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.

在风险评估的第一阶段或危险识别阶段，人们经常对与各种物质（例如特定的手机、药品或杀虫剂）相关的假定风险产生争议。不同科学家的结论，同时发表在参考期刊上，往往相互矛盾的存在一些危险。虽然政治或艾滋病驱动的资金来源有助于解释一些冲突，但许多冲突似乎是由于对用于解释流行病学统计数据和风险数据的因果推断的方法论分歧造成的。至少10年来，这些冲突被称为“流行病学战争”-其中一个焦点是对用于评估风险数据的3种方法规则的分歧。这些规则是流行病学证据规则（EER），根据该规则，关于伤害的因果推断需要（人类）流行病学数据，而不仅仅是动物或实验室数据;显著性规则（SSR），根据该规则，只有在有统计学上显著的伤害证据时，才应拒绝无效或无效应假设（p或= 0.05）;以及相对风险规则（RRR），根据该规则，危险识别（声称某些物质已造成特定伤害）需要至少2.知识价值的相对风险证据。该项目-评估如何有效地接受，拒绝，或修改这3个方法规则，在推进流行病学风险评估的各种认知目标-有7个主要目标。这些是：（1）提供对EER、SSR和RRR优点的方法学概述;（2）使用（1）评估每个规则的方法学弱点;（3）评估使用/不使用每个规则的不同实际情况;（4）评估接受/拒绝每个规则服务于哪些认知和实践目标;（5）通过接受/拒绝每一条规则来确定哪些流行病学分界标准;（6）调查对每一条规则的哪些修正可能适合不同的流行病学分界标准、实际情况和认知目标;（7）利用评审者的批评意见来修正项目发现。在阐述方法规则时（例如，Doppelt，Laudan，Schmaus），因果解释（例如，Cartwright，Gaviour，Suppes），统计哲学和实验推理（例如，马约），特别是在医学上（例如，克劳泽，凯堡，沙夫纳）-科学哲学家做了极好的基础研究。然而，这个项目是必要的，因为没有科学哲学家研究EER，SSR和RRR，相对于流行病学风险评估或其划界标准，事实背景和认知目标。PI资格包括数学和科学哲学学位; 3个博士后（经济学，生物学，水文地质学）; 30年的风险评估方法（但不包括项目的3个方法规则）赠款/出版物;共同撰写许多美国国家科学院风险评估研究，包括1996年的经典，了解风险。在美国环保署的科学顾问委员会工作的许多年里，PI评估了许多风险评估中使用的流行病学方法/规则，特别是农药。主要项目方法（文献研究，概念分析，评估方法假设，评估结果）被用于PI的早期赠款/出版物。在相互冲突的风险评估中检查EER，SSR和RRR（32种有机磷农药，为2006年美国重新注册完成）-PI熟悉，因为科学顾问委员会的工作-PI将评估13个关于划界标准，事实背景和认知目标如何帮助解释方法规则冲突的假设。