The "Risks of Routine Tests" and Analogical Reasoning in Assessments of Minimal Risk.

IF 1.3 3区 哲学 Q3 ETHICS Journal of Medicine and Philosophy Pub Date : 2024-01-13 DOI:10.1093/jmp/jhad042
Adrian Kwek
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Abstract

Research risks have to meet minimal risk requirements in order for the research to qualify for expedited ethics review, to be exempted from ethics review, or to be granted consent waivers. The definition of "minimal risk" in the Common Rule (45 CFR 46) relies on the risks-of-daily-life and risks-of-routine-tests as comparators against which research activities are assessed to meet minimal risk requirements. While either or both comparators have been adopted by major ethics codes, they have also been criticized. In response to criticisms, elaborations, and alternative comparators have been proposed. In this paper, I approach the search for workable comparators from the point of view that ethical reasoning about minimal risk involves analogical reasoning using comparators. In this regard, I develop two necessary conditions for an adequate minimal risk conception, which I use to assess three comparators. I conclude that the risks-of-routine-tests best fits the analogical reasoning operating in minimal risk assessments.

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“常规测试的风险”和最小风险评估中的类比推理。
研究风险必须满足最低风险要求,才能使研究符合快速伦理审查、免于伦理审查或获得同意豁免的资格。通用规则(45 CFR 46)中“最小风险”的定义依赖于日常生活风险和常规测试风险,作为评估研究活动以满足最小风险要求的对照。虽然主要的道德准则采用了其中一个或两个比较标准,但它们也受到了批评。针对批评,提出了详细说明和替代比较方法。在本文中,我从关于最小风险的伦理推理涉及使用比较器的类比推理的角度来寻找可行的比较器。在这方面,我为充分的最低风险概念提出了两个必要条件,我用这两个条件来评估三个比较。我的结论是,常规测试的风险最适合在最小风险评估中进行的类比推理。
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来源期刊
CiteScore
2.90
自引率
6.20%
发文量
30
期刊介绍: This bimonthly publication explores the shared themes and concerns of philosophy and the medical sciences. Central issues in medical research and practice have important philosophical dimensions, for, in treating disease and promoting health, medicine involves presuppositions about human goals and values. Conversely, the concerns of philosophy often significantly relate to those of medicine, as philosophers seek to understand the nature of medical knowledge and the human condition in the modern world. In addition, recent developments in medical technology and treatment create moral problems that raise important philosophical questions. The Journal of Medicine and Philosophy aims to provide an ongoing forum for the discussion of such themes and issues.
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