Human intentional environmental exposure studies: what risks are acceptable, and to whom?

Rutgers, The State University Of New Jersey, Newark

Investigators

Abstract

In intentional environmental exposure studies (IEES), scientists expose healthy volunteers to pollutants to understand their effects on human health. These studies raise ethical questions, including under what conditions is it acceptable to expose participants to these potentially harmful materials? In addition, substantial attention is currently being given to the importance of representative inclusion of minority participants in health research and the inclusion of pregnant women (now often excluded from health-related research that presents any level of risk), since findings of trials including these groups are more likely to be applicable to them. However, in the case of IEES, increasing inclusion raises additional ethical questions: minority populations are already more likely to be exposed to harmful pollutants, is it fair to invite them to take on the additional risks involved with research about these same pollutants? This bioethics project will collect data on the views of scientists who conduct IEES, communities disproportionately affected by pollution, pregnant women, and the American public on related questions. Findings will benefit the public by improving research regulations and making IEES research more fair and socially beneficial. Through interviews with researchers, focus groups with diverse communities affected by air pollution, with pregnant women, and with environmental justice activists, and an online experiment/survey of the American public, this project will generate new insights on: a) how IEES researchers view questions of fairness and inclusion and how helpful current regulations are in achieving these goals, b) how affected groups would balance protection from risks vs. inclusion in IEES, and, c) how the public perceives IEES, how much risk is acceptable relative to a study’s social value, and under what conditions Americans would be willing to participate in IEES. These findings will serve as the basis for recommendations for improvements to current IEES regulation and guidance. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.