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Reference Documents
Informed Consent
Assent Forms
Recruitment
Special Situations
VA Consent Forms
HIPAA Templates
Revocation of Authorization Template

Reference Documents

Item Number	Document	Version Date	Description
	FAQs		See answers to the frequently asked questions.
1.	NEW!! Instructions, Additional Elements and Suggested Language Consent Forms	07.21.2008	Includes special clauses, additional phrases and elements to be included in the consent form
2.	Key Elements for a Biomedical Protocol
3.	Key Elements for a Social & Behavioral project
4.	Lay Language of Medical Terms (NEW) Posted with Permission from the University of Michigan Medical School:	01.20.1999	A handy tool when revising the Risk Section of the Consent Form
5.	Consent Form Language in Lay Language (NEW)	07.16.2008	This document provides suggested language to be used when preparing your consent forms.
6.	Consent Form Wording in Lay Language (NEW)	07.16.2008	This document provides suggested language to be used when preparing your consent forms.

NU Informed Consents
This template is updated regularly. Investigators should check the site if they are writing a new consent form or submitting a periodic review to see what changes have been made.

Item Number	Document	Version Date	Description
1.	eIRB Social/Behavioral Consent Form Template	07.23.2008	The template should only be used for project that was initiated within eIRB or was transitioned into eIRB
2.	Biomedical Consent Form and Authorization for Research Template	07.23.2008	Consent form with HIPAA language: This template should be used for consenting subjects in a research study which involves the use or disclosure of protected health information (PHI). Please consult the Consent Form Instructions below prior drafting your consent form.
3.	Biomedical Consent Form for Research Template	07.23.2008	Consent form without HIPAA language: This template should be used for consenting subjects in a research study which will not involve the use or disclosure of PHI. Any PHI will be obtained directly from the subjects (e.g. healthy volunteers). If tests are performed during the conduct of the study, they will be performed at the research facility and will not be processed by a health care provider.
4.	eIRB Biomedical Consent Form and Authorization for Research Template	07.23.2008	The template should only be used for project that was initiated within eIRB or was transitioned into eIRB
5.	eIRB Biomedical Consent Form Template	11.01.2007	The template should only be used for project that was initiated within eIRB or was transitioned into eIRB
6.	Verbal Consent Form Template
7.	Sample Verbal consent template for for studies involving Questionnaires and interviews		A recruitment /introduction letter may be used when a waiver of written consent has been granted. This letter typically accompanies a questionnaire but may be an introductory letter to direct someone to a website to respond to a questionnaire; to call if they wish to participate in an interview, or receive a questionnaire in the mail.

Assent Forms

Item Number	Document	Version Date	Description
1.	Assent Form Template	01.30.2007	This template should be used for creating the assent for minors 7-12 years old.
2.	Assent Form Template	01.30.2007	This template should be used for creating the assent for minors 13-15 years old.
3.	Assent Verbal Script	01.30.2007	This template should be used for creating a script to obtain assent from minors less than 7 years old.

Recruitment Templates

Item Number

Document

Version Date

Description

Simple Recruitment Template

Recruitment Scenarios and FAQs

11.12.2004

A researcher can ask care providers to inform their patients of a research study. The researcher should create a simple referral form (Example) that the patient completes to give his permission for the researcher to contact him regarding the study. The care providers ask their patients if they would like to be contacted to learn more about the study, the patients complete the form if interested and the care provider then forward these notes of permission to the researcher. The researcher may contact anyone who has documented his or her approval.

Consent Templates for Special Situations

Item Number	Document	Version Date	Description
1.	Template for Consent Form for Documentation of an Emergency Procedure	12.06.2002
2.	2. Clinical Consent Form for a Humanitarian Use Device	12.06.2002

VA Consent Forms

The VA Consent Forms Templates have been moved to the VA Investigator Page of our website

HIPAA Templates

Item Number Document Version Date Description

1. VA_HIPAA_Final 07.23.2008

2. Template for VA HIPAA Authorization 08.28.2007 This template should be used in conjunction with the VA consent form 10-1086 when the research project involves the use and disclosure of Protected Health Information (PHI).

Revocation of Authorization Template

Item Number Document Version Date Description

1. Revocation of Authorization Template 11.01.2004 It is not necessary to submit this form to the IRB. A Principal Investigator can use this form if one subject wants to revoke his/her HIPAA authorization. Note that the PI has to report the number of revocations on the periodic review form.