How do I know if I need an IRB review from the Utah Department of Health (UDOH)?
You do not need an IRB review by UDOH when your project:
- is a quality improvement project;
- is program evaluation; or
- falls under existing public health authority to conduct the project and to collect data.
You may need an IRB review by UDOH when you:
- are working with vulnerable populations;
- plan on publishing your results; or
- have had no other IRB review your proposal.
You always need an IRB review by UDOH when:
- you are placing vulnerable populations at risk;
- you are depriving someone of an authorized benefit;
- there are ethical concerns in your research;
- the project may jeopardize the public stewardship of UDOH data and a citizen’s right to privacy and confidentiality; or
- you are using identifiable data for research.
How do I submit a request to the UDOH Institutional Review Board? (IRB Checklist)
You must provide all documentation by the 15th of the month to be reviewed the second Monday of the following month. The UDOH IRB review meetings are held the second Monday of each month from 9:30-11:00 a.m., unless there is a holiday. In cases of a holiday, the meeting will be held the following Monday at the same time. Most meetings are held at the Highland Building or by teleconference.
Steps for submitting a UDOH IRB request:
- Submit your proposal to your university affiliate, governing bodies, or any other third parties that have authority over the data you intend to use and get approval BEFORE submitting to the UDOH Institutional Review Board.
- 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) 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 your Bureau Director or their designee MUST also approve your research proposal prior to the IRB review.
- Download the UDOH Request for Review form. Complete the form, with required signatures, and submit it to the UDOH IRB along with the following:
- University protocol
- Documentation of University IRB approval
- Signed UDOH data sharing agreement(s) with list of data variables to be collected
- Consent form reviewed using the Flesch-Kincaid readability assessment method found in Microsoft Word and adjusted to a 6-8th grade reading level
- Email the completed documents and your contact information by the 15th of the month to UDOH_IRB@utah.gov.
- Your request for review will be discussed at the next Ethics/IRB Advisory Committee meeting, the second Monday of the following month. 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.
- Request for IRB Review Form
- Data Sharing Agreement Template
- Data Steward List
- Informed Consent/Assent Checklist
- Personal Health Information Attestation Form for De-identified Data Sets
- Personal Health Information Attestation Form for Limited Data Sets
- Elements of a Research Protocol
- Research Repositories, Databases, and the HIPPA Privacy Rule
- Misconduct Investigation Policy
- Current UDOH IRB Members
- List of UDOH IRB Projects
- The Federal Wide Assurance (FW) for UDOH is FWA00002191. All federal grants need to use this number.
Links to other IRB sites:
- University of Utah
- Weber State University
- Utah State University
- CDC IRB
- DHHS Office of Research Integrity
For any questions regarding your IRB request, please contact:
UDOH IRB Chairperson
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/IRB review for state and local health department programs, act as 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.