SECTION 310:2-31-7. IRB procedures

(a)   All approved IRB research projects, whether approved by OSDH IRB or an external IRB, are subject to a review by OSDH data use review board to ensure release of OSDH data is allowable, limited to, and meets the statutory provisions pertaining to public health data sharing. Data may or may not be released based on the data use review board's findings.

(b)   The OSDH and the OSDH IRB will established written procedures for:

(1)   verifying whether proposed activities qualify for exemption from, or waiver of, IRB review;

(2)   conducting IRB initial and continuing review, approving research, and reporting IRB findings to the investigator and the institution;

(3)   reviewing the informed consent process including documentation using the federal regulations and guidance from the Office of Human Research Protections;

(4)   determining which projects require review more often than annually, and which projects need verification from sources other than the investigator that no material changes have occurred;

(5)   ensuring that changes in approved research are reported promptly and are not initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to the subject; and

(6)   ensuring prompt reporting to the IRB, institutional officials, the relevant department or agency head, any applicable regulatory body, and OHRP of any:

(A)   unanticipated problems involving risks to subjects or others in any covered research;

(B)   serious or continuing noncompliance with federal, institutional, or IRB requirements; and

(C)   suspension or termination of IRB approval for federally- supported research.

(7)   not allowing any member to participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB; and

(8)   inviting individuals with competence in special areas to assist in the review of issues, which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

[Source: Added at 36 Ok Reg 1649, eff 9-13-19]