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Malfeasance and Misconduct - Definitions

The definition of Research Misconduct has been debated for at least a decade and the Federal Government has just completed the final rule. It includes not only the definitions of research misconduct but also the regulations by which institutions must address allegations of misconduct as they apply to research in which PHS funds either support the institution or the research. The following is taken directly from the Federal Register:

Sec. 93.103 Research misconduct.

Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
  1. Fabrication is making up data or results and recording or reporting them.
  2. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
  3. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
  4. Research misconduct does not include honest error or differences of opinion.
Sec. 93.104 Requirements for findings of research misconduct.

A finding of research misconduct made under this part requires that--
  1. There be a significant departure from accepted practices of the relevant research community; and
  2. The misconduct be committed intentionally, knowingly, or recklessly; and
  3. The allegation be proven by a preponderance of the evidence.
Sec. 93.105 Time limitations.
  1. Six-year limitation. This part applies only to research misconduct occurring within six years of the date HHS or an institution receives an allegation of research misconduct.
  2. Exceptions to the six-year limitation. Paragraph (a) of this section does not apply in the following instances:
    1. Subsequent use exception. The respondent continues or renews any incident of alleged research misconduct that occurred before the six-year limitation through the citation, republication or other use for the potential benefit of the respondent of the research record that is alleged to have been fabricated, falsified, or plagiarized.
    2. Health or safety of the public exception. If ORI or the institution, following consultation with ORI, determines that the alleged misconduct, if it occurred, would possibly have a substantial adverse effect on the health or safety of the public.
    3. ``Grandfather'' exception. If HHS or an institution received the allegation of research misconduct before the effective date of this part.
Sec. 93.106 Evidentiary standards.

The following evidentiary standards apply to findings made under this part.
  1. Standard of proof. An institutional or HHS finding of research misconduct must be proved by a preponderance of the evidence.
  2. Burden of proof.
    1. The institution or HHS has the burden of proof for making a finding of research misconduct. The destruction, absence of, or respondent's failure to provide research records adequately documenting the questioned research is evidence of research misconduct where the institution or HHS establishes by a preponderance of the evidence that the respondent intentionally, knowingly, or recklessly had research records and destroyed them, had the opportunity to maintain the records but did not do so, or maintained the records and failed to produce them in a timely manner and that the respondent's conduct constitutes a significant departure from accepted practices of the relevant research community.
    2. The respondent has the burden of going forward with and the burden of proving, by a preponderance of the evidence, any and all affirmative defenses raised. In determining whether HHS or the institution has carried the burden of proof imposed by this part, the finder of fact shall give due consideration to admissible, credible evidence of honest error or difference of opinion presented by the respondent.
    3. The respondent has the burden of going forward with and proving by a preponderance of the evidence any mitigating factors that are relevant to a decision to impose administrative actions following a research misconduct proceeding.
Applicability paraphrased from 93.100:
  1. Research misconduct involving PHS support is contrary to the interests of the PHS and the Federal government and to the health and safety of the public, to the integrity of research, and to the conservation of public funds.
  2. The Department of HHS and the institutions that apply for and receive PHS support for research, training, or research-related activities jointly share the responsibility for the integrity of the research process. HHS has the rights of oversight and recipient institutions have an affirmative duty to protect PHS funds from misuse by ensuring the integrity of all PHS-supported work, and primary responsibility for responding to and reporting allegations of research misconduct.

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