Forms and Instructions
IRB Application Forms
Paper IRB Applications removed as of August 1, 2011. New protocols should be created and submitted in eIRB. Emergency Use, HUD, Compassionate Use and in some cases NCI CIRB Review applications are still being accepted on paper forms.
Emergency Treatment Form
This form 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 contact the IRB for the 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 (NEW)
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 cooperative research involving Children's Oncology Group. This form will be used in lieu of the full SLU IRB application. For guidance, plese see the Guidelines for using NCI C-IRB.
Single Use of a Drug, Biologic or Device Application
Single Use Consent Template (NEW)
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 (NEW)
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 (NEW)
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.
Assent Form Template (NEW)
Model Addendum Consent Document (NEW)
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 (NEW)
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
Change-in-Protocol / For Information Form
This form should be used for existing (paper) protocols. 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. See the IRB guidelines for Closure of Human Subjects Research Studies for guidance on when to close a study.
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.
The IRB no longer requires submission of non-protocol specific OR external adverse events. Please see the Memorandum regarding changes to SLU IRB requirements for SAE reporting.
UP Tracking Table (Do not submit to the IRB)
Investigators are required to report Unanticiapted 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.
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 did not properly get conducted in eIRB.
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 email@example.com 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.