PPT-Revised Common Rule: Changes to Exempt Categories and Limited IRB Review

Author : reagan | Published Date : 2021-12-08

Kristina Borror PhD Director of Policy and Education VHA Office of Research Oversight 1 Overview Background Exemptions and Subpart Applicability Exemptions Limited

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Revised Common Rule: Changes to Exempt Categories and Limited IRB Review: Transcript

Kristina Borror PhD Director of Policy and Education VHA Office of Research Oversight 1 Overview Background Exemptions and Subpart Applicability Exemptions Limited IRB Review Broad Consent. 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. . 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. . Angela Bain, . IRB Administrator. abain@uga.edu. . 706-542-3821. IRB Protocol Types. 2. Not Human Subjects Research. Exempt . Expedited . Full Committee. Exempt Categories. Category 1: Research conducted in commonly accepted educational settings. . 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. HOSPITALS AND OTHER PROPERTY. Presented by:. Mark e. Giaquinta. Sarah . l.. . schreiber. EXEMPTIONS GENERALLY. EXEMPTIONS GENERALLY. What?. Reduce tax obligation; or. Eliminate obligation to pay tax.. Vivienne Carrasco, MPH, CIP. Senior IRB Regulatory Analyst. Social & Behavioral Sciences IRB. Human Subject Research Office. Assurance and Regulations. The University of Miami requires review and approval by an IRB of all research involving human subjects, if any UM faculty, staff, or students are engaged as key personnel in that research (FWA Policy 2.4, Revised May 10, 2011)… conducted in accordance with its FWA (binding agreement with DHHS, OHRP and FDA, when applicable).. 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. . Director Policy & Education, ORO. Richard D’Augusta, RPh, MPA, CHRC . Director, Human Research Protection, ORO. Karen Jeans, PhD, CCRN, CIP. Associate Director of Regulatory Affairs, CSR&D, ORD. Kristina Borror, PhD. Director of Policy and Education. VHA Office of Research Oversight. 1. Overview. Background. Exemptions and Subpart Applicability. Exemptions. Limited IRB Review. Broad Consent. 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.. I. INTRODUCTION .................................................................................................................1 II. FREQUENTLY ASKED QUESTIONS ABOUT MEDICAL DEVICES ................ Ellen McCann, Ph.D. , Statistician June, 2019 Criminal Justice Coordinating Council Institutional Review B oards Brief 1 Research Tools: What is an Institutional Review Board? The study of human sub

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