Risk Communication in EPA's Controlled Inhalation Exposure Studies and in Support.

On March 28, 2017, the National Academy of Sciences, Engineering, and Medicine (NASEM) released a much-anticipated report on the Environmental Protection Agency's controlled human inhalation exposure studies. This essay reviews the ethical controversies that led to the genesis of the report, summarizes its key findings, and comments on its approach to informing human subjects about the risks of inhalation exposure studies. NASEM's report makes a valuable contribution to our understanding of the scientific and ethical issues involved in conducting human inhalation exposure studies. Its definition of "reasonably foreseeable risks" provides useful guidance to investigators, research participants, and institutional review board members.