SECTION 310:2-31-1. General purpose

  The Oklahoma State Department of Health (OSDH) is committed to providing an organizational structure in accordance with Title 45 of the Code of Federal Regulations Part 46 (45 C.F.R. Part 46) in order to establish and maintain an environment dedicated to the ethical principles for safeguarding the rights and welfare of the human beings recruited to participate in research activities. The OSDH Institutional Review Board (IRB) has been established to comply with federal regulations to protect the rights and welfare of human research participants. The OSDH IRB has the responsibility to assure that the risks of proposed research are justified by the potential benefits to the participants and to society, and that risks are minimized to the extent possible consistent with sound research design. The OSDH IRB must assure that the risks of research do not fall disproportionately on one group while the potential benefits accrue to another. The OSDH IRB oversees the consent process to assure voluntary and knowing consent to participate in research. Individuals who are particularly vulnerable or whose capacity to consent may be in doubt require additional protection during the consent process. The OSDH IRB must assure that the research is designed to respect individual privacy and preserve the confidentiality of private information. The OSDH IRB has the on-going oversight responsibility of approved research to monitor the welfare of the participants and to determine that the risks and potential benefits remain unchanged. The OSDH IRB may approve, disapprove, or require modifications to research protocols. It may also suspend or terminate its approval of ongoing (previously approved) research.

[Source: Added at 36 Ok Reg 1649, eff 9-13-19]