The Environmental Protection Agency’s Office of Assistant Inspector General for Program Evaluation (OIG),Carolyn Copper, sent a memorandum to the EPA’s Lek Kadeli, Acting Assistant Administrator for Research and Development, in late October and gave notice that the IG will “begin an evaluation of the Environmental Protection Agency’s (EPA’s) Research on Human Subjects.” According to the memo posted on the EPA’s website, the assignment is in response to a Congressional request.
“Our objective is to determine whether EPA, as part of its research, followed applicable laws, regulations, policies, procedures, and guidance when it exposed human subjects to diesel exhaust emissions or concentrated airborne particles.” :
Specifically, in conducting the XCON, KINGCON, OMEGACON, and any related studies exposing 41 human subjects to diesel exhaust emissions or concentrated air particles from 2010 to 2011, we plan to determine whether EPA:
1)Obtained sufficient approval to expose subjects to specific levels of diesel exhaust emissions or concentrated airborne particles;
2)Obtained adequate informed consent from human study subjects before exposing them to diesel exhaust emissions or concentrated airborne particles;
3)Adequately addressed any adverse events that occurred, including notifying the University of North Carolina at Chapel Hill’s Institutional Review Board (IRB), the Human Studies Review Board, and the Human Subjects Research Review Official, revising consent forms as needed, and providing clinical follow-up in accordance with the approved protocol.
The IG investigation comes on the heels of a late September lawsuit filed by biostatistician and securities lawyer Steven Milloy, who runs the website junkscience.com. Milloy began his lawsuit over what he discovered through evidence from a Freedom of Information Act (FOIA) request. Working with the National Legal and Policy Center, Milloy found through the FOIA that the EPA was conducting ” disturbing experiments that exposed humans to inhalable particulates the agency has said are deadly.”
Following Milloy’s lawsuit, the EPA immediately responded in a September 25th e-mail statement to me:
EPA is one of 15 federal departments and agencies that conduct or support research with human subjects under the governance of the Common Rule. All human exposure studies conducted by EPA scientists are independently evaluated for safety and ethics, and the results are peer-reviewed. The complaint has been referred to the Department of Justice and further inquiry regarding litigation should be directed to them.
Mr. Milloy then responded back in an e-mail statement:
The alleged “independent” safety and ethics evaluation is conducted by the University of North Carolina (UNC) for EPA on a contract basis.In addition to UNC being an EPA contractor (ka-ching), the EPA extramural grants database indicates that the EPA has given UNC $33,602,103 for 92 projects (ka-ching,ka-ching).
UNC documents indicate that UNC received from EPA $8,252,644.45 in 2004;$4,586,728.98 in 2005; $8,884,433.00 in 2006; and $5,696,188.32 in 2010.
Documents for other years could not be found.We report. You decide. Does that sound “independent” to you?