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Investigation Finds EPA Could Improve Human Study Subject Protection

In late March, the U.S. Environmental Protection Agency’s (EPA) Office of the Inspector General (OIG) released its findings from an investigation into the agency’s human study subject protections [1]. The investigation was requested by Oversight Subcommittee Chairman Paul Broun, M.D. (R-Ga.), who raised concerns over several EPA studies examining the impact of diesel exhaust emissions on human health. The studies, conducted between 2010 and 2011, further explore the EPA’s claims that diesel exhaust emissions harm human well-being and the environment.

In an October 2012 letter to the EPA’s Inspector General, Arthur A. Elkins, Rep. Broun questioned whether the EPA had obtained sufficient approval to undertake the studies, obtained adequate informed consent from participants, and properly addressed any adverse events that occurred during the studies.

The OIG’s report, released on March 31, 2014, claims that the EPA adhered to applicable regulations during the diesel exhaust emissions studies: the EPA obtained sufficient approval to conduct the studies from the EPA Human Studies Research Review Official (HSRRO) and a biomedical institutional review board (IRB); the EPA obtained informed consent from the 81 individuals who participated in the studies; and the EPA addressed adverse events during its studies and provided clinical follow-up.

While the EPA officials followed relevant legal policies and procedures, the OIG recommended several improvements to enhance the EPA’s protection of human study subjects. After discovering that all study participants did not receive the same consent information, the OIG recommended that the EPA establish more consistent communication of health risks to participants. “Presenting consistent information about risks further ensures that study subjects can make the most informed choice about participating in a study,” states the report.

Additionally, the EPA did not include information on long-term cancer risks associated with exposure to exhaust emissions. While the EPA found cancer risks from short-term exposure to be marginal, the OIG emphasized that “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.”

The OIG noted a lack of guidelines for study modifications. When the EPA made methodological changes to the diesel exhaust studies, it was unclear whether officials needed to confer with oversight committees. Similarly, there were inadequate guidelines on handling adverse events associated with human study subjects. Adverse events include immediate detrimental health impacts during a study. The EPA also reported several adverse events later than required, and neglected to report some events to the biomedical IRB. Though “the clinical follow-up appeared to be reasonable,” the OIG recommended the establishment of consistent procedures when handling adverse events.

In response to the report, Rep. Broun stated that, “It is abhorrent for the EPA to be conducting these human experiments without providing robust information and notification to the patients about the risks of death and following the strictest protocols.” [2]

In response to the OIG’s investigation, the EPA agreed with all recommendations, prepared corrective actions and a timeline for proper implementation. “We are in the process of embracing their recommendations,” wrote Bob Kavlock, deputy assistant EPA administrator for science, on an EPA blog. “Thanks to their generous spirit and contribution of time, our research volunteers play a vital role in helping EPA scientists advance the cause of protecting the health of all Americans.” In 2013, the EPA strengthened protections of human study subjects involved in pesticide research [3].




This article is part of the Spring 2014 issue of Professional Ethics Report (PER). PER, which has been in publication since 1988, reports on news and events, programs and activities, and resources related to professional ethics issues, with a particular focus on those professions whose members are engaged in scientific research and its applications.