<p> HSSC IRB REQUEST FOR COOPERATIVE REVIEW</p><p>Full Study Title: </p><p>Lead / Approving IRB: </p><p>IRB Protocol Number at Lead / Approving IRB: </p><p>Approval Date: </p><p>Principal Investigator for Lead / Approving IRB: </p><p>Accepting / Deferring IRB: </p><p>IRB Protocol Number at Accepting / Deferring IRB: </p><p>Principal Investigator for Accepting / Deferring IRB: </p><p>Co-Investigator(s) at Accepting / Deferring Institution: </p><p>Other HSSC Institutions Involved in Study: </p><p>Co-Investigator(s) at other HSSC Participating Institutions: </p><p>Attachments: (check) Protocol with approved amendment to include additional site(s) Consent Document(s) Consent Form Addendum (if applicable) Data Collection Form(s) IRB Approval Letter(s) Approval Letter from Scientific Review Committee (if applicable)</p><p>Education: (check) Investigators have completed required research education, including site- specific module(s).</p><p>1 Revised 5-6-10 PRINCIPAL INVESTIGATOR’S ASSURANCE:</p><p>I agree not to involve human subjects in this project until I receive the {NAME OF ACCEPTING / DEFERRING INSTITUTION} IRB’s formal written approval, and obtain informed consent from the involved subjects or the subjects’ legally authorized representative(s).</p><p>No changes in the {NAME OF LEAD / APPROVING INSTITUTION} informed consent documentation will be made without prior written approval of the {NAME OF ACCEPTING / DEFER RING INSTITUTION} IRB.</p><p>I attest that I understand and will follow all DHHS and FDA guidelines (as applicable) as well as institutional policies regarding the ethical use of human subjects in research.</p><p>Principal Investigator at Accepting / Deferring Institution (Printed Name)</p><p>______Principal Investigator (Signature) Date</p><p>Possible Review Determinations</p><p>1. GHS retains the authority to accept the reviewing IRB’s approval, or to make minor changes through the GHS “facilitated review”, or to require review by a convened GHS IRB. 2. The GHS IRB Chair will either:  Accept the reviewing IRB approval  Accept the reviewing IRB approval with minor modifications  Not accept the reviewing IRB approval and refer the study to a convened GHS IRB for review 3. If the reviewing IRB approval is accepted, the investigator will be sent written notification by the GHS IRB that the reviewing IRB approval is affirmed.</p><p>______Accepting / Deferring HSSC IRB Signature</p><p>Date: ______</p><p>Phone: ______</p><p>Fax: ______</p><p>Response Required from Accepting / Deferring HSSC IRB Within 10 Business Days of Receipt 2 Revised 5-6-10</p>