PPT-Conditional IRB Approval

Author : alexa-scheidler | Published Date : 2017-07-19

Kevin L Nellis MS CIP Executive Director Human Research Protections and Quality Assurance Criteria for IRB Approval 111 Findings 2 Risks to research participants

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Conditional IRB Approval: Transcript

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 . 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. General Procedures for Ceding IRBMED Oversight. Procedures Specific to Chesapeake IRB. Medical School. Institutional Review Board (IRBMED). Introductions . Representatives. . Chesapeake. . IRBMED. Medical School. 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. 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. 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. . 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?. & 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?. 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. . . From Initial Submission, Through the Informed Consent Process and Continuing Review, To Inactivation. Kimberly Summers, PharmD. Deputy ACOS for Research. South Texas Veterans Health Care System. Research & Development Service. & 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?. 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. �� USA IRB Policy and Procedure��Page of may be unexpected serious adverse effects and to take appropriate measures to ensure that this is understood by the patient or the

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