When do I need Utah Department of Health (UDOH) Institutional Review Board (IRB) Review?
The UDOH Institutional Review Board
- Conducts reviews of human subjects research under 45 CFR 46 in which UDOH is considered engaged.
- Conducts ethical consultations of projects that are not human subjects research under 45 CFR 46 and are not subject to oversight by OHRP. This includes:
- Releases of restricted datasets that are not part of human subjects research in which UDOH is engaged, and are not covered by an alternate IRB, existing MOA, and is permitted under state law.
- Activities, policies, agreements, laws, for which a UDOH employee requests an ethical consultation.
- When required by UDOH data stewards, law, or statute for external reviewers.
How do I submit a request to the UDOH Institutional Review Board?
You must provide all documentation by the 15th of the month to be reviewed the following month.
Steps for submitting a UDOH IRB request:
- Contact relevant UDOH data steward(s) for your project and determine the feasibility of obtaining the data you are requesting. Get a signed data sharing agreement(s) or a Data Steward Approval Form from the data steward(s). If you are using multiple data sets, you will need signatures from all relevant data stewards. The data steward(s) and Bureau Directors or their designee MUST also approve your research proposal prior to the IRB review.
- Download the UDOH IRB Application and complete.
- Submit the following to the UDOH IRB by the 15th of the month to UDOH_IRB@utah.gov:
- Completed UDOH IRB Application
- Signed UDOH data sharing agreement(s) or a Data Steward Approval Form must include list of data variables to be used in study.
- Consent form reviewed using the Flesch-Kincaid readability assessment method found in Microsoft Word and adjusted to a 6-8th grade reading level.
- All other relevant materials such as surveys, recruitment announcements, interview forms, other IRB review determinations, list of data variables to be used in the study.
Your request for review will be discussed at the next IRB Committee meeting. Be available for the scheduled IRB meeting relevant to your review for clarification questions only. You will be informed in writing of the decision regarding your IRB review.
Other Relevant Information/Forms
- Misconduct Investigation Policy
- Informed Consent Requirements
- DHHS Guidance Research Data and the HIPAA Privacy Rule
- Data Steward List
- Current UDOH IRB Members
- Annual Review, Amendment, Termination Form
The Federal Wide Assurance (FW) for UDOH is FWA000024843. All federal grants need to use this number.
For any questions regarding your IRB request, please contact:
UDOH Institutional Review Board Vision Statement: Public health practice and research solidly based on the highest ethical standards.
UDOH Institutional Review Board Mission Statement: Promote ethical research to advance the Utah Department of Health’s (UDOH) efforts to improve the health of Utah residents, provide ethical consultation or IRB review for state and local health department programs, act as a forum for discussion of ethical issues arising in the practice of public health and educate staff of state and local health departments on issues of participant confidentiality; participant privacy; protection against harm; security of records and identifiable information; right of subjects to withdraw without negative consequences; appropriate methodologies and project design when needed; the expectation of sample power where appropriate; informed consent and participant reading literacy; differentiation of research from public health authority, quality improvement and program evaluation; and overall risk analysis of costs to benefits.