#12 David Wendler: Are we overprotecting kids in research?

In this episode, we speak with Dr. David Wendler, Head of the Section on Research Ethics in the Department of Bioethics at the National Institutes of Health Clinical Center and philosopher by training. We discuss the ethics of pediatric research: how much risk we should expose kids to in research; what we should do when the federal research regulations don’t make sense; and what was and wasn’t wrong with the Kennedy Krieger Lead Abatement Study.

(00:00) Our introduction
(05:25) Interview begins
(13:56) How risky can pediatric research be?
(32:38) What counts as “minimal risk”? Risks of daily life standard
(45:28) Understanding research participation as a charitable activity
(49:48) Why the rules say we can expose kids to more risk when they don’t stand to benefit
(1:00:05) How to interpret research regulations when they are flawed
(1:03:42) Do kids need to understand altruism to assent to research?
(1:12:49) Should there be laws governing pediatric research?
(1:20:40) David’s take on the Kennedy Krieger Lead Abatement Study

Mentioned or referenced:

• US pediatric research regulations: HHS/OHRP 45 CFR 46 Subpart D
• NIH Inclusion Across the Lifespan
• Creating Hope Act of 2011/2012
• Pediatric Research Equity Act of 2003
• Mott Poll Report: Is my child’s medicine FDA-approved?
• Hwang et al., “Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act”
• Grodin and Glantz, Children as Research Subjects: Science, Ethics, and Law
• Wendler and Shah, “Should Children Decide Whether They Are Enrolled in Nonbeneficial Research?”
• Shah et al., “How do institutional review boards apply the federal risk and benefit standards for pediatric research?” [note: we refer to this as a 2008 study, but it was actually published in 2004]
• Wendler and Forster, “Why we need legal standards for pediatric research”
• Grimes v. Kennedy Krieger Institute, Inc. (Court of Appeals of Maryland)

Bio(un)ethical is a bioethics podcast written by Leah Pierson and Sophie Gibert, with editing and production by Ambedo Media (previous production support by Audiolift.co). Our music is written by Nina Khoury and performed by Social Skills. We are supported by a grant from Amplify Creative Grants.