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Templates

Informed Consent

Biomedical Consent Form and Authorization for Research Template Updated: 04.26.2007	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. 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. This template should not be used for projects conducted at the VA. If you are using the Veterans Lakeside Hospital as a site, additional VA-specific forms are required.
Biomedical Consent Form for Research Template Updated: 04.26.2007	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. This template should not be used for projects conducted at the VA. If you are using the Veterans Lakeside Hospital as a site, additional VA-specific forms are required.
FAQs	See answers to the frequently asked questions.
Social/Behavioral Consent Form Template Updated: 5.4.2006	This is the IRB's suggested text for social and behavioral science consent forms.
Assent Form Template Updated: 01.30.2007	This template should be used for creating the assent for minors 7-12 years old.
Assent Form Template Updated: 01.30.2007	This template should be used for creating the assent for minors 13-15 years old.
Assent Verbal Script Updated: 01.30.2007	This template should be used for creating a script to obtain assent from minors less than 7 years old.
eIRB Social/Behavioral Consent Form Template Updated: 10.19.2006	The template should only be used for project that was initiated within eIRB or was transitioned into eIRB
eIRB Biomedical Consent Form and Authorization for Research Template Updated: 11.1.2007	The template should only be used for project that was initiated within eIRB or was transitioned into eIRB
eIRB Biomedical Consent Form Template Updated: 11.1.2007	The template should only be used for project that was initiated within eIRB or was transitioned into eIRB
Instructions, Additional Elements and Suggested Language Consent Forms Updated: 04.26.2007	Includes special clauses, additional phrases and elements to be included in the consent form.
Simple Recruitment Form Updated: 11.12.04	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.
Template for VA Consent Form Updated: 05.04.07	Guidelines for VA policies-- OPRS, in collaboration with the Jesse Brown VA Medical Center has developed new consent form templates for use when research studies are conducted at the VA or with VA research subjects.
Template for Recruitment of VA Patients Updated:	For studies that are only recruiting and/or prescreening VA patients while at the VA
Template for VA Patients Transferred to Another Site Updated:	This form should be completed when VA Subjects are participating in a study at another location, such as NMH or RIC. The VA template is also required.
Consent Templates for Special Situations Please see links to the right Updated: 12.06.02	1. Template for Consent Form for Documentation of an Emergency Procedure 2. Clinical Consent Form for a Humanitarian Use Device
IRB Consent Form Checklist	This is the checklist used by the IRB during review of the proposed consent form. It is a useful tool when preparing your form for submission to make sure it meets the minimum requirements of the IRB.

HIPAA Templates

Revocation of Authorization Template

Updated: 11.01.04

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.

Template for VA HIPAA Authorization (NEW)

Updated: 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).