IRB RELIANCE AGREEMENT REQUEST FORM Non-UVa IRB to serve as IRB of Record INSTRUCTIONS AND INFORMATION The purpose of this form is to facilitate centralized review of research and encourage multi-site collaborations and to eliminate, where possible, reviews by multiple IRBs. The request will be considered by the IRB-HSR on a case by case basis. A Reliance Agreement also known as an IRB Authorization Agreement allows an institution to rely on the IRB of another institution for review of human subject’s research. This form should be completed if you would like to implement an agreement to rely on a nonUVa IRB to serve as the IRB of record for a single protocol or a group of protocols. . See the IRB Reliance Agreement Request Form: UVa IRB to serve as IRB of Record if you would like the UVa IRB-HSR to serve as the IRB of record. Complete this form and submit it along with the IRB Reliance Agreement from the IRB of Record to [email protected] Submission Date: Submitted By: Phone: Email: Website: http://www.virginia.edu/vpr/irb/hsr/index.html Phone: 434-924-2620 Fax: 434-924-2932 Box 800483 Version Date: 05/30/17 Page 1 of 5 IRB RELIANCE AGREEMENT REQUEST FORM UVa IRB-HSR to serve as IRB of Record NOTE: The IRB-HSR may decline a request to rely on a non UVA IRB. For more information, contact the IRB-HSR. UVa IRB for Health Sciences Research (IRB-HSR) Information Name of Institution FWA # IRB-HSR Registration Number IRB Contact Name/Phone Number Signatory Official/Phone Number Signatory Official Contact Address University of Virginia 00006183 00000447 Susie Hoffman/434-924-9634 David Hudson/ 434-243-0900 Senior Associate VP for Research University of Virginia PO Box 400301 136 Hospital Drive Charlottesville, Virginia 22904 UVa Information PI of Protocol(s) at UVa --Name --Title --Address --Phone --Email UVa Contact -- Name --Contact UVa Box Number --Contact-Phone Number --Contact- Email Designating the IRB of Record Name of IRB of Record Institution affiliation of IRB (if applicable) FWA # ( if applicable) IRB Registration Number YES NO Do you confirm that the IRB of Record is a member of SMART IRB and will use the SMART IRB Reliance Agreement If NO, explain reason template and SOP’s IRB Contact Information --Name --Phone number --Email Website: http://www.virginia.edu/vpr/irb/hsr/index.html Phone: 434-924-2620 Fax: 434-924-2932 Box 800483 Version date: 05/30/17 Page 2 of 5 Is this agreement for a single protocol or a group of protocols? Does UVA have an existing IRB Reliance Agreement with the IRB of Record that would cover this study? If NO answer this set of questions: Single (Protocol Title: ) Group ( Group Name: ) YES NO Do not know Will the IRB of Record serve as the HIPAA Privacy Board? YES If (study is /studies are) not federally funded or not regulated by the FDA does the IRB of Record apply the federal regulations to all research regardless of funding source ( e.g. “unchecked the box” on their FWA)? (Study team will need to confirm the answer with the IRB of Record) NA YES Is the IRB of Record in the state of Virginia? YES NO Do you confirm you have attached the IRB Reliance Agreement from the IRB of Record? If NO, explain reason for not attaching: YES NO NO NO Research Information Provide a brief description of the study. Explain the roles & responsibilities of UVA researchers. Explain the roles & responsibilities of non- UVA researchers if different from UVA researchers. NA OR Explain: Do you confirm that a CIRB Application will be submitted through Protocol Builder for each protocol to be covered under this IRB Reliance Agreement? YES NOTE: The IRB-HSR may decline a request to rely on a non-UVa IRB. For more information, contact the IRB-HSR. Website: http://www.virginia.edu/vpr/irb/hsr/index.html Phone: 434-924-2620 Fax: 434-924-2932 Box 800483 Version date: 05/30/17 Page 3 of 5 ACKNOWLEDGMENT OF RELYING INSTITUTIONS AGREEMENT TO CEDE IRB REVIEW & ACKNOWLEDGMENT OF REVIEWING IRB’S AGREEMENT TO SERVE AS IRB OF RECORD This form documents that IRB review will be: ceded under the SMART IRB Master Common Reciprocal IRB Authorization Agreement and that all will follow the SMART IRB SOPS. will not be ceded under the SMART IRB Master Common Reciprocal IRB Authorization Agreement. 1). The University of Virginia agrees to cede IRB review to the Click here to enter name of Reviewing IRB for the study noted below: Study Title: Overall PI or Sponsor Name UVA Investigator: Attach CV Relying Institution IRB Contact acknowledging approval to cede IRB review: Date: Name: Phone: Email: AND 2) The Click here to enter name of Reviewing IRB agrees to serve as the Reviewing IRB (IRB of Record) for the study and relying institution noted above. Reviewing IRB Contact acknowledging approval to serve as IRB of Record: Date: Name: Phone: Email: Website: http://www.virginia.edu/vpr/irb/hsr/index.html Phone: 434-924-2620 Fax: 434-924-2932 Box 800483 Version date: 05/30/17 Page 4 of 5 A copy of the completed form will be shared with the IRB contact of the relying institution. Website: http://www.virginia.edu/vpr/irb/hsr/index.html Phone: 434-924-2620 Fax: 434-924-2932 Box 800483 Version date: 05/30/17 Page 5 of 5
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