SECTION 340:2-39-5. Purpose, scope, and authority

(a)   Purpose. The purpose of the Oklahoma Department of Human Services (DHS) Institutional Review Board (DHSIRB) is to:

(1)   protect the rights and welfare of DHS employees and DHS clients and/or patients, including individuals receiving DHS benefits or services provided at DHS- operated facilities, who participate in a research activity as a "research subject" or "human subject" as defined in this Part; and

(2)   assist the investigator and DHS in their mutual obligation to comply with all applicable federal, state, and local laws, rules, and regulations, including DHS internal policies, with respect to the research participants and investigators.

(b)   Scope. DHSIRB operates, per Part 46 of Title 45 of the Code of Federal Regulations and applicable state laws. Unless the research meets the criteria for review exemption, per Oklahoma Administrative Code (OAC) 340:2-39-11(d), DHSIRB reviews research projects including program evaluation projects with a human subjects research component that involve:

(1)   direct interaction between the investigator and the research subject, including:

(A)   experimentation, such as experimental medication or treatment, involving the research subject;

(B)   surveys or interviews with research subjects;

(C)   interaction with research subjects beyond normal service delivery; and

(D)   performance of any procedures not performed for the sole benefit of the person involved, and any procedures in which either a primary or secondary purpose or objective is the collection of data for research analysis;

(2)   any research intended to contribute to generalized knowledge; and

(3)   the collection of protected information about research subjects from third parties for research analysis.

(A)   Research involving human subjects is not limited to deliberate experimentation with human subjects. It also includes the performance of any procedures not performed for the sole benefit of the person involved and any procedures in which either a primary or secondary purpose or objective is the collection of data for research analysis.

(B)   The scope of research involving human subjects covered by this Part not only involves physical, chemical, electrical, or psychological stimulation of responses within the human body, but also includes:

(i)   interviews;

(ii)   observation of behavior in which an investigator interacts with human subjects;

(iii)   test administration; or

(iv)   other measurement techniques.

(C)   Some research involving human subjects may be exempt from on-going DHSIRB review. Authority for the decision on whether a research or evaluation project is exempt resides with DHSIRB. Research involving human subjects is not intended to cover data obtained as part of the teaching or training of individuals in which the performance of therapeutic procedures is for the direct and sole benefit of the person involved, or for any area of investigation of individuals as part of the performance of professional services.

(D)   All activities related to human subject research, regardless of funding source, is guided by the ethical principles in The Belmont Report.

(c)   Authority.

(1)   DHSIRB receives its authority from the DHS Director. DHSIRB is registered with the federal Department of Health and Human Services (DHHS) and has approved the Federalwide Assurance of Protection for Human Subjects submitted to DHHS.

(2)   DHSIRB has the authority to review any research funded through DHS or that focuses on DHS staff or individuals receiving DHS benefits or services. In addition, DHSIRB has the authority to:

(A)   approve, disapprove, or order research modification based upon consideration of the risks and benefits to the human subjects;

(B)   oversee the conduct of the research and require periodic progress reports from research investigators;

(C)   suspend or terminate prior approval of a research project;

(D)   place restrictions on a research project;

(E)   require research investigators to report breaches of confidentiality, within five-business days; and

(F)   require research investigators to report within five-calendar days of discovery when any researcher or research participant is endangered physically or psychologically during the data collection period of the study.

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