PPT-Navigating the IRB for Education Research

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. 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. 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. 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. & 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?. A Brief Overview of the Types of Projects Which Need IRB Oversight. Back to Basics…. Anyone engaged in human subjects research at Emory is bound to comply with regulations and policies for protecting participants. . 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. 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. 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?. Obtaining . protocol approval . Melanie Locher, B.S., CIP. Assistant Director of Monitoring and Education, . UVM Research Protections Office. Aims of today’s presentation. Detail the steps for a PI to obtain IRB approval. 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. What Every Investigator. (and his/her research staff). Should Know about. Conducting. Human Research Activities. *. Based on David Lettermen’s Top Ten . PI Responsibility #1. In designing the study, the investigator should take into consideration the three underlying ethical principles for conducting research with human subjects as delineated in the. Review and Approval of Research . Molly Klote, MD, CIP. C. Karen Jeans, . PhD, CCRN, CIP. VHA Office of Research and Development (ORD). 2023 IRB and R&D Committee Chair Workshop. February 7, 2023.