PPT-Maintaining Recruitment and Informed Consent in the

Later Stages of a Trial the ByBandSleeve Study Paul Whybrow Sangeetha Paramasivan Jane Blazeby Chris Rogers and Jenny Donovan on behalf of the ByBandSleeve Trial Management Group . coin on or before 12122014 at 500 pm San Bernardino/Riverside District Offices. Presenters:. Debra Brown, . PharmD. , Pharmaceutical Consultant. . Edwin Hoffmark, RN, Chief of RN Unit. State of California. Department of Public Health. Ricardo Perez, DO, JD. Assistant Professor of Medicine. UMDNJ-SOM. Ethical and Legal Issues in the Treatment of Older Adults. This . Care of the Aging Medical Patient in the Emergency Room. . (CAMP. 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. You work at the East Texas Cancer Center in Tyler, Texas as a physicist who “maintains and checks the machine regularly.” (Huff 2005). Patient complains of “a bright flash of light, heard a frying, buzzing sound, and felt a thump and heat like an electric shock.” (Huff 2005). 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. MS-3 Case Based Series. 1. Updated . May. 2012. Objectives. Review ethical principles. Review principles of informed consent. Understand the role of confidentiality in patient care. Describe legal and ethical issues in the care of minors. 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. version: February 2021 . Example. 2. Someone you don’t know hands you a cup of tea.. Questions that may come to mind:. Who made this tea?. What is in this tea?. Why was I given this tea?. Prospective participants may have similar questions when you ask them to participate in research.. 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. 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.