Bundy M
Environ Health Perspect. 1981 Dec;42:67-72. doi: 10.1289/ehp.814267.
The question of adequacy of studies for regulatory purposes has been debated for years. Nine questions need answers to determine adequacy: (1) Does the study deal with a defined problem or a defined segment of it? (2) Do the study data justify the conclusions drawn? (3) Were appropriate statistical analyses used? Is there evidence of bias versus objectivity in the collection or analysis of data? (4) Does the study support, supplement (or complement) or refute information in the literature? Is the study truly new information? (5) Does the study conform to the Interagency Regulatory Liaison Group (IRLG) guidelines for documentation of Epidemiologic Studies? (6) Does the study stand up to peer review? (7) Have other investigators been able to confirm the findings by duplicating the study? (8) Is the study acceptable or can it be made acceptable for publication in a reputable scientific journal? (9) Is the problem of such magnitude or significance that regulation is required? Because there is no such thing as a risk-free environment or absolute safety and there is no definitive "yes" answer to each of the questions, the regulated would hope--yes, insist--that the regulators exercise judgement with great skill in promulgation of rules or regulations. The application of safety factors and the determination of acceptable levels of risk should be social decisions. A discussion of instances where the "regulated" believes that studies have not been adequate, or others habe been ignored, or misinterpreted for regulatory purposes in included.A method of settling controversial questions to eliminate the litigation route is proposed. Judgment which is so often eliminated by regulation needs to find its way back into the regulatory process. The regulated recognize the need for regulations. However, when these regulations are based on less than good scientific judgment, harm will be done to the regulatory process itself in the long run.
关于监管目的研究是否充分的问题已经争论多年。需要回答九个问题来确定其充分性：（1）该研究是否针对一个明确的问题或其明确的部分？（2）研究数据是否能证明所得出的结论？（3）是否使用了适当的统计分析？在数据收集或分析中是否存在偏向性而非客观性的证据？（4）该研究是否支持、补充（或完善）或反驳文献中的信息？该研究是否真的是新信息？（5）该研究是否符合跨部门监管联络小组（IRLG）关于流行病学研究记录的指南？（6）该研究是否经得起同行评审？（7）其他研究人员能否通过重复该研究来证实这些发现？（8）该研究是否可接受或能否使其可接受在著名科学期刊上发表？（9）该问题是否严重到需要进行监管？由于不存在无风险的环境或绝对安全，而且对每个问题都没有确定的“是”答案，受监管者会希望——是的，会坚持——监管者在制定规则或法规时能极其巧妙地运用判断力。安全系数的应用和可接受风险水平的确定应该是社会决策。文中讨论了一些情况，即“受监管者”认为研究不充分，或者其他研究被忽视，或者为了监管目的被错误解读。提出了一种解决有争议问题以避免诉讼途径的方法。常常被监管排除的判断力需要重新回到监管过程中。受监管者认识到需要法规。然而，如果这些法规基于不太好的科学判断力，从长远来看会对监管过程本身造成损害。
