Saint Louis University

Forms and Instructions

 

Getting Started

Is Your Project Human Subjects Research? Complete and submit the SLU IRB Human Subjects Research Determination Form for an official determination.

Tips for Choosing the Appropriate IRB Application 


IRB Application Forms

Paper IRB Applications were removed as of August 1, 2011. New protocols should be created and submitted in eIRB. Emergency Use, HUD, WIRB and CIRB Applications are still being accepted on paper forms.  Exempt Applications not yet converted in eIRB can also use post-approval paper forms, such as the Change-in-Protocol Form.

***Go to eIRB to create and submit your protocol electronically***

Emergency Treatment Form   
Emergency Use Informed Consent Template (New)
Emergency Treatment Status Update/Closure Form (New) 
These forms should be used when 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 obtain IRB approval [21 CFR 56.102(d)]. 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 Guidance for Emergency Use of Test Articles.

Humanitarian Use Device (HUD) Application
Humanitarian Use Device (HUD) Protocol Instructions
Humanitarian Use Device (HUD) Consent Form Template (Revised)
A humanitarian use device (HUD) is intended to benefit in the treatment and diagnosis of diseases or conditions that affect or are manifested in fewer than 4,000 individuals in the United States per year. Because the Saint Louis University IRB must conduct an initial and continuing review of HUD submissions, SLU clinicians will need to complete and submit these forms for review.

NCI Central IRB (CIRB) Application 
This form should be used ONLY for authorized NCI Cooperative Group clinical trials.  This form will be used in lieu of the full SLU IRB application. For guidance, please see the Guidelines for using NCI CIRB and the Quick Sheet for Submitting to NCI CIRB.  Please note: CIRB-SLU boilerplate language must be incorporated into the locally-developed consent/assent forms.

Single Use of a Drug, Biologic or Device Application 
Single Use Consent Template (Revised)
These forms should be used if 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.

 
Informed Consent Templates and Related Documents

Model Recruitment Statement/Cover Letter
This document can be used for projects where the use of an informed consent document is not appropriate 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 (Revised)
This template should be used for biomedical/clinical projects submitted on the full IRB application (not exempt studies). 

Behavioral & Social Sciences (Non-clinical) Consent Template (Revised)
This document should be used for behavioral and social sciences/non-clinical projects submitted on the full IRB application (not exempt studies).

Investigators are required to use the new Consent templates (above) for all new IRB submissions. NOTE: HIPAA authorization language has been separated from the informed consent templates. See HIPAA Authorization Form, below.

HIPAA Authorization Form

Lay Language Glossary for Consent Forms

Assent Form Template

Model Addendum Consent Document (Revised)
This document should be used 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
Use of the short form consent process and short form documents require prior IRB approval.
For more information see Guideline For Studies Involving Non-English Speaking Subjects.


Post-IRB Approval Forms For Paper Protocols

Post-IRB Approval Submission Requirements

Change-in-Protocol / For Information Form
This form should be used for existing paper protocols ONLY. If an approved study requires a change, the protocol should be submitted to the IRB office along with this form and any pertinent materials for review by the IRB prior to implementation; (however, changes may be implemented immediately when it is necessary to eliminate apparent hazards to subjects). This form may also be used to notify the IRB of study related information and to report Unanticipated Problems (UP).

Continuing Review Form/Notice of Study Closure (This Form only accepted for HUD, Emergency Use and NCI CIRB protocols that are not available in eIRB)
This form may be used to request continuation or closure for HUD , Emergency Use and NCI CIRB facilitated reviews ONLY.  All other continuing reviews and study closure requests (final report forms in eIRB) must be requested in eIRB. All projects, excluding exempt research, are reviewed by the IRB on a continuing basis. The investigator is responsible for submitting the request for continuing review along with pertinent materials. Please see the IRB guidelines for Closure of Human Subjects Research Studies for guidance on when to close a study. 

Serious Adverse Event (SAE) Report Form  

Instructions for completing SAE Report Form  
This form should be used when reporting serious adverse events (SAEs) on paper protocols to the IRB. Investigators must report all SAEs possibly related to a protocol approved by the SLU IRB. Please see the Requirements for Reporting Events Relating to Subject Safety  for an explanation of the SAE reporting requirements at SLU.
SAE Memo 01/2015
(New)
 

UP Tracking Table (Do not submit to the IRB)
Investigators are required to report Unanticipated Problems (UPs) possibly related to a protocol approved by the SLU IRB on the Change-in-Protocol/For Information/UP form (use eIRB if reporting UP on electronic protocol). A tracking form has been created to assist investigators in logging UPs submitted to the IRB (similar to the cumulative table on the SAE form). This form is only a tool for investigators, and does not require submission to the IRB.

Other Forms

Scientific Review Form for Investigator Initiated Studies 
This form should be completed by the Scientific Review Committee for investigator initiated research studies. The link will take you to the guidance and the form which is located at the end of the guidance.  If submitting in eIRB, the Scientific Review process occurs within the system and this form is only needed if scientific pre-review was not properly conducted in eIRB.

Department Chair Approval Form
This form should be completed by the Department Chair if the Department Chair Approval was not properly conducted in eIRB during the initial submission, when the Principal Investigator is changed, or upon IRB request.

Research in Concept Only
This form should be used when there are no definite plans for research involving human subjects. Submit form to the IRB office at irb@slu.edu when completed.

Preparatory to Research Review Application
This form should be used by researchers to request approval to review protected health information (PHI) for the purpose of designing a research study, determining feasibility for a research study or identifying potential research subjects.

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