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IRB Applications & Forms

All new applications to the IRB for Full, Expedited and Exempt categories of review will use the same Standard IRB Application format, submitting the documents noted below. Please note that an Internal Indemnification Form is no longer required.

Instructions for completing a Standard IRB Application may be found within HRP-211 Application for Initial Review (page 2), HRP-101 Human Research Protection Program Plan, and HRP-103 Investigator Manual.

At a minimum all application will include:

And the most appropriate HRP-503 from below

Additional forms and/or material are to be provided for IRB review as applicable. Supplemental IRB review documents may include consent or assent forms, advertisements and flyers, questionnaires/surveys, letters of permission for use of privately controlled data or facilities.

The GCP form is to be completed and submitted to the IRB when compliance with Good Clinical Practice is a requirement of the sponsor or protocol.

Protocols required to document the consent of subjects for participation in research will use the most appropriate Template Consent Document available from the list below.

Short Form Consent Guidance to Investigators (PDF)

The Short Form Consent Documents are NOT a replacement for the HRP 502 Template Consent Forms.  Please review the “Short Form Consent Guidance to Investigators” at the link above for appropriate use of the Short Form Consent Document.

Investigators planning on any other type of new initial submission will use the category specific application. Examples include Case Study/Case Report and Letter of Determination (LOD).

Additional application and reporting documents may be found below in addition to a comprehensive listing of SOPs and Guidance documents.

IRB Electronic Application/Communication and Submission Procedures

All NEW/Initial submissions to the DU IRBs and/or the WIRB for review will be provided to the Human Research Protection (HRP) Office in an “electronic” format. This change in application format coincides with and enhances the pending implementation of the Coeus electronic application program. Instructions for the paperless application process may be found at:IRB Paperless Electronic Application/Communication and Submission Procedures

Investigators planning to conduct research involving St. Christopher’s Hospital for Children should note the following.

IRB submissions that use physician/staff/patient/resources of St. Christopher’s Hospital for Children must first be sent to the SCHC Office of Research Support. The IRB will not process a protocol that has not initially been reviewed by both the Office of Research Support and the investigator’s Department Head or designee. Please submit original applications in an electronic format to Eusebia Cruz (Eusebia.cruz@tenethealth.com) , SCHC-Office of Research Support, Annex Building, 2nd Floor.

IRB Application Forms 

IRB Reporting Forms