PPT-Informed Consent UTHSC Institutional Review Board (IRB)

Session Overview Process and Documentation Vulnerable Populations Informed Consent of NonEnglish Speakers Illiterate Subjects AlterationWaiver 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. 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?. February 26, 2015. IRB Function. Review human-subject research. Ensure the rights & welfare of human subjects are adequately protected. Why?. Historical events such as:. The Nazi Experiments. Tuskegee Syphilis Study. 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. History and Ethics. 2. Ethical History. 1939-1945: Holocaust. 1945-1949: Nuremburg Trials. 1964: Declaration of Helsinki. 1932-1972: PHS Syphilis Study. 1946-1948: PHS Guatemala Inoculation Study. 1961-1963: . 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. A How-To Guide. http://www.uthsc.edu/research/research_compliance/IRB. /. (901) 448-4824. irb@uthsc.edu. UTHSC Institutional Review . Board (IRB). Charged with protecting human research subjects. Ensures compliance with the federal regulations (DHHS, FDA, & HIPAA) with regards to research applications, consent forms and other research materials to be used; and with regards to the conduct of the research itself. 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. 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 . IRB Application and Review Process. The primary responsibility of the Institutional Review Board is to protect the rights, welfare, and privacy of all individuals participating in research sponsored by Cal Lutheran.  The IRB reviews all research studies involving human subjects for safety and compliance with regulations and ethical standards.. http://www.uthsc.edu/research/research_compliance/IRB. /. (901) 448-4824. irb@uthsc.edu. UTHSC Institutional Review . Board (IRB). Charged with protecting human research subjects. Ensures compliance with the federal regulations (DHHS, FDA, & HIPAA) with regards to research applications, consent forms and other research materials to be used; and with regards to the conduct of the research itself. Board. The . Who. , What, When, Where, How, and Whys . of the IRB.. Presented by Deborah Hofer. What is the IRB?. Presidential committee mandated by Federal guidelines.. Reviews all research activities involving the use of human subjects.. http. ://research integrity.syr.edu/. Office . of Research Integrity and Protections . (. ORIP) . . Step 1. Is it Research?. Definition of Human Subjects Research as defined in 45 CFR 46.102(e). 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.