Non-beneficial pediatric research and the best interests standard: A legal and ethical reconciliation (8th edition)

Yale Journal of Health Law 8 (2008)
  Copy   BIBTEX

Abstract

Federal efforts beginning in the 1990's have successfully increased pediatric research to improve medical care for all children. Since 1997, the FDA has requested 800 pediatric studies involving 45,000 children. Much of this research is "non-beneficial"; that is, it exposes pediatric subjects to risk even though these children will not benefit from participating in the research. Non-beneficial pediatric research (NBPR) seems, by definition, contrary to the best interests of pediatric subjects, which is why one state supreme court has essentially prohibited it. It also appears that the only plausible rationale for this research is utilitarian, as it risks some children for the good of all. But that rationale is troubling. This Article answers two related questions: (1) What is the appropriate legal relationship between NBPR and the "best interests of the child" standard? (2) What is the ethical justification for this research? I argue that courts should hold that the "best interests" standard governs pediatric research. But, contrary to existing case law, courts must consider the benefits to each child, including pediatric subjects, from a policy that permits NBPR, and not simply consider that a non-beneficial protocol presents more risk than potential benefit to a child. Moreover, I argue that the justification for the practice need not be utilitarian. There is no need to appeal to the greater good to justify the research because each child has reason to endorse a policy permitting NBPR where there is a very low ceiling on acceptable risk, and each child has reason to participate in a practice from which she benefits. More controversially, I argue that each child, like other persons, has reason to help others when she can do so at little to no cost to herself. The Article then highlights practical implications of the offered justifications.

Links

PhilArchive



    Upload a copy of this work     Papers currently archived: 92,100

External links

Setup an account with your affiliations in order to access resources via your University's proxy server

Through your library

Similar books and articles

Risk standards for pediatric research: Rethinking the.David Wendler - 2004 - Kennedy Institute of Ethics Journal 14 (2):187-198.

Analytics

Added to PP
2009-01-28

Downloads
51 (#313,029)

6 months
4 (#795,160)

Historical graph of downloads
How can I increase my downloads?

Author's Profile

Paul Litton
University of Missouri, Columbia

References found in this work

No references found.

Add more references