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Risk Communication in EPA's Controlled Inhalation Exposure Studies and in Support.
Perspectives in Biology and Medicine
|September 12, 2017
Summary
The National Academy of Sciences, Engineering, and Medicine (NASEM) report addresses ethical issues in Environmental Protection Agency (EPA) human inhalation exposure studies. It offers guidance on defining "reasonably foreseeable risks" for research participants and investigators.
Area of Science:
- Environmental Health
- Bioethics
- Regulatory Science
Background:
- Ethical controversies surrounded the Environmental Protection Agency's (EPA) controlled human inhalation exposure studies.
- A report by the National Academy of Sciences, Engineering, and Medicine (NASEM) was released on March 28, 2017, to address these issues.
Purpose of the Study:
- To review the ethical controversies leading to the NASEM report.
- To summarize the key findings of the NASEM report.
- To comment on the report's guidance for informing human subjects about risks in inhalation studies.
Main Methods:
- Review of ethical controversies.
- Analysis of the NASEM report's findings.
- Commentary on risk communication strategies.
Main Results:
- The NASEM report provides a valuable contribution to understanding scientific and ethical issues in human inhalation exposure studies.
- The report defines "reasonably foreseeable risks," offering guidance to investigators, participants, and institutional review boards.
Conclusions:
- NASEM's report is a significant resource for navigating the complexities of human inhalation exposure research.
- The definition of "reasonably foreseeable risks" enhances ethical oversight and participant protection.
