PPT-Part 2 of 3 part series: Informed consent: The Process

Wendy Lloyd BA LPN CIPCCRP Regulatory Affairs and Compliance Specialist Objectives Identify consent process requirements Distinguish between IRB PIDesignee consent process responsibilities. 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. consent: . Documentation. Wendy Lloyd. BA, LPN, . CIP,CCRP. Regulatory Affairs and Compliance Specialist. Objectives:. Regulations and IRB . Policies. Suggestions . of what to include in the . documentation. U-MIC. To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press . enter. .. writing informed consent documents. Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. kathleen.omalley@jefferson.edu. Why is it so important?. Why is it referred to as a process?. Types of Informed Consents and How to Write . (and Conduct) Them. Denise Lin-. DeShetler. , M.P.H., M.A.. Director, Human Studies Program. CTE Dissertation Series - IRB Series 2. October 27, 2014. What is informed consent and why is it important?. 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. consent: . Documentation. Wendy Lloyd. BA, LPN, . CIP,CCRP. Regulatory . Compliance Analyst. Objectives:. Regulations and IRB . Policies. Suggestions . of what to include in the . documentation. Citations when documentation is not present. Informed Consent: . The Document. Wendy Lloyd, BA, LPN, CIP, CCRP. Regulatory Affairs and Compliance Specialist. Process Improvement Team. Agenda. Identify consent document requirements. Distinguish between IRB, PI and Coordinators consent document responsibilities. 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. Informed Consent: . The Document. Wendy Lloyd, BA, LPN, CIP, CCRP. Regulatory Affairs and Compliance Specialist. Process Improvement Team. Agenda. Identify consent document requirements. Distinguish between IRB, PI and Coordinators consent document responsibilities. consent: . Documentation. Wendy Lloyd. BA, LPN, . CIP,CCRP. Regulatory Affairs and Compliance Specialist. Objectives:. Regulations and IRB . Policies. Suggestions . of what to include in the . documentation. 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. Anne Roussell, RN. Office of Clinical Research. QA Study Audits. The purpose:. provide . principal investigators (PI) and study teams . early . detection regarding study conduct . issues; . provide . Webinar. Introduction and Framework. Pooja Khatri, MD MSc. Welcome. Local IRB and HRPP officials. PIs and Coordinators. RCC. Satellite. Trial. Why now?. COVID-19 increases urgency. Improves ICF process regardless.