The EPA Tweaks Human Research Regulations
WASHINGTON (CN) - The Environmental Protection Agency has finalized amendments to its rules concerning the protection of human subjects participating in third-party studies involving intentional exposure to pesticides.
The rule applies to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to those who submit the results of human research with pesticides to the EPA.
"The amendments broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers," the EPA said. "The amendments also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally, the amendments identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS)."
Under the new provisions, the EPA is required to consider the ethical aspects and scientific validity, and reliability, of research that is consistent with requirements under the "common rule." The common rule is a reference to the Federal Policy for the Protection of Human Subjects established in 1991 by the Office of Science and Technology Policy. The rule contains "a widely accepted set of standards for conducting ethical research with human subjects, together with a set of procedures designed to ensure that the standards are met."