{"title":"The \"Risks of Routine Tests\" and Analogical Reasoning in Assessments of Minimal Risk.","authors":"Adrian Kwek","doi":"10.1093/jmp/jhad042","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47377,"journal":{"name":"Journal of Medicine and Philosophy","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2024-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Medicine and Philosophy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/jmp/jhad042","RegionNum":3,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ETHICS","Score":null,"Total":0}
引用次数: 0
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.
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.