Abstract
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.
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Selected References
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