SECTION 340:2-39-12.1. Research project changes after Oklahoma Department of Human Services Institution Review Board (DHSIRB) approval

(a)   After initial approval of a research project by the DHSIRB, the investigator conducts the research activity in accordance within the terms of the DHSIRB approval.

(b)   The investigator may not make changes in an approved research activity until the proposed changes are submitted to the DHSIRB for review and approval, except when necessary to eliminate apparent immediate hazards to the subject.

(c)   When the investigator encounters any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this Part or with DHSIRB requirements or determinations, those problems and difficulties must be immediately reported to the human protections administrator.

(d)   An investigator may ask the DHSIRB to review and approve a proposed change by submitting a completed DHS Form 20AD085E, Oklahoma Department of Human Services Institutional Review Board (DHSIRB) Application and Instructions, per OAC 340:2-39-11(b).

(1)   Form 20AD085E and all required attachments must be received by the DHSIRB. When Form 20AD085E and all required attachments are received 14 or more calendar days prior to the next meeting, the application is reviewed at the next regularly scheduled DHSIRB meeting. When Form 20AD085E and attachments are received 13 or fewer calendar days prior to the next meeting, the application is reviewed at the following regularly scheduled DHSIRB meeting.

(2)   The investigator may request an expedited review for minor changes in a research activity.

[Source: Added at 37 Ok Reg 1752, eff 9-15-20]