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Toxicological Sciences 2005 85(1):419-421; doi:10.1093/toxsci/kfi140
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Toxicological Sciences vol. 85 no. 1 © The Author 2005. Published by Oxford University Press on behalf of the Society of Toxicology. All rights reserved. For Permissions, please email: journals.permissions@oupjournals.org

TOXICOLOGICAL HIGHLIGHT & FORUM

Toxicological Research Involving Humans: Ethical and Regulatory Considerations

Bernard A. Schwetz*,1, Lois Lehman-McKeeman{dagger} and Linda S. Birnbaum{ddagger}

* Department of Health and Human Services, Office of Public Health and Science, Office for Human Research Protection, Rockville, Maryland 20852; {dagger} Discovery Toxicology, Bristol Myers Squibb Company, Princeton, New Jersey 08543; and {ddagger} U.S. Environmental Protection Agency, Office of Research and Development, National Health and Environmental Effects Research Laboratory, Experimental Toxicology Division, Research Triangle Park, North Carolina 27709

1 To whom correspondence should be addressed at 1101 Wootton Parkway, Suite 200, Rockville, MD 20852. E-mail: bschwetz@osophs.dhhs.gov.

Received March 3, 2005; accepted March 3, 2005

The first 150 words of the full text of this article appear below.


   INTRODUCTION
 
This paper discusses the need for the Society of Toxicology (SOT) to develop a policy for ethical research in humans, and a review for publication of these studies. Observations on human beings have been the foundation upon which toxicologic knowledge has been built since the inception of toxicology as a science that developed information on cause-and-effect relationships between exposures to substances and subsequent undesired health effects. Observations by Sir Percival Pott and others in the 1700s were instrumental in creating an understanding between occupational exposures and cancer. In the 20th century, many sources of exposure from the workplace, foods, drugs, and environment were found to contribute to the human disease load based on observations on humans.

During this same span of time, humans came to be the subjects of research in many countries throughout the world in areas of basic and applied research, including both biomedical and social/behavioral studies. The . . . [Full Text of this Article]


   SOT INVOLVEMENT IN HUMAN RESEARCH
 

   HUMAN RESEARCH POLICIES
 

   CONCLUSIONS ON A SOT POLICY FOR HUMAN RESEARCH
 

   APPENDIX 1: RESOURCES
 
Policies, Reports, and Policy Statements
General Information Web Sites

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