Electronic Informed Consent:
Ethical, Regulatory, and Practical Implications

Electronic Informed Consent

Ethical, Regulatory, and Practical Implications

Online

In recent years, there has been increased interest in and greater use of electronic methods of informed consent (eIC) in research. In December 2016, the Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) published joint guidance on the use of eIC for IRBs, investigators, and sponsors. As the prevalence of eIC increases, IRBs and investigators need to anticipate and address its specific challenges, and be prepared to take advantage of its potential benefits.

Presented by a health science policy analyst at FDA and a bioethicist at the University of Iowa who conducts empirical research on eIC, this intermediate-level webinar will:

Speakers will be joined by additional panelists from FDA and the University of Iowa during an interactive question and answer session at the conclusion of the webinar.

What will I learn?
After attending this webinar, attendees will be able to:

  • Understand what eIC is
  • Grasp the regulatory requirements and context for using eIC in FDA-regulated clinical investigations
  • Better anticipate the challenges and benefits associated with eIC
  • Recognize how investigators and IRBs can help in promoting ethical and effective eIC

Who should attend?
IRB professionals, members, investigators, and compliance staff who currently utilize or will utilize electronic methods of informed consent in the future will benefit from this webinar.

Thank You to our Webinar Supporter!

HRP Consulting Group provides expert advice to institutions seeking to develop or improve all aspects of their human research protection program. For more information, please visit www.thehrpconsultinggroup.com.

Mention of commercial products, processes, or services on our website or in our email publications should not be construed as an endorsement or recommendation.

Continuing Education

Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.5 continuing education credits towards CIP recertification.

Speakers

Cheryl Grandinetti, PharmD

Cheryl Grandinetti, PharmD

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Christian Simon, PhD

Christian Simon, PhD

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David Klein, PhD

David Klein, PhD

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Leonard Sacks, MD

Leonard Sacks, MD

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Helen A. Schartz, PhD, JD

Helen A. Schartz, PhD, JD

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Additional Resources

Fees

If you are not yet a PRIM&R member, we encourage you to join today, and take advantage of your very first membership benefit immediately: a discounted registration fee to this webinar.

Member $0
Nonmember $200
Member $325
Nonmember $400