North Texas Chapter: 2023 FDA Updates - Informed Consent Guidance for IRBs, Investigators, and Sponsors
Event Description:
The guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The guidance provides the Agency's recommendations regarding informed consent and describes FDA regulatory requirements to help assure the protection of the rights and welfare of human subjects in clinical investigations. This guidance finalizes the draft guidance entitled, “Informed Consent Information Sheet: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors,” issued on July 15, 2014, and supersedes FDA's guidance entitled “A Guide to Informed Consent,” issued in September 1998.
Speaker:
Iris C. MacInnes
Learning Objectives:
1. Discuss reasons for the changes to the FDA Guidance on Informed Consent
2. Discuss updates to the FDA Guidance on Informed Consent
3. Determine how much you know about informed consent with Jeopardy!
Event Agenda:
9:00 - 10:30 a.m., CT – Presentation
10:30 - 11:00 a.m., CT – Jeopardy & Q&A
Registration Information:
Contact Hour Information:
This event will offer 2 contact hours. Click here to purchase the contact hours. Please purchase and claim your contact hours by 10/21/2024.
- Chapter Member: $0
- ACRP Member: $15
- Non-Member: $30
To receive contact hours: Purchase the contact hours and attend the program. After attending the event, log on to the ACRP website and visit learning.acrpnet.org, click “GO TO MY COURSE”. Select your event, confirm attendance and take the event evaluation between 1 and 30 days following the event and obtain the online certificate. After 30 days, contact hours are no longer available.