December 12, 2001
The Bush administration seems poised to accept the testing of potentially toxic pesticides on human subjects -- a practice that has raised ethical concerns.
EPA officials acknowledged in Nov. 2001 that the agency is still accepting pesticide industry data on deliberate exposures for review during the re-registration process. But agency officials say the data aren't influencing their decisions. The Clinton EPA reportedly had been moving toward an informal freeze on use of human test data for pesticides. Dec. 11, 2001 AP story on human testing.
After lower-level officials reportedly signaled the Bush administration position to the pesticide industry last month, EPA Administrator Christie Whitman is expected to publicly address the agency's policy on human test subjects, at least regarding pesticides, in December 2001. EPA media, Dave Deegan, 202-564-7839.
"Informed consent" by subjects is a key element of guidelines for human testing under federal agencies. But both researchers and test subjects often have a poor understanding of the risks and rewards of such trials, according to a study published in The Lancet Nov. 24, 2001.
A House member plans to introduce a bill addressing the use of human test subjects no later than mid-January 2002. Rep. Diana DeGette (D-CO) media office, Carol Shirley, 202-225-4431. U.S. senators also are working on the issue, but introduction of legislation isn't expected soon. Sen. William Frist (R-TN) media office, Nick Smith, 202-224-3355.
- U.S. Department of Health and Human Services, Office of Inspector General, "Protecting Human Research Subjects: Status of Recommendations," OIG media, 202-619-1343. OIG is scheduled in 2002 to investigate recruitment of human test subjects -- see document page 12.
- U.S. General Accounting Office, "Human Subjects Research: HHS Takes Steps to Strengthen Protections, But Concerns Remain," Janet Heinrich, 202-512-7250. GAO is scheduled to release a report no later than Dec. 26 on financial conflicts of interest in biomedical research. Marcia Crosse, 202-512-3407.
- U.S. Department of Health and Human Services, Office for Human Research Protections, media office: Bill Hall, 202-690-6343.
- For additional information, see TipSheet of March 7, 2001.
- Environmental Working Group, "The English Patients" July 27,1998.
- American Crop Protection Assn.: Karen Reardon, (202) 872-3864.
- "U.S. Will Use Once-Banned Human Tests," by Elizabeth Shogren, Los Angeles Times, Nov. 27, 2001.