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New FDA Draft Guidance on Ethical Considerations for Including and Protecting Children in Clinical Trials

The U.S. Food and Drug Administration (FDA) issued a new draft guidance, entitled Ethical Considerations for Clinical Investigations of Medical Products Involving Children. As a vulnerable population in research, children require additional safeguards to participate in clinical investigations. This guidance details ethical considerations for pediatric clinical investigations of medical products and reviews how to apply 21 CFR part 50, subpart D.

Who is this guidance intended for?

This guidance provides information for industry, sponsors, and institutional review boards (IRBs).

What issues does the guidance address?

Along with how to determine if regulatory criteria for clinical investigations involving children has been met, this guidance reviews the following fundamental concepts for the ethical framework that IRBs should consider when reviewing clinical investigations that include children.

  • Principle of Scientific Necessity
  • Risk Categories for Interventions or Procedures without Prospect of Direct Benefit
  • Prospect of Direct Benefit
  • Assessment of Risk for Interventions or Procedures with a Prospect of Direct Benefit
  • Component Analysis
  • Potential for Review per 21 CFR 50.54
  • Parental/Guardian Permission and Child Assent

View the FDA news release to download the document and for information on how to submit a formal comment.