Oklahoma Administrative Code
Title 310 - Oklahoma State Department of Health
Chapter 2 - Procedures of the State Department of Health
Subchapter 31 - Human Subjects Protection
Section 310:2-31-27 - The investigation report
Current through Vol. 41, No. 13, March 15, 2024
(a) Elements of the investigation report. The final report will be in accordance with the requirements in 42 C.F.R. Section 93.313 (Institutional investigation report).
(b) Comments on the draft report.
(c) Institutional review and decision. Based on the evidence, the DO will make the final determination whether to accept the investigation report, its findings, and the recommended institutional actions. If this determination varies from that of the investigation committee, the DO will explain in detail the basis for rendering a decision different from that of the investigation committee in the institution's letter transmitting the report to ORI. The Deciding Official's explanation should be consistent with the PHS definition of scientific misconduct, the institution's policies and procedures, and the evidence reviewed and analyzed by the investigation committee. The DO may also return the report to the investigation committee with a request for further fact- finding or analysis. The DO's determination, together with the investigation committee's report, constitutes the final investigation report for purposes of ORI review. When a final decision on the case has been reached, the RIO will notify both the respondent and the whistleblower in writing. In addition, the DO will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the respondent in the work, or other relevant parties should be notified of the outcome of the case. The RIO is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.
(d) Transmittal of the final investigation report to ORI. After comments have been received and the necessary changes have been made to the draft report, the investigation committee should transmit the final report with attachments, including the respondent's and whistleblower's comments, to the DO, through the RIO.
(e) Time limit for completing the investigation report. An investigation should ordinarily be completed with submission to ORI within 120 days of its initiation, with the initiation being defined as the first meeting of the investigation committee.