PPT-Disruptive Influences on Research in Academic Pathology Departments: Proposed Changes

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. 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. An IRB . Infoshort. , June 2013. Informed Consent: Basis. The federally mandated requirements for informed consent are grounded in the Belmont Report.. . Respect for Persons:. “Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. Longitudinal . Research with . ‘Rich” Behavioral & Biospecimen Data . from Multiple Family Members . Workshop on Proposed Revisions to the Common Rule in Relation to the Behavioral and Social Sciences. 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. Angela Bain, . IRB Administrator. abain@uga.edu. . 706-542-3821. Criteria for Approval. 45 CFR 46.111. 25 CFR 56.111. Minimized Risks. Reasonable Risk/. B. enefit Ratio. Equitable Subject Selection. Brown Bag Series: First Tuesday of the Month. The Revised Common Rule. federally funded human subjects research regulations. Dartmouth CPHS. February 7, 2017. Timeline. 1979 . Belmont Report. . . Basic . An IRB . Infoshort. , June 2013. Informed Consent: Basis. The federally mandated requirements for informed consent are grounded in the Belmont Report.. . Respect for Persons:. “Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy. Presentation to HL7 Community-Based Collaborative Care FHIR Consent WG . June . 9. th. , 2017. Agenda. Brief . o. verview of project and current activities. High-level overview of use case scenarios. Susan Sonne, . PharmD. , BCPP. Associate Professor of Psychiatry. Chair, IRB II. Presentation slides were adapted from . citiprogram.org. Introduction. Final Rule to revise the current regulations at 45 CFR 46, Subpart A (Common Rule) was published by HHS on . 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. 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) . 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. 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.