PPT-Informed Consent Process

Kathleen OMalley RN BSN CCRP Manager of Education and Training Jefferson Clinical Research Institute kathleenomalleyjeffersonedu Why is it so important Why is it referred to as a 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. 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. th. Anniversary. An IRB . Infoshort. December 2013. Purpose. A statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data. Mary T. Brophy, MD MPH. mary.brophy@va.gov. Point of Care Research. The State of Clinical Evidence Generation. Randomized Controlled Trials. Gold standard. Resource . intense. Relatively few in number. 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. 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. 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 . 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. and Refusal of Treatment. The notion of informed consent is a recent one. . Prior to the 1950’s, there was no firm ground in which a commitment to informed consent could be grounded. . It is important that we work to understand exactly what it means to make an informed decision, so that we can be certain that our patients are able to act autonomously. . 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. . Protocol. K-SADS part 1 . 10:45 Coffee break. 11:00 K-SADS . part . 2. . Good Clinical Practice. . Study medications & logistics . Laboratory . procedures . & MRI. 12:30 Lunch. Agenda - morning. 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.. Waiver of Consent, Alteration of Consent, and Waiver to Document Consent . Definitions. Waiver of consent – the IRB waives all consent requirements (process, document, signature). Alteration – the IRB waives some or alters some of the elements of informed consent (document, signature).