Forms

New Projects

Please submit all New Projects using our eIRB system. To access eIRB, please click on the eIRB icon and then click on 'login' at the upper right hand corner.

All VA Forms and HIPAA Forms have been moved to their respective pages.

Many of the forms listed on this page have been revised to include new Conflict of Interest information.

Post-Approval Forms
	Title	Revision	Overview, Guidelines and Instructions
1.	Continuing Review of Research Form (CRRF) Prompt Reporting Form Summary for Continuing Review Death Reporting for Continuing Review	7/29/2009 (NMH, RIC, PM&R and Department Chair Sign-offs are no longer required) 8/19/2008 8/9/2007	All projects are reviewed at least annually. The original review form, a copy of the consent form, and other attachments are required. Definition of Clinical Trial If you want to renew a grant approval, do not use this form, use the submission form for grants (Umbrella grants).
2.	Prompt Reporting Form Reporting Guide for the Prompt Reporting Form	03/11/2009 (Updated to include Items 5.7 and 5.8) 07/29/2009	Frequently Asked Questions UPIRSO Letter to Sponsors Reportable Events Reference Sheet
3.	Revision Submission Form	02/02/2009 (revised to include information regarding NIH supported or conducted Genome-Wide Association Studies (GWAS)
4.	Revision to Authorized Personnel (to accompany a Revision Form)	8/19/2008	IRB Approved projects must maintain an accurate record of who is authorized to work on a research project and hwat each person's role in the project is. Changes in personnel should be reported as new personnel have been included and deleting the names of those who have left the project.
5.	Project Termination/Closure Form	8/19/2008	When a research project has been completed, a Termination Report must be submitted to the Institutional Review Board to give a final "snapshot" of the research study.
6.	Media Relations Submission Form for Open Human Clinical Trials Guidance for NU Relations Communications and Marketing personnel Guidance for Principal Investigators and/or their Research Personnel	3/30/2009	NOTE: The Media Relations Form IS NOT for subject recruitment materials such as flyers, brochures, posters, letters or paid advertising in print or broadcast outlets. These must be submitted on an IRB Revision Form. Please contact NU Media Relations, NMH Media Relations or NMH Communications for assistance before submitting media relations materials to the IRB.
7.	Project Submission Form for Grants (PSFG) (Umbrella projects) (To only be used for Continuing Review submissions)	07/29/2009 (NMH, RIC, PM&R and Department Chair Sign-offs are nolonger required)	This form is used for training grants and grants composed of individually approved project. Please only use this form for continuing review of a grant submission.
8.	Reciprocal Agreement Submission Form (To only be used for Continuing Review submissions)	07/29/2009 (NMH, RIC, PM&R and Department Chair Sign-offs are nolonger required)	Use when research is conducted at Evanston Northwestern Healthcare (ENH) or Childrens Memorial Hospital (CMH) as a site of primary contractual authority and procedures of the study are being done at a Northwestern University (NU). Use only for the continuing approval.
Supplemental Submission Form
	Title	Revision	Overview, Guidelines and Instructions
1.	Request to Waive Consent Form	11/1/2004	Use to request a waiver of consent from the IRB. Guidelines
2.	HIPAA Waiver of Authorization Form	4/21/2006
3.	The Radiation Dosimetry Form Required Risk language for all research related Radiation procedures	3/30/2009	Use this form if radiation exposure is involved with your project.
Forms for Special Conditions:
	Title	Revision	Overview, Guidelines and Instructions
1.	Documentation of Emergency Use or Procedure Form	3/12/2009	See Emergency Use Exemption for Drugs, Biologics and Devices for guidance. Also see the Consent Form for Documentation of Emergency Procedure template. The definition for emergency use procedures can be used within a very limited framework of FDA guidance. See Guidelines for additional information.
2.	Humanitarian Use Device Submission Form	4/24/2006	When using a Humanitarian Device Exemption please be sure you have read all the guidelines and understand the limitations of the category of FDA exemption. See Guidelines for additional information.
3.	OHRP Guidance in Use of the "Short Form"	11/09/1995	OHRP's Guidance on obtaining and documenting informed consent of subjects who do not speak English
4.	Posted with Permission from the University of Minnesota Arabic Consent Short Form Croatian Consent Short Form English Short Form French Consent Short Form Hmong Consent Short Form Khemer Consent Short Form Lao Consent Short Form Oromo Consent Short Form Russian Consent Short Form Somali Consent Short Form Spanish Short Form Vietnamese Consent Short Form		The following process should be used to consent non-English speaking subjects: Obtain the consent short form in the language understandable to the research subject. A summary of what will be said to the subject or the representative must be approved by the IRB and then presented orally to the subject or representative in front of a witness. The IRB-approved English consent document may serve as the summary. A witness must be present for the oral presentation of the summary. The non-English speaking subject or the representative should sign the consent short form. The witness should sign both the consent short form and the IRB approved summary or IRB-approved English consent document. The person obtaining consent should sign the IRB-approved summary or IRB-approved English consent document. A copy of the IRB-approved summary or IRB-approved English consent document and consent short form should be given to the non-English speaking subject or the representative.