PPT-HOW TO PREPARE FOR IRB SUBMISSION

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. SLSQ v12-8-11. What is ‘IRB Awareness’ . Many of our Bronze Medallion members are asked to assist with the manual handling and set up/pack down of IRBs when on . patrol. It is important that these members know how to operate safely around IRB equipment if/when asked to help by the IRB . . 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). 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. . 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. 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. 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. . Objectives. What is an amendment?. What projects are required to submit an amendment?. How do I find the form?. How do I . fill . out the form. ?. What are the required documents with submission?. 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?. Harmonised Technical Guidance for eCTDSubmissions in the EU A baseline submission is a compiledsubmission of the current status of the dossier, i.e. resubmission CMDHBest Practice Guide he Use he Ele Mary Eckart, BS, CIP, VA Central IRB Manager . Mikaela Myers, MA , VA Central IRB Manager. Jessica Kroll, MA, CIP, VA Central IRB Administrator . Webinar Housekeeping. Recording. - This session is recorded, and the associated handouts will be available on ORPP&E’s Education and Training website within a week after the webinar.. An IRB . Infoshort. February 2014. FYIs. FYIs are notifications to the IRB regarding a specific research activity or event that does not invoke a standard protocol submission.. FYIs - 2. A variety of items are submitted to the IRB as For Your...