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Friday, November 18, 2005 


The audacity of this one is shocking. Even to me.


Follow the above link to the OCA's website. They've found some reprehensible things that are trying to be passed in a rule by the EPA. It's criminal.

I'm going to put the sub-rules that I am talking about in this blog, just incase there are any ultra-short attention spans floating by. These are straight from the EPA's website. Here is the entire rule in PDF or HTML format.

Let's get started.

70 FR 53865 26.408(a) "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..."

The language used here is seemingly Orwellian. Consulted and assent? Give me a break.

Not to mention the rest of this rule is just flat out absurd.

70 FR 53865 26.408(c) "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..."

So, let me get this straight, the EPA wants a broad-sweeping power to test who knows what on wards of the state under circumstances that may or may not be extreme? And if said child is in state custody for being abused or neglected, they might not need permission to conduct experiments?

70 FR 53864 26.401 (a)(2) "To What Do These Regulations Apply? It also includes research conducted or supported by EPA outside the United States, but in appropriate circumstances, the Administrator may, under § 26.101(e), waive the applicability of some or all of the requirements of these regulations for research..."

I'll quote the OCA on this one. "This clause is stating that the Administrator of the EPA has the power to completely waive regulations on human testing, if the testing is done outside of the U.S. This will allow chemical companies to do human testing in other countries where these types of laws are less strict. This loophole in the rule must be completely removed."

70 FR 53857 "EPA proposes an extraordinary procedure applicable if scientifically sound but ethically deficient 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..."

The first three sub-rules really got my ire going but this one, oh boy, this one is a piece of work. Again with the Owellian language used. "Ethically deficient human research" being used in mission critical circumstances? Keep in mind there is no regulation on what a mission criticial circumstance might entail for the EPA here.

The juxtaposition for these extreme open ended go-aheads, in what is an otherwise benign document for protecting research subjects, is sickening. They're just packed in there nice and neat, hoping no one will notice. Major kudos to the folks at the OCA for discovering these. I've written the EPA, expressing my concerns in a rather unpleasant manner. I urge everyone to do the same when they have a moment.

To openly try to pass this under the noses of the citizenry really ticks me off. It's one thing to go behind our backs with things like this, because we'd probably never know about them. Lots of people are always carrying on about "How can we make a difference?" or "Even if we speak up, it wouldn't be loud enough for anyone to care." Well, here is a great opportunity to let the goverment know that we're wise to them and refuse to idly stand by while this sort of injustice to humanity is allowed to proceed any further.

Click here to let the EPA know how you feel. Sign the OCA's petition and your voice will be heard.

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