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. 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. 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. 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. Consent and HIV Cure Research. HIV Cure Research Training Curriculum. Informed Consent Module by:. . Gail E. Henderson, UNC School of Medicine. Professor, Department of Social Medicine. 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). 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. . 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) . 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 . 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). 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.