Okla. Admin. Code § 340:2-39-7

Current through Vol. 42, No. 4, November 1, 2024

Section 340:2-39-7 - Principles and policies

(a)Ethical principles. The Oklahoma Department of Human Services Institutional Review Board (DHSIRB) is guided by the ethical principles regarding research involving human subjects set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled, " Ethical Principles and Guidelines for the Protection of Human Subjects of Research" or "The Belmont Report." The DHSIRB recognizes the principles of respect for persons; beneficence, including minimization of harms and maximization of benefits; and justice as stated in The Belmont Report and strives to apply these principles in all research covered by this Part. In addition, DHSIRB makes all reasonable efforts to comply with the requirements in Part 46 of Title 45 of the Code of Federal Regulations ( 45 C.F.R. Part 46) for all research subject to its review.

(b)Institutional policies.

(1) DHSIRB acknowledges and accepts its responsibility for protecting the rights and welfare of human research subjects.

(2) DHSIRB acknowledges that it, and its investigators, accept those responsibilities necessary for the performance of all research covered by this Part including compliance with applicable federal, state, and local laws.

(3) DHSIRB works to ensure that, before subjects are involved in research, the requirements in (A) - (G) are met.

(A) Risks to participants are minimized by:

(i) using procedures consistent with sound research design that do not unnecessarily expose participants to risks; and

(ii) employing procedures already being performed on the participants for prevention, diagnostic, or treatment purposes, when appropriate.

(B) Risks to human subjects are reasonable relative to anticipated benefits, if any, to human subjects, and the importance of the knowledge that may reasonably be expected to result.

(C) Selection of human subjects is equitable.

(D) Human subjects , or their legally authorized representatives , provide voluntary informed consent for participating in research, unless otherwise exempted by state or federal law, per Oklahoma Administrative Code 340:2-39-11.1.

(E) There are adequate provisions for ensuring human subjects' safety.

(F) There are adequate provisions to protect human subjects' privacy and maintain data confidentiality.

(G) When necessary, appropriate additional safeguards are included in research involving subjects who are likely to be vulnerable to coercion or undue influence, such as children, including those who are wards of the state or any other agency, prisoners, individuals with impaired decision-making capacities , or economically or educationally disadvantaged persons.

(4) DHSIRB encourages and promotes constructive communication among its administrators, research supervisors, research investigators, and all other relevant parties as a means of maintaining a high level of awareness to safeguard the rights and welfare of research subjects.

(5) DHSIRB exercises appropriate administrative oversight to ensure its practices and procedures designed for the protection of the rights and welfare of human subjects are effectively applied.

(6) DHSIRB serves in a collaborative relationship with research investigators to ensure that research with human subjects is conducted in accordance with legal requirements and ethical principles of respect for persons, beneficence, and justice.

(7) DHSIRB provides each individual conducting or reviewing human subject research, such as research investigators, research supervisors, research reviewers, and division directors with a copy of this Section.

(8) Per 45 C.F.R. § 46.108(a)(3), DHSIRB is responsible for:

(A) conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and to appropriate Oklahoma Department of Human Services (DHS) managers, supervisors, and directors;

(B) determining which projects require review more often than annually and which projects need verification from sources other than the investigators when no material changes occurred since the previous DHSIRB review; and

(C) ensuring prompt reporting by investigators to DHSIRB of proposed changes in a research activity; and ensuring investigators conduct the research activity in accordance with DHSIRB terms of approval until any proposed changes are reviewed and approved by DHSIRB, except when necessary to eliminate apparent immediate hazards to the subject.

(9) DHSIRB is responsible for ensuring prompt reporting by investigators to DHSIRB; appropriate DHS officials; the department or agency head; and the Office for Human Research Protections, the Department of Health and Human Services (DHHS), or any successor office, or the equivalent office within the appropriate federal department or agency of any:

(A) unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the DHSIRB requirements or determinations; and

(B) DHSIRB suspension or termination of approval.

(c)Support for DHSIRB functions and operations.

(1) In order to ensure that DHSIRB has the necessary resources to carry out its duties, DHS provides sufficient:

(A) staff support, which includes at a minimum, the human protections administrator (HPA). The HPA provides administrative support to DHSIRB, serves as the Office of Human Research Protection's primary DHS contact, and has the administrative responsibility for DHSIRB functions and operations; and

(B) meeting space for the Board to convene.

(2) Additional necessary resources, such as filing space, reproduction equipment, and computers for DHSIRB are provided by DHS through the Innovation Services (IS) division.

Okla. Admin. Code § 340:2-39-7

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