Utah Admin. Code R495-820-8 - DHS IRB Reviews
(1) DHS IRB reviews
may be expedited in accordance with
45
CFR 46.110, in which case the division
gatekeeper, alone or in consultation with the DHS IRB chair, may find research
to be exempt, may defer a decision, grant conditional approval, or grant final
approval of the research.
(2)
Mandatory review by a convened quorum of the DHS IRB is required for the
following:
(a) Research involving any
interaction or intervention as defined in
45 CFR
46.102 with minors.
(b) Research involving any interaction or
intervention as defined in
45 CFR
46.102 with vulnerable adults.
(c) Research involving prisoners or
detainees.
(d) Research that is
greater than minimal risk.
(e)
Research involving the use of pharmaceuticals or biomedical
devices.
(3) The DHS IRB
meets on a monthly basis to review proposed research.
(4) The determinations of the DHS IRB will be
submitted to the researcher in writing and may include the following:
(a) Final Approval for a timeframe not to
exceed 12 months.
(b) Conditional
Approval, including conditions that must be met to get final
approval.
(c) Deferred decision
including the information that will be needed in order to complete the
review.
(d) Disapproval, including
reasons for the disapproval.
(e)
Exempt from DHS IRB review
(5) DHS IRB review may make recommendations
on research methodology that is unlikely to yield clear results.
(6) In accordance with
45 CFR
46.109 it is the IRB that has authority to
approve, require modifications to, or disapprove research. As stated in
45 CFR
46.112 agency officials may not approve
research that has not been approved by the IRB. Researchers who disagree with
the IRB determination may submit a revised protocol to address the IRB concerns
or ask to meet with the IRB for further discussion.
Notes
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