1. Children who "cannot be reasonably consulted," such as those that are mentally handicapped or orphaned newborns, may be tested on. With permission from the institution or guardian in charge of the individual, the child may be exposed to chemicals for the sake of research.The actual text of the EPA regulation, which when published in the Federal Register, becomes Federal Law (emphasis added):
2. Parental consent forms are not necessary for testing on children who have been neglected or abused.
3. Chemical studies on any children outside of the U.S. are acceptable.
Sec. 26.408 Requirements for permission by parents or guardians and for assent by children.posted by orthogonality at 11:29 PM on January 23, 2006
(a) In addition to the determinations required under other applicable sections of this subpart, the IRB 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. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, 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 under circumstances in which consent may be waived in accord with Sec. 26.116(d).
(b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by Sec. 26.116, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under Sec. 26.404 or Sec. 26.405.
(c) In addition to the provisions for waiver contained in Sec. 26.116, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, State or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.
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. This proposal, the first of several possible Agency actions, focuses on third-party intentional dosing human studies for pesticides, but invites public comment on alternative approaches with broader scope.So by "testing pesticides on pregnant women and children" you meant "would ban testing of pesticides on pregnant women and children."
[...]
With respect to human research conducted by EPA (``first-party research'), or by others with EPA's support (``second-party research'), this proposed rule would: (1) Categorically prohibit any intentional dosing studies involving pregnant women or children as subjects; and (2) adopt the Department of Health and Human Services (HHS) regulations that provide additional protections to pregnant women and children as subjects of other than intentional dosing studies.
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posted by troutfishing at 8:21 PM on January 23, 2006