R495-820-5 - Research Involving Human Subjects

R495-820-5. Research Involving Human Subjects

(1) The requirements of the United States regulations at 45 CFR 46, 21 CFR 50, 21 CFR 56, 45 CFR 164.508, and 45 CFR 164.512 are incorporated by reference.

(2) In addition to the federal regulations incorporated by reference, the Department requires standard procedures for all research involving human subjects. Researchers are required to complete and electronically submit all forms in the application section of the DHS IRB website and to comply with these rules.

(3) Final approval from the DHS IRB must be granted before the researcher begins any research involving human subjects.

(4) Informed consent must follow requirements outlined in 45 CFR 46.116. In addition the researchers must adhere to the following:

(a) The researcher must consult with the division gatekeeper to determine who has legal authority to grant consent for their clients. If a minor's or vulnerable adult's guardianship changes then research shall be suspended until the researcher obtains an updated consent from the new guardian.

(b) The research participant (human subject) must give written informed consent. Depending on the participant population, the DHS IRB may require a written determination by the proposed participant's health care provider of capacity to consent, or require questions to assess comprehension. Where minors or vulnerable adults are involved as human subjects, provisions must be made for obtaining the informed assent of the minors or vulnerable adults, in addition to the written informed consent of their parents, guardians, or legally authorized representatives, in accordance with 45 CFR 46.408.

(c) Utah is a mandatory reporting state pursuant to UCA 62A-4a-403 and 62A-3-305; mandatory reporting requirements must be disclosed to potential participants during the consent/assent process and reflected in consent/assent documents. Mandatory reporting IS NOT REQUIRED when the survey or intervention is done anonymously with no means of identifying the respondent.

(d) The informed consent document must contain the DHS IRB gatekeeper's name and contact information as a person whom the participants can contact to gather more information regarding their rights as research participants.

(e) The informed consent document must contain a statement that the DHS IRB may review the researcher's records as part of the oversight authority referenced in section R495-820-14.

(5) Placebo research is restricted, see Utah Administrative Code R495-820-6.

(6) Remuneration for participation in the study must not be coercive, have the appearance or effect of being coercive, or be offered to entice individuals to participate in the study rather than receive traditional treatment. Compensation to research participants must be restricted to fair and reasonable remuneration. The DHS IRB reserves the right to determine whether proposed compensation is coercive or fair and reasonable.

(7) In addition to the restrictions in federal regulations, the DHS IRB will not approve the following:

(a) Studies which, in the discretion and professional judgment of the DHS IRB, involve a greater-than-minimal risk, and provide no benefit to the human subject, or provide no generalizable or program knowledge.

(b) Phase I and II studies.

(8) The DHS IRB will not review or approve medical research that includes pregnant women or fetuses as part of its target subject population where there is any foreseeable risk to a pregnant woman or her unborn fetus. Medical research studies shall include precautions to avoid enrollment of pregnant women, including requiring a pregnancy test prior to enrollment and requiring that women have a birth control plan they will follow while enrolled in the study.

(9) The DHS IRB shall require a written assurance from the researcher that upon completion of the study, the researcher will provide final closure information and findings to the DHS IRB. Study results shall be provided to DHS IRB and shall either be in a written report, an electronic format, or in a Clinical Trial Registration, and must have data analyzed and presented in a comprehensible and meaningful manner.

(a) Industry sponsors of and researchers involved in research studies, must commit in writing to publicly sharing final study results on or before the date that all sites have been closed, or all data analysis and report writing is completed.

(b) If a researcher or sponsor fails to make the study results public, the DHS IRB may refuse to consider future proposals from that researcher or sponsor.

(c) If a researcher or sponsor fails to provide study results to the DHS IRB, the DHS IRB may refuse to consider future proposals from that researcher or sponsor.

(10) Greater than minimal risk studies must address requirements outlined in 45 CFR 46.405 and 45 CFR 46.406.

(Adopted by Utah State Bulletin Number 2015-14, effective 6/18/2015)

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