PPT-Common Errors to avoid in IRB-03 (VA) Applications

Overview of Todays presentation How do I know if I am using VA Resources What are the VA training requirements What do I do if I am storing PHI at my UI office Record retention policy . General Procedures for Ceding IRBMED Oversight. Procedures Specific to Chesapeake IRB. Medical School. Institutional Review Board (IRBMED). Introductions . Representatives. . Chesapeake. . IRBMED. Medical School. Show the data.. Jeffery W. Rodamar. Workshop on Revisions to the Common Rule. In Relation to Behavioral and Social Sciences . National Research Council. March 21-22, 2013. . 1. Disclaimer . This presentation is intended to promote the exchange of ideas among researchers and policy makers. The views expressed in it are those of the author as part of ongoing research and analysis and do not necessarily reflect the position of the US Department of Education or any other Common Rule department or agency. . February 26, 2015. IRB Function. Review human-subject research. Ensure the rights & welfare of human subjects are adequately protected. Why?. Historical events such as:. The Nazi Experiments. Tuskegee Syphilis Study. COMPLIANCE PROGRAM:. Repository Protocols . and FAQs. Compliance Deadline: August 31, 2011. Kathryn Schuff, MD, MCR Andrea Johnson, JD. IRB Co-Chair Regulatory Specialist, ORIO. Agenda. What’s a repository?. Carl . Stepnowsky. Barbara . Filkins. IRB streamlining = identifying ways to improve the IRB review and approval process. Wide spectrum of opportunity:. The larger the change . . . the longer and more complex the effort. Kevin L. Nellis, MS, CIP. Executive Director, Human Research Protections and Quality Assurance. Criteria for IRB Approval (111 Findings). 2. Risks . to . research participants are . minimized; . Risks . A How-To Guide. http://www.uthsc.edu/research/research_compliance/IRB. /. (901) 448-4824. irb@uthsc.edu. UTHSC Institutional Review . Board (IRB). Charged with protecting human research subjects. Ensures compliance with the federal regulations (DHHS, FDA, & HIPAA) with regards to research applications, consent forms and other research materials to be used; and with regards to the conduct of the research itself. . Objectives. Why are renewals necessary?. What projects require a renewal?. How do I find the form?. How do I . fill . out the form. ?. What are the required documents with submission?. When do I submit the renewal?. & Where. Kevin L. Nellis, MS, CIP. Executive Director, Human Research Protections and Quality Assurance. Objectives. 2. WHY. is IRB approval required? . WHEN. do activities require IRB approval?. 2. AURA-IRB Trainers. Candace Washington, . cdwashington@uchicago.edu. ; 2-2925. Steve Aldape, . saldape@uchicago.edu. ; 4-2182. Your Name. Department. If you could be any . . Rockstar. . . Overview of Today’s presentation . How do I know if I am using VA Resources? . What are the VA training requirements? . What do I do if I am storing PHI at my UI office?. Record retention policy . Hila Berger, Director Research Integrity and Compliance. Mylka Biascochea, Compliance Coordinator IRB/IACUC. 1. Objectives . What is the Institutional Review Board (IRB) responsible for? And why?. What is Human subjects research?. Amy Krenzer, CIP, IRB Coordinator. Hila Berger, MPH, CIP, Research compliance Officer. 1. Objectives . What is the Institutional Review Board (IRB) responsible for? And why?. What is Human subjects research?. Let’s Play Jeopardy!. Go to the Bank. Time for Your Review. Fast Lane. I’ve Got Friends. 200. 200. 200. 200. 400. 400. 400. 400. 600. 600. 600. 600. Go to the Bank for 200. You have a population of interest (e.g., women who have been diagnosed with breast cancer) that you would like to contact for future studies..