Research is a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
An OKDHS employee or client who is: voluntarily participating as a human subject in a research project; voluntarily participating in a survey or interview conducted as part of a research or program evaluation project; and/or whose protected information is disclosed to and used by an investigator during a research or program evaluation project.
It includes those individuals 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, pregnant women, cognitively impaired persons, or economically or educationally disadvantaged persons.
The probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life.
It is an individual's voluntary agreement to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, or institution from liability for negligence.
Generally, an institution is considered to be engaged in non-exempt human subject research when the institution's employees or agents for the purpose of a research project: engage living individuals through intervention or interaction to obtain data about them; obtain individually identifiable private information; or obtain informed consent of human subjects.
The members of the DHSIRB have varying backgrounds to promote complete and adequate review of research activities commonly conducted by an institution or state-operated facilities. In addition to possessing the experience and expertise necessary to review specific research activities, the members are able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
Membership within the DHSIRB strives to achieve sufficient diversity and take into consideration such factors as race, gender, cultural and professional backgrounds, and sensitivity to community attitudes and other issues. There is at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas. In addition, DHSIRB includes at least one member who is not otherwise affiliated with the Oklahoma Human Services (OKDHS) and who is not part of the immediate family of a person who is affiliated with the institution.
The composition of the DHSIRB can be found in the Members page.
A designated member of the DHSIRB screens each submission to determine if it satisfies the criteria required to be exempt from the review process. If a study qualifies for an exempt review, it will not need to go through expedited or full review. These findings are presented for consideration to the full DHSIRB at the next scheduled meeting.
A DHSIRB senior member or experienced member reviews applications that qualify for expedited review. Research projects can qualify for expedited review so long as the research presents no more than minimal risk to its participants. Proposals subject to expedited review may be approved, conditionally approved, or referred for full DHSIRB review if not approved as proposed. Research may not be disapproved if subjected only to an expedited review.
Research applications are reviewed by the full DHSIRB at regularly scheduled meetings. After consideration and discussion, each member then votes to approve, conditionally approve, disapprove, or defer. Based upon the tabulated vote of the Board members, the approval state of the research proposal is then determined.
The requirements for each review protocol can be found in the Application and Review Process page
The DHSRIB meets monthly on the first Tuesday of every month.
The length of time a study will take to be reviewed and approved depends on the type or level of review required. Factors such as the type of review the application qualifies for, the completeness of the application, and the quality of the application influence the time between submission and review and approval action. In general, the board strives to take action on all applications within two months after submission.
Researchers may request reconsideration of a DHSIRB decision regarding a research protocol. The request is submitted in writing and includes any pertinent information relative to the decision. The reconsideration is accomplished in the manner described for initial review. Upon reexamination and reconsideration of its actions, the decision of the DHSIRB is then final.
Economically or educationally disadvantaged persons are those who are likely to be vulnerable to coercion or undue influence due to socioeconomic and/or educational background:
Persons may include those who struggle to provide basic necessities for themselves and their families or communities. This population may include one or more of the following: an individual who receives, or is a member of a family that receives, a total income that, in relation to family size does not exceed the higher of the poverty line or 70 percent of the Lower Living Standard Income Level (LLSIL); an individual/family who receives or is eligible to receive Temporary Assistance for Needy Families (TANF); an individual/family who receives or is eligible to receive any of the following: public assistance, Supplemental Nutrition Assistance Program (SNAP), Medicaid, or the national free or reduced price lunch program.
Persons may include those who have educational deficits, learning disabilities, or cultural backgrounds that limit communication with a researcher. This population can also include, but is not limited to, persons who come from economically disadvantaged families, families with limited English proficiency, migrant worker families, or families in which one or both parents have dropped out of secondary school.