Handling Misconduct Introduction Technical Assistance Complainant Respondents Allegations Preliminary Assessment Inquiries Investigations Institutional Decision ORI Oversight Review PHS/HHS Decision Hearings Administrative Actions Case Summaries Legal Concerns

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