When ORI receives a report of an institutional inquiry or investigation into allegations of research 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 often results in agreement on the findings between the institution and ORI. Occasionally, ORI concludes that it is unable to base a PHS finding on the institutional finding because of differences in the definition of research 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, HHS, 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. If such an agreement is not reached, ORI makes a finding of research misconduct and recommends the imposition of administrative actions to the Assistant Secretary for Health or submits a charge letter to the HHS Departmental Appeals Board.