The Environmental Protection Agency’s inspector general found that the agency didn’t notify test subjects in recent pollutant studies that they were being exposed to cancer-causing chemicals.
At the request of House Science, Space, and Technology Oversight Subcommittee Chairman Paul Broun (R-Ga.), the OIG looked into five research studies the EPA conducted in 2010 and 2011 involving 81 human subjects to test the effects of diesel exhaust.
The OIG found the “consent forms inconsistently addressed the risks of being exposed to [Concentrated Airborne Particles] and diesel exhaust,” with only one of the five studies’ forms providing the test subject “with information on the upper range of the pollutant he or she would be exposed to” and just two of the five “alerted study subjects to the risk of death for older individuals with cardiovascular disease.”
“Only two of the five studies’ consent forms included the risk of death from exposure to high levels of selected air pollutants such as [Particulate Matter] and diesel exhaust, and only one study’s consent form included the upper limits of exposure levels,” the report stated.
“…Evidence suggests that at least some human study subjects would like to know if a study involves risk of death, even if the risk is very small. In the future, the EPA should include the long-term risk of cancer to potential subjects in its consent forms so study subjects can make the most informed decisions about whether to participate in a study.”
Six “adverse events” happened with test subjects in the five studies. “The EPA’s clinical follow-up for the six adverse events ranged from 1 day to 3 months after the event and included phone calls and emails by the EPA nurses. While the EPA’s clinical follow-up appeared to be reasonable, the EPA’s policies and guidance do not establish the EPA’s clinical follow-up responsibilities. In our view, the EPA should revise its guidance to establish the agency’s clinical follow-up responsibilities after an adverse event.”
Two of those “adverse events” were reported by the EPA “later than required,” the report noted.