Thursday, November 17, 2005

EPA proposes rule that would allow pesticide testing on pregnant women, mentally handicapped children and orphaned children

What's the title of the proposed rule, you ask? Amazingly, it is "Protections for Subjects in Human Research"! [emphasis added] The first paragraph of the proposed rule's summary is below. It indicates that this rule would ban testing when the human subjects are pregnant women or children, but towards the end of the 30 page rule those protections are reversed. See the excerpts below.

SUMMARY: EPA proposes and invites public comment on a rulemaking to ban intentional dosing human testing for pesticides when the subjects are pregnant women or children, to formalize and further strengthen existing protections for subjects in human research conducted or supported by EPA, and to extend new protections to adult subjects in intentional dosing human studies for pesticides conducted by others who intend to submit the research to EPA.

Page 53857: "EPA proposes an extraordinary procedure applicable if scientifically sound but ethically deficient (read: morally wrong) human research is found to be crucial to EPA’s fulfilling its mission to protect public health. This procedure would also apply if a scientifically sound study covered by proposed § 26.221 or § 26.421--i.e., an intentional dosing study involving pregnant women or children as subjects--were found to be crucial to the protection of public health."

Page 53865: "The IRB (Independent Review Board) shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent...If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement..."

Send a letter to the EPA prior to the end of the 12/12/05 commenting window.


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