PPT-Differentiating Institutional Review Board (IRB) vs. Research & Development (R&D)

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 RampD Committee Chair Workshop February 7 2023. General Procedures for Ceding IRBMED Oversight. Procedures Specific to Chesapeake IRB. Medical School. Institutional Review Board (IRBMED). Introductions . Representatives. . Chesapeake. . IRBMED. Medical School. 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. 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. 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 . May 19, 2017. Topics. Drivers for Centralized IRB Review. Regulatory changes . Trial Innovation Network. How JHM IRB will address the Single IRB requirements . Key Decisions. When JHM is serving as the IRB of Record. 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. . Presented by:. Joanne Muratori & . Patria Davis. Agenda. Objective. Review . history, role, and function of the Institutional Review Board. Review federal definition of human subjects research and levels of review. 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?. 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. Institutional Review Board. What is an IRB?. What is its job?. What are its guiding Principles?. Belmont Report (i.e., Respect for Persons, Beneficence, Justice). Code of Federal Regulations, Title 45 – Public Welfare, Part 46 Protection of Human Participants (aka . USAID Takamol Jordan Gender Program(AID-278-A-14-00001)This Information Package is made possible by the support of the American people through the Takamol Program implemented by with nancing fr * CHAPTER I * Administration of the Institutional Review Board Establishment of the Institutional Review Board Membership Record Keeping Institutional Responsibilities Principal Investigators Complia April 06, 2023. Maya Monges-Hernandez, CIP. IRB Administrator. Bonny Burn-Whitmore, . IRB Chair, RD, DrPH. Office of Research Compliance. Learning Objectives. Basics of the IRB. Institutional Review Boards.