Feature

When a hiker sprays himself with insect repellent at the start of a trail, he's probably just thinking about keeping ticks and mosquitoes at bay. What may not be on his mind is the amount of research that went into developing the pesticide in his repellant, and how a psychologist is working to help keep him safe.

That psychologist is Celia Fisher, PhD, chair of the new congressionally mandated Environmental Protection Agency (EPA) Human Subjects Review Board, chartered in February to advise EPA on ways to strengthen its programs for protection of human research subjects. Fisher will lead the 16-member panel's ethical and scientific review of human-dosing studies on pesticides and other chemicals.

She and her colleagues will evaluate these studies-submitted to EPA for approval-to determine, for example, whether the studies meet scientific criteria sufficient for EPA to use them in its risk assessments of pesticide compounds and ethical criteria such as whether participants gave truly informed and voluntary consent.

With her psychology background, Fisher brings a unique perspective to the EPA board. Psychologists can enhance the field of bioethics-traditionally seen as the province of philosophy and theology-with their particular knowledge of human cognition and emotion, shedding light on how diverse populations will respond to recruitment and participation in chemical studies, she explains.

"As a representative of my discipline, I apply the…characteristics of individuals that are at the heart of psychology to understand the effects of research on participants," says Fisher.

EPA's creation of the new board, and Fisher's appointment as its chair, reflects a federal push to hold third-party industry accountable in human-subjects research, say observers.

"Having Fisher on the EPA board makes clear a commitment to integrity in a federal agency too often criticized as being 'in the pocket' of commercial and industrial interests," says APA President Gerald P. Koocher, PhD. "Her rigor, conscience and dedication will provide outstanding leadership."

Pesticide safety

Pesticides are a part of life for most Americans. People apply them to their skin to repel insects, paint them on wood to rid their homes of termites or spray them on fruits and vegetables to deter field pests.

To test the safety of those pesticides, third-party chemical manufacturers typically conduct studies on animals. From there, EPA uses complex calculations to estimate the safety level of the compound for humans, usually resulting in a more conservative threshold. Some manufacturers seek to further test the products on people because if they can prove that humans respond similarly to animals to a certain product, the risk assessment could be adjusted, says Fisher.

Chemical manufactures also conduct observational studies, in which they monitor people's responses to chemical exposure in their daily lives. Participants wear special gear that monitors the body's absorption of a particular compound, such as how much pesticide an orchard worker is exposed to when spraying apple trees.

Until the February passage of new EPA Protections for Subjects in Human Research, federal regulations governing such human-subjects research did not apply to these third-party manufacturers as long as they were unaffiliated with government agencies or institutions receiving federal funding, or did not indicate in advance that they intended to submit their research to EPA for product registration. However, under the new rule, these industries must submit all completed and proposed human studies for review by the new EPA board if they want EPA to consider the data for product approval.

After the board reaches a conclusion on a particular study, it will advise EPA on their findings. EPA will then decide whether to approve-or renew approval of-a particular product for public use.

As a result of this new process, the new rule will force industries to have higher scientific and ethical standards in their human-dosing research, Fisher says.

Ethical specialty

Fisher's board will evaluate both the scientific validity and ethical implications of pesticide manufacturers' human-subjects research. For example, the board might question the ethics of an employer asking an orchardworker to participate in a pesticide study. The worker might feel that he would lose his job if he refused to participate, which would constitute a threatening or coercive situation for him.

Such ethical considerations are Fisher's specialty. Over the past 15 years, she has chaired APA's Ethics Code Task Force; served on the Department of Health and Human Services Secretary's Advisory Committee on Human Research Protections; and conducted federally supported research on informed consent and the perspectives of vulnerable populations on research ethics.

This wealth of experience prompted EPA to appoint Fisher chair of the new ethics board, says Paul I. Lewis, PhD, designated federal officer on the board.

"EPA's selection of Dr. Fisher as chair was based in part on her internationally recognized expertise in ethics with 100 publications in the areas of ethics and life-span development," says Lewis.