EPA proposes new human subjects protection rule
Some studies of pregnant women, children banned
The Environmental Protection Agency has released a draft of its proposed rule limiting the use of intentional dosing research on human subjects. The rule would outlaw all new intentional dosing studies involving children or pregnant women and establish a Human Studies Review Board (HSRB) to review study protocols.
But critics of the EPA’s controversial pesticide study that was shelved earlier this year after raising the issue of pesticide studies involving children, say the proposed rule still isn’t stringent enough.
"It must be changed dramatically from the version EPA forwarded to OMB If not, it will still be an attack on our most vulnerable citizens," Sen. Barbara Boxer, D-CA, said in a statement released shortly after the EPA unveiled the proposed rule in September.
The proposed rule, available for review on the agency's web site (www.epa.gov/pesticides/) bans inclusion of pregnant women, infants and children in intentional dosing studies, or studies in which individuals are deliberately exposed to a substance to determine its safety.
The ban applies to EPA-conducted or EPA-supported studies, as well as so-called third-party studies, which are conducted by outside entities, often pesticide manufacturers, in hopes of winning looser restrictions on pesticide use by demonstrating safety.
Under the proposed rule, all proposed intentional dosing studies would have to comply with the requirements of the Common Rule and would have to be reviewed by an IRB prior to submission to the EPA’s new Human Subjects Review Board.
John Carley, PhD, program analyst for the EPA’s Office of Pesticides Programs and one of the principal authors of the proposed rule, says the Human Subjects Review Board was one recommendation made by the National Academy of Sciences when the EPA asked for guidance on this issue.
The NAS report suggests that the board be comprised of a "small but broadly knowledgeable group of experts, with core expertise in human toxicology, biostatistics, and research ethics." It would not, however, function as the EPA’s IRB, Carley says. "It would complement and supplement oversight by local IRBs but not supersede it."
The NAS report suggests that the HSRB review proposed studies before the IRBs, lending their guidance to subsequent IRB review. But Carley says the proposed rule calls for IRB review first, with the HSRB serving as a final check on the process.
Although the proposed rule would ban new studies that intentionally expose pregnant women and children to pesticides, it does leave open the door for EPA to consider such studies in their regulatory actions in cases where public health would benefit. Carley says the intention would be to only do so in cases where considering a non-complying study would lead to a tougher regulatory standard for a pesticide.
"The idea is that yes, we want to discourage unethical research, but we also want to protect public health," he says. In the case of a completed study that doesn’t comply with the rules, "no action that we do could change the conduct of the study or how the subjects were treated."
Some critics of the proposed rule have suggested that its wording would allow use of an unethical study that could weaken an existing regulatory standard for a pesticide.
"We never had anything like that in mind, and we will do our very best to make it impossible to misunderstand in the final rule," Carley says.
The issue of pesticide studies involving children got national attention earlier this year, when the EPA canceled the Children’s Health Environmental Exposure Research Study (CHEERS), which would have measured pesticide exposure of children in everyday residential settings. Critics including Boxer raised ethical concerns over the study.
CHEERS was not designed as an intentional dosing study, but as an observational study of pesticide use in homes with small children.
Carley says he believes a study of that kind could be designed in compliance with the proposed rule, as long as the study did not alter families’ decisions about pesticide use. He declined to say whether the CHEERS study met that criterion, saying changes were made to the design of that study as it went through the review process.
Comments about proposed changes must be received by December 12 and may be submitted in one of the following ways:
— online (go to www.epa.gov/oppfead1/guidance/comment.htm and follow the directions for online submissions);
— by e-mail, at [email protected] (Attention Docket ID No. OPPOPP-2003-0132);
— by mail, Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs, U.S. Environmental Protection Agency, Mail Code: 7502C, 1200 Pennsylvania Ave., NW, Washington, DC, 20460-0001, Attention: Docket ID Number OPP-2003-0132.
The Environmental Protection Agency has released a draft of its proposed rule limiting the use of intentional dosing research on human subjects.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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