{"product_id":"fda-s-updated-informed-consent-guidance-what-s-new-2026-08-05","title":"FDA's Updated Informed Consent Guidance: What's New?","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThis web seminar will review the updated FDA Guidance Document titled \"Informed Consent Guidance for IRBs, Clinical investigators and Sponsors\" dated August 2023. This guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA's informed consent regulations for clinical investigations. The revisions include significant changes to the provisions regarding informed consent and provide guidance related to the requirements described in 21 CFR part 50; as well as regulations pertaining to informed consent found in FDA's regulations on Investigational New Drug Applications (21 CFR part 12) and Investigational Device Exemptions (21 CFR part 812). An overview of the guidance will include general consent requirements and exceptions, review of the basic elements, documentation requirements, and responsibilities of each party. Additional questions to be addressed include consideration in pediatrics, non-English speakers, considerations for Legally Authorized Representatives (LARs), and electronic informed consent.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eReview contents and key elements in the new Guidance Document\u003c\/li\u003e \u003cli\u003eDiscuss responsibilities for informed consent for IRBs, clinical investigators, sponsors, and FDA\u003c\/li\u003e \u003cli\u003eEvaluate applications in pediatrics, non-English speakers, LARs, and electronic informed consent\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Trial Investigators and Coordinators\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\/Compliance Officers\u003c\/li\u003e \u003cli\u003eEthics Committee Members\u003c\/li\u003e \u003cli\u003eInstitution Review Board (IRB) Members\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eQuality Assurance Professionals\u003c\/li\u003e \u003cli\u003eResearch Ethics Professionals\/Legal Counsel\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eNikki Christison, B.S., C.C.R.A., T.I.A.C.R.\u003c\/p\u003e\u003cp\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-24-036-L99-P. Released: 1\/24. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375390843245,"sku":"BI17349","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/fda-s-updated-informed-consent-guidance-what-s-new-2026-08-05","provider":"Barnett International ","version":"1.0","type":"link"}