Misconduct in Science

IX. Requirements for Reporting to ORI

A. Initiation
An institution's decision to initiate an investigation (as defined in Section II involving federal funds must be reported in writing to the Director, ORI, or appropriate officer of the involved federal agency on or before the date the investigation begins. At a minimum, the notification should include the name of the person(s) against whom the allegations have been made, the general nature of the allegation as it relates to the HHS definition of misconduct, and the federal applications or grant number(s) involved. ORI or office of the involved federal agency must also be notified of the final outcome of the investigation and must be provided with a copy of the investigation report. Any significant variations from the provisions of the institutional policies and procedures should be explained in any reports submitted to ORI or office of the involved federal agency.

B. Termination
If an institution plans to terminate an inquiry or investigation for any reason without completing all relevant requirements of the HHS regulation, the Research Integrity Officer will submit a report of the planned termination to ORI or the appropriate office of involved federal agency, including a description of the reasons for the proposed termination.

C. Non-completion
If the institution determines that it will not be able to complete the investigation in 120 days, the Research Integrity Officer will submit to ORI or appropriate office of the involved federal agency, a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the request is granted, the Research Integrity Officer will file periodic progress reports as requested by the ORI or office of the involved federal agency.

D. Involvement of Federal Funding
When federal funding or applications for funding are involved and an admission of misconduct is made, the Research Integrity Officer will contact ORI or the appropriate office of the involved federal agency for consultation and advice. Normally, the individual making the admission will be asked to sign a statement attesting to the occurrence and extent of misconduct. When the case involves federal funds, the institution cannot accept an admission of misconduct as a basis for closing a case or not undertaking an investigation without prior approval from ORI or the appropriate office of the involved federal agency.

E. Duties of Research Integrity Officer
The Research Integrity Officer will notify ORI or the appropriate office of the involved federal agency immediately and at any stage of the inquiry or investigation if:

1. there is an immediate health hazard involved;
2. there is an immediate need to protect Federal funds or equipment;
3. there is an immediate need to protect the interests of the person(s) making the allegations or of the individual(s) who is the subject of the allegations as well as such individual’s co-investigators and associates, if any;
4. it is probable that the alleged incident is going to be reported publicly; or
5. the allegation involves a public health sensitive issue, e.g., a clinical trial; or
6. there is a reasonable indication of possible criminal violation.