ORI OVERSIGHT
When ORI receives a report of an institutional inquiry or investigation into
allegations of scientific misconduct, it reviews the report for timeliness,
objectivity, thoroughness, and competence. During its review, ORI staff examine
the institution’s report and conclusions to determine whether the
institutional findings are defensible, well supported by the evidence, and
acceptable as a final resolution of the allegations.
During the oversight process, ORI may need to review all substantial
documentation used or prepared by the institution during the inquiry or
investigation. This includes grant applications, publications, computer files,
research data, slides, letters, memoranda, transcripts, summaries of interviews,
etc. ORI reviews the appropriateness and sufficiency of any analysis the
institution conducted. If the institution has not provided an adequate
justification of how it reached its conclusions, ORI may reanalyze or perform a
new analysis of the research data, publications, or other source documents to
determine whether to accept the institution’s conclusions. ORI frequently asks
institutions to provide additional information, consider additional questions,
or provide further analysis.
The oversight review usually results in agreement on the findings between the
institution and ORI. Occasionally, ORI concludes that it is unable to base the
PHS finding on the institutional finding because of differences in the
definition of scientific misconduct, the standard of proof, or other pertinent
factors. Under these circumstances, ORI may decline to pursue the allegation or
it may refer the case to the Office of Inspector General for investigation.
When ORI completes an oversight review of an institutional inquiry or
investigation, it usually prepares an ORI oversight report that describes the
institutional process and the rationale it developed for determining whether the
allegation was substantiated. If the allegation was not supported, ORI sends a
copy of the report to the institution and requests that the institution notify
the respondent and whistleblower directly of the outcome of the investigation.
If the allegation was supported, ORI may negotiate with the respondent a
Voluntary Exclusion Agreement (VEA) in which the respondent accepts the
imposition of PHS administrative actions without necessarily admitting the
misconduct. If such an agreement is not reached, ORI recommends a finding of
research misconduct and the imposition of administrative actions to the
Assistant Secretary for Health for final decision.
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Updated
January 11, 2002
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