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

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. 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. . August 30, 2016. Presented by: Craig O’Loughlin and Lindsay Fiore. What has and has not changed with the new rule? . How will the new rule impact employers? . What are an employer’s options for ensuring compliance? . Presented by:. Lisa Frey – . Gowlings. WLG (Canada) LLP. Jim Allison – Assertive Northwest Property Management Group Ltd. . Jamie Bleay - Access Law Group. Moderator: Sean Ingraham, FirstService Residential BC. Chief . Human Resources Officer. Meeting Objectives. Briefly review FLSA rule changes & terminology. Update on FLSA legal challenge. FLSA determination process. Changes to University Classification Policy. 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).. 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.. Basic hhs and nih requirements. Yvonne lau – Office of human research protections. Ann hardy – Nih Office of Extramural research. Dawn Corbett – NIH Office of extramural research. May 2017. Describe the role of the Office for Human Research Protections (OHRP) and the federal regulations on human research protections;. 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. Content, Documentation, Broad Consent, and Posting of Informed Consent Forms. 1. Overview. Introduction. Major changes to informed consent content and process. Broad consent. Waiver of Alteration of Informed Consent. Content, Documentation, Broad Consent, and Posting of Informed Consent Forms. 1. Overview. Introduction. Major changes to informed consent content and process. Broad consent. Waiver of Alteration of Informed Consent. 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. 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 3. .21.17. The HSPH Job Review Committee, consisting of . Harvard Chan S. HR Partners, meets on a weekly basis to . review. non-exempt job review requests. Communication. Average turnaround time for a job review, from when the form is submitted to HR, to when the written recommendation is emailed, is between two to three weeks.