PPT-Working with Western IRB

Agenda GRU IRB Development and Changes WIRBCopernicus Group Process for transfer of Chesapeake IRB protocols Process for the new WIRB submissions GRU IRB Development and Changes WIRB and IRBNet. 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 . June CE 2013. Objectives. Review IRB Member Guidelines: Conduct & Expectation of IRB Members. Review motions and voting options for submissions being reviewed during the meeting.. Review eBridge RSVP locations, Meeting Agendas and Meeting Minutes. 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. 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.. . 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?. From Initial Submission, Through the Informed Consent Process and Continuing Review, To Inactivation. Kimberly Summers, PharmD. Deputy ACOS for Research. South Texas Veterans Health Care System. Research & Development Service. Practice Runs Training Outline. Defining practice runs. Purpose of a practice run. Allowed practice runs. IRB determinations. What is a practice run?. Practice Run (aka Dry Run or Walk Through):. Investigators and study staff who practice a study or conduct a ‘dry run’ to ensure feasibility . Where do I start?. IRB Process Basic Overview. https://research.uga.edu/hso/resources. History:. H. uman Subjects Research Protection. 4. 1974. Congress established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. IRB protocol no. 2837. PI: Dr. David F. . Chhieng. Screening medical records and pathology slides . for research purposes. You likely review patient records all the time, e.g.,. PowerPath. , EPIC, etc.. 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?.