FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF
MASSACHUSETTS [Hon. Denise J. Casper, U.S. District Judge]
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
Thompson, Selya and Kayatta, Circuit Judges.
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.
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
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
administrative exhaustion but modify the judgment to ensure
that the suit receives a full airing at the appropriate time.
STATUTORY AND REGULATORY FRAMEWORK
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).
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, 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).
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.
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 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).
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).
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 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.
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).
beyond the notice requirements, opportunities for comment,
and time limits described above, the regulatory framework
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.
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
capricious. See id. The Assistant Secretary's
decision constitutes final agency action for most purposes,
subject to review in the federal courts under the
Administrative Procedure Act (APA). See 5 U.S.C.
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.
it is manifest that neither the statute nor the regulations
contemplate enforcement by private parties. Instead,
enforcement is left to the Secretary, acting ...