After submission of your IRB application it must go through a series of approval steps before being assigned for IRB review. You should plan for the time required to move through these steps when you are submitting your application. In some cases it may take 1-2 weeks before it the IRB can begin their review process.
All applications submitted by a student as the PI must first be approved by the student’s faculty advisor. The student will be asked to identify who their advisor is during the application process. It is the responsibility of the advisor to review the application to ensure it is well-written and contains all required documents before they approve. After faculty advisor approval the application will follow the same steps as a faculty/staff proposal outlined above.
All UVU human subjects’ research projects must undergo review and approval by the IRB prior to initiation of research activities. There are 3 categories of IRB review (exempt, expedited, and full board) defined by the Federal Regulations for Protection of Human Research Subjects (45 CFR 46). While an investigator may identify the likely level of review for their application, final review decision is at the discretion of the IRB.
Human subject’s research is reviewed by the UVU IRB according to the following categories:
Research can be approved as “exempt” if it is no more than “minimal risk” and fits one of the exempt review categories as defined by federal regulation 45 CFR 46. Studies that may qualify for “Exempt” must be submitted to the IRB for review. Exempt reviews are conducted solely by the IRB director or chair. They do not require a convened committee meeting. The IRB approval process for exempt review takes approximately 1-2 weeks.
Research can be approved as “expedited” if it is no more than “minimal risk” and fits in one of the federally designated expedited review categories. Expedited reviews are conducted by a member of the IRB committee in addition to the director or chair. They do not require a convened committee meeting. The IRB approval process for expedited review takes 2-4 weeks.
Research that does not qualify for expedited or exempt review (presents more than minimal risks to subjects) will receive review at a fully convened IRB committee meeting. The IRB approval process for full board review is dependent on the monthly scheduled IRB board meetings. Review takes approximately 1-3 months.;
Often times the IRB will require additional information from the PI before they are able to approve the research. This additional information may be missing documentation or request for clarifications/expanded details so that the risk to study subjects can be better assessed. You will receive an email from the IRB chair or director with a description of the requested information.
To complete requested revisions:
If you need to make modifications to a previously approved study, the IRB requires submission of a study amendment that must be approved before the changes are implemented. Examples of changes may include addition or removal of questions from an approved survey, modifications to the inclusion/exclusion criteria for subjects, or changes to the research methodology. To request an amendment you will need to submit an “Amendment summary” document that describes the change being requested, the reason for the change, and if/how this change affects the risks to the study subjects. Additionally, edits must be made to all forms that relate to the requested modification, including the addition of a new informed consent document if necessary. The IRB will review the submitted amendment and may request additional information. The study may not proceed with the requested changes until the amendment is approved by the IRB.
Once the IRB review process is complete the IRB chair will approve, or in a small number of cases reject, your research application. Upon approval you will receive an email through the Axiom Mentor system stating that your project has been approved to proceed and provide your IRB application number. The IRB number should be printed on all recruiting material and the informed consent document. Please note you CANNOT begin your research project until it has been approved by the IRB. Any data collected before IRB approval is ineligible to be included in the research project and you will be considered in non-compliance.
For certain projects, the IRB requires continuing review of research based on the degree of risk for the research study. This continuing review will occur once per year and must occur before the project end date. The PI will receive an email 60 days before the due date for continuing review and then another 30 days before the review date. If continuing review is not completed before the project approval expires, all study related activities such as subject enrollment and data collection must cease. The project will be administratively closed and the PI will need to submit a new application to get re-approved before study activities can begin again.
Investigators applying for continuing review must describe the progress of the study including current project enrollment and any ongoing/future enrollment still required, the status of data collection, and any unforeseen or adverse effects observed.
Please note that continuing review is NOT required for projects that were verified exempt. Additionally, the majority of projects approved with expedited review will NOT require continuing review unless the PI is seeking to continue the project past the approved expiration date.
When your project is completed (or discontinued) a final report should be submitted to the IRB. The final report should include:
A project is eligible for final report submission when all of the following are met:
Please note: projects approved before January 2019 may not submit an amendment to extend the end date of their proposal. These projects must terminate their original research and resubmit a new IRB application under the new revised Common Rule 45CFR46.
