PPT-Creating an IRB Proposal

Human Research Protection Program 357 Administration Building 8067422064 Donna Peters Esther Lucey Rick Shupe The Belmont Report The guiding principles behind human subjects research. 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 . . Mechanics: Looking under the hood. IRB Administrators 2012. PRIDE. Lucindia Shouse, MS, CIP. May 31, 2012. Road Map. Question-and-Answer Session. Traveling to and fro (basic, beyond and in between). 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. 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. 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?. 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. 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. 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.. . 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?. 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. VA Central IRB Administrator. . Updated: . March 27, 2017. Purpose of VA Central IRB. Primary Purpose. Improve human research protections in VA multi-site studies by ensuring:. Consistent expert ethical and scientific 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?.