Skip to main content
Journal of Medical Ethics logoLink to Journal of Medical Ethics
. 2001 Apr;27(2):110–113. doi: 10.1136/jme.27.2.110

Is it in a neonate's best interest to enter a randomised controlled trial?

P Allmark 1, S Mason 1, A Gill 1, C Megone 1
PMCID: PMC1733379  PMID: 11314153

Abstract

Clinicians are required to act in the best interest of neonates. However, it is not obvious that entry into a randomised controlled trial (RCT) is in a neonate's best interest because such trials often involve additional onerous procedures (such as intramuscular injections) in return for which the neonate receives unproven treatment or a placebo. On the other hand, neonatology needs to develop its evidence base, and RCTs are central to this task. The solution posited here is based on two points. First, "best interest" is not equivalent to "the best possible interest" only to "best interest within a certain realm". The realm of deliberation when asking the title question is the neonate's health. Deliberating in this realm may involve the exclusion from consideration of some factors that might be thought relevant (such as parental wealth). Furthermore, circumstances may dictate the need to deliberate on other factors that might be thought irrelevant (such as health care resources). Second, deciding on a neonate's best interest does not involve "putting oneself in its shoes". Rather, it involves asking in what it has an interest, or stake. These will include some things in which we all, as human beings, have a stake, such as medical progress. Putting these two points together, in the realm of health the answer to whether RCT entry is in a neonate's best interest is usually very finely balanced. Where this is the case, it is reasonable to invoke a broader notion of best interest and include a broader range of elements in which the neonate has a stake, including medical progress. In this way RCT entry can, usually, be said to be in a neonate's best interest.

Key Words: Neonates • randomised controlled trials • best interest • ethics

Full Text

The Full Text of this article is available as a PDF (78.8 KB).

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Arras J. D. Toward an ethic of ambiguity. Hastings Cent Rep. 1984 Apr;14(2):25–33. [PubMed] [Google Scholar]
  2. De Deyn P. P., D'Hooge R. Placebos in clinical practice and research. J Med Ethics. 1996 Jun;22(3):140–146. doi: 10.1136/jme.22.3.140. [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. Hassn A. M., Hassan A. Do we always need to tell patients the truth? Lancet. 1998 Oct 3;352(9134):1153–1153. doi: 10.1016/s0140-6736(05)79804-4. [DOI] [PubMed] [Google Scholar]
  4. Kopelman L. M. The best-interests standard as threshold, ideal, and standard of reasonableness. J Med Philos. 1997 Jun;22(3):271–289. doi: 10.1093/jmp/22.3.271. [DOI] [PubMed] [Google Scholar]

Articles from Journal of Medical Ethics are provided here courtesy of BMJ Publishing Group

RESOURCES