Oklahoma Administrative Code › Title 340 - Department of Human Services › Chapter 2 - Administrative Components › Subchapter 39 - Innovation Services › Part 3 - OKLAHOMA DEMENT OF HUMAN SERVICES INSTITUTIONAL REVIEW BOARD (DHSIRB) › Section 340:2-39-7 - Principles and policies

Current through Vol. 41, No. 20, July 1, 2024
(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.