Biomaterial Database

Intentional exposure studies of environmental agents on human subjects: assessing benefits and risks. 2007

David B Resnik

National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina 27709, USA. resnikd@niehs.nih.gov

In this article, I assess the benefits and risks of studies that intentionally expose research subjects to environmental agents. I describe these types of studies, identify their benefits and risks, compare them to other research methods that can be used to investigate the relationship between environmental exposures and disease, and discuss some issues related to research design and risk minimization. I argue that the benefits of intentional environmental exposure studies outweigh the risks when 1) the knowledge gained is likely to improve our understanding of the relationship between environmental exposure and disease, 2) this knowledge cannot be obtained by other methods, 3) the experiments are well designed, 4) the subjects will receive some benefits, such as medical evaluations, 5) risks are minimized, and 6) the risks to human subjects are less than those encountered in a typical Phase I drug study. Only in rare circumstances (i.e., when an intentional environmental exposure study is needed to implement an important environmental or public health intervention or regulation) may such studies expose research subjects to risks as high as those encountered in a typical Phase I drug trail.

UI	MeSH Term	Description	Entries
D010575	Pesticides	Chemicals used to destroy pests of any sort. The concept includes fungicides (FUNGICIDES, INDUSTRIAL); INSECTICIDES; RODENTICIDES; etc.	Pesticide
D004781	Environmental Exposure	The exposure to potentially harmful chemical, physical, or biological agents in the environment or to environmental factors that may include ionizing radiation, pathogenic organisms, or toxic chemicals.	Exposure, Environmental,Environmental Exposures,Exposures, Environmental
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000818	Animals	Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA.	Animal,Metazoa,Animalia
D014481	United States	A country in NORTH AMERICA between CANADA and MEXICO.
D014484	United States Environmental Protection Agency	An agency in the Executive Branch of the Federal Government. It was created as an independent regulatory agency responsible for the implementation of federal laws designed to protect the environment. Its mission is to protect human health and the ENVIRONMENT.	Environmental Protection Agency (U.S.),Environmental Protection Agency,Environmental Protection Agency, United States,USEPA
D018570	Risk Assessment	The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988)	Assessment, Risk,Benefit-Risk Assessment,Risk Analysis,Risk-Benefit Assessment,Health Risk Assessment,Risks and Benefits,Analysis, Risk,Assessment, Benefit-Risk,Assessment, Health Risk,Assessment, Risk-Benefit,Benefit Risk Assessment,Benefit-Risk Assessments,Benefits and Risks,Health Risk Assessments,Risk Analyses,Risk Assessment, Health,Risk Assessments,Risk Benefit Assessment,Risk-Benefit Assessments
D032984	Ethics, Research	The moral obligations governing the conduct of research. Used for discussions of research ethics as a general topic.	Research Ethics