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New Projects

New!!!
Effective September 2, 2008, OPRS will no longer accept or process new projects submitted on paper for our Biomedical Research. In order to adjust to the time required to collect all required signatures prior to submission, the link to all New Project Submission Forms has been removed from our web-site on 8/15/2008.

For existing studies (i.e., studies originally submitted on paper), continue to use paper forms to submit revisions, continuing reviews, reportable events, and termination requests.

Please note that we will continue to receive the following applications on our paper forms:
Humanitarian Use Device Exemption
Emergency Use Exemption

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.	New Continuing Review of Research Form (CRRF) New Prompt Reporting Form Summary for Continuing Review Death Reporting for Continuing Review	8/19/2008 8/19/2008 8/9/2007	All projects are reviewed at least annually. See the Guidelines for Periodic Review for information on this important responsibility. The original review form, a copy of the consent form, and other attachments are required. See Guidelines for additional information. 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.	New Prompt Reporting Form Reporting Guide for the Prompt Reporting Form	08/19/2008	New Frequently Asked Questions UPIRSO Letter to Sponsors Reportable Event Reference Sheet
3.	New Revision Submission Form	08/19/2008
4.	New 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.	New 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. See Guidelines for additional information.
6.	Media Relations Submission Form for Open Human Clinical Trials	8/1/2007	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. (Form available only thru NUMR, NMHMR or NMH Communications)
7.	Project Submission Form for Grants (PSFG) (Umbrella projects)	01/31/2007	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. See Guidelines for additional information.
8.	Reciprocal Agreement Submission Form	08/21/2008	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 for the initial and 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.	The Radiation Dosimetry Form	4/24/2006	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	3/6/2006	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.	(NEW) 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.

Food and Drug Administration Forms:

Title

Revision

Overview, Guidelines and Instructions

FDA 1571

For Investigator - held IND - "A Sponsor - Investigator is an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug is being administered or dispensed."

See: www.fda.gov/cder/about/smallbiz/Forms.htm
www.fda.gov/cder/forms/1571-1572-help.html for the forms and for information.

FDA 1572

Statement of investigator for drug studies.

See: www.fda.gov/cder/about/smallbiz/Forms.htm
www.fda.gov/cder/forms/1571-1572-help.html for the forms and for information.