SECTION 340:2-39-11. Application procedures

(a)   General requirements.

(1)   Investigators or researchers wanting to conduct research focused on OklahomaDepartment of Human Services (DHS) employees or DHS clients must first secure written approval from the Department of Human Services Institutional Review Board (DHRIRB).

(2)   Investigators submit an application to the DHSIRB before initiating any part of a research project, including subject recruitment.

(3)   Permission requests may be made through the application procedures described in this rule.

(b)   New research proposals.

(1)   The DHSIRB provides DHS Form 20AD085E, Application and Instructions, for investigators who want to submit a research proposal to DHSIRB.

(2)   The application and all required attachments must be submitted to DHSIRB. When received 14 or more calendar days prior to the next meeting, the application is reviewed at the next regularly scheduled DHSIRB meeting. When received 13 or fewer calendar days prior to the next meeting, the application is reviewed at the following regularly scheduled DHSIRB meeting. No application is considered for approval until it is fully completed and submitted along with any required attachments.

(3)   Information provided to the DHSIRB in Form 20AD085E includes, at a minimum:

(A)   the professional qualifications of the principal investigator as well as co-investigators;

(B)   a description of necessary support services and facilities;

(C)   a description of the research protocol, including and addressing the:

(i)   research title;

(ii)   research purpose, including identifying any expected benefits as a consequence of doing the research;

(iii)   research sponsor;

(iv)   results of previous, related research;

(v)   research participant inclusion or exclusion criteria;

(vi)   justification for the use of special or vulnerable participant populations;

(vii)   research design including appropriateness of research methods discussion;

(viii)   description of procedures to be performed;

(ix)   potential risks and a discussion of their relationship to potential participant benefits;

(x)   circumstances surrounding consent procedure, including the:

(I)   setting;

(II)   participant autonomy concerns;

(III)   language difficulties;

(IV)   reading level; and

(V)   particularly vulnerable subjects;

(xi)   procedures for documentation of informed consent, including any procedures for obtaining assent from minors, using witnesses, translators, and document storage;

(xii)   compensation to participants for their involvement;

(xiii)   compensation for injured research participants;

(xiv)   provisions for protection of subjects' privacy;

(xv)   extra costs to participants for their involvement in the research; and

(xvi)   extra costs to third-party payers because of participant's involvement;

(D)   investigator's brochure, when one exists;

(E)   informed consent document; and

(F)   each application must include a description of how the investigator obtains human subject consent, including a copy of the investigator's proposed consent document. For further guidance, refer to Oklahoma Administrative Code (OAC) 340:2-39-11.1.

(4)   The DHSIRB makes a determination on the request using procedures, per OAC 340:2-39-12.

(c)   Requesting a determination that a proposed research project is not human subject research.

(1)   The principal investigator is responsible for obtaining the DHSIRB determination on whether a proposed project does or does not qualify as human subject research. A determination includes, whether human subjects, as defined in OAC 340:2-39-6, are involved.

(2)   To receive a determination that a research project does not constitute human subject research, the investigator must submit a request in writing to DHSIRB. The request must include:

(A)   a completed Form 20AD085E, as described in (b) of this Section; and

(B)   the proposed justification for determining the research does not constitute human subjects research.

(3)   The DHSIRB makes a determination on the request using procedures, per OAC 340:2-39-12(b).

(d)   Requesting a determination that a proposed research project is exempt from review.

(1)   In some limited circumstances, per this Section and in federal regulations, per Title 45 of the Code of Federal Regulations, an investigator may request that DHSIRB recognizes his or her proposed research project as a project exempt from DHSIRB review and oversight.

(2)   To receive a determination that a research project is exempt from review, the investigator must submit a request in writing to DHSIRB. The request must include a completed Form 20AD085E, per (b) of this Section, and written justification why the investigator is seeking an exemption determination.

(3)   The DHSIRB makes a determination on the request using the procedures, per OAC 340:2-39-12(c).

(e)   Requesting an expedited review.

(1)   An expedited review may be requested if the principal investigator submits to the DHSIRB that the proposed research project involves no more than minimal risk and:

(A)   the proposed research falls within a category of research, as determined by the U.S. Secretary of Health and Human Services and is specifically identified in the DHSIRB application, that it is eligible for expedited review by the DHSIRB;

(B)   minor changes in previously approved research during the period for which approval is authorized; or

(C)   the proposed research for which limited DHSIRB review is sought qualifies as a condition of exemption, per Title 45 C.F.R. 46.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8).

(2)   The investigator must submit a request in writing to the DHSIRB to ask for an expedited review of his or her proposed research project. The request must include a completed Form 20AD085E, per (b) of this Section, and written justification why the investigator is seeking an expedited review.

(3)   The DHSIRB makes a determination on the request, per OAC 340:2-39-12(d).

(f)   Cooperative research projects.

(1)   A cooperative research project is a research project that involves DHS and at least one other institutional review board, per 45 C.F.R. § 46.114.

(2)   An investigator, in limited circumstances, may request the DHSIRB recognize his or her proposed research project as a cooperative research project, per 45 C.F.R. § 46.114.

(3)   In the conduct of cooperative research projects, each institutional review board including the DHSIRB, is responsible for safeguarding the rights and welfare of human subjects.

(4)   To receive recognition that a research project is a cooperative research project, the investigator must submit a request in writing to the DHSIRB. The request must include:

(A)   a completed Form 20AD085E, per OAC 340-2-39-11(b)(1);

(B)   identifying information about the other institution, including a reliable point of contact; and

(C)   a description of the other institution's proposed role in the cooperative research project.

(5)   The DHSIRB makes a determination on the request, per OAC 340:2-39-12(f).

[Source: Added at 32 Ok Reg 1828, eff 9-15-15; Amended at 37 Ok Reg 1752, eff 9-15-20]