Do the EPA Exposure Studies Violate Do No Harm and Informed Consent?

by Craig Klugman, Ph.D

A government agency recruits elderly and sick patients for an important research study. In a controlled environment, subjects are exposed to airborne pollutants at levels many times higher than found in the real world. Some pollutants are considered so dangerous that the FDA considers any exposure to be dangerous.

Such a scenario may sound like a historical case study of human subjects abuse, but such studies are actually the subject of an 18-month review by the EPA on ethical conduct of research. Such studies are not a secret. In fact, a 2000 article in the journal Environmental Health Perspectives talks about the benefit of exposing people to pollutants at controlled doses in controlled environments. The last meeting of the review committee was August 24, 2016.

Subjects are consented to participate in the experiments, but the EPA’s own inspector general has questioned whether potential subjects truly understood the risks and whether researchers immediately and properly reported all adverse events. Specifically, the inspector general refers to a study of 81 subjects, exposing them to airborne particles and diesel exhaust fumes in 2010 and 2011. The concerns range from lack of review board approval and notification of study modifications, to addressing risks differently to different subjects in the same study, to a lack of procedures for reporting and acting on adverse events.

The public health benefits of this research are important for answering how much exposure is safe as well as what are the effects of exposure at various levels to a diverse pool of people (based on age, ethnicity, health status).

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.