Aside from humanitarian use device (HUD) and emergency use submissions, new applications to the Saint Louis University Institutional Review Board should be created and submitted in the eIRB submission system at https://eirb.slu.edu/.
The type of application you’ll need to complete depends on a few factors: the nature of the research (biomedical or not), risk level and whether certain regulatory criteria are met. It is important to choose the right IRB application, as forms are not inter-changeable and selecting the wrong application could result in duplicate work.
There are three types of IRB review:
Exempt Review: Studies that involve minimal risk and can be justified under one or more of the exempt categories of review. Choose the Biomedical Exempt Application or Social, Behavioral and Education Exempt Application depending on the nature of the research.
Expedited Review: Studies that involve minimal risk and can be justified under one of the expedited categories of review. Choose the Biomedical Research Application or Social, Behavioral and Education Research Application depending on the nature of the research.
Fullboard Review: Studies involving more than minimal risk or those that do not fit exempt or expedited review categories. Choose the Biomedical Research Application or Social, Behavioral and Education Research Application depending on the nature of the research.
See the Tips for Choosing the Appropriate IRB Application for more information.
The following technical resources may help you prepare your application in eIRB:
Need Support? Contact 314-977-7744 or firstname.lastname@example.org.
Have feedback? Click here to access the eIRB System Feedback Form.
An Emergency Use Treatment Form should be submitted for the use of a test article on 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 proactively obtain IRB approval [21 CFR 56.102(d)]. This form is not in eIRB; once completed, email to email@example.com any supplemental information.
Prior to the use of the test article, please verify whether the article has been used previously at SLU, and contact the IRB for reporting requirements, including the requirement to obtain informed consent [21 CFR 50.23(a)].
For additional guidance, please refer to the SLU IRB Guidelines for Emergency Use of Test Articles.
As defined in 21 CFR 814.3(n), and updated by the 21st Century Cures Act, a HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year.
Though not research, use of a HUD requires prior approval by the IRB. The HUD Application is not in eIRB. Use the forms below to request IRB approval to use an HUD; once completed, email to firstname.lastname@example.org any supplemental information. See the HUD Submission Guidelines for more information.
If the IRB Application indicates that your study is one that requires a consent process, the appropriate SLU template(s) should be customized for use in your study. Descriptions of each are below.
Assent Form Templates
For use in studies that enroll minors who must provide assent, as approved by the IRB:
Short Form Consent Process
For use in studies that were not intending to enroll non-english speaking (NES) participants, but a potential NES participant presents and must be enrolled in a time window that does not allow for full translation of the English consent form and HIPAA Authorization form, if applicable.
For more information see Guidelines For Studies Involving Non-English Speaking Subjects.
If a participant speaks a language other than what is provided below, the English version can be used to translate into the targeted language. (A verification of translation must be submitted with the translated short form).