Human Experimentation: A Rule Gone Awry?

• Published in: Environmental health perspectives Vol. 114; no. 6; pp. A361 - A362
• Main Author: Burton, Adrian
• Format: Journal Article
• Language: English
• Published: United States National Institute of Environmental Health Sciences. National Institutes of Health. Department of Health, Education and Welfare 01.06.2006; National Institute of Environmental Health Sciences
• Subjects: Administrative agencies; Child; Children; Corporate responsibility; Environews; Environmental agencies; Environmental Exposure; Environmental health; Ethical behavior; Female; Human Experimentation; Human experimentation in medicine; Humans; Interest groups; Medical ethics; Medicine, Research, Law and legislation; Pesticide toxicity; Pesticides; Pesticides - toxicity; Pregnancy; Press releases; Public Health; Research ethics; Spheres of Influence; U.S. Environmental Protection Agency; United States; United States Environmental Protection Agency; United States
• ISSN: 0091-6765; 1552-9924
• DOI: 10.1289/ehp.114-a360

The U.S. EPA's new Protections for Subjects in Human Research rule came into effect on 7 April 2006, born of a need to tighten the ethical guidelines controlling human experimentation to determine pesticide toxicity. Just two weeks after the rule came into force a coalition of labor and environmental interest groups filed suit against the EPA, charging that the rule fails to adequately protect human subjects, especially vulnerable subgroups such as pregnant women and children, and actually ultimately encourages, rather than deters, human testing. The case is now before the Second Circuit Court of Appeals in New York City, which must determine if the rule safeguards Americans against unethical pesticide experimentation. A ruling could take a year or more to be issued; meanwhile, the new rule is in force.