The Ramazzini Institute
for Occupational and Environmental Health Research   

Who Are We?

EPA's New Policy
Research Subject Protection

     On October 4, in Washington, the Environmental Protection Agency issued a policy on the use of data from the testing of human research subjects. In a process that began more than two years ago, the document defines what the agency believes is “an ethically appropriate human study.”

     Measures to protect humans from pollutants we breathe or drink require observations of the effects of toxic agents on humans in their homes, places of work, in laboratories and in clinics. There is a difference, however, between collecting data – histories, symptoms, results of clinical tests and examinations - from patients presenting themselves in a clinic for treatment, on one hand, and on the other of perpetuating the exposure at home or work to observe an effect, or exposing humans to the agents in a laboratory or clinic to see what happens. In the past, the moral difference sometimes has been ignored by both private and government sponsored scientists and their agencies.

     The problem for the Environmental Protection Agency is not new. William Ruckelshaus, during his second reign as Administrator at EPA, faced the problem of whether or not it was ethical to use data from so-called human experiments in the Nazi concentration camps of World War II, where prisoners were exposed to a variety of agents to determine, among other observations, thresholds of effects, or what is now called a NOAEL or No Observable Adverse Effect Level. The “threshold” issue is still one that holds the attention of environmental regulators and scientists, although many believe that such thresholds for toxic substances in populations are a “chimera”, to quote the late Dr. David Rall, former Director of the National Institute for Environmental Health Sciences. In any case, the Nazi data was so bad that it was a rather moot issue. More recently, however, as increasing attention has been placed by the public on morality in science, the agency’s Science Advisory Board has had to take another look at large-scale studies EPA sponsors, such as NHEXAS, its National Human Exposure Assessment Survey.

     NHEXAS is still a pilot study, but already it has recruited more than five hundred people being studied in Arizona, the Midwest and Maryland. Investigators from eleven universities and research organizations are looking at a broad range of toxic metals, pesticides, solvents and other chemicals, such as lead, asbestos, cadmium, chromium, benzene, chlordane, styrene, malathion, and perchloroethylene. In the Midwest a special children’s study is being conducted. Pregnant women were not precluded by federal policy.

     To deal with the problems posed by studies like NHEXAS, the new agency policy deals firmly with toxicity studies to establish a NOAEL. Fourteen such studies have been received in recent years to support the approval of pesticides under the Food Quality Protection Act. The whole point of such studies is to find a level at which no adverse effect is found, which may mean increasing the exposures to the point at which they can be observed. These experiments are no longer acceptable when humans are used, but may be done with experimental animals.  A minority of the Science Advisory Board wanted stronger language, but there is total consensus by the Science Advisory Board on the main issue.

     The SAB report, available on the EPA web site, makes a number of improvements on government policy, especially in its discussion of the coercive nature of financial incentives for “volunteers.” The practice of paying research subjects clouds the voluntariness in the voluntary informed consent doctrine at the heart of all government-sponsored and, hopefully, private research. In Holmes County, Mississippi, for instance, where median family income is about $11,302, a $40 dollar fee may be adequate to induce volunteers to take a pesticide cocktail. In Nassau County, New York, with a median family income of nearly $54,000, the fee might have to be $100. Knowledge of the risks, whether adequate or not, is perceived differently among different socio-economic classes, allowing greater opportunities for the exploitation of precisely those humans least able to deal with adverse effects.