Consistency of Human Pesticide NOAEL Studies With the Common Rule Governing the Ethical Treatment of Human Subjects. J. Patterson and G. Charnley, Toxicology Excellence for Risk Assessment (TERA), HealthRisk Strategies
A review of no-observed-adverse-effect-level (NOAEL) human studies on a group of organophosphate pesticides was performed to determine whether their conduct met the criteria established under the US federal regulations entitled the "Federal Policy for the Protection of Human Subjects," (known as the "Common Rule").The Common Rule guides the conduct of government-funded research involving human subjects. The conduct of human studies that are not funded by the US government generally follows the provisions of the Declaration of Helsinki and the Guidelines for Good Clinical Practice; such studies are not required to follow the Common Rule. Nonetheless, EPA’s Office of Pesticide Programs has expressed concern regarding the ethical treatment of human subjects by third parties because the consistency of such studies with Common Rule requirements was unknown. The present evaluation was undertaken to determine whether contemporary pesticide studies meet the criteria for ethical treatment of human subjects as specified by the Common Rule. Recent studies on seven pesticides were selected for evaluation. Copies of study reports, protocols, and ethics committee documentation were obtained. Key elements of the Common Rule were identified and the provided documentation for each study was evaluated to determine whether the key elements were met. Each study included an ethics committee review and approval of the study protocol, of the use of volunteer subjects for the study, and of requirements for written informed consent from the volunteers. From our review it is apparent that the design and conduct of this sample of human NOAEL studies were consistent with the requirements of the Common Rule. This finding is important in the context of EPA’s recent decision to prohibit consideration of human NOAEL data as part of regulatory decision-making and the National Academy of Sciences’ pending review of the scientific, public health, and ethical consequences of EPA’s decision.
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