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EPA Significantly Strengthens and Expands Safeguards on Human Studies Research

Release Date: 01/26/2006
Contact Information: Enesta Jones, (202) 564-4355 / [email protected]

(Washington, D.C.-January 26, 2006) Under new rules announced today, all third-party intentional dosing research on pesticides involving children and pregnant women intended for submission to EPA is banned, and EPA will neither conduct nor support any intentional dosing studies that involve pregnant women or children for all substances EPA regulates. These final new rules also establish stringent enforceable ethical safeguards to protect individuals who volunteer to participate in third-party intentional dosing research.

"These final rules will protect pregnant women and children from unethical human research involving pesticides and other environmental substances," said Susan B. Hazen, acting assistant administrator in EPA's Office of Prevention, Pesticides and Toxic Substances. "Pregnant women and children should never be involved in these types of studies. Now adult volunteers (non-pregnant) will have the highest level of ethical safeguards available if they choose to participate in research studies."

These final regulations adopt and implement many of the recommendations from the prestigious National Academy of Sciences, have benefited from public comments, and adhere to the legislation passed by Congress in August 2005. Under the new rules, the provisions of the Federal Policy for the Protection of Human Subjects of Research (the Common Rule) are extended to cover all third-party intentional dosing studies submitted to EPA under the pesticide laws. Third party studies are those studies not conducted or supported by a federal agency. EPA is also establishing a Human Studies Review Board to obtain independent scientific and ethical review on whether to accept certain existing human studies as well as review all new study protocols before the studies are started.

This rule makes it clear that all pregnant women and all children are excluded from all such studies involving intentional exposure. For any new, intentional dosing studies with pesticides, this final rule requires researchers to do the following: (1) assure that pregnant women and children are not participants, (2) comply with the requirements of the Common Rule (current ethical standards for research conducted or supported by the federal government); (3) 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 (4) once the study is conducted, provide detailed information to EPA describing how the study met the necessary ethical protections.

The sweeping requirements of this final rule will lay the groundwork and provide an important foundation for the Agency to build upon in future actions that may be determined necessary to provide further protections to public health.

More information on today's announcement: epa.gov/oppfead1/guidance/human-test.htm