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EPA Proposes Strict Ethical Safeguards on Human Studies Research

Release Date: 09/07/2005
Contact Information:


Contact: Eryn Witcher, 202-564-4355 / witcher.eryn@epa.gov

(Washington, D.C.-September 7, 2005) EPA today proposed a rule that will establish stringent enforceable ethical safeguards governing the conduct of third-party intentional dosing research with human subjects. Among other new ethical protections, EPA proposes to prohibit all new third-party intentional dosing research on pesticides with children and pregnant women intended for submission to EPA, and announced a categorical ban that EPA will neither conduct nor support any intentional dosing studies that involve pregnant women or children.

"We are pursuing a rigorous set of protections for human research participants," said Susan B. Hazen, Principal Deputy Assistant Administrator in EPA's Office of Prevention, Pesticides, and Toxic Substances. "EPA believes that regulatory decisions should be supported by the best scientific information. We should consider human data only if that information has been developed with the foremost goal of providing protections for research participants. We want to send a clear signal to the public that unethical research should never be conducted and will not be accepted by EPA."

This rule is intended to ensure that people who volunteer for third-party pesticide studies involving exposure to humans are treated ethically, with full disclosure as to potential risks. These regulations from EPA are designed to strongly discourage and prevent the conduct of human studies that do not meet the highest ethical and scientific standards. In addition, the protections in the proposed rule are consistent with the recommendations from the National Academy of Sciences, the nation's foremost scientific review body.

For any new, intentional dosing studies with pesticides, this proposal would require researchers to do the following: (1) comply with the requirements of the Common Rule (current ethical standards for research conducted or supported by the federal government); (2) submit detailed study protocols to EPA prior to initiation so that EPA can review to ensure the study meets the new ethical protections and is scientifically sound; and (3) once the study is conducted, provide detailed information to EPA describing how the study met the necessary ethical protections.

This rule would also put in place standards that EPA would follow in determining whether to rely on human studies. The agency is proposing to establish a Human Studies Review Board to review study protocols and selected available studies. The new protections would apply to pesticide intentional dosing studies conducted by EPA, those supported or sponsored by EPA, and those conducted by a pesticide manufacturer or other researchers.

This rule focuses largely on pesticide studies because such studies have elicited a strong expression of public concern, and because the risks they potentially present to people who volunteer to participate. Today's proposal is the first in a series of potential actions that will address the full spectrum of human studies issues at EPA. The agency has been conducting a comprehensive review of older pesticides to ensure that they meet current health and safety standards so that the public, especially infants, children and other sensitive individuals, are protected from pesticide risks. EPA sponsored or supported research meets current federal ethical standards set forth in the Common Rule, and today's proposal would extend those and other safeguards to third party research involving pesticides.

EPA welcomes public input, and the proposal includes a 90-day public comment period. For more information on the rulemaking, visit: http://www.epa.gov/oppfead1/guidance/human-test.htm