The Association of Clinical Research Professionals

Improving the Understanding of Informed Consent Among Vulnerable Populations

As efforts are made to enroll more diverse people in clinical trials, including those who are considered vulnerable from among minority populations and the elderly, those for whom English is a second language, and/or those from lower social economic backgrounds, their understanding of informed consent forms (ICFs) and the entire informed consent process becomes ever more important to the successful conduct of research.

Date: April 10, 2024
Time: 12:00 – 1:00 PM ET

ICFs are often too detailed, technical, and not written in the appropriate reading levels for the potential trial participants. Further, due to pressures to meet enrollment timelines, many patients enroll into studies with a poor understanding from the informed consent process of the possible risks and benefits and what is expected of them to remain engaged. Not only is this unethical, it also leads to poor protocol adherence and poor patient retention. This live webinar will address practical ways that stakeholders in research can help improve the creation of ICFs and better the overall process to ensure patients have a fuller understanding of the risks, commitment, and cost of agreeing to participate in a clinical trial.

Upon completion of this continuing education program, participants should be able to:

  • Learn how the current manner in which ICFs are written and administered is unethical and inappropriate.
  • Gain techniques for an improved way of writing ICFs.
  • Obtain a template for ensuring a better patient understanding of ICFs before they are signed.


Gerald Klein, MD
Adjunct Professor of Pharmacology and Toxicology
Brody School of Medicine, East Carolina University

Gerald L. Klein, MD, has spearheaded numerous clinical trials as a PI before founding a SMO and CRO, where he served as CEO and CMO. Following the CRO’s acquisition by Quintiles (now IQVIA), Dr. Klein became an SVP at Quintiles in Drug Development and Medical Affairs. He co-founded Pathway Diagnostics, Klein Medical News Service, Entera Health, and currently is a Principal at MedSurgPI LLC. His executive experience extends to roles like CEO, CMO, SVP, and VP in various companies, including Dey/MerckKgAa, Specialty Labs, Talecris/Grifols, Oxygen Biotherapeutics/Tanex, and Pathway Diagnostics. Dr. Klein serves on the Board of Directors for several biotech firms.

Academically, Dr. Klein is an Adjunct Professor in Pharmacology at East Carolina University’s Brody School of Medicine and a former Professor at the University of California, Irvine. He has published extensively, including peer-reviewed articles, a textbook chapter, presentations, white papers, educational materials, and blogs.

Approved for 1.0 ACRP Contact Hours

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