PPT-Common Rule Changes to Consent and Template

Patrick Herbison MEd CIP Assistant Director of Compliance Office of Human Research OHR Common Rule The Federal Policy for the Protection of Human Subjects 1991 45 CFR 46 Title 45 Code of Federal Regulations Part 46 . Jeri R. . Barney. , JD, . MS . . Michele . Antisdel, . MBA/CCRP. HRPP Compliance Manager IRB Regulatory Analyst. Human Research Protection Program (HRPP). May 16, 2013. Discussion. Consent Process. Jeri R. . Barney. , JD, . MS . . Michele . Antisdel, . MBA/CCRP. HRPP Compliance Manager IRB Regulatory Analyst. Human Research Protection Program (HRPP). May 16, 2013. Discussion. Consent Process. Contract Enforceability. Learning Objectives. In what types of situations might voluntary consent to a contract’s terms be lacking? . What is the difference between a mistake of value or quality and a mistake of fact?. 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. Assistant Director of Compliance. Office of Human Research (OHR). patrick.herbison@jefferson.edu. These slides contain summaries of regulations (mainly 45 CRF 46) and OHR Policies. Please follow the full regulations and policies.. Jeri R. . Barney. , JD, . MS . . Michele . Antisdel, . MBA/CCRP. HRPP Compliance Manager IRB Regulatory Analyst. Human Research Protection Program (HRPP). May 16, 2013. Discussion. Consent Process. 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. November 2018 How was the Common Protocol Template Developed and What Does it Look Like? How was the Common Protocol Template (CPT) First Developed? Structure and Content Structure – Level 1 and 2 Headings 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. 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. Jon Mark Hirshon, MD, MPH, PhD. Professor, Department of Emergency Medicine. Senior Vice-Chairman, IRB. University of Maryland Baltimore. Disclosures. Commercial. . Pfizer. Sickle Cell Disease Council for Change & Advisory Board. Proposed Changes to the Common Rule Governing Informed Consent for Research Use of . Biospecimens. Association of Pathology Chairs Annual Meeting. July 12, 2016. Mark E. Sobel, MD, PhD. Executive Officer.