Okla. Admin. Code § 310:2-31-27

Current through Vol. 42, No. 4, November 1, 2024

Section 310:2-31-27 - The investigation report

(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.

(1)Respondent. After first redacting the identity of the whistleblower, the RIO will provide the respondent with a copy of the redacted draft investigation report for comment and rebuttal. The respondent will be allowed five (5) days to review and comment on the draft report. The respondent's comments will be attached to the final report. The findings of the final report should take into account the respondent's comments in addition to all the other evidence.

(2)Whistleblower. The RIO will provide the whistleblower, if he or she is identifiable, with those portions of the draft investigation report that address the whistleblower's role and opinions in the investigation. The report should be modified, as appropriate, based on the whistleblower's comments.

(3)Institutional counsel. The draft investigation report will be transmitted to the institutional counsel for a review of its legal sufficiency.

(4)Confidentiality. In distributing the draft report, or portions thereof, to the respondent and whistleblower, the RIO will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. The identity of the whistleblower will be subject to public disclosure only as the RIO may determine is reasonable and appropriate by balancing the needs of the whistleblower to remain confidential with the needs of the IRB to comply with federal regulations enacted to protect the rights and welfare of human research participants.

(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.

Okla. Admin. Code § 310:2-31-27

Adopted by Oklahoma Register, Volume 36, Issue 24, September 3, 2019, eff. 9/13/2019

Amended by Oklahoma Register, Volume 38, Issue 24, September 1, 2021, eff. 9/11/2021