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What Conditions Justify Risky Nontherapeutic or “No Benefit” Pediatric Studies: A Sliding Scale Analysis

Published online by Cambridge University Press:  01 January 2021

Loretta M. Kopelman
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Extract

Many pediatric research regulations, including those of the United States, the Council for International Organizations of Medical Science (CIOMS), and South Africa, offer similar rules for review board approval of higher hazard studies holding out no therapeutic or direct benefit to children with disorders or conditions (See Table 1). Authorization requires gaining parental permissions and the children’s assent, if that is possible, and showing that these studies are intended to gain vitally important and generalizable information about children’s conditions; it also requires limiting the risks of harm to no more than a “minor increase over minimal risk” and showing the study is commensurable with the children’s experiences. For convenience, these investigations will be called “no benefit, higher hazard” studies.

Despite the existence of these policies for decades, studies show that review boards’ judgments vary about what “no benefit, higher hazard” studies should be approved.

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Independent
Information
Journal of Law, Medicine & Ethics , Volume 32 , Issue 4 , Winter 2004 , pp. 749 - 758
Copyright
Copyright © American Society of Law, Medicine and Ethics 2004

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References

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Values are things we regard as important. All value judgments express the view that someone or something has (or has not) worth, importance, significance, ability or merit to us in some way. Insofar as they are not responsible for their illness or sickness, the badness is not moral. See Kopelman, L.M., “If HIV/AIDS is Punishment, Who is Bad?” The Journal of Medicine and Philosophy 27, no. 2 (2002): 231–43, for a fuller discussion of this as well as of moral and nonmoral values. For further discussion of the evaluative basis of diagnosing and duties of those given the social authority to say someone has a disease, malady, disability, disorder or condition see Kopelman, L.M., “On the Evaluative Nature of Competency and Capacity Judgments,” International Journal of Law and Psychiatry 13, no. 4 (1990): 309–29. These overlapping and potentially conflicting duties include being accurate in making observations and descriptions, to benefit the person by signaling that he or she has important or unique needs, and to benefit society.CrossRefGoogle Scholar
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