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U.S. Environmental Protection Agency
Office of Inspector General
At a Glance
14-P-0154
March 31, 2014
Why We Did This Review
In response to a congressional
request, we conducted this
review to determine whether
the U.S. Environmental
Protection Agency (EPA)
followed applicable laws,
regulations, policies,
procedures and guidance when
it exposed human subjects to
diesel exhaust emissions or
concentrated airborne particles.
In particular, we reviewed five
studies that the EPA conducted
during 2010 and 2011 to
determine whether the agency
(1)	obtained sufficient approval
to conduct these studies;
(2)	obtained adequate informed
consent from the human study
subjects; and (3) adequately
addressed adverse events that
occurred during the studies.
The EPA's human studies are
governed by 40 Code of
Federal Regulations (CFR)
Part 26, also known as the
Common Rule, which
establishes minimum
standards. The EPA conducts
human research studies to
better understand the health
effects of pollution on humans.
This report addresses the
following EPA theme:
• Addressing climate change
and improving air quality.
For further information,
contact our public affairs office
at (202) 566-2391.
The full report is at:
www.epa.aov/oia/reports/2014/
20140331-14-P-0154.pdf
Improvements to EPA Policies and Guidance Could
Enhance Protection of Human Study Subjects
What We Found
The EPA followed applicable regulations when
it exposed 81 human study subjects to
concentrated airborne particles or diesel
exhaust emissions in five EPA studies
conducted during 2010 and 2011. However, we
identified improvements that could be made to
the EPA's policies and guidance to enhance
protection of study subjects.
The EPA can enhance its
human studies by improving
how it obtains approval for
studies; how it communicates
risk to people who participate
in EPA studies; and how it
addresses adverse events in
its guidance.
The EPA obtained approval to conduct the five human research studies, including
approval from a biomedical Institutional Review Board (IRB) and the EPA Human
Studies Research Review Official (HSRRO). However, the EPA's policies and
guidance do not address when HSRRO approval is needed for significant study
modifications. Developing guidance for when HSRRO must approve significant
modifications would ensure their independent review.
The EPA obtained informed consent from the 81 human study subjects before
exposing them to pollutants. While the consent forms met the requirements of
40 CFR Part 26, we found that exposure risks were not always consistently
represented. Further, the EPA did not include information on long-term cancer
risks in its diesel exhaust studies' consent forms. An EPA manager considered
these long-term risks minimal for short-term study exposures. We believe
presenting consistent information about risks further ensures that study subjects
can make the most informed choice about participating in a study.
The EPA addressed six adverse events during its studies, reported them to the
IRB, and provided clinical follow-up after the events. 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. According to EPA managers,
the agency uses the latest University of North Carolina at Chapel Hill (UNC) IRB's
adverse event definitions and reporting timeframes to respond to adverse events.
However, the agency's guidance provides different definitions and reporting
timeframes and does not state that the EPA has adopted the UNC-IRB definitions
and timeframes. Using EPA's guidance, the EPA reported two of the six adverse
events later than required and did not report two other events to IRB.
Recommendations and Planned Corrective Actions
We recommend that the EPA establish procedures for obtaining HSRRO approval
of significant study modifications, ensure consent forms consistently address
pollutant risks, update its guidance to include the EPA's clinical follow-up
responsibilities, and address a number of other recommendations. The EPA
concurred with all recommendations and provided planned corrective actions and
completion dates that meet the intent of the recommendations. All
recommendations have been resolved.

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