Forms to Use When Submitting to SLU IRB

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/.

Go to eIRB to submit your IRB Application

Choosing the Right Application

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.

Checklist: Eligibility for Exempt Review

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.

Checklist: Eligibility for Expedited Initial Review

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.

Submitting an Emergency Use or Humanitarian Use Device (HUD)
Emergency Use Treatment

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 irb@slu.eduwith 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.

Humanitarian Use Device (HUD)

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 irb@slu.eduwith any supplemental information. See the HUD Submission Guidelines for more information.

Consent/Assent/HIPAA Templates

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.

Model Recruitment Statement/Cover Letter

  • For projects where the use of a full written informed consent document is not indicated, but subjects still need to be informed about the research (i.e. exempt research and certain types of minimal risk research)

Biomedical (Clinical) Informed Consent Template

  • For biomedical/clinical projects submitted on the full IRB application (not exempt studies) 

Behavioral & Social Sciences (Non-clinical) Consent Template

  • For behavioral and social sciences/non-clinical projects submitted on the full IRB application (not exempt studies)

HIPAA Authorization Form

  • At SLU, HIPAA Authorization Forms are separate from the consent document. If your study requires HIPAA Authorization, you must obtain signatures and maintain both documents for each research participant.

Lay Language Glossary for Consent Forms

  • This document contains lay language text alternatives to standard medical terms.

Assent Form Templates
For use in studies that enroll minors who must provide assent, as approved by the IRB:

 
Model Addendum Consent Document

  • For subjects who are already enrolled on a project and need to be informed of new information or changes relating to that project.

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).

 
Single Use Consent Template

  • For use in Single Use Applications (when a physician or researcher plans to treat a single patient who is not enrolled in a research study with an investigational drug, biologic or device). Single Use applications are submitted on the Biomedical Expedited/Full form in eIRB.

ClinCard Research Participant Employee Payment Supplemental Form

  • This optional form can be used to capture payment preferences of research participants are who employees of SLU. This form does not need to be submitted to the IRB. It is pre-approved for use.