Ensuring Legally-Effective Informed Consent: Basic to Advanced Issues for Investigators and IRBs

Instructor: George Gasparis
Product ID: 703562
Training Level: Intermediate to Advanced
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

This webinar on informed consent will review the regulatory requirements to ensure that legally-effective consent is obtained for enrollment of subjects in human research regulated by the Department of Health and Humans Services (HHS) and/or the Food and Drug Administration (FDA). You will gain an understanding of not only the basic requirements, but also several challenging areas to ensure legally-effective consent.

Why Should You Attend:

  • Are you confident that you are liable for not obtaining legally-effective consent for the enrollment of participants in your studies?
  • How can you improve comprehension of your informed consent forms?
  • Do you appropriately enroll participants who are not English-speaking or who lack capacity?
  • Do you appropriately obtain permission from parents for the enrollment of children based on the risk level of a study?
  • Are you appropriately documenting the consent process?

If you do not know the answer to one or more of these questions, attending this 90 minute webinar will help you to be better informed about you can ensure legally-effective consent.

This session will briefly review the elements of informed consent required by U.S. regulations. Legally-effective consent is not defined by the federal regulations. Attendees will learn how to increase comprehension of their consent forms, enhance the consent process, and ensure legally effective consent. We will explore several challenges to obtaining legally-effective consent and solutions to appropriately address these challenges. Finally, some innovations and technological solutions to further enhance legally-effective consent will be explored.

Learning Objective:

At the end of this webinar, participants will understand regulatory expectations for obtaining legally-effective consent for enrolling participants in research studies. The webinar will provide insights for investigators and IRBs and provide knowledge that can minimize or eliminate findings of noncompliance in the area of informed consent during an audit or FDA inspection.

Areas Covered in the Webinar:

  • Elements of informed consent
  • Insights to enhance the consent process
  • Methods to increase comprehension of informed consent
  • Regulatory requirements for enrolling non-English speaking subjects
  • Insights on how to assess capacity for participants to provide their consent
  • Technological innovations to enhance the consent process

Who will benefit:

This webinar will provide valuable assistance to the following personnel:

  • Investigators
  • Coordinators
  • IRB Members and IRB Staff
  • Regulatory Specialists
  • Compliance Officers
  • Industry Sponsors
  • Clinical Research Associates

Instructor Profile:

George Gasparis, CIP, has over 30 years of experience in the administration or conduct of human subjects research. Prior to starting “PEER”, he served as the Executive Director, HRPP/IRB at Columbia University (CU), CU Medical Center (CUMC) from 2003-12. He worked at the Office for Human Research Protections (OHRP) for seven years and served as the Director, Division of Assurances and Quality Improvement from 2000-03, where he led the development of the OHRP QI Program. He has also served as the Director, The George Washington University Medical Center (GWUMC) IRB and as a Data Manager for over 40 clinical trials at GWUMC.

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