PPT-Operationalizing Free, Prior and Informed Consent

Consultation and Unity Conference March 15 2017 Gillian Paul OKT LLP 1 Introduction On the threshold of some big changes on how Aboriginal people are engaged Consultation is not working Moving from an Aboriginal Consultation to an Aboriginal Consent Framework . 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. 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?. 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. 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. 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). Session Overview. Process and Documentation. Vulnerable Populations. Informed Consent of Non-English Speakers. Illiterate Subjects. Alteration/Waiver of Informed Consent. Informed Consent Process. Informed Consent is not just a form; it is an ongoing process of information exchange that may include:. 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. 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. 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.