Protecting Our Research Volunteers

Protecting human health is both a core mission, and a natural extension of everything we do here at EPA. Our commitments to protecting the nation’s air, water, and natural ecosystems, taking action on climate change, and working with local communities to help them become more resilient and sustainable all lead back to protecting human health.

Recently, we have revisited that commitment in one particular area of great importance as we continue using the latest, and best-available science to support our work.

Each year, dozens of people agree to be part of EPA research efforts by becoming participants in highly controlled studies that advance the understanding of the links between our environment and human health. The protection of our volunteers is paramount.

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.

Agency human health researchers who study the effects of air pollution on our cardiovascular and pulmonary systems conduct what are known as exposure studies. In doing so, they recruit volunteers to explore cell-level and other physiological changes that can be sparked by exposures to precisely-controlled amounts of pollutants. These reversible changes inform us about adverse health effects that would occur with higher exposure levels or in individuals with health conditions that put them at higher risk.  The results of the studies help us understand the associations between environmental exposures and adverse health outcomes observed in population studies, thus providing evidence for a causal relationship.

Protecting the health of our study participants is job one, and there is no room for compromise. If there is even the slightest concern that a proposed study or protocol will not meet the highest safety standards, it will not be carried out.  To maintain such strict standards, EPA is among 15 federal agencies that have adopted rules governing the protection of human subjects in research.

But we go even further. EPA’s own guidelines far exceed what is generally accepted and required by universities, industry, and other government agencies. For example, any of our research that involve human participants typically undergo more than eight separate levels of approval stages before any research is initiated. These include statistical and medical reviews of the study, reviews by an Institutional Review Board, Quality Assurance Officer review, and review by at least three other senior officials, whose approvals must be documented before a study can begin.

And even with these protocols already in place, in response to a congressional request and to ensure we continue to maintain the strictest safeguards possible, EPA’s Office of Inspector General recently released a report reviewing our human studies policies.

The report recognized the importance and efficacy of such high standards, and identified opportunities to strengthen our internal procedures even further. We are in the process of embracing their recommendations, including incorporating extra levels of feedback and review as study procedures are changed through the review process, strengthening how we communicate internally, and sharing even more information about exposure risks with study volunteers, even when these risks are minimal.

We will continue to meet our commitment to setting—and meeting—the highest safety and ethical standards for protecting our human studies volunteers while we work to advance the science needed to protect human health. That effort is part of our core mission, and the foundation of advancing the protection of human health and the environment.

 

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