PDF-JHSPH IRB Policies

Date of Approval 12108 Approved By Janet DiPietro Definitions Dispensing Drugs DUCI Drug Used in a Clinical Investigation Any drug biological botanical or other substance used specifica. 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. 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. Susan Loess-Perez, MS, CIP, CCRC. Director of Research Compliance. Office of Research Services. Graduate Thesis and Dissertation Conference. February 6, 2016. Purpose of IRB. What Requires Review. Levels of Review. 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?. 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.. & 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?. & Where. Kevin L. Nellis, MS, CIP. Executive Director, Human Research Protections and Quality . Assurance. Updated: . 03/13/2017. Objectives. 2. WHY. is IRB approval required? . WHEN. do activities require IRB approval?. 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 . 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. 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?.