Webinar: Electronic Informed Consent

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Overview

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.

Faculty

Cheryl GrandinettiCheryl Grandinetti, PharmD joined the FDA’s Office of Medical Policy within the Center for Drug Evaluation and Research (CDER) in September 2010. She is part of the clinical methodologies staff within the Office of Medical Policy, and is the technical lead on a number of FDA guidances related to the conduct of clinical trials with a focus on the integration of electronic systems in clinical trials. Dr. Grandinetti received her BS in pharmacy from West Virginia University in 1988 and her Doctor of Pharmacy degree from Virginia Commonwealth University in 2000. Prior to joining the FDA, Dr. Grandinetti was a senior clinical research pharmacist for the Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute (NCI). At CTEP, she managed several investigational agents in support of NCI-sponsored cancer treatment trials as well as a variety of activities related to new drug development.

Christian SimonChristian Simon, PhD is based in the Program in Bioethics and Humanities at the University of Iowa Carver College of Medicine, where he researches, teaches, and consults in the field of bioethics and research ethics in particular. With a background in anthropology and the social sciences, Dr. Simon conducts interview, focus groups, and ethnographic research on ethical dilemmas facing clinical, translational, and genetic researchers, research subjects, and affected communities. Dr. Simon directs the clinical research ethics training course associated with the Institute of Clinical and Translational Science at the University of Iowa, teaches in the Humanities Distinction Track in the Carver College of Medicine, and is director for the Clinical Research Ethics Consultation Service. Dr. Simon also serves on the behavioral/social science IRB (IRB-02) at the University of Iowa.

Additional Panelists

David Klein, PhD, Leonard Sacks, MD, and Helen A. Schartz, PhD, JD

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Dave KleinDavid Klein, PhD is director of technology and a researcher at the Law, Health Policy, and Disability Center (LHPDC) at the University of Iowa, where he oversees LHPDC’s implementation of technology and distance learning, which includes federally and privately funded projects. He has a PhD in Education (instructional design and technology) and an MA in English. Dr. Klein has been working in instructional technology and developing computer-assisted instruction since 1981. Prior to coming to LHPDC, Dr. Klein was involved in the development of AT&T's Writer's Workshop Educational Package software, was managing editor for Pico: Laptops & Portables magazine and was the principal developer at the Patient Education Institute for X-Plain patient education software, which for fifteen years comprised the “Interactive Tutorials” at NIH's MEDLINEplus. Dr. Klein's research interests include multimedia learning and accessible and usable web design. He has published articles and presented numerous workshops on web accessibility and on accessible, closed-captioned web-based video. His most recent research, as co-principal investigator with Helen A. Schartz and Chris M. Simon, has investigated the use of interactive, multimedia electronic consent for research.

Leonard SacksLeonard Sacks, MD received his medical education in South Africa, moving to the USA in 1987. After completing fellowships in immunopathology and infectious diseases and working as an attending physician in Washington DC and South Africa, he joined the FDA in 1998. Beginning as medical reviewer in the Office of New Drugs, Dr. Sacks was extensively involved in the development and review of new anti-infective agents. Subsequently he moved to the Office of Critical Path Programs at FDA where he served as acting director. He now occupies the position of associate director for clinical methodology in the Office of Medical Policy in the Center for Drug Evaluation and Research. Besides his involvement in the design and analysis of clinical trials, he maintains a special interest in tuberculosis and other tropical diseases and has published and presented extensively on these topics. He is board certified in Internal Medicine and Infectious Diseases and holds an academic appointment as associate clinical professor of medicine at George Washington University.

Helen SchartzHelen A. Schartz, PhD, JD is director of research at the University of Iowa's Law, Health Policy, and Disability Center (LHPDC). Her primary focus is conducting social science research on legal issues. She has a PhD in clinical psychology and a JD from the University of Iowa. Prior to coming to LHPDC, Dr. Schartz was faculty at and co-chair of the clinical psychology graduate program at Missouri State University (formerly Southwest Missouri State) in Springfield, Missouri. She returned to the University of Iowa to attend law school and became LHPDC's director of research in 2012. Her research at LHPDC has often focused on employment issues for people with disabilities, including work with the Job Accommodation Network to estimate the cost of workplace accommodations. Her recent research, as co-principal investigator with Chris Simon and David Klein, has been investigating the use of interactivity and multimedia to improve the informed consent process for research.

Background Reading

Use of Electronic Informed Consent: Questions and Answers: Guidance for Institutional Review Boards, Investigators, and Sponsors, US Department of Health and Human Services

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Certificates of Attendance

Certificates of attendance will be made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

CE Credit for Certified IRB Professional (CIP®) Recertification

Webinar participants holding the CIP® credential who wish to apply credits from this webinar toward CIP® recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 90-minute webinar counts as 1.5 CE credit hours. Additional information about recertification can be found here.

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