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principessa
RealPoor Guru
Joined: 11 Oct 2002
Posts: 3149
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 Posted: 12/02/05 - 22:48 Post subject: EPA Looking to allow testing on orphans and handicapped kids
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EPA
They truly must be kidding 
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Booker
RealPoor Guru
Joined: 12 Oct 2002
Posts: 2562
Location: Corvallis, Oregon
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Posted: 12/02/05 - 22:57 Post subject:
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uhh. i searched that document, did not find the word "handicapped" or "orphan" a single time.
the quoted phrase they use "cannot be reasonably consulted" isnt in it either.
*/ponder*
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principessa
RealPoor Guru
Joined: 11 Oct 2002
Posts: 3149
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Posted: 12/02/05 - 23:08 Post subject:
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I can' t even get EPA's site to load atm, but it does look like the OCA's interpretation of the proposed rule.
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Soriak
Toomuchtimeonhands
Joined: 11 Oct 2002
Posts: 952
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Posted: 12/03/05 - 03:21 Post subject:
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Here's a section that addresses part of the OCA's issue - sounds different in the proper context.
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Sec. 26.405 Research involving greater than minimal risk but
presenting the prospect of direct benefit to the individual subjects.
EPA will conduct or fund research in which the IRB finds that more
than minimal risk to children is presented by an intervention or
procedure that holds out the prospect of direct benefit for the
individual subject, or by a monitoring procedure that is likely to
contribute to the subject's well-being, only if the IRB finds and
documents that:
(a) The risk is justified by the anticipated benefit to the subjects.
(b) The relation of the anticipated benefit to the risk is at least
as favorable to the subjects as that presented by available alternative
approaches.
(c) Adequate provisions are made for soliciting the assent of the
children and permission of their parents or guardians, as set forth in
Sec. 26.408.
Sec. 26.406 [Reserved]
Sec. 26.407 [Reserved]
Sec. 26.408 Requirements for permission by parents or guardians and
for assent by children.
(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.
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I don't see anything shocking about it. It gives children in critical medical conditions access to experimental drugs, even though they themselves can't consent to it.
It's also reasonable not to require parental consent, if that parent has neglected the kid in the past. Chances are, they don't care too much.
Those drugs are already available to adults who consent to it and (like any drug) had to pass stages of clinical trials just to get to that point. No one is playing Dr. Mengele here - not that a WW2 reference isn't good to fire up people...
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