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Oklahoma Administrative Code (Last Updated: March 11, 2021) |
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TITLE 310. Oklahoma State Department of Health |
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Chapter 2. Procedures of the State Department of Health |
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Subchapter 31. Human Subjects Protection |
SECTION 310:2-31-3. Definitions
Latest version.
- The following words and terms, when used in this subchapter, shall have the following meaning, unless the context clearly indicates otherwise:"Allegation" means any written or oral statement or other indication of possible scientific misconduct made to an institutional official."Commissioner" means the Commissioner of Health."Conflict of interest" means the real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships."Deciding official" means the institutional official appointed by the Commissioner who makes final determinations on allegations of scientific misconduct and any responsive institutional actions."Good faith allegation" means an allegation made with the honest belief that scientific misconduct may have occurred. An allegation is not in good faith if it is made with reckless disregard for or willful ignorance of facts that would disprove the allegation."Human subject" means a living individual about whom an investigator (whether professional or student) conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens."Inquiry" means gathering information and initial fact-finding to determine whether an allegation or apparent instance of scientific misconduct warrants an investigation."Institution" means the Oklahoma State Department of Health unless the context clearly indicates otherwise."Investigation" means the formal examination and evaluation of all relevant facts to determine if misconduct has occurred, and, if so, to determine the responsible person and the seriousness of the misconduct."IRB" means the OSDH Institutional Review Board established in accord with 45 C.F.R. Part 46 for the purposes expressed in this subchapter."IRB approval" means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements."OHRP" means the Office of Human Research Protections within the U.S. Department of Health and Human Services (DHHS) that is responsible for guidance, compliance, and oversight relative to the DHHS regulations for the protection of human subjects."ORI" means the Office of Research Integrity within the DHHS that is responsible for the scientific misconduct and research integrity activities of the U.S. Public Health Service."PHS" means the U.S. Public Health Service, an operating component of the DHHS."PHS regulation" means the Public Health Service regulation establishing standards for institutional inquiries and investigations into allegations of scientific misconduct."PHS support" means PHS grants, contracts, or cooperative agreements or applications therefore."Research" means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this Chapter, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities."Research Integrity Officer" means the OSDH official appointed by the Commissioner responsible for assessing allegations of scientific misconduct and determining when such allegations warrant inquiries and for overseeing inquiries and investigations."Research record" means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of scientific misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files."Respondent" means the person against whom an allegation of scientific misconduct is directed or the person whose actions are the subject of the inquiry or investigation. There may be more than one respondent in any inquiry or investigation."Retaliation" means any action that adversely affects the employment or other institutional status of an individual that is taken by an institution or an employee because the individual has in good faith, made an allegation of scientific misconduct or of inadequate institutional response thereto or has cooperated in good faith with an investigation of such allegation. Action taken may include an intentional act of omission."Scientific misconduct" or "misconduct in science" means fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data."Whistleblower" means a person who makes an allegation of scientific misconduct.