Okla. Admin. Code § 340:2-39-8

Current through Vol. 42, No. 7, December 16, 2024

Section 340:2-39-8 - [Effective until 9/14/2025] Membership

(a) Oklahoma Department of Human Services Institutional Review Board (DHSIRB) membership requirements

(1) The DHSIRB is comprised of at least seven members. Membership criteria includes, but is not limited to, consideration of earned degrees, representative capacity, and indications of experience, such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to DHSIRB deliberations.

(2) Prior to serving on the DHSIRB, all members submit certificates of completed Human Subject Assurance Training offered by the federal Office for Human Research Protections (OHRP).

(3) Prior to serving on the DHSIRB, all members must sign an Acknowledgment of Receipt stating they have received and reviewed the DHSIRB rules.

(4) To the greatest extent reasonably possible, the DHSIRB members have varying academic, professional, and personal backgrounds to promote complete and adequate review of research activities commonly conducted by Oklahoma Human Services (OKDHS) or at state-operated facilities. In addition to possessing the experience and expertise necessary to review specific research activities, the members are expected to ascertain the acceptability of proposed research in terms of OKDHS commitments and rules and regulations, applicable law, and standards of professional conduct and practice.

(5) The DHSIRB similarly strives, through member experience, expertise, and diversity, including race, gender, cultural backgrounds, and sensitivity to issues, such as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

(A)Scientific background. The DHSIRB includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

(B)A member not affiliated with OKDHS. The DHSIRB includes at least one member who is not otherwise affiliated with OKDHS and who is not an immediate family of a person who is affiliated with OKDHS.

(C)Ad hoc members with special competence. The DHSIRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond, or in addition to, that normally available to DHSIRB members. These individuals may not vote on any DHSIRB matter.

(6) DHSIRB membership consists of at least a member of OKDHS:

(A) Legal Services;

(B) Child Welfare Services;

(C) Children's Services;

(D) Adult and Family Services;

(E) Adult Services;

(F) Information Security; and

(G) Innovation Services. The Innovation Services member serves on the DHSIRB representing scientific areas.

(7) The OKDHS Director approves the selection of DHSIRB members, including the Chair, Vice-Chair, and alternates, and is notified by the Chair of any studies that are disapproved by the DHSIRB.

(b)Alternate members.

(1) Primary DHSIRB members may designate an alternate member from his or her respective programs or divisions, who subject to Director approval, serves as a voting member in the event the primary member is not available to attend any regularly scheduled meeting. Alternate members complete any primary DHSIRB member required training, and may then vote on any new submission, when needed. Alternate members receive meeting documents, such as agendas, minutes, and protocols for review and are encouraged to attend all meetings.

(2) An alternate member-at-large is designated and approved by the Director to serve when both a voting member and his or her alternate are not available to attend a regularly scheduled meeting. The alternate member-at-large is approved based on the same criteria per (a)(5), of this Section.

(c)Ad hoc members.

(1) When the DHSIRB reviews research applications involving prospective research subjects who have impaired decision-making capacity or who otherwise are considered vulnerable to coercion or undue influence, consideration is given to including one or more individuals who are knowledgeable about, and experienced in, working with these prospective subjects.

(2) DHSIRB may, at its discretion, invite individuals with competence in specific areas to assist in the review of issues that require expertise beyond or in addition to that available on the DHSIRB.

(3) Ad hoc members are non-voting members.

(4) No person outside of the DHSIRB may override a not-approved vote.

(d)Roles and responsibilities.

(1) DHSIRB Chair:

(A) is appointed by the OKDHS Director;

(B) serves for a minimum of one year, with the possibility of reappointment;

(C) does not resign when the majority of the DHSIRB membership consists of new members who have served for less than one year;

(D) serves as a member of the DHSIRB in addition to his or her authority as Chair;

(E) prepares for, and convenes meetings with, the assistance of the human protections administrator (HPA);

(F) ensures meeting coverage by the Vice-Chair when not able to serve as chair;

(G) ensures a quorum is present for all meetings;

(H) carries out an initial assessment of submissions with the Vice-Chair and a third member appointed by the Chair;

(I) carries out an expedited review of submissions that qualify under such conditions by convening a DHSIRB subcommittee to complete the expedited review, per Oklahoma Administrative Code 340:2-39-12(d);

(J) distributes copies of the submissions to the appropriate DHSIRB members with HPA assistance;

(K) ensures adequate expertise for review and determinations;

(L) consults with investigators as necessary;

(M) assists the reviewers and other members with any concerns in preparing for the meeting;

(N) ensures assigned reviewers present a clear and concise review of research materials;

(O) votes on each DHSIRB action;

(P) is temporarily removed in the event of a conflict of interest;

(Q) is permanently removed in the event of termination of employment or at the Director's discretion; and

(R) notifies the Director of any disapproval.

(2) DHSIRB Vice-Chair:

(A) is appointed by the Director;

(B) serves for a minimum of one year, with the possibility of reappointment;

(C) serves as a member of the DHSIRB in addition to his or her DHSIRB authority as Vice-Chair;

(D) assists or acts on behalf of the Chair in particular DHSIRB matters and at DHSIRB meetings;

(E) carries out an initial assessment of submissions with the Chair and a third member appointed by the Chair;

(F) carries out an expedited review of submissions that qualify under such conditions by participating on a DHSIRB subcommittee to complete the expedited review, per OAC 340:2-39-12(d);

(G) is temporarily removed in the event of a conflict of interest;

(H) is permanently removed in the event of termination of employment or at the Director's discretion.

(3) DHSIRB members:

(A) are approved by the Director;

(B) serve at least one year with the option of rotating with designated alternate;

(C) do not resign from the DHSIRB, without good cause, when the majority of the members are in their first year of serving;

(D) are responsible for reviewing research protocols submitted for full DHSIRB review;

(E) are responsible for attending all scheduled meetings;

(F) are removed from the DHSIRB when more than two consecutive meetings are missed without having the designated alternate attend;

(G) are temporarily removed in the event of a conflict of interest; and

(H) are permanently removed in the event of termination of employment or at the Director's discretion.

(4) DHSIRB Chair, Vice-Chair, and members:

(A) ensure any required IRB training is completed and sufficient IRB training certification is submitted as necessary;

(B) annually ensure DHSIRB primary members and designates submit signed acknowledgments affirming the DHSIRB procedures and that supporting documents were reviewed and submitted as necessary;

(C) have access to the reference materials available through the DHSIRB HPA-maintained library;

(D) receive no compensation for serving as members of the DHSIRB;

(E) conduct reviews of submitted research proposals as delegated, mandated, or requested;

(F) provide written responses to the research investigator and organization containing DHSIRB findings;

(G) determine which research requires review more often than annually;

(H) determine which research needs verification that material changes have not occurred since previous DHSIRB review, from sources other than the investigators;

(I) advise research investigators to report changes to the approved research activities;

(J) advise research investigators that changes in approved research are not initiated without DHSIRB review and approval, except when necessary to eliminate apparent immediate hazards; and

(K) advise research investigators to promptly, within five-business days, report to DHSIRB and appropriate DHS officials of:

(i) unanticipated problems involving risks to research participants, interviewers, or others;

(ii) serious or continuing noncompliance with DHSIRB requirements;

(iii) suspension or termination of DHSIRB approval; or

(iv) disapproval of other DHSIRB submissions.

(5) Consultants may be invited to review submissions and attend meetings when a proposal contains information outside of the scope of DHSIRB members' collective knowledge. No individual with an interest or involvement in the research study application under DHSIRB consideration is utilized in any consultative capacity.

(e)Conflict of Interest. No DHSIRB member votes on a submission when there is an actual or potential conflict of interest with regard to member's professional or personal interests, including financial interests. Every DHSIRB member recuses himself or herself from consideration of any research study application in which that member or the member's immediate family has any involvement or interest in the study or its outcome.

(1) Based on a DHSIRB majority vote, any DHSIRB member may be excluded from participating in an initial or continuing review of any project in which the member has an actual, apparent, or potential conflicting interest.

(2) A conflict of interest exists when any DHSIRB member, including alternate members and ad hoc members, has an interest sufficient to influence, or appear to influence, the objective exercise of his or her official duties. A conflicting interest may:

(A) be personal in nature or may result from divergent professional responsibilities;

(B) arise when a DHSIRB member is involved with a research project as an investigator, a researcher, a director, an assistant, an advisor, or as another type of stakeholder;

(C) arise when any DHSIRB member or the member's immediate family has a financial interest in the outcome of the research. Immediate family includes spouses/domestic partners, siblings, parents, and dependent minors and adult children; and

(D) be recognized for any other reason that is considered to be an unacceptable conflict of interest by the member or by DHSIRB.

(3) When a DHSIRB member has a conflict of interest, the member:

(A) discloses his or her conflict of interest; and

(B) recuses himself or herself from participation in the meeting while the submission is reviewed or discussed, and

(C) abstains from voting on the submission.

(4) Recusal means the member with a conflict of interest:

(A) refrains from discussing any research project in which he or she has a conflict of interest;

(B) does not seek to influence other DHSIRB members prior to a vote; and

(C) removes himself/herself from the meeting room while the discussion and DHSIRB vote takes place, except to provide DHSIRB-requested information.

(5) It is each DHSIRB member's duty to ensure participant protection, DHSIRB review integrity, and that research projects conducted are not jeopardized by an undisclosed, unidentified, or unmanaged conflict of interest.

Okla. Admin. Code § 340:2-39-8

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

Amended by Oklahoma Register, Volume 42, Issue 5, November 15, 2024, eff. 10/8/2024, exp. 9/14/2025 (Emergency)