Scholars Award: Three Methodological Rules in Risk Assessment

学者奖：风险评估的三大方法论规则

• 批准号: 0724781
• 负责人: Kristin Shrader-Frechette
• 金额: $ 9.6万
• 依托单位: University of Notre Dame
• 依托单位国家: 美国
• 项目类别: Continuing Grant
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-15 至 2009-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=0724781&HistoricalAwards=false
• 关键词: Scholars; Award; Three; Methodological; Rules

At the first or hazard-identification stage of risk assessment, there are frequent controversies over supposed risks associated with various agents - such as particular cell phones, pharmaceuticals, or pesticides. Often conclusions of different scientists, published concurrently in refereed journals, contradict each other regarding the existence of some hazard. While politics or agenda-driven funding sources help explain some conflicts, many appear to arise from methodological disagreements over the causal inferences used to interpret epidemiological statistics and risk data. For at least 10 years, these conflicts have been known as "the epidemiology wars" - one focal point of which is disagreement over 3 methodological rules used to assess risk data. These are the epidemiological-evidence rule (EER), according to which causal inferences about harm require (human) epidemiological data, not merely animal or laboratory data; the statistical-significance rule (SSR), according to which the null or no-effect hypothesis ought to be rejected only if there is statistically significant evidence of harm (p or = 0.05); and the relative-risk rule (RRR), according to which hazard identification (alleging that some agent has caused a given harm) requires evidence of a relative risk of at least 2.Intellectual Merit. The project - evaluating how effective accepting, rejecting, or amending these 3 methodological rules is, in advancing various cognitive goals of epidemiological risk assessment - has 7 main objectives. These are (1) to provide a methodological overview of strengths of EER, SSR, and RRR; (2) to use (1) to assess each rule's methodological weaknesses; (3) to evaluate different factual circumstances on which using/not using each rule is contingent; (4) to assess which cognitive and practical goals are served by accepting/rejecting each rule; (5) to determine which epidemiological demarcation criteria are served by accepting/ rejecting each rule; (6) to investigate which amendments to each rule might fit different epidemiological demarcation criteria, factual circumstances, and cognitive goals; and (7) to use reviewers' criticisms to revise the project findings. In explicating methodological rules (e.g., Doppelt, Laudan, Schmaus), causal explanation (e.g., Cartwright, Glymour, Suppes), philosophy of statistics and experimental inference (e.g., Mayo), especially in medicine (e.g., Clouser, Kyburg, Schaffner) - philosophers of science have done superb basic research. However, this project is needed because no philosophers of science have investigated EER, SSR, and RRR, relative either to epidemiological risk assessment or to its demarcation criteria, factual context, and cognitive goals. PI qualifications include degrees in mathematics and in philosophy of science; 3 post-docs (economics, biology, hydrogeology); 3 decades of grants/publications on risk-assessment methods (but not on the project's 3 methodological rules); and coauthoring many US National Academy of Sciences risk-assessment studies, including the 1996 classic, Understanding Risk.Broader Impact. In many years on US EPA's Science Advisory Board, the PI has evaluated epidemiological methods/rules used in scores of risk assessments, especially for pesticides. Key project methods (bibliographical research, conceptual analysis, assessing methodological assumptions, evaluating consequences) were used in the PI's earlier grants/publications. Examining EER, SSR, and RRR in conflicting risk assessments (of 32 organophosphate pesticides, done for 2006 US re-registration) - with which the PI is familiar, because of Science Advisory Board work - the PI will assess 13 hypotheses about how demarcation criteria, factual contexts, and cognitive goals help explain conflicts over methodological rules.

在风险评估的第一个或危害识别阶段，关于与各种药物（例如特定的手机，药品或农药）相关的假定风险存在频繁的争议。通常，不同科学家的结论同时出版在被裁定的期刊上，与存在某种危险的存在相互矛盾。尽管政治或议程驱动的资金来源有助于解释一些冲突，但许多政治似乎是由于用于解释流行病学统计和风险数据的因果推断的方法论分歧而产生的。至少十年来，这些冲突一直被称为“流行病学战争” - 其中一个焦点是用于评估风险数据的3种方法论规则的分歧。这些是流行病学的证据规则（EER），据此，关于危害的因果推论需要（人）流行病学数据，而不仅仅是动物或实验室数据；统计意义规则（SSR），根据该规则，仅在统计学上有显着的损害证据时，才应拒绝无效的假设或无效假设（p或= 0.05）；以及相对风险的规则（RRR），据此，危害识别（指控某些代理人已造成了危害）需要证据表明相对风险至少具有至少2.智能优点。该项目 - 评估这3种方法论规则的有效接受，拒绝或修改如何促进流行病学风险评估的各种认知目标 - 具有7个主要目标。这些是（1）提供了EER，SSR和RRR优势的方法论概述； （2）使用（1）评估每个规则的方法论弱点； （3）评估使用/不使用每个规则的不同事实情况； （4）通过接受/拒绝每个规则来评估哪些认知和实践目标； （5）通过接受/拒绝每个规则来确定哪些流行病学分界标准； （6）调查哪些规则的修正可能符合不同的流行病学分界标准，事实情况和认知目标； （7）使用审稿人的批评来修改项目的发现。 In explicating methodological rules (e.g., Doppelt, Laudan, Schmaus), causal explanation (e.g., Cartwright, Glymour, Suppes), philosophy of statistics and experimental inference (e.g., Mayo), especially in medicine (e.g., Clouser, Kyburg, Schaffner) - philosophers of science have done superb basic research.但是，之所以需要该项目，是因为没有科学哲学家调查了EER，SSR和RRR，既可以涉及流行病学风险评估，也可以调查其分界标准，事实背景和认知目标。 PI资格包括数学和科学哲学学位； 3个后（经济学，生物学，水文学）；关于风险评估方法的30年赠款/出版物（但没有项目的3种方法论规则）；并合着许多美国国家科学院的风险评估研究，包括1996年的经典，了解风险。在美国EPA科学顾问委员会的多年中，PI评估了数十种风险评估中使用的流行病学方法/规则，尤其是针对农药。 PI的较早赠款/出版物中使用了关键项目方法（书目研究，概念分析，评估方法论，评估后果）。在冲突的风险评估中检查EER，SSR和RRR（32种有机磷酸盐农药，为2006年美国进行重新注册） - 由于科学咨询委员会的工作，PI熟悉了，PI将评估13个关于界定标准，事实背景以及认知目标的界定标准，对方法论的范围有何冲突的假设。