Utah Admin. Code 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.
Notes
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