Forms and Instructions

Find the necessary forms your need to submit paper protocols to Saint Louis University's Institutional Review Board, as well as additional guidelines and resources.

Does My Project Require IRB Review?

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, which can be found below.

Investigators trying to determine which IRB application to use can refer to the Tips for Choosing the Appropriate IRB Application guide.

Emergency Treatment Form

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, 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, refer to the SLU IRB Guidance for Emergency Use of Test Articles.

Humanitarian Use Device (HUD) Application

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.

Informed Consent Templates 

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. 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 This form should be used when reporting serious adverse events on paper protocols to the IRB. Investigators must report all SAEs possibly related to a protocol approved by the SLU IRB. See the Requirements for Reporting Events Relating to Subject Safety for an explanation of the SAE reporting requirements at SLU.

  • 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
  • Genomic Data Sharing Form Investigators needing certification for sending genomic data to any NIH database should complete this form. Institutional certification can only be made by the SLU IRB. Either attach the completed form to your protocol in eIRB or email it to irb@slu.edu.