PPT-HawkIRB Research TEAM IRB Training May 2014

Michele Myrvik Program Specialist Research amp Development MicheleMyrvikvagov VA Ext 7645 This TAB httpsloginuiowaeduuiploginpageservicehttpshawkirbresearchuiowaeduhawkirb. Show the data.. Jeffery W. Rodamar. Workshop on Revisions to the Common Rule. In Relation to Behavioral and Social Sciences . National Research Council. March 21-22, 2013. . 1. Disclaimer . This presentation is intended to promote the exchange of ideas among researchers and policy makers. The views expressed in it are those of the author as part of ongoing research and analysis and do not necessarily reflect the position of the US Department of Education or any other Common Rule department or agency. . 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. 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. 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?. 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. 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.. clinical research studies were carried out at single . institutions. Increasingly, studies . are . being . conducted at multiple sites to help increase the number and diversity of the participants, improve operational efficiencies, and accelerate the generation of research results. 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. 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.. 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 . (now DLMP!). Erica C. Jonlin, PhD. ejonlin@uw.edu. . IRB Consultant. Department of Pathology. July 22, 2020. Institutional Review Boards (IRBs). An Institutional . Review Board (IRB) . is a . board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, .