cussed is peculiar to exposure science, how they present themselves can pose special challenges for observational studies. That is particularly true of ethical issues associated with ubiquitous technologies—new personal and environmental monitoring tools—whose use and availability are expected to become more prevalent. As technologies evolve our capacity to detect chemicals and other stressors at increasingly lower levels is outpacing our capacity to interpret what the findings mean for health, subclinical effects, or even for elucidating potential exposure reduction strategies, creating scientific and ethical challenges for society.

PROTECTING RESEARCH VOLUNTEERS

Exposure-science research may involve observational studies of humans and the environments in which they live. The ability to conduct exposure studies in all populations, particularly among the most vulnerable (for example, the elderly, children, and the infirm) is critical to understanding and preventing harmful exposures and risks in society. As with all research involving human subjects, it is vital that measures be implemented at the beginning of a study to protect the rights and welfare of participants (volunteers). In cases that lack such protections, research subjects may be needlessly placed at increased risk, which can threaten not only their well being but the long-term success of human and environmental exposure-science research.

All exposure-science research involving human subjects must be reviewed and approved by an appropriate institutional review board (IRB) and be consistent with national ethics standards. Many of the ethical considerations that should guide the conduct of observational exposure studies are discussed in the recent EPA report Scientific and Ethical Approaches for Observational Exposure Studies, which provides well-defined and documented procedures for conducting exposure-related research. That report describes two primary elements for human-subject protections: review by an impartial IRB and informed consent of research subjects.

High standards of ethical conduct in human-subjects research are enforced by multiple oversight committees or review boards, which examine both scientific and ethical details of the proposed research. IRBs include appropriate medical and scientific experts who are not directly involved in the conduct of the research and who do not have any personal interests in the study. They also have members outside the scientific community. In deciding whether a research study is acceptable, IRB members are asked to consider whether or not the foreseeable risks to participants are appropriately minimized and acceptable in light of the potential benefits to participants and to society.

The process of seeking informed consent of participants is a second key element of ethical conduct in research. Informed consent ensures that subjects give their voluntary and informed consent to be participants in a research study.



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