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Legal Concerns
Departmental Appeals Board Decisions and Rulings
Introduction
The process for handling allegations of scientific misconduct has
been the subject of Departmental Appeals Board (DAB) rulings since
the PHS organized its efforts to respond to these allegations in
1989. Summaries of some DAB decisions and rulings are
available below. Beginning in 2006, hearings were held before an Administrative Law Judge rather than the DAB.
Institutions and individuals should contact their legal counsel
for information on the applicability of the cited decisions. ORI
makes no representations regarding the accuracy of these summaries
or the binding nature of the summarized decisions in future
proceedings.
Scope of ORI’s Jurisdiction
PHS authority to prosecute scientific misconduct extends to
unfunded grant applications. John C. Hiserodt, M.D., Ph.D., DAB
No. 1466 (Feb. 25, 1995); Ruling on Respondent's Motion to
Dismiss the Complaint, Board Docket No. A-93-50 (Sharma) (May
10, 1993). John C. Hiserodt, M.D., Ph.D., DAB No. 1466 (Feb.
25, 1995).
PHS scientific misconduct regulations apply to research even when
no grant application has been submitted to the National Institutes
of Health. Preliminary Analysis of Legal Issues, Board Docket No.
A-2000-72 (Evan B. Dreyer, M.D., Ph.D.), at 6-7 (Oct. 18, 2000).
All institutions or individuals, foreign and national, regardless
of where they are physically located, who apply for or receive PHS
funds for biomedical or behavioral research do so with the
understanding that they are bound by the provisions of the
research misconduct regulations. This authority extends to the
locus of the research -- even if it is outside the territory of the
United States. Ruling on Respondent's motion to Dismiss for Lack
of Jurisdiction: Notice of Further Procedures, Board Docket No.
A-95-123 (Kerr) (Aug. 15, 1995).
Scope of ORI’s Oversight Review
The Department of Health and Human Services has broad authority
under the Public Health Service Act, 42 U.S.C. § 289b, to
"protect the integrity of research it funds by taking
administrative actions against those who have engaged in scientific
misconduct." Thereza Imanishi-Kari, Ph.D., DAB Decision
No. 1582 (1996). In addition, the Department has inherent "discretionary authority to protect the integrity of federal
research grant funds entrusted to it." Kimon J. Angelides,
Ph.D., DAB No. 1677, at 5 (1999).
The ORI oversight review is not limited to the issues addressed
during the institutional inquiry or investigation because "the
Department has always had, and retains after the most recent
restructuring [of ORI], the power both to reject institutional
findings and evidence and to go beyond them, where appropriate, as a
result of differing or additional evidence or findings generated in
the course of evaluating the institutional findings." Preliminary
Analysis of Legal Issues, Board Docket No. A-2000-72 (Evan B.
Dreyer, M.D., Ph.D.), at 20-21 (Oct. 18, 2000).
Misleading Statements
Making statements that are
deliberately or knowingly false or are materially misleading
constitutes research misconduct both prior to and after the
adoption of the 1989 regulations. John C. Hiserodt, M.D., Ph.D., DAB
No. 1466 (Feb. 25, 1995).
Data in a Laboratory Notebook or Computer Disk
The "deliberate making up of data" in a laboratory notebook or
on a computer disk to support statements made in an application for
PHS research funds is "fabrication" and constitutes
research misconduct under the 1989 regulations. Preliminary
Analysis of Legal Issues, Board Docket No. A-2000-72 (Evan B.
Dreyer, M.D., Ph.D.), at 5-7 (Oct.18, 2000); John C. Hiserodt,
M.D., Ph.D., DAB No. 1466, at 50 (Feb. 25, 1995). It may also
constitute an independent basis for debarment. Preliminary
Analysis of Legal Issues, Board Docket No. A-2000-72 (Evan B.
Dreyer, M.D., Ph.D.), at 9-10, 12 (Oct. 18, 2000).
Each Presentment of Falsified or Fabricated Data Constitutes
An Independent Act of Scientific Misconduct
"[E]ach act of
presenting the [falsified or fabricated] data in a new context as
though it was real data has a bearing on [the Respondent’s]
trustworthiness and present responsibility." Preliminary
Analysis of Legal Issues, Board Docket No. A-2000-72 (Evan B.
Dreyer, M.D., Ph.D.), at 12 (Oct. 18, 2000). Thus, the Research
Integrity Adjudications Panel ("RIAP") appointed by the
Departmental Appeals Board (DAB) rejected the Respondent’s
argument that the presentment of the same allegedly falsified or
fabricated data in five different contexts is not an isolated act,
but amounts to five possible charges of research misconduct.
De Novo Review of Scientific Misconduct Findings by
the DHHS Research Integrity Adjudications Panel
The Research Integrity Adjudications Panel ("RIAP")
appointed by the Departmental Appeals Board (DAB) "provides an
independent and de novo adjudication of the facts and merits of the
charges against [a] Respondent. Even if, as the Respondent alleged,
the record before ORI was tainted by inaccuracies or improprieties
in the [institution’s] investigatory process or report, the RIAP
decision, as Respondent recognized, will not be a review of what ORI
did or whether ORI’s findings were reasonable based on the record
before it, but rather an independent decision based on the complete
record before the Panel." Ruling on Preliminary Legal Issues,
Board Docket No. A-97-98 (Angelides), at 2 (Dec. 30, 1997); Thereza
Imanishi-Kari, Ph.D., DAB Decision No. 1582, at 3 (1996). Thus, "to the extent that [a] Respondent complains of the adequacy of
the procedural and administrative process provided by the
[institution] or ORI, these complaints will be fully cured by the
full and fair hearing process guaranteed before the Panel." Id.
The scope of a research misconduct hearing is not limited to
the issues addressed in the institution’s inquiry and
investigation. Preliminary Analysis of Legal Issues, Board Docket
No. A-2000-72 (Evan B. Dreyer, M.D., Ph.D.), at 20-21 (Oct. 18,
2000). For example, "the issues before an institution are not
precisely the same as before the federal agency since the
institution has no authority to impose federal remedies for
misconduct such as debarment. Id.
Burden of Proof
ORI's burden of proof on all issues of
research misconduct is to establish by a preponderance of the
evidence that facts exist that meet the legal test for misconduct. Ruling
on Preliminary Legal Issues, Board Docket No. A-97-98 (Angelides),
at 2 (Dec. 30, 1997); John C. Hiserodt, M.D., Ph.D., DAB No.
1466 (Feb. 25, 1995).
Pre-1989 Misconduct
HHS' discretionary authority to take appropriate administrative
actions to protect the Federal Government's interest in the
integrity of federally-funded research preexisted enactment of the 1985 statute on scientific fraud and the 1989 research misconduct
regulation. Therefore, under this preexisting discretionary
authority ORI can prosecute research misconduct cases, whether
intramural or extramural, in which the alleged misconduct occurred
prior to promulgation of the 1985 statute or the 1989 regulation.
See e.g., Preliminary Determination on Respondent's Motions to
Dismiss, Board Docket No. A-93-1 00 (Popovic) (May 24, 1993); Ruling
on Respondent's Motion to Dismiss the Complaint, Board Docket No.
A-93-50 (Sharma) (May 10, 1993); accord John C. Hiserodt, M.D.,
Ph.D., DAB No. 1466 (Feb. 25, 1995).
The PHS policies and procedures for responding to allegations of
research misconduct adopted prior to the 1989 regulation
constituted non-binding guidelines and, thus, did not require notice
and comment rulemaking. As such, the policies and procedures did not
violate the Administrative Procedure Act. Ruling on Respondent's
Motion to Dismiss the Complaint, Board Docket No. A-03-50
(Sharma) (May 10, 1993).
Equal Access to Justice Act: When PHS misconduct findings
are overturned by the Departmental Appeals Board, respondents may
not recover attorneys' fees and expenses under the Equal Access
to Justice Act (EAJA). EAJA applies only if a full evidentiary
hearing is statutorily required; research misconduct hearings, by
contrast, are established by agency discretion. See for example, Ruling
on Respondent's Application for Attorneys' Fees and Expenses under
the Equal Access for Justice Act, Board Docket No. A-93-50
(Sharma) (Nov. 9, 1993); Ruling on Applicability of Equal Access
to Justice Act, Board Docket No. A-94-41 (Popovic) (Dec. 22,
1993).
Departmental Appeals Board Rulings (Full Text
Versions)
Kimon J. Angelides, Ph.D., DAB No. 1677
(1999), 1999 WL 88783 (H.H.S.).
Case SummaryFull Text of Decision
Full-text copies of other DAB decisions (listed
below) are available on the DAB web site under the heading Decisions.
Thereza Imanishi-Kari, Ph.D. DAB No. 1582
(1996), 1996 WL 399931 (H.H.S.).
John C. Hiserodt, M.D., Ph.D., DAB No. 1466
(1994), 1994 WL 321797 (H.H.S).
Mikulas Popovic, M.D., Ph.D., DAB No. 1446
(1993), 1993 WL 762622 (H.H.S).
Dr. Rameshwar K. Sharma, DAB No. 1431(1993),
1993 WL 742551 (H.H.S.).
Dr. Paul F. Langlois, DAB No. 1409 (1993),
1993 WL 742594 (H.H.S.).
Dr. David Bridges, DAB No. 1232 (1991), 1991
WL 634972 (H.H.S.).
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