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As Jon Gabriel noted earlier this week, the Environmental Protection Agency, while doing air quality studies, failed to adequately inform test participants of the deadly risks involved in being exposed to pollutants, according to the EPA’s Office of Inspector General.
The report says that while the EPA followed “applicable laws, regulations, policies, procedures, and guidance” when it exposed 81 people to diesel exhaust and concentrated airborne particles, “exposure risks were not always consistently represented.”
Therefore, the IG has recommended that improvements be made by the EPA to “enhance” protection of human subjects.
The IG reviewed five studies—all approved by a biomedical Institutional Review Board and the EPA’s own Human Studies Research Review Official—between 2010 and 2011. The studies were done at the EPA’s Human Studies Facility, located at the University of North Carolina at Chapel Hill.
The IG found that “the EPA did not include information on long-term cancer risks in its diesel exhaust studies’ consent forms.” That’s because an EPA manager determined that the long-term risks were “minimal for short-term study exposures.”
However, the EPA’s own fact sheet in 2002 says there’s evidence that “diesel exhaust exposure is causally associated with lung cancer.”
In the particle pollution studies, the consent forms compared the subject’s exposure to being in “a large city on a smoggy day.” Only one study actually provided information on the “upper range of the pollutant” that the participants would be exposed to, and only two studies alerted them to the risk of death for older individuals with cardiovascular disease.
The EPA itself released a fact sheet in 2003 that short-term exposure to particle pollution is “linked to heart attacks and arrhythmias for people with heart disease.” Another EPA report in 2006 said that short-term exposure is linked to “mortality and morbidity.”
Only one study identified the upper range of pollutant exposure for each study subject. The other four studies did not mention the levels and only mentioned the large city on a smoggy day. The study manager said this was just a practical way for subjects to understand the relative risk of exposure.
One of the participants interviewed, however, believed, in hindsight, that the pollutant exposure range should have been included on the consent form.
The IG agreed, concluding that “presenting consistent information about risks further ensures that study subjects can make the most informed choice about participating in a study.”
The IG also found that there were inconsistencies with the EPA’s clinical follow-up responsibilities. The EPA addressed six adverse events and reported them to the IRB, as well as providing clinical follow-up after the events. However, while the clinical follow-up “appeared to be reasonable, the EPA’s policies, guidance, and consent forms do not establish the EPA’s clinical follow-up responsibilities.”
As a result of confusion over what guidelines were to be used in clinical follow-up, some adverse events were reported to the IRB later than required and some were not reported at all.
According to UNC’s Human Research Protection Program’s Standard Operating Procedures, any research involving human subjects should conform to three ethical principles: 1) “Respect for persons (applied by obtaining informed consent, respecting privacy and confidentiality, and affording additional protections for vulnerable populations)”; 2) “Beneficence (applied by weighing risks and benefits)”; and 3) “Justice (applied by the equitable selection of subjects).”
While the IG has determined that the EPA did not technically violate any regulations or laws in its pollution studies, one has to ask—when it comes to ethics—whether it actually conformed to the principle of beneficence in its application of weighing risks and benefits. One also has to ask whether a private company would have been given as much leeway with its “inconsistencies” and ethical incongruities as the EPA was given.Published in