Based on EPA’s response to the original FOIA request, Milloy requested on May 14, 2012 that the EPA Inspector General investigate the researchers for violations of the Common Rule and EPA Order 1000.17. Click for the entire letter (with attachments), which contains and analysis of the regulations and facts known as of May 14, 2012.
Below is a summary of the potential violations of human testing rules cited and described in available detail in the letter:
- EPA researchers violated EPA Order 1000.17 by intentionally exposing human study subjects to lethal levels of PM2.5.
- EPA researchers may have violated the Common Rule by failing to obtain adequate informed consent.
- EPA may have violated EPA Order 1000.17 by failing to review and terminate the experiment following the serious injury sustained in the Case Report.
- EPA researchers may have violated the common rule and EPA Order 1000.17 by failing to amend the IRB-approved consent forms.
- The University of North Carolina violated the Common Rule by approving the experiment.