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.