Protections for Subjects in Human Research: Final Rule at a Glance

This final rule prohibits third-party intentional dosing research involving all children and pregnant women for all intentional dosing studies intended to be submitted to EPA under the pesticide laws.
This final rule prohibits EPA from conducting or supporting any intentional dosing studies that involve pregnant or children for all substances it regulates, including pesticides.
This final rule is consistent with the recommendations by the National Academy of Sciences, the nation's foremost scientific review body.
These new rules extend the provisions of the Federal Policy for the Protection of Human Subjects of Research (known as the Common Rule) to cover all third-party intentional dosing studies intended for submission to EPA under the pesticide laws.
This final rule establishes a Human Studies Review Board of independent ethicists and scientists to provide advice and recommendations to EPA on decisions on whether to rely or reject a human study. This Board will also review study design and protocols before any studies are generated to ensure they meet the new ethical standards in the final rule.
Now adult volunteers (non-pregnant) who choose to participate in this research will have the highest level of ethical safeguards available.
These final regulations adopt and implement many of the recommendations from the prestigious National Academy of Sciences, have benefited from a 90-day public comment period, and adhere to the legislation passed by Congress in August 2005.