PPT-2012 VA IRB Chair Meeting

Tuesday August 14 2012 Remembering Ethics When Legal amp Ethical Constraints Diverge in Human Subjects Protection Valerie H Bonham Senior Attorney Office of the General Counsel US Department of Health and Human Services. Find us online. Information available online. IRB procedures and bylaws. IRB FAQs. Definition of research. Link to the CITI ethics training. Application form. Instructions to fill out the application form. 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 . SLSQ v12-8-11. What is ‘IRB Awareness’ . Many of our Bronze Medallion members are asked to assist with the manual handling and set up/pack down of IRBs when on . patrol. It is important that these members know how to operate safely around IRB equipment if/when asked to help by the IRB . 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. . Agenda. GRU IRB Development and Changes. WIRB-Copernicus Group. Process for transfer of Chesapeake IRB protocols. Process for the new WIRB submissions. GRU IRB Development and Changes. WIRB and IRBNet. Micheal A. Kuhn, MD. Vice Chair, Loma Linda University. Institutional Review Board. What type of . research needs. IRB review?. Anything and everything . that involves human subjects. Navigating the IRB process. 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. Define research and human subjects research.. Show the "gray area" between research and practice.. Describe the distinction between a medical education initiative and a medical education research initiative.. Simplified process. Electronic submission to IRB. “Robust” guidance from HSO. One reporting mechanism (no separate forms). New 60 day amendment submission deadline. IRB Makes the Determination. When . Cynthia Gage. TAC Training Coordinator. June 20, 2014. Outline. Voting Process. Establishing Quorum. 2/3. rds. or simple majority. ?. Recording votes. When does Chair vote. ?. When there is no quorum. New Opportunities :: new challenges. Michael Zimmer, PhD. Assistant Professor, School of Information Studies. Director, Center for Information Policy Research. University of Wisconsin-Milwaukee. zimmerm@uwm.edu. 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?.