New Studies

The University of Utah IRB is required to review all human subject research and clinical investigations that are conducted through the following institutions:

The University of Utah, including:

Human subject research is defined by the Office of Human Research Protections (OHRP) in 45 CFR 46.102. A clinical investigation is defined by the Food and Drug Administration (FDA) in 21 CFR 50.3(c). Please read Definition of Human Subject Research [PDF] for the full definition according to IRB policy. Research that does not meet the definition of research involving human subjects must be determined by the IRB staff, not an individual investigator. Investigators must complete and submit an IRB new study application with any applicable documents.

Please Note: For-profit and/or industry sponsored studies must pay IRB fees before the review process begins. IRB Fee Schedule.

New Study Application Submission Requirements

Investigators applying for any initial approval of a proposed research protocol must submit a completed ERICA new study application. The ERICA system uses a smart form application which requires specific information based upon the responses of the applicant (e.g. only if an investigator indicates that the study will be a placebo-controlled trial will an additional page in the application will be required). Applications which are incomplete cannot be submitted electronically.

Additional forms within the ERICA system and documents created outside of the ERICA system may be required to complete an ERICA new study application. Forms should be completed within ERICA as indicated. Documents should be attached to the Documents and Attachments page of the ERICA new study application. Templates for documents can be found on the IRB Forms page.

Required Documents and Forms for IRB Applications [PDF]

Submitting a New Study Application in ERICA

  • Log onto ERICA
  • Click on the IRB Studies tab
  • Click on the Create a New Studies Application button
  • Complete the new study application entirely
  • Attach required and supporting documents to the Documents and Attachments page
  • Submit the new study application to the IRB for review

Note: It is the PI's responsibility to handle the submission of information. This includes the submission of all applications pertaining to the study, as well as revisions requested during the IRB review of an application.