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

Author : mila-milly | Published Date : 2021-01-27

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. . 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. . West Virginia University. Office of Research Integrity & Compliance. Human Research Protections Program. Human Subjects Research. Any . Human Subjects Research conducted by or under the auspices of any WVU faculty, student or staff must be reviewed by the WVU IRB. . 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.. 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.. 45 CFR 46. http://research-compliance.umich.edu/human-subjects/common-rule-other-changes. October . 2017. Cindy Shindledecker. Director – IRB-HSBS. Final Revisions to the Common Rule. The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protections of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19. 2017. It implements new steps to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.. Mariette Marsh, MPA, CIP. Director, Human Subjects Protection & Privacy Program. Agenda. Background. New Definitions. Changes to exemptions. Changes to informed consent. Single IRB review. Other items. Reilly Auditorium. December . 7 and 12, . 2017. Effective January 19, 2018. Updates to the human subjects regulations (45 CFR 46 Subpart A) are effective . January 19, 2018.. Promoting individual autonomy . Presented by. Sonu Jose. https://www.uwec.edu/orsp/faculty-academic-staff/research-using-human-subjects/. Outline. What is IRB?. Types of IRB Review. IRB Application Procedure . 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?. (now DLMP!). Erica C. Jonlin, PhD. ejonlin@uw.edu. . IRB Consultant. Department of Pathology. July 22, 2020. Institutional Review Boards (IRBs). An Institutional . Review Board (IRB) . is a . board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, . I. INTRODUCTION .................................................................................................................1 II. FREQUENTLY ASKED QUESTIONS ABOUT MEDICAL DEVICES ................

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