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Comments Sought on Protections for Human Subjects

Release Date: 02/03/2005
Contact Information:


Contact: Enesta Jones 202-564-7873 / jones.enesta@epa.gov

(02/03/05) Consistent with a court decision, EPA is publishing a notice that describes the rigorous standards EPA is using to evaluate whether or not to rely on human studies that have been submitted to the agency. The agency's principal considerations are the protection of the welfare of human research subjects and adherence to rigorous ethical and scientific standards.

In this process, the agency is following instructions from the ruling by the U.S. Court of Appeals for the District of Columbia to determine on a case-by-case basis, applying statutory requirements, the Common Rule, and high ethical standards as a guide, whether third-party human studies will be relied on in the regulatory decision-making process. The Common Rule defines ethical standards necessary for conducting human research and applies to research conducted or supported by the 17 participating federal agencies.

EPA's approach does not encourage private parties to conduct nor commit EPA to rely on, human studies, but establishes a credible plan to develop and implement agency policy in this area. EPA will be applying the protections found in the Common Rule, as well as high ethical standards, to determine if human studies can be considered in regulatory decisions. Studies conducted by third parties, including private industry organizations, are not currently required to meet the requirements of the Common Rule, although many do.

By using acceptable human studies, the agency can generate more realistic and accurate risk assessments, and ensure that all relevant data is taken into account in regulatory decisions.

Another part of this notice invites comments on the initiatives the agency will undertake to develop a comprehensive plan for the review and consideration of future studies involving human subjects. A major part of this effort will be to evaluate and adopt, as appropriate, the recommendations from the National Academy of Sciences (NAS) on human testing. In December 2001, the agency asked the NAS to provide recommendations to the agency to help address the difficult scientific and ethical questions related to whether to accept, consider or rely on human subjects research submitted to the agency. EPA is seeking comments on its future plans, which include rule making processes, extensive public engagement and developing additional guidance as needed.

The public comment period is open for 90 days. To obtain a copy of the notice and background information on human studies, visit: : http://www.epa.gov/oppfead1/guidance/human-test.htm .