Many historical ethical violations in human subjects research have involved pediatric populations.

From the study of untreated hepatitis at Willowbrook to the human radiation experiments at the Fernald Center to the gene therapy study involving 17-year-old Jesse Gelsinger, research in pediatric populations has come with a multitude of ethical considerations. 

In this session, research ethics experts will discuss the current thinking on three specific aspects of pediatric research:

1. The ethical considerations of risk/benefit assessments which had led to new draft FDA guidance referencing the concept of “component analysis”;
2. The ethics of assent, parental permission, and descriptions of the risk/benefit in particular studies during the informed consent process; and finally,
3. The ethics of payment to pediatric participants (and their parents) and associated considerations of potential undue influence and profiling of populations with low-socioeconomic status.

Presentation Topics and Speakers

• Reviewing the Ethical Considerations of the New FDA Draft Regulations regarding Pediatric Research - Dave Borasky
• Assent, Consent, Permission: The Ethics of Obtaining Consent in Pediatric Studies  - Jessica Rowe and Bridget Strong
• The Ethics of Paying Research Participants in Pediatric Research - Sanjur Brooks and Rachel Lally