Non-beneficial pediatric research and the best interests standard: A legal and ethical reconciliation
David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Jack Alan Reynolds
Learn more about PhilPapers
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.
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library||
References found in this work BETA
No references found.
Citations of this work BETA
No citations found.
Similar books and articles
Michael Gill, Picu Prometheus: Ethical Issues in the Treatment of Very Sick Children in Paediatric Intensive Care.
Jacquelyn Slomka (2009). Manufacturing Mistrust: Issues in the Controversy Regarding Foster Children in the Pediatric Hiv/Aids Clinical Trials. Science and Engineering Ethics 15 (4):503-516.
Denise Avard, Karine Sénécal, Parvaz Madadi & Daniel Sinnett (2011). Pediatric Research and the Return of Individual Research Results. Journal of Law, Medicine and Ethics 39 (4):593-604.
Howard Kunin (1997). Ethical Issues in Pediatric Life-Threatening Illness: Dilemmas of Consent, Assent, and Communication. Ethics and Behavior 7 (1):43 – 57.
Jessica Masty & Celia Fisher (2008). A Goodness-of-Fit Approach to Informed Consent for Pediatric Intervention Research. Ethics and Behavior 18 (2 & 3):139 – 160.
Sonja Grover (2003). On the Limits of Parental Proxy Consent: Children's Right to Non-Participation in Non-Therapeutic Research. [REVIEW] Journal of Academic Ethics 1 (4):349-383.
Eric Chwang (2010). Against Risk-Benefit Review of Prisoner Research. Bioethics 24 (1):14-22.
Mutsawashe Bwakura-Dangarembizi, Rosemary Musesengwa, Kusum Nathoo, Patrick Takaidza, Tawanda Mhute & Tichaona Vhembo (2012). Ethical and Legal Constraints to Children's Participation in Research in Zimbabwe: Experiences From the Multicenter Pediatric Hiv Arrow Trial. BMC Medical Ethics 13 (1):17-.
David Wendler (2004). Risk Standards for Pediatric Research: Rethinking The. Kennedy Institute of Ethics Journal 14 (2):187-198.
David Wendler (2012). A New Justification for Pediatric Research Without the Potential for Clinical Benefit. American Journal of Bioethics 12 (1):23 - 31.
Added to index2009-01-28
Total downloads31 ( #65,177 of 1,410,035 )
Recent downloads (6 months)2 ( #107,760 of 1,410,035 )
How can I increase my downloads?