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Briefing Date:02/12/2004
Topic:Intentional Human Dosing Studies for EPA Regulatory Purposes: Scientific and Ethical Issues

THE NATIONAL ACADEMIES
National Research Council
Policy and Global Affairs Division
Science, Technology, and Law Program
Committee on the Use of Third Party Toxicity Research with Human Research Participants

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Congressional Briefings
Thursday, February 12, 2004
1301 Longworth House Office Bldg. -- 3:00 p.m.
645 Dirksen Senate Office Bldg. -- 4:00 p.m.
and
2318 Rayburn House Office Bldg. -- 5:00 p.m.

on

Intentional Human Dosing Studies for EPA Regulatory Purposes:
Scientific and Ethical Issues

The U.S. Environmental Protection Agency (EPA) is considering use of research from "third-party" studies -- conducted in other countries or by private companies without federal money or support -- that intentionally dose human subjects with toxic substances to measure the effects. Because these studies do not comply with EPA's rules for the protection of human research participants, the agency does not currently consider them in its regulatory decision-making. This report examines the complex scientific and ethical issues that might arise if the agency decided to do so.

These series of briefings were for members of Congress and congressional staff only. The report was publicly released on February 19, 2004 and can be found, in its entirety, on the Web site of the National Academies Press.

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