IRB Forms and Templates
FORMS
In almost all cases, submissions to the BSD/UCMC IRBs are done through AURA-IRB. For more information, including policies, submission guidance, and deadlines, please see the home page.
| Type of Submission | Link to Online Form | Details |
|---|---|---|
|
Submissions requiring BSD/UCMC IRB review and approval |
AURA-IRB | This includes new protocols (including requests for exemption), amendments to approved studies, continuing reviews, and unanticipated problem reports. |
|
Requests to rely on an external IRB |
AURA-IRB | Users should select "create CIRB study" as the submission type to submit a new request to rely on an external IRB. Please see the IRB Reliance page for more information. |
|
Determinations that a project does not require IRB review because it does not involve research or does not involve human subjects |
AURA-IRB | Users should select "Not Research" or "Not Human Subjects Research" as applicable in view 2.1 of the main IRB submission form. Note, QI determinations can be obtained through HDSI at https://hdsi.uchicago.edu/qi-determination/ . |
However, certain types of submissions will require a different submission format. Please use the following links to forms in REDCap for the following types of submissions.
| Type of Submission | Link to Online Form | Details |
|---|---|---|
|
Request for Research on Decedents regulated under HIPAA |
Research on Decedents | This form is intended to be used if you plan to view deceased subjects' Protected Health Information and your research is limited to deceased individuals. |
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Request for Review Preparatory to Research regulated under HIPAA |
Review Preparatory for Research | This request should be submitted if you intend to view potential subjects' Protected Health Information before submitting a protocol to the IRB. This service can only be used if you will not be sharing any of this information outside the U of C prior to submitting a protocol. Once you have obtained enough information to justify your planned study, please submit a full protocol proposal to the IRB. |
|
Emergency use Request |
Emergency Use Request | Emergency use is defined as the use of an investigational drug or biological product with a human subject in a life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)]. |
TEMPLATES
When submitting to the IRB in AURA-IRB, the IRB will often recommend the use of a template to create a required document. BSD/UCMC IRB template documents can be found at the links below.
Please contact the IRB Office if you have questions about how or when to use a template.
