in September of 2014, acknowledging that he 

had discussed the investigation with a colleague. 
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misconduct investigations mandated exhaustion. See id. at 32. 

Alternatively, the court held that common-law principles of 

administrative exhaustion militated in favor of dismissal. See 

id. at 34. This timely appeal followed. 

IV. ANALYSIS 

Given the structure of the district court's disposition, 

an issue of jurisdictional priority looms. Even though the 

doctrines of statutory and administrative exhaustion have a common 

objective — delaying a plaintiff's day in court while 

administrative proceedings run their course — the two doctrines 

rest on different foundations. The question whether a statutory 

scheme requires the channeling of claims through the 

administrative process implicates the jurisdiction of the district 

court. See, e.g., Free Enter. Fund v. Pub. Co. Accounting 

Oversight Bd., 561 U.S. 477, 489-91 (2010); Thunder Basin Coal Co. 

v. Reich, 510 U.S. 200, 207-09 (1994). By contrast, administrative 

exhaustion applies "where Congress has not clearly required 

exhaustion," and cedes discretion to a district court to decline 

the exercise of jurisdiction and await the conclusion of 

administrative proceedings. See McCarthy v. Madigan, 503 U.S. 

140, 144 (1992). 

Here, the district court's ruling consists of two 

alternative holdings. Taken together, these holdings amount to a 

double-barreled conclusion that the statutory structure forbade 
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the district court's exercise of jurisdiction over the action and 

— even if it had jurisdiction — it would decline to exercise that 

jurisdiction for prudential reasons. 

In the ordinary course, questions about the existence of 

subject matter jurisdiction take precedence in our analysis of a 

case.5 See Acosta-Ramírez v. Banco Popular de P.R., 712 F.3d 14, 

18 (1st Cir. 2013). This approach is consistent with the Supreme 

Court's admonition that a court "may not rule on the merits of a 

case without first determining that it has jurisdiction over the 

category of claim in suit." Sinochem Int'l Co. v. Malaysia Int'l 

Shipping Corp., 549 U.S. 422, 430-31 (2007). But the two 

exhaustion doctrines at issue here do not implicate this principle: 

they are simply alternative "threshold grounds for denying 

 

 5 The parties have not contested the existence of Article III 

jurisdiction, and the district court did not consider that 

question. Nevertheless, we have an obligation to assure ourselves 

of our own jurisdiction. See Watchtower Bible & Tract Soc'y of 

N.Y., Inc. v. Colombani, 712 F.3d 6, 10 (1st Cir. 2013). In 

keeping with that obligation, we note that Article III jurisdiction 

exists in this case notwithstanding that the controversy is between 

non-diverse parties and asserts exclusively state-law claims. 

Federal question jurisdiction under 28 U.S.C. § 1331 encompasses 

a narrow swath of cases in which "a state-law claim necessarily 

raise[s] a stated federal issue, actually disputed and 

substantial, which a federal forum may entertain without 

disturbing any congressionally approved balance of federal and 

state judicial responsibilities." Grable & Sons Metal Prods., 

Inc. v. Darue Eng'g & Mfg., 545 U.S. 308, 314 (2005). Given that 

all of the plaintiffs' claims turn on the interpretation of the 

federal regulations governing research misconduct investigations 

and the importance of those regulations to the Congressional 

scheme, this case plainly falls within the narrow swath of cases 

described in Grable.
- 16 - 

audience to a case on the merits." Ruhrgas AG v. Marathon Oil 

Co., 526 U.S. 574, 585 (1999). In comparable situations, the 

Supreme Court has made pellucid that a nonjurisdictional threshold 

reason for pretermitting a merits determination — such as a 

decision not to exercise pendent jurisdiction over state-law 

claims, dismissal on the basis of forum non conveniens, or Younger 

abstention — may be applied without first resolving a difficult 

jurisdictional question. See Sinochem Int'l, 549 U.S. at 431-32. 

Such an approach — bypassing the jurisdictional inquiry 

— is preferable here. The statutory exhaustion analysis is complex 

and uncertain, and its outcome would have no bearing on the 

ultimate result: as we explain below, the district court acted 

well within its discretion in insisting upon administrative 

exhaustion. Thus, we proceed directly to the merits of the 

district court's administrative exhaustion ruling. 

Administrative exhaustion is governed by "sound judicial 

discretion." McCarthy, 503 U.S. at 144. Consequently, the 

customary practice among the circuits has been to review a district 

court's decision to compel the exhaustion of administrative 

remedies, in the absence of a statute directing exhaustion, for 

abuse of discretion. See, e.g., Koch v. White, 744 F.3d 162, 164-

65 (D.C. Cir. 2014); Thermal Sci., Inc. v. U.S. Nuclear Regulatory 

Comm'n, 184 F.3d 803, 805 n.3 (8th Cir. 1999) (per curiam). 

Although we have never explicitly stated the standard in this 
- 17 - 

manner, we have recognized that application of the administrative 

exhaustion doctrine is a matter of discretion, guided by the 

factors identified in McCarthy. See Portela-Gonzalez v. Sec'y of 

the Navy, 109 F.3d 74, 77 (1st Cir. 1997). We hold, therefore, 

that appellate review of a district court's decision to require 

administrative exhaustion should be for abuse of discretion. 

Generally, aggrieved parties are required to exhaust 

available federal administrative remedies before bringing suit in 

federal court. See Myers v. Bethlehem Shipbuilding Corp., 303 

U.S. 41, 50-51, 51 n.9 (1938); Portela-Gonzalez, 109 F.3d at 77. 

This principle rests on solid foundations: exhaustion normally 

"serves the twin purposes of protecting administrative agency 

authority and promoting judicial efficiency." McCarthy, 503 U.S. 

at 145. Preserving agency authority is particularly important 

insofar as "the action under review involves exercise of the 

agency's discretionary power or when the agency proceedings in 

question allow the agency to apply its special expertise." Id. 

Insisting upon exhaustion not only gives an agency the first 

opportunity to apply that expertise and correct possible errors, 

but also respects congressional prerogative by "prevent[ing] 

litigants from bypassing Congress' carefully crafted remedial 

scheme." Irizarry v. United States, 427 F.3d 76, 79 (1st Cir. 

2005). So, too, insisting upon exhaustion promotes judicial 

efficiency both by obviating the need for review in cases in which 
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the agency provides appropriate redress, see Portela-Gonzalez, 109 

F.3d at 79, and by creating "a useful record for subsequent 

judicial consideration, especially in a complex or technical 

factual context," McCarthy, 503 U.S. at 145. 

Where, as here, Congress has not mandated exhaustion, 

federal courts have some leeway to relax this requirement. See 

Swirsky v. Nat'l Ass'n of Sec. Dealers, 124 F.3d 59, 63 (1st Cir. 

1997). That leeway is built into the common-law doctrine of 

administrative exhaustion. In considering whether to exercise it, 

"courts must balance the interest of the individual in retaining 

prompt access to a federal judicial forum against countervailing 

institutional interests favoring exhaustion." McCarthy, 503 U.S. 

at 146. This analysis is "'intensely practical,' because attention 

is directed to both the nature of the claim presented and the 

characteristics of the particular administrative procedure 

provided." Id. (internal citations omitted) (quoting Bowen v. 

City of New York, 476 U.S. 467, 484 (1986)). 

In discussing how to construct this balance, the Supreme 

Court described three "sets of circumstances in which the interests 

of the individual weigh heavily against requiring administrative 

exhaustion." Id. These situations arise when "requiring resort 

to the administrative remedy may occasion undue prejudice to 

subsequent assertion of a court action," id. at 146-47; when an 

administrative remedy may be insufficient because the agency is 
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powerless to grant effective relief or incompetent to adjudicate 

the claims at issue, see id. at 147-48; or when the administrative 

body is clearly biased, see id. at 148-49. 

The plaintiffs asseverate that their case falls within 

two of these categories. In their view, the administrative process 

cannot grant them appropriate relief and, moreover, they face an 

indefinite (and, therefore, unreasonable) timeline. These 

drawbacks, they say, more than outweigh whatever may be gained by 

exhaustion because — in this instance — exhaustion will neither 

preserve agency authority nor promote judicial economy. 

We start our inquiry into the district court's 

application of administrative exhaustion with the plaintiffs' 

suggestion that completion of the administrative process in this 

case will not advance the interests that exhaustion exists to 

protect. We do not agree. To begin, the plaintiffs vastly 

understate the ongoing importance of ORI's expertise to the 

administrative proceedings. They similarly understate the degree 

to which ORI's expertise already has played a valuable role in the 

institutional investigation. The issues raised by the plaintiffs' 

suit are in many respects the very kind of issues that call for 

the exercise of ORI's special insights. We explain briefly. 

The enabling statute requires that ORI be led by a 

professional experienced in research misconduct investigations, 

and the regulations envision that ORI's oversight of the 
- 20 - 

institutional investigation process will allow it to apply that 

expertise. This know-how is reflected, for example, in ORI's 

ability to grant extensions to an institution to complete an 

investigation and to conduct a review of the institution's 

investigation before issuing findings of research misconduct. 

What is more, ORI — in the course of its review — may well comment 

on the interpretation of key components of the regulations 

undergirding the plaintiffs' claims, such as the appropriate 

standard for initiating an investigation, the scope of 

confidentiality obligations, and the qualifications needed for 

panel members. 

Permitting the agency to apply its expertise in the first 

instance is especially important because it protects ORI's 

authority even if the plaintiffs' state-law claims are not 

themselves adjudicated in the agency-supervised proceeding. The 

statutory structure contemplates that the first tier of review in 

research misconduct cases will take place at the institutional 

level with ORI oversight. Respect for Congress's judgment in this 

area counsels in favor of allowing the agency to exercise that 

oversight authority before a federal court intervenes. ORI's 

authority would be severely undermined if, for example, we were to 

permit a jury to decide whether an ongoing investigation, with 

extension requests reviewed and approved by ORI, had dragged on so 
- 21 - 

long as to amount to a breach of contract based on the very rules 

that ORI is tasked with administering. 

The plaintiffs' countervailing interests in immediate 

review do not outweigh these substantial advantages to exhaustion. 

Arguing to the contrary, they assert that the administrative 

process cannot provide them with appropriate relief. In support, 

they note that ORI lacks any mechanism to review state-law claims 

and has no authority to award money damages (the primary form of 

relief demanded in their suit). Although they acknowledge ORI's 

oversight role, they observe that they will not be parties to any 

enforcement action taken by ORI against the institutions. 

Furthermore, even if they were to challenge a hypothetical future 

finding of research misconduct before an ALJ, the ALJ would not 

have the authority to consider the institution's conduct of either 

the inquiry or the investigation. There is some truth in what the 

plaintiffs say — but we conclude that neither the unavailability 

of a monetary remedy in agency proceedings nor the agency's lack 

of capacity to adjudicate the state-law claims at issue is 

dispositive. 

With respect to the unavailability of money damages, the 

plaintiffs rely on the McCarthy Court's statement that "the 

uncertainty of the administrative agency's authority to award 

[monetary] relief counsels against requiring exhaustion." Id. at 

155. But the McCarthy Court mentioned the unavailability of a 
- 22 - 

specific form of relief merely as one factor in the exhaustion 

calculus. Other circumstances (such as the agency's lack of 

interest in exhaustion, the fact that the claim at issue did not 

call for the application of agency expertise, and the fact that 

record development before the agency would provide only minimal 

assistance to future judicial review) combined to make exhaustion 

unnecessary. See id. at 155-56. Because no comparable mix of 

factors is present here, the unavailability of monetary relief 

through ORI does not relieve us of the duty to carry out the 

intensely practical analysis required by McCarthy. See Munsell v. 

Dep't of Agric., 509 F.3d 572, 592 (D.C. Cir. 2007) ("The rationale 

for requiring exhaustion does not depend on the existence of money 

damages as a remedy. So long as the administrative process offers 

the possibility of some redress . . . the administrative process 

can serve its proper function."). 

We add, moreover, that there are significant 

institutional advantages in compelling exhaustion here. 

Addressing a similar claim in an analogous context, we recognized 

that "[e]xhaustion is beneficial regardless of whether the 

administrative process offers the specific form of remediation 

sought by a particular plaintiff" because "the administrative 

process facilitates the compilation of a fully developed record," 

which "is an invaluable resource for a state or federal court 

required to adjudicate a subsequent civil action covering the same 
- 23 - 

terrain." Frazier v. Fairhaven Sch. Comm., 276 F.3d 52, 61 (1st 

Cir. 2002). 

So it is here. Although ORI will not adjudicate the 

plaintiffs' state-law claims as such, the district court's 

eventual disposition of those claims would benefit greatly from 

any legal interpretations or factual findings made by ORI in the 

course of its review.6 Indeed, the shape of the plaintiffs' claims 

may well change based on the outcome of the institutional 

investigation. The regulations specifically require institutions 

to make "[a]ll reasonable and practical efforts, if requested and 

as appropriate, to protect or restore the reputation of persons 

alleged to have engaged in research misconduct but against whom no 

finding of research misconduct is made." 42 C.F.R. § 93.304(k). 

Insofar as the complaint seeks to remedy "[l]ong-term injury to 

[the plaintiffs'] professional reputations and careers," the 

outcome of the institutional investigation and any subsequent 

action under this provision may reconfigure the contours of the 

 

 6 It is worth noting that this is not a case in which selfsufficient state-law claims merely run parallel to administrative 

regulations. Rather, the plaintiffs invoke the federal court's 

subject matter jurisdiction only by advancing claims that turn on 

the answers to embedded federal questions concerning the meaning 

and application of the very federal regulations that ORI exists to 

enforce. To allow the case to proceed to judgment and run the 

risk of having ORI's ongoing oversight thereafter arrive at 

conclusions that conflict with that judgment makes little 

practical sense. 
- 24 - 

controversy by the time it is ripe for district court 

consideration. 

Our review of the record persuades us that the district 

court made the "intensely practical" assessment that the McCarthy 

Court required. We think that the totality of the circumstances 

— particularly the unique characteristics of this two-tiered 

investigatory system, Congress's manifest desire to ensure that 

ORI is able to use its expertise to guide and evaluate an initial 

round of investigation at the institutional level, and the 

significant advantages that exhaustion could bring — warrants a 

finding that the district court did not abuse its discretion in 

applying the doctrine of administrative exhaustion. In the 

circumstances at hand, neither the unavailability of a monetary 

remedy in the administrative proceeding nor the agency's inability 

to adjudicate state-law claims demands a different result. 

The plaintiffs have a fallback position. They press the 

notion that forcing them to delay their suit will cause undue 

prejudice to its subsequent prosecution because they face an 

indefinite timeframe for administrative action. They emphasize 

the length of the inquiry to date and the several extensions to 

the investigation (which has entered its third year). This problem 

is exacerbated, they say, by the institutions' lackadaisical 

approach to the matter and by the repeated widening of the scope 

of the investigation. In their view, these developments show that 
- 25 - 

the time limits in the regulations are effectively meaningless and 

that ORI has abdicated its responsibility to superintend the 

investigation. 

Although we understand the plaintiffs' frustration with 

the pace of the proceedings, we do not believe that matters have 

reached the tipping point. The duration of administrative 

proceedings, without more, cannot suffice to demonstrate that an 

agency's actions are unreasonable. Rather, determining whether a 

timeframe for agency action is unreasonable involves more than a 

matter of simple arithmetic. Cf. Telecomms. Research & Action 

Ctr. v. FCC, 750 F.2d 70, 80 (D.C. Cir. 1984) (limning range of 

factors for evaluating the reasonableness of agency delay). An 

inquiring court must pay close attention to the specific regulatory 

framework and its relationship to the claims presented. See 

McCarthy, 503 U.S. at 146. 

Here, the district court fulfilled that responsibility. 

The features of the ongoing process are every bit as consistent 

with a conclusion that the investigation is proceeding apace 

through a complex area of medical research as with an inference of 

indefiniteness. Virtually by definition, research misconduct is 

a complicated area; and the regulations specifically envision that 

research misconduct inquiries and investigations may take longer 

than the time limits spelled out in the regulations. Both the 

inquiry process and (with ORI's consent) the investigatory process 
- 26 - 

can be extended when circumstances warrant. See 42 C.F.R. 

§§ 93.307(g), 93.311(b). Such flexibility is crucial, given the 

regulatory imperative that institutions must "[p]ursue diligently 

all significant issues and leads discovered that are determined 

relevant to the investigation." Id. § 93.310(h). 

In the case at hand, all indications are that the 

investigation is being actively pursued, and the repeated 

expansions of its scope suggest compliance with the mandate to 

explore "any evidence of additional instances of possible research 

misconduct" that comes to light during the investigation. Id. 

Against this backdrop, we discern no principled basis for viewing 

this timeframe, at present, as unreasonable. 

The plaintiffs advance one other strain of this 

argument. They submit that the duration of the investigation and 

subsequent ORI review could cause the statute of limitations to 

expire on some or all of their state-law claims. See, e.g., Mass. 

Gen. Laws ch. 260, § 2A (establishing three-year statute of 

limitations for tort claims). This is a legitimate concern: the 

running of the statute of limitations could well "occasion undue 

prejudice to subsequent assertion" of the plaintiffs' claims. 

McCarthy, 503 U.S. at 146. At least some of the plaintiffs' claims 

already may have accrued, and the district court's order of 

dismissal without prejudice will be of little consolation should 

those claims become time-barred. 
- 27 - 

This concern, however, does not demand the solution that 

the plaintiffs urge. In light of the strong interests in 

exhaustion that are extant here, permitting this action to go 

forward in parallel to the administrative proceedings is not the 

most salutary way to guard against a potential limitations problem. 

In the context of state habeas proceedings (which present similar 

temporal snares), federal appellate courts have acknowledged that 

district courts may stay a petition filed within the statute of 

limitations until state remedies have been exhausted. See, e.g., 

Pace v. DiGuglielmo, 544 U.S. 408, 416 (2005); Rhines v. Weber, 

544 U.S. 269, 274-78 (2005); Neverson v. Bissonnette, 261 F.3d 

120, 126 n.3 (1st Cir. 2001); see also Dolis v. Chambers, 454 F.3d 

721, 725 (7th Cir. 2006) (collecting cases). Such a prophylactic 

approach is well-suited to administrative exhaustion cases because 

it protects agency authority while administrative proceedings are 

ongoing yet ensures that limitations concerns will not bar the 

ultimate consideration of the plaintiffs' claims. 

For these reasons, we hold that, as a matter of practice, 

a district court ordinarily should stay, rather than dismiss, an 

action when it finds that principles of administrative exhaustion 

require it to act. We apply that prescription here: though 

upholding the district court's determination that administrative 

exhaustion is warranted, we think it appropriate to direct that 

its order of dismissal be converted to a stay of judicial 
- 28 - 

proceedings pending the timely resolution of the administrative 

proceedings. 

V. CONCLUSION

The defendants have raised a gallimaufry of other 

grounds for dismissing this action, but we need go no further. 

Thus, we take no view of these other grounds. Suffice it to say 

that we affirm the district court's decision, based on the commonlaw doctrine of administrative exhaustion, and the plaintiffs must 

exhaust their administrative remedies before proceeding with their 

suit. However, we direct that the district court, on remand, 

convert its order of dismissal to an order staying the case pending 

the timely resolution of administrative proceedings. 

Affirmed as modified. All parties shall bear their own costs.