Frequently Asked Questions

Does the IRB require a complete copy of the grant application with a new Submission?

If the grant is awarded to the University of Utah or to the affiliated investigator, yes. The complete grant application must be attached to the “Documents and Attachments” page of the ERICA application in the designated section. Regulations require that the IRB review the application in order to ensure that procedures being funded by the grant are being implemented in the proposed protocol.

Does the consent document given to research participants have to be the IRB approved/stamped consent?

Yes. Unstamped consent documents are not considered to be IRB approved. Using unstamped or expired consents constitutes non-compliance.

Do I need to submit an adverse event that is not related to the study participation?

No. Only a subset of adverse events should be promptly reported to the IRB using the Report Form application. Please see our policy on “Unanticipated Problems” on the A-Z Index for more information.

When should study subjects be informed of changes in the study?

Changes to an IRB approved protocol must be submitted by way of Amendment application. Once the Amendment is approved, subjects should be informed of the change in a way the researcher deems it appropriate; however, the IRB may require that existing subjects be re-consented or notified in a specific way. Protocol amendments must receive IRB approval before they are implemented unless an immediate change is necessary to eliminate apparent hazard to the subjects.

Must and Investigator's Brochure be included for submissions involving an investigational drug study?

Yes, the IRB is required to review much of the information provided in the brochure. IF the investigational agent is an approved drug or dietary supplement, the package insert or nutritional summary is required.

What is an Expedited Review?

Expedited studies meet certain federal regulations and do not require full board discussion, unless a reviewer has significant concerns and would like to address them with the convened panel. The term “expedited” does not refer to the amount of time it takes to review the study. It does not mean the study receives a cursory review. It refers to the fact that the review type only requires one board reviewer to approve the study, instead of a vote of approval from a convened panel of board members. Please review the “Expedited Categories of Research” on the A-Z Index for more information.

Do the regulations require anything more than a signed consent document from the subject's?

Yes. Informed Consent is a process, not a document. The consent document is a written summary of the information that must be provided to the subject. The subject’s signature is only part of the process. The entire informed consent process involves:

1. Providing adequate information and opportunity to discuss all options with potential subjects;
2. Answering all questions;
3. Ensuring that the subject comprehends the information, and;
4. Ensuring that the subject understands his/her participation is voluntary.

This process should be seen as a constructive and highly informative exchange between investigator and a potential subject.

My study participants are 7 to 18 years of age. What consent documents are required?

The age of assent at the University of Utah is 7 to 17 years old. Participants from age 7 to 17 are required to sign an Assent Document, and an accompanying Parental Permission Document is also required. If your participants are ages 7 to 18, a Parental Permission Document and Assent Document are required for the 7 to 17 age group, AND a Consent Document is required for the 18 year old participants.

After the Board reviews my study, when can I begin enrolling subjects?

When you have received your official electronic approval letter from the IRB, you may log into ERICA to download and print stamped copies of your approved consent documents (if applicable), and you may begin enrolling subjects.