Thompson FDA

Obtaining Informed Consent in Clinical Trials:
Minors, Language, Technology and Other Challenges

Thursday, June 29, 2017 • 2:00-3:30 PM ET


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OnDemand Recording
(Available for viewing
until 06.29.2018)

$199.00 Obtaining Informed Consent in Clinical Trials: Minors, Language, Technology and Other Challenges (OnDemand)

Between the myriad of complex legal issues and the confusing ethical “fine lines” that plague it, the process of obtaining informed consent from clinical trial participants can be extremely challenging.

From special requirements that apply to children and incapacitated adults, to dealing with individuals who have limited English proficiency, to cutting edge research that involves advanced technologies, the list of procedures to follow is growing ever larger.

Emerging challenges continue to add nuances—and with them new pitfalls. Disclosing too much information, for example, can trigger problems with the FDA just as easily as disclosing too little. Plus, even the smallest of problems can take a considerable amount of time and money to fix, while major problems can result in rejection of the study, an FDA Warning Letter or an OHRP Determination Letter.

Handling clinical trial regulations is no time for guesswork! Let an expert help you understand today’s challenges how to address them.

Register now for Obtaining Informed Consent in Clinical Trials: Minors, Language, Technology and Other Challenges.

In this 90-minute webinar, Robyn Shapiro—an expert on informed consent and regulatory compliance—will help you understand the legal and ethical issues involved in using human subjects in clinical trials. From a case-based discussion of today’s toughest challenges, you’ll gain practical insights into what you should and shouldn’t  do to obtain informed consent in a variety of different situations.

Protect the integrity of the study—and the entire site.  You’ll learn exactly where today’s challenges lie and the best approaches for avoiding informed consent mistakes that could cost valuable time and money to fix, and even trigger enforcement letters from the FDA or OHRP. Plus, you’ll have the chance to ask your own questions during the Q&A portion of the webinar. 

Learning Objectives:

Reserve your space now to understand how emerging challenges shape the process of obtaining informed consent, including:

  • The legal and ethical underpinnings of informed consent
  • The special challenges posed when subjects are children, incapacitated adults, or persons with limited English proficiency
  • How to disclose information when research involves complex technology with uncertain risks
  • Approaches when research involves the possibility of incidental findings or findings of importance to third parties
  • Impact of changes in the Common Rule and 21st Century Cures Act

Remember, outdated consent practices could not only delay your research, they could trigger inspections and enforcement actions that could derail your work. Don’t miss this opportunity to see where the challenges are—and how to meet them.

Register now for Obtaining Informed Consent in Clinical Trials: Minors, Language, Technology and Other Challenges.

Who Will Benefit

This webinar is of value to third-party clinical trial companies, FDA-regulated companies conducting clinical trials on humans, and law firms. Attendees who will benefit the most include:

  • FDA Attorneys
  • Clinical evaluations department staff
  • Independent clinical trial company executives
  • Regulatory compliance officers/managers
  • Clinical research directors, coordinators, managers
  • Clinical research staff
  • Clinical research attorneys
  • Institutional review board members


Robyn Shapiro
Robyn S. Shapiro is a partner in the Health Care Practice Group at Drinker Biddle. Ms. Shapiro provides legal counsel on matters relating to research compliance, bioethics, health care compliance, medical staff matters, health information privacy, informed consent, regulatory and licensing matters, and corporate and commercial issues faced by pharmaceutical and medical device manufacturers and hospitals and academic medical centers. Attorney Shapiro is a frequent presenter at national conferences and seminars on health care and research compliance issues, and she has authored more than 60 articles and book chapters on these and other topics.

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