Saint Louis University

Forms and Instructions

 

Does my Project Require IRB Review?

IRB Application Forms

  • New protocols should be created and submitted in eIRB.
  • Emergency Use, HUD, Central IRB Applications and pre-existing Exempt Application amendments are still submitted on paper forms (see below). 
  • Investigators trying to determine which IRB Application to use can refer to the Tips for Choosing the Appropriate IRB Application.

***Go to eIRB to submit your IRB Application*** 

Emergency Treatment Form   

Humanitarian Use Device (HUD) Application

Central IRB Submissions

  • Forms and steps for submitting to Central IRBs can be found on the Use of Central IRBs pages of the IRB website.

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

  • 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

  • This document should be used 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 seperate from the consent document. Researchers 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

  • These templates should be used in studies that enroll minors, as approved by the IRB

Model Addendum Consent Document

  • 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

Single Use Consent Template

  • Submit Single Use Applications using the Biomedical Expedited/Full form in eIRB. This consent template 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.

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.

 Human Gene Transfer (IBC) Consent Guidelines (New)

  • Sample language and consent guidelines for studies involving human gene transfer.

Radiation Risks Consent Language

  • Sample language and consent guidelines for studies involving research related ionizing radiation.

Post-IRB Approval Forms For Paper Protocols

Post-IRB Approval Submission Requirements

  • The IRB requires notification of events throughout the life of a study. This document lays out reporting requirement details for investigators conducting human subjects research.

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 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  

SAE Policy Memo 01/2015

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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