PPT-UTHSC IRB:

A HowTo Guide httpwwwuthsceduresearchresearchcomplianceIRB 901 4484824 irbuthscedu UTHSC Institutional Review Board IRB Charged with protecting human research subjects Ensures compliance with the federal regulations DHHS FDA amp 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. General Procedures for Ceding IRBMED Oversight. Procedures Specific to Chesapeake IRB. Medical School. Institutional Review Board (IRBMED). Introductions . Representatives. . Chesapeake. . IRBMED. Medical School. 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. . 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. June CE 2013. Objectives. Review IRB Member Guidelines: Conduct & Expectation of IRB Members. Review motions and voting options for submissions being reviewed during the meeting.. Review eBridge RSVP locations, Meeting Agendas and Meeting Minutes. 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. 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. Carl . Stepnowsky. Barbara . Filkins. IRB streamlining = identifying ways to improve the IRB review and approval process. Wide spectrum of opportunity:. The larger the change . . . the longer and more complex the effort. 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 . . 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. . . Session Overview. Process and Documentation. Vulnerable Populations. Informed Consent of Non-English Speakers. Illiterate Subjects. Alteration/Waiver of Informed Consent. Informed Consent Process. Informed Consent is not just a form; it is an ongoing process of information exchange that may include:. 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?.