As an agency under the Department of Health and Human Services (HHS), NIH follows the Public Health Service (PHS) Policies on Research Misconduct 42 CFR 93. According to this, research misconduct is defined as fabrication, falsification and plagiarism, and does not include honest error or differences of opinion.
All institutions receiving PHS funding must have written policies and procedures for addressing allegations of research misconduct.
NIH has specific procedures in place to handle allegations of research misconduct. All allegations of research misconduct received at the NIH are promptly and carefully reviewed. However, NIH does not have the authority to conduct investigations of these allegations except for the ones involving NIH intramural research. Ultimately, all research misconduct allegations involving NIH awards are forwarded to the HHS Office of Research Integrity (ORI) for their oversight.
ORI is responsible for overseeing and directing PHS research integrity activities. ORI has the authority and the responsibility to review and monitor investigations of research misconduct allegations involving PHS funding.
Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results, according to 42 CFR Part 93.
Research misconduct does NOT include honest error or differences of opinion
Fabrication: Making up data or results and recording or reporting them
- An possible example of fabrication: In order to meet recruitment pressure and expectations, a study coordinator completed trial enrollment forms using faked names and participants' information.
- Vermont investigator Eric Poehlman made up patients' data that never existed to support his scientific claims. Read about Poehlman's case in the New York Times
- Read June 2012 article "Parkinson's Researcher Fabricated Data" in The Scientist
Falsification: 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.
- Investigators might falsify results by 'splicing and pasting' together different segments of western blot images so that the final image presented appeared to have come from a single western blot procedure.
- Harvard investigator Marc Hauser was found to have fabricated and manipulated research results. Read about Hauser's case in Boston.com
- Read news article "Image Manipulation: CSI: cell biology" in Nature.com
Plagiarism: The appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
ORI's policy on Plagiarism excludes:
- the limited use of identical or nearly-identical (general) phrases that are not substantially misleading or of great significance
- disputes among former collaborators
Requirements for making a finding of research misconduct
42 CFR 93.104
- There be a significant departure from accepted practices of the relevant research community;
- The misconduct be committed intentionally, knowingly, or recklessly; and
- The allegation be proven by a preponderance of the evidence.
|NOTE: The Regulation imposes a 6-year time limitation for occurrences of research misconduct to be brought to the attention of an institution or the Department of Health and Human Services (HHS) (see § 93.105)
NIH Process for Handling Research Misconduct Allegations
What happens if there is a finding of research misconduct?
If an individual involved in NIH funded research is found to have committed research misconduct, the administrative actions PHS/HHS may take against them include, but are not limited to:
- debarment from eligibility to receive Federal funds for grants and contracts,
- prohibition from service on PHS advisory committees, peer review committees, or as consultants,
- certification of information sources by the respondent that is forwarded by the institution,
- certification of data by the institution,
- imposition of supervision on the respondent by the institution,
- submission of a correction of published articles by the respondent, and
- submission of a retraction of published articles by the respondent.
In addition, NIH may take further administrative action, including:
- modification of the terms of an award such as imposing special conditions, or withdrawing approval of the PI or other key personnel,
- suspension or termination of an award,
- recovery of funds, and
- resolution of suspended awards.
The institution (university) may impose additional penalties:
- Loss of employment
- Reassignment of personnel
- Mentorship program
Is there an appeals process?
Yes. The process for contesting a decision is outlined in 42 CFR Part 93, Subpart E (PDF - 52 KB). For more on appeals, please see the Hearings page on the ORI Web site.