DeGrazia David, Groman Michelle, Lee Lisa M
George Washington University, Washington, District of Columbia, USA.
National Institutes of Health, Bethesda, Maryland, USA.
J Med Philos. 2017 Apr 1;42(2):132-153. doi: 10.1093/jmp/jhw038.
We argue that the current ethical and regulatory framework for permissible risk levels in pediatric research can be helpfully understood in terms of children's moral right to adequate protection from harm. Our analysis provides a rationale for what we propose as the highest level of permissible risk in pediatric research without the prospect of direct benefit: what we call "relatively minor" risk. We clarify the justification behind the usual standards of "minimal risk" and "a minor increase over minimal risk" and explain why it is permissible to impose any risks at all on child participants who do not stand to benefit directly from enrollment in research. Finally, we illuminate some aspects of the concept of "best interests."
我们认为，当前关于儿科研究中可允许风险水平的伦理和监管框架，可以从儿童获得充分保护免受伤害的道德权利角度得到有益的理解。我们的分析为我们所提议的在无直接受益前景的儿科研究中可允许的最高风险水平——即我们所称的“相对较小”风险——提供了理论依据。我们阐明了“最小风险”和“比最小风险略有增加”这些通常标准背后的理由，并解释了为何对于那些不会直接从参与研究中受益的儿童参与者施加任何风险都是可允许的。最后，我们阐明了“最大利益”概念的一些方面。
