Webinar: Pediatric Risk Determination: IRB Considerations and Cases

Wednesday, September 18 | 1:00-2:15 PM ET

Overview

Pediatric subjects participating in HHS-funded or FDA-regulated studies are afforded additional protections not codified in subpart A of the Federal Policy for the Protection of Human Subjects (the Common Rule). Subpart D—which describes additional considerations when children are research subjects—introduces new terms like assent, parental permission, minor increase over minimal risk, prospect of direct benefit, and one and two parent signatures.

When assessing risk for pediatric studies, an IRB must evaluate all procedures and interventions against four categories of research. To make this determination properly, the IRB has to decide on two inconsistently defined concepts: 1) is there prospect of direct benefit? Or 2) does the research present minimal risk or a minor increase over minimal risk? During this webinar, speakers will address such questions and more.

Agenda

  • Overview of pediatric subpart D regulations
  • Approvable research categories
  • Prospect of direct benefit
  • Minimal risk and minor increase over minimal risk
  • Interactive case studies for the IRB

What will I learn?

After attending this webinar, you will be able to:

  • Identify the criteria for pediatric approvable research
  • Compare and contrast minimal risk with minor increase over minimal risk
  • Evaluate if the interventions or procedures in a protocol hold the prospect of direct benefit

Who should attend?

IRB staff and members will benefit from attending this webinar. No prerequisite knowledge is required, but those who have wrestled with issues of risk determination in pediatric studies will benefit in particular.

Continuing Education

Webinar participants holding the Certified IRB Professional (CIP®) credential may apply 1.25 continuing education credits towards CIP recertification. Learn More »

Thank You to our Webinar Supporter!

Advarra logo_updatedAdvarra is the premier provider of IRB, IBC and global research quality and compliance consulting services in North America. We provide customized, dedicated services for more than 3100 institutions, academic medical centers and research consortia and are fully sIRB ready. By delivering exceptional client service, innovative technology and unmatched regulatory expertise, Advarra provides integrated research compliance capabilities to help make research altogether better.

For more information, please visit advarra.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.

Speakers

Rich-GormanRich Gorman, MD earned his BA in physics at the Catholic University of America and his MD degree from the State University of New York, Downstate. Dr. Gorman has been the director of the University of Maryland Pediatric Emergency Department, medical director of the Maryland Poison Center, chair of the American Academy of Pediatrics (AAP) Committee on Drugs, and the AAP Section on Clinical Pharmacology and Therapeutics. He practiced pediatric primary care for 20 years. In 1993, he was a founding member of Chesapeake Research Review IRB. He served for 10 years as an IRB chairperson. He now serves as an independent contractor to Advarra. From 2008-2016, Dr. Gorman served as the associate director for clinical research at the Division of Microbiology and Infectious Disease at the National Institute for Allergy and Infectious Disease at National Institutes of Health. In this role he directed and managed clinical research on vaccines, therapeutics, and diagnostics in service of the goal of advancing the protection, diagnosis, and treatment of individuals susceptible to infectious diseases. He was the initial chairperson of the Peds-OB Integrated Program Team for the Public Health Emergency Medical Countermeasures Enterprise.

Donna-SnyderDonna L. Snyder, MD is the senior pediatric ethicist in the Office of Pediatric Therapeutics (OPT) in the Office of the Commissioner at the US Food and Drug Administration (FDA). Dr. Snyder has worked at FDA since 2012, serving as a medical officer and acting team lead in the Division of Pediatric and Maternal Health within the Office of New Drugs before joining OPT in 2016. Dr. Snyder received her MD from the University of Virginia, completed her internship and residency at the University of Maryland Hospital, her chief residency at Sinai Hospital in Baltimore, and completed a Pediatric Academic Development Fellowship at Johns Hopkins Hospital. She is board certified in pediatrics and a fellow of AAP. Dr. Snyder has spent time in pediatric private practice and has consulted for the pharmaceutical industry and the National Institute of Child Health and Human Development IRB. Just prior to coming to the FDA, she worked as a research ethics consultant to an independent IRB, serving as an IRB chair for three years.

Additional Resources

A collection of relevant readings accompany each PRIM&R webinar. Groups that register for webinars receive a discussion guide containing thought-provoking questions and facilitation tips that may help in using the webinar as an educational tool for IRBs.

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.

Individual rates
Member $145
Nonmember $200
Group rates
Member $325
Nonmember $400

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