PPT-Common Problems in Informed Consent

Jeri R Barney JD MS Michele Antisdel MBACCRP 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. 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. 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. 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?. 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. 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. . 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. 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. Director of IRB Operations. UMass Medical School. Tuskegee Study . This study was initiated in the 1930s as an examination of the natural history of untreated syphilis; it continued until 1972. 400 black men with syphilis participated. 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.