WASHINGTON, April 2, 2014 -- The EPA’S Inspector General is criticizing the agency for failing to “consistently represent” risks to human volunteers in consent forms for air pollution experiments, including information on long-term cancer risks in some instances.

In five studies conducted during 2010 and 2011, the EPA exposed 81 subjects to concentrated airborne particles or diesel exhaust emissions, after getting the necessary approvals, including the OK from a biomedical Institutional Review Board, the IG said in a report. Informed consent forms were obtained from all subjects, the IG said.

“While the consent forms met the requirements of (the Code of Federal Regulations), we found that exposure risks were not always consistently represented,” the IG said in a summary of its findings. “Further, the EPA did not include information on long-term cancer risks in its diesel exhaust studies’ consent forms.” An EPA manager had considered the long-term risks minimal for short-term study exposures, it said.

The IG said presenting consistent information about risks “ensures that subjects can make the most informed choices about participating in a study.”

The Inspector General also said there were six “adverse events” during the studies and that the EPA provided what appeared to be “reasonable” follow-up, including medical attention. Still, it said, EPA policies and consent forms did not specify what the agency’s responsibilities are related to the follow-up. Additionally, the EPA reported two of the six events to the Institutional Review Board later than required, and failed to report two other events.

The adverse events included migraine, persistent cough and irregular or faster-than-normal heart rate.

The IG recommended, among other things, that EPA ensure its consent forms consistently address pollutant issues and that the agency update its guidance to include its follow-up responsibilities. It said all recommendations had been resolved.

The EPA’s human studies are governed by a set of federal regulations known as the Common Rule, which establishes minimum standards, the IG said. The agency conducts the studies “to better understand the health effects of pollution on humans,” the IG said.


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