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?
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
- 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 and Social Sciences (Non-clinical) Consent Template
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.
- In research where child assent is being obtained, parental permission is required
(unless waived). Parents will sign the Informed Consent Document in two places. One
is the signature of consent, and one is an attestation that their child has received
a proper explanation covering all points of the assent information sheet and has agreed
- 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 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.
- 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 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
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
- 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.
- 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 firstname.lastname@example.org 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 email@example.com.