Templates

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

Reference Documents
	Document	Date	Description
FAQs - See answers to the frequently asked questions.
1.	Instructions, Additional Elements and Suggested Language Consent Forms	08.24.2009 (Updated to include RIC's language subject compensation- see page 27)	Includes special clauses, additional phrases and elements to be included in the consent form Definition of Financial and Significant Conflict of Interest Final Gadolinium Consent Form Instructions 7.21.2009
2.	Key Elements for a Biomedical Protocol
3.	Key Elements for a Social & Behavioral project		Consent_Form_Instructions_November2008
4.	Chart Review Protocol Template	10.6.2009 NEW!!	Chart Review Protocol Instructions
5.	Lay Language of Medical Terms 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
6.	Consent Form Language in Lay Language	07.16.2008	This document provides suggested language to be used when preparing your consent forms.
7.	Consent Form Wording in Lay Language	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. The consent form template for paper submissions has been removed from our website. If your project has not yet been converted into eIRB and you are still using the paper version consent form, simply remove the footer from the eIRB consent form and replace it with the version date and page numbers.
	Document	Date	Description
1.	eIRB Social/Behavioral Consent Form Template	09.01.2009 (Updated to include the date line for the submission preparer)	The template should only be used for project that was initiated within eIRB or was transitioned into eIRB
2.	eIRB Biomedical Consent Form and Authorization for Research Template	09.16.2009 (If you plan to revoke your consent language)	The template should only be used for project that was initiated within eIRB or was transitioned into eIRB
3.	eIRB Biomedical Consent Form Template	09.01.2009 (Updated to include the date line for the submission preparer)	The template should only be used for project that was initiated within eIRB or was transitioned into eIRB
4.	eIRB consent form footer	04.23.2009	Consent form template to be used when converting your paper projects into eIRB
5.	Verbal Consent Form Instructions
6.	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
	Document	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.
Recruiment Templates
	Document	Date	Description
1.	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
	Document	Date	Description
1.	Template for Consent Form for Documentation of an Emergency Procedure	12.06.2002
2.	Clinical Consent Form for a Humanitarian Use Device	12.06.2002
Revocation of Authorization Template
	Document	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.