PURPOSE SCOPE: DEFINITIONS: 1 12

The RIO will contact the sponsor of the research, and the Director of the HHS ORI if the research is under the US PHS, as needed, to determine the reporting requirements or guidelines pertinent to inquiry and investigation of allegations of misconduct. [...] In the event that an investigation is undertaken, and the research is funded by the US PHS, the RIO shall, in accordance with 42 CFR §93.309(a), report to the HHS ORI the decision to initiate the investigation on or before the date the investigation begins. [...] Additionally, the RIO shall inform the sponsor of the research (if required), applicable journals, and any other associated agencies or entities in writing, including the name(s) of the respondent(s), the general nature of the charges, and the grant or contract number(s) involved. [...] The committee may find that: (1) the evidence supports the charge of misconduct; (2) the evidence does not support the charge of misconduct; or (3) the evidence does not support the charge of misconduct but supports serious errors in the research. [...] If the research is funded by US PHS, in accordance with 42 CFR §93.311(b), the RIO shall then request an extension of the 120-day investigative period from the ORI and US PHS, including an explanation for the delay, the interim report of the committee, and an estimate for the date of completion of the investigation.