EPA proposed a rule last week that will establish stringent, enforceable safeguards governing the conduct of third-party intentional dosing research with human subjects. Among other new ethical protections, research on pesticides intended for submission to EPA would not be allowed on children and pregnant women. Additionally, EPA announced it 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 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 prevent 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.
For any new, intentional dosing studies with pesticides, this proposal would require researchers to do the following:
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 of the risks they potentially present to people who volunteer to participate. The 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 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 this 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: