PPT-IRB RESEARCH REPOSITORY
Author : briana-ranney | Published Date : 2017-06-08
COMPLIANCE PROGRAM FAQs Designing and Managing Repositories Compliance Deadline August 31 2011 Susan Bankowski MS JD Kathryn Schuff MD MCR IRB Chair IRB CoChair
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IRB RESEARCH REPOSITORY: Transcript
COMPLIANCE PROGRAM FAQs Designing and Managing Repositories Compliance Deadline August 31 2011 Susan Bankowski MS JD Kathryn Schuff MD MCR IRB Chair IRB CoChair Agenda Review Repository Basics. 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. Overview of Today’s presentation . How do I know if I am using VA Resources? . What are the VA training requirements? . What do I do if I am storing PHI at my UI office?. Record retention policy . 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. 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. 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. 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. 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.. 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?. Let’s Play Jeopardy!. Go to the Bank. Time for Your Review. Fast Lane. I’ve Got Friends. 200. 200. 200. 200. 400. 400. 400. 400. 600. 600. 600. 600. Go to the Bank for 200. You have a population of interest (e.g., women who have been diagnosed with breast cancer) that you would like to contact for future studies.. 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
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