340:2-39-12 - Review and approval process

340:2-39-12. Review and approval process

(a) Preliminary review and assessment.

(1) Upon receipt of a completed application for a proposed research project, a preliminary assessment of the application is performed by the Oklahoma Department of Human Services Institution Review Board (DHSIRB).

(2) The preliminary assessment is completed by the chair or the Chair's designee. The assessment determines if the applicant is seeking a full review, an expedited review, or an exemption from review and ensures the provided documentation complies with the pertinent application, per Oklahoma Administrative Code (OAC) 340:2-39-11.

(3) When the application is incomplete in any way, the Chair or the Chair's designee notifies the applicant and explains any deficiencies. The applicant is invited to re-submit the application with deficiencies corrected.

(4) When the application is determined to be complete, the Chair or the Chair's designee assigns a unique identifier number to the proposed research project. This number is used in all future correspondence with the applicant and/or investigator.

(5) When the chair determines the application satisfactorily seeks an expedited review or exemption review, the application and its materials are presented to the Vice-Chair and the DHSIRB Office of Client Advocacy member for review.

(6) When the chair determines the application requires a full review, the application and its materials are presented to all DHSIRB members for review and consideration at the next DHSIRB meeting.

(7) When it is determined that additional information and/or clarification is needed for an application's review, the Chair or the Chair's designee notifies the applicant. The applicant has 90-calendar days to respond.

(A) When the applicant does not respond in a satisfactory manner to the request for additional information and/or clarification within 90-calendar days, the DHSIRB notifies the applicant that the application was administratively closed.

(B) An application that is administratively closed may not be re-opened; however, a new application may be submitted.

(b) Determination that a proposed research project is not human subjects research.

(1) When an investigator or researcher submits an application with a request for a determination of not human subjects research, the DHSIRB chair follows the procedures described in (A) and (B) of this paragraph.

(A) The Chair convenes a subcommittee consisting of the Chair, the Vice-Chair, and the Office of Client Advocacy member.

(B) The subcommittee reviews completed Form 0AD085E and the principal investigator's justification why the proposed research does not qualify as human subjects research.

(i) Based on this review, if the subcommittee determines the proposed research project does not constitute human subjects research, the Chair or the Chair's designee informs the applicant, in writing, of the DHSIRB decision.

(ii) When the subcommittee determines that the proposed research project does constitute human subjects research, the Chair or the Chair's designee informs the applicant, in writing, of the DHSIRB subcommittee decision. The applicant is directed to re-submit the application with a request for an exempt, expedited, or full board review.

(2) DHSIRB members are notified each time a research proposal is determined to not constitute human subjects research. The information is presented electronically or in hard copy format at the earliest possible DHSIRB regular meeting.

(3) If the investigator or researcher disagrees with the DHSIRB decision, a request for reconsideration may be submitted, per OAC 340:2-39-13(c).

(c) Applications with an exemption request.

(1) When an investigator or researcher submits an application with a request for recognition that his or her project is exempt from review, the DHSIRB chair follows the procedures in (A) and (B) in this paragraph.

(A) The chair convenes a subcommittee consisting of the Chair, the Vice-Chair, and the Office of Client Advocacy member.

(B) The subcommittee reviews the completed application and materials supporting the justification why the research project is exempt from review.

(i) Based on this review, if the subcommittee determines that the proposed research project is properly exempt from any review, the Chair or the Chair's designee informs the applicant, in writing, of the DHSIRB decision.

(ii) If the subcommittee determines that the proposed research project is conditionally exempt from DHSIRB review, the subcommittee must also conduct a limited review, per (g) of this Section.

(I) The subcommittee conducts a limited review when the proposed research is of a type described in the federal regulations at Title 45 C.F.R. § 46.104(d)(2)(iii), (d)(3)(i)(C), (d)(7) or (8).

(II) The subcommittee may conduct a limited review when the subcommittee believes a limited review is necessary in order to protect the privacy of subjects or to maintain the confidentiality of data or to ensure broad consent was properly obtained and documented.

(iii) If the subcommittee determines that the proposed research project is not exempt from a review, the subcommittee proceeds with an expedited review of the project using the procedures in (e) of this Section.

(2) Within 14-calendar days after the DHSIRB action on the exemption request, the Chair or Chair's designee sends a written notification informing the applicant of the determination. The written notification includes:

(A) the unique identifier DHSIRB number;

(B) research name; and

(C) reason(s) the exemption request was approved or denied.

(3) If the investigator or researcher disagrees with the DHSIRB decision, a request for reconsideration may be submitted, per OAC 340:2-39-13(c).

(4) The DHSIRB members are notified each time a research proposal is approved through exemption. The information is presented electronically or in hard copy format at the earliest possible DHSIRB regular meeting.

(d) Applications with a request for an expedited review.

(1) When an investigator or researcher submits an application with a request for an expedited review, the DHSIRB Chair follows the procedures described in this paragraph.

(A) The chair convenes a subcommittee consisting of the Chair, Vice-Chair, and Office of Client Advocacy member. The subcommittee reviews the completed application and assesses the proposed research project based upon the criteria for an expedited review, per OAC 340:2-39-11(e).

(i) Based on this review, if the subcommittee determines that the proposed research project satisfies the criteria for an expedited review, the subcommittee carries out the proposed project initial review.

(I) The subcommittee may exercise all DHSIRB authorities except disapproving research.

(II) When the subcommittee fails to accept the research project for an expedited review, then the proposed research project is reviewed in accordance with the non-expedited procedures described in (e) of this Section.

(III) A research project may be disapproved only after review in accordance with the non-expedited procedure.

(ii) If the subcommittee determines that the proposed research project does not meet the criteria for an expedited review, the Chair presents the application to the DHSIRB for a non-expedited review at the next scheduled meeting.

(B) The Director may restrict, suspend, terminate, or choose not to authorize the DHSIRB's use of this expedited review procedure.

(2) The DHSIRB members are notified each time a research proposal is approved through the use of this expedited process. Information about each expedited approval is given to the DHSIRB members in a written report of expedited actions. The report is presented in written or electronic form and disseminated to all board members or at the earliest possible DHSIRB regular meeting. DHSIRB members are given an opportunity to review the report of expedited actions. The review must include an opportunity for members to ask questions or raise concerns about any expedited action. A motion to accept or approve the report may be entertained.

(e) Full review of new research projects, non-exempt, non-expedited.

(1) Review at a convened meeting. Except when an expedited review procedure is used, per (d), the DHSIRB performs an initial review of proposed new research projects at a convened meeting when a quorum is present. In order for the research to be approved, it must receive the approval of a majority of those members present at the meeting.

(2) Reliance on the written application. To complete its review, the DHSIRB may choose to rely solely on the written application, including attachments submitted by the applicant.

(3) Optional review of other information. In addition to its review of the written application, including attachments, the DHSIRB may also choose to invite:

(A) the primary investigator to provide additional information;

(B) subject matter experts to assist in the review; or

(C) experts and guests to attend the meeting when the review takes place.

(4) Review criteria. In order to approve new research covered by this subsection, the DHSIRB determines, per 45 C.F.R. § 46.111 that the requirements in (A) through (G) are satisfied.

(A) Risks to subjects are minimized by using procedures:

(i) consistent with sound research design and that do not unnecessarily expose subjects to risk; and

(ii) already performed on the subjects for diagnostic or treatment purposes, whenever appropriate.

(B) Risks are reasonable in relation to anticipated benefits to subjects, if any, and the importance of the knowledge that may be expected to be gained. In evaluating risks and benefits, DHSIRB considers only those risks and benefits that may result from the research as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research. Per 45 C.F.R. § 46.111(a)(2), DHSIRB does not consider possible long-range effects of applying the knowledge gained in the research.

(C) Selection of subjects is equitable. In making this assessment the DHSIRB takes into account the research purposes and the setting in which the research is conducted. Additionally, the DHSIRB is particularly cognizant of the special problems of research involving subjects who are likely to be vulnerable to coercion or undue influence, such as children, prisoners, economically or educationally disadvantaged persons, or individuals with impaired decision-making capacities.

(D) The proposed research includes a plan to seek informed consent from each prospective participant or the subject's legally authorized representative, per OAC 340:2-39-11.1.

(E) Informed consent is appropriately documented or appropriately waived, per OAC 340:2-39-11.1.

(F) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the subjects' safety.

(G) When appropriate, there are adequate provisions to protect the subjects' privacy and maintain the confidentiality of data.

(5) Additional requirements. In order to approve new research projects covered by this subsection the DHSIRB reviews the investigator's qualifications to conduct and supervise the proposed research. This process may include:

(A) reviewing the investigators', sub-investigators', and other necessary research staffs' resumes, verifying professional associations and licenses and may include a review of the investigators' previous specific experience as demonstrated by recent presentations or publications;

(B) using previous DHSIRB experience with the investigators; and

(C) requesting additional information confirming the investigators' qualifications from an administrator of the investigators' institutions.

(f) Review and approval of cooperative research projects.

(1) Cooperative research projects are those projects that involve the Oklahoma Department of Human Services (DHS) as well as one or more additional institutions.

(A) In the conduct of cooperative research projects, DHSIRB and the other institution(s) are responsible for safeguarding the rights and welfare of human subjects.

(B) DHSIRB makes arrangements with the other institution(s) to avoid duplication of efforts.

(C) When a cooperative research project is sponsored by a federal department or agency that is supporting or conducting the research, DHSIRB relies on the federal department or agency to identify the reviewing Institution Review Board (IRB).

(D) Consistent with the federal regulations, per Title 45 C.F.R. § 46.114(b), DHSIRB recognizes that any institution located in the United States (U.S.) engaged in cooperative research must generally rely upon approval by a single IRB for the portion of the research conducted in the U.S., unless:

(i) more than a single IRB review is required by law, including tribal law passed by the official governing body of an American Indian or Alaska Native tribe;

(ii) a federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context; or

(iii) the cooperative research project does not have a federal sponsor.

(2) When DHSIRB participates with another institution in a cooperative research project that does not have a federal sponsor, DHSIRB seeks to avoid duplication of effort by:

(A) entering into a joint review agreement with the other institution;

(B) relying on the review of the other institution's IRB; or

(C) making similar arrangements for avoiding duplication of effort.

(g) Limited reviews.

(1) If the DHSIRB affirms that a research proposal meets the criteria for a conditional exemption from review, per OAC 340:2-39-12(c), the DHSIRB performs a limited review of the proposal.

(2) The scope of the limited review depends on the type of research proposal. The four types of research are in (A) through (D).

(A) Mildly obtrusive interactions research, per 45 C.F.R. § 46.104(d)(2)(iii), is defined as research with features in (i) and (ii) of this subparagraph.

(i) Mildly obtrusive interactions research only includes interactions involving:

(I) educational tests, such as cognitive, diagnostic, aptitude, and achievement tests;

(II) survey procedures;

(III) interview procedures; or

(IV) observation of public behavior, including visual or auditory recording; and

(ii) the information obtained is recorded by the investigator so the human subjects' identity can readily be ascertained, directly or through identifiers linked to the subjects.

(B) Benign behavioral interventions, per 45 C.F.R. § 46.104(d)(3)(i)(C), is defined as research with features in (i) and (ii) of this subparagraph.

(i) Benign behavioral interventions involves interventions in conjunction with the collection of information from an adult subject through verbal or written responses, including data entry, or audiovisual recording if the subject prospectively agrees to the intervention and information collection.

(ii) The information obtained is recorded by the investigator so the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects.

(C) Storage or maintenance for secondary research for which broad consent is required, per 45 C.F.R. § 46.104(d)(7), is defined as research involving the storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use.

(D) Secondary research for which broad consent is required, per 45 C.F.R. § 46.104(d)(8), is defined as research involving the use of identifiable private information or identifiable biospecimens for secondary research use, when the conditions in (i) through (iii) are present.

(i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained.

(ii) Documentation of informed consent or waiver of documentation of consent was obtained, per OAC 340:2-39-11.1.

(iii) The investigator does not include returning individual research results to subjects as part of the study plan.

(3) For mildly obtrusive interactions research and for benign behavioral interventions, the DHSIRB review is limited to determining that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(4) For storage or maintenance for secondary research for which broad consent is required, and for secondary research for which broad consent is required, the DHSIRB review is limited to determining that:

(A) broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained, per OAC 340:2-39-11.1(b);

(B) broad consent is appropriately documented or waiver of documentation is appropriate, per OAC 340:2-39-11.1(d); and

(C) if there is a change made for research purposes in the way the identifiable private information or identifiable biospecimens are stored or maintained, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(h) Review and approval notification.

(1) Approval categories. As a result of the DHSIRB review, each research proposal is assigned to one of the categories in (A) through (E) of this paragraph.

(A) Not human subjects research. Proposal determined to not constitute human subjects research. Investigators whose proposals receive this determination may begin work immediately.

(B) Approved. Research is approved as submitted. Investigators whose proposals are approved may begin work immediately.

(C) Conditionally approved. Research is conditionally approved, but research may not begin until investigators comply with items identified by the DHSIRB for final approval.

(D) Deferred. DHSIRB does not have enough information to make a determination. Investigators whose proposals receive a deferral must resubmit the entire application to address the required changes.

(E) Not approved. The magnitude and/or number of concerns are such that conditional approval is not appropriate. Investigators whose work is disapproved may not conduct the research or resubmit their proposals.

(2) Notification required. The DHSIRB notifies investigators and appropriate managers, supervisors, and directors within DHS in writing of its decision regarding the proposed research activity, including any modifications or conditions required to secure DHSIRB approval of the research activity.

(A) Approved applications.

(i) At a minimum, the approval letter contains:

(I) the unique identifier DHSIRB number;

(II) the research name;

(III) the date of approval;

(IV) all reviewed and approved DHSIRB documents;

(V) the duration of the approval; and

(VI) circumstances, such as adverse events or closure of the research, for which DHSIRB must be contacted.

(ii) The approval date is the date when the application is approved.

(iii) Continuing review is not required except when there is a good reason for doing so, per OAC 340:2-39-12.2(c).

(B) Conditionally approved applications.

(i) A letter describing the concerns of the DHSIRB is sent to the investigator. The letter makes it clear the research may not begin until DHSIRB issues a letter of approval.

(ii) Investigators have 90-calendar days from the day they are notified about the conditionally approved research to respond. If a response is not received during this period, investigators must resubmit the entire application.

(iii) To review the investigator's response, the chair convenes a subcommittee consisting of the Chair, the Vice-Chair, and the Office of Client Advocacy member. The subcommittee reviews the investigator's response for appropriateness.

(iv) The subcommittee makes a determination as to whether the response adequately addresses the DHSIRB concerns.

(v) A DHSIRB final approval letter is sent to the investigator when the response is approved. At that time, the research may begin. The approval date is the date the investigator's response is approved. Continuing review is not required except when there is a good reason for doing so, per OAC 340:2-39-12.2(c).

(C) Deferred. A letter describing the determination is sent to the investigator.

(D) Not approved. A designation of not approved indicates the magnitude and/or number of concerns is such that conditional approval is not appropriate, as determined by the DHSIRB.

(i) A letter describing the DHSIRB decision and concerns is sent to the investigator. The investigator is notified of the opportunity to respond to the DHSIRB, in writing or in person, regarding the determination, per OAC 340:2-39-13.

(ii) The DHSIRB accomplishes any reconsideration in the same manner as the preliminary review and assessment described in (a) of this Section.

(iii) The investigator is not advised to resubmit disapproved research without consulting the DHSIRB.

(iv) In the event of a resubmission, the DHSIRB submission is given a new number and addressed as a completely new submission.

(3) In general, action on all proposals is taken within two months after submission. Investigators are notified, in writing, of the DHSIRB decisions within two weeks of board action.

(i) Further reviews by DHS. Research covered by this Part approved by the DHSIRB may be subject to further appropriate review and approval or disapproval by DHS officials. However, DHS officials may not approve the research if it was not approved by the DHSIRB.

(Adopted by Oklahoma Register, Volume 32, Issue 24, September 1, 2015, eff. 9/15/2015 Amended by Oklahoma Register, Volume 37, Issue 24, September 1, 2020, eff. 9/15/2020)

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