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 . 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 . . Mechanics: Looking under the hood. IRB Administrators 2012. PRIDE. Lucindia Shouse, MS, CIP. May 31, 2012. Road Map. Question-and-Answer Session. Traveling to and fro (basic, beyond and in between). 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. 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?. 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. . . 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. VA Central IRB Administrator. . Updated: . March 27, 2017. Purpose of VA Central IRB. Primary Purpose. Improve human research protections in VA multi-site studies by ensuring:. Consistent expert ethical and scientific review. 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. 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?.