This subpart applies to all research involving children as
November 21, 2005 6:49 AM Subscribe
Who needs bunnies when you have kids to test on? "Protections for Subjects in Human Research," a newly proposed EPA rule allows for: for government and industry scientists to treat children as human guinea pigs in chemical experiments in the following situations:
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.
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. And don't miss the Q&A section below. Sec. 26.408 of the EPA document is where you'll find the provisions and waivers mentioned (it refers to other sections absent from the document, weirdly).
Quoting out of context. How about this section?
Sec. 26.420 Prohibition of research involving intentional dosing of
children.
Notwithstanding any other provision of this part, under no
circumstances shall EPA or a person when covered by Sec. 26.101(j)
conduct or support research involving intentional dosing of any child.
I think that the referenced websitee is making stuff up by selective quoting.
posted by GuyZero at 7:05 AM on November 21, 2005
Sec. 26.420 Prohibition of research involving intentional dosing of
children.
Notwithstanding any other provision of this part, under no
circumstances shall EPA or a person when covered by Sec. 26.101(j)
conduct or support research involving intentional dosing of any child.
I think that the referenced websitee is making stuff up by selective quoting.
posted by GuyZero at 7:05 AM on November 21, 2005
I'm surprised they would ask the children for assent at all.
posted by smackfu at 7:05 AM on November 21, 2005
posted by smackfu at 7:05 AM on November 21, 2005
Maybe I'm totally misreading the proposal, but it seems that this is intended to strengthen the existing "common rule" on human testing.
From the first paragraph:
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.
From section VI, Additional Protections for Children:
EPA has never conducted or supported intentional dosing studies with children, but EPA has both conducted and sponsored observational studies in which some of the subjects were children. None of these studies have involved intentional dosing. They were observational studies that did not alter the children's exposure to substances routinely experienced in their community.
posted by justkevin at 7:08 AM on November 21, 2005
From the first paragraph:
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.
From section VI, Additional Protections for Children:
EPA has never conducted or supported intentional dosing studies with children, but EPA has both conducted and sponsored observational studies in which some of the subjects were children. None of these studies have involved intentional dosing. They were observational studies that did not alter the children's exposure to substances routinely experienced in their community.
posted by justkevin at 7:08 AM on November 21, 2005
After 30 minutes of reading that EPA link, I'm with GuyZero. I call shenanigans.
posted by chuma at 7:11 AM on November 21, 2005
posted by chuma at 7:11 AM on November 21, 2005
It's the waiver parts that lay out the exceptions. I read that proposal as along the lines of the "Healthy Forests" thing and other misnamed govt. proposals and policy changes. They explicitly speak of the value to be derived from human testing, and lay out the waivers in clear language.
and this: Sec. 26.421: In its regulatory decision-making under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), EPA shall not rely on any research involving intentional dosing of any child, except when such research is deemed scientifically sound and crucial to the protection of public health, under the procedure defined in Sec. 26.603. (there are a bunch of those "excepts" in there)
posted by amberglow at 7:12 AM on November 21, 2005
and this: Sec. 26.421: In its regulatory decision-making under the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) or section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a), EPA shall not rely on any research involving intentional dosing of any child, except when such research is deemed scientifically sound and crucial to the protection of public health, under the procedure defined in Sec. 26.603. (there are a bunch of those "excepts" in there)
posted by amberglow at 7:12 AM on November 21, 2005
From the EPA doc:
"...this proposed rule would: (1) Categorically prohibit any intentional dosing studies involving pregnant women or children as subjects."
Unless "categorically prohibit" means "allow," I don't follow at all, how this states that human guinea pigs are now ok? Am I missing something?
posted by tpl1212 at 7:14 AM on November 21, 2005
"...this proposed rule would: (1) Categorically prohibit any intentional dosing studies involving pregnant women or children as subjects."
Unless "categorically prohibit" means "allow," I don't follow at all, how this states that human guinea pigs are now ok? Am I missing something?
posted by tpl1212 at 7:14 AM on November 21, 2005
and 26.408 completely says something different from 26.420.
posted by amberglow at 7:15 AM on November 21, 2005
posted by amberglow at 7:15 AM on November 21, 2005
This sounds too outrageous to be true.
At least, god I hope so.
If not then the US has undoubedly and without abandon become an evil society.
posted by djeo at 7:17 AM on November 21, 2005
At least, god I hope so.
If not then the US has undoubedly and without abandon become an evil society.
posted by djeo at 7:17 AM on November 21, 2005
You can't categorically prohibit something and allow for waivers at the same time.
From June: Some government-funded researchers who tested AIDS drugs on foster children over the past two decades violated federal rules designed to protect vulnerable youths, U.S. investigators have concluded. ...
posted by amberglow at 7:20 AM on November 21, 2005
From June: Some government-funded researchers who tested AIDS drugs on foster children over the past two decades violated federal rules designed to protect vulnerable youths, U.S. investigators have concluded. ...
posted by amberglow at 7:20 AM on November 21, 2005
If not then the US has undoubedly and without abandon become an evil society.
You mean this hasn't happened already? If all of this 'lets test on children' stuff is true, then I think it's just one more thing to add to the list of stuff that makes the US evil.
posted by chunking express at 7:21 AM on November 21, 2005
You mean this hasn't happened already? If all of this 'lets test on children' stuff is true, then I think it's just one more thing to add to the list of stuff that makes the US evil.
posted by chunking express at 7:21 AM on November 21, 2005
"cannot be reasonably consulted,"
Where does this quotation come from? I can't find it in the EPA document.
posted by biffa at 7:21 AM on November 21, 2005
Where does this quotation come from? I can't find it in the EPA document.
posted by biffa at 7:21 AM on November 21, 2005
I can think of one kid I would suggest for testing, it would probably just cost some chocolate milk.
posted by stifford at 7:25 AM on November 21, 2005
posted by stifford at 7:25 AM on November 21, 2005
26.420 says that the EPA won't "conuct or support research" that doese children directly. 26.421 says they won't rely on such research, except where necessary. "Relying" on research is different (I assume) from "conducting" research; I would assume that if there was some circumstance where (say) Australia conducted tests directly on children, the EPA would not rely on such research excpt if there was some pressing reason to do so, but they'd never conduct such research directly under any circumstances. But IANAL.
Also, children have to be given permission to participate in observational studies - this is how I read the sections on "abused children": that they can be observed even without permission. But they'd never be dosed.
This is a complex, confusing document that uses highly legalistic language. I don't claim to be able to interpret it correctly and I doubt the author of the linked article is any more qualified than I am.
posted by GuyZero at 7:27 AM on November 21, 2005
Also, children have to be given permission to participate in observational studies - this is how I read the sections on "abused children": that they can be observed even without permission. But they'd never be dosed.
This is a complex, confusing document that uses highly legalistic language. I don't claim to be able to interpret it correctly and I doubt the author of the linked article is any more qualified than I am.
posted by GuyZero at 7:27 AM on November 21, 2005
Biffa:
It's from 26.408, the quote spans a line so doesn't show up in a search.
posted by justkevin at 7:30 AM on November 21, 2005
It's from 26.408, the quote spans a line so doesn't show up in a search.
posted by justkevin at 7:30 AM on November 21, 2005
it's in part A of 26.408: 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.
posted by amberglow at 7:30 AM on November 21, 2005
posted by amberglow at 7:30 AM on November 21, 2005
Here's an SFGate article that addresses some of the issues that insiders are evidently upset about.
posted by taz at 7:33 AM on November 21, 2005
posted by taz at 7:33 AM on November 21, 2005
I guess my main question after reading the admittedly confusing document is: Would this proposal do more harm than good? I can't seem to find any case where it would actually weaken existing regulations, but I wouldn't say it doesn't. Will this allow any kind of testing that is not currently allowed?
posted by justkevin at 7:34 AM on November 21, 2005
posted by justkevin at 7:34 AM on November 21, 2005
Not hard to figure out.
Section 26.408 basically boils down to "Ask the relevant decision-maker for the child for consent. Usually that will be the parents, but in some circumstances it will be some other guardian of the child's interests. For that matter, ask the kid for consent too where that's reasonable."
Section 26.420 says that EPA won't conduct or support research that involves dosing kids or pregnant women with pesticide, ever, even if something else in the rules somewhere might make it seem permissible if you squint at it.
Section 26.421 says that EPA won't even pay attention to those intentional-dosing studies that have already been done when it's making regulations, unless that really is a vital source of important information.
posted by ROU_Xenophobe at 7:36 AM on November 21, 2005
Section 26.408 basically boils down to "Ask the relevant decision-maker for the child for consent. Usually that will be the parents, but in some circumstances it will be some other guardian of the child's interests. For that matter, ask the kid for consent too where that's reasonable."
Section 26.420 says that EPA won't conduct or support research that involves dosing kids or pregnant women with pesticide, ever, even if something else in the rules somewhere might make it seem permissible if you squint at it.
Section 26.421 says that EPA won't even pay attention to those intentional-dosing studies that have already been done when it's making regulations, unless that really is a vital source of important information.
posted by ROU_Xenophobe at 7:36 AM on November 21, 2005
It seems that the word "intentional" is the dancing area.
posted by taz at 7:41 AM on November 21, 2005
posted by taz at 7:41 AM on November 21, 2005
Why is the "cannot be reasonably consulted" shocking? If you're doing an observational study of blood levels of pesticide in infants near farms, you can't ask infants for consent, because they, you know, can't talk. Instead, you ask the parents for permission to draw blood, or you ask the relevant guardians if the parents are out of the picture.
posted by ROU_Xenophobe at 7:42 AM on November 21, 2005
posted by ROU_Xenophobe at 7:42 AM on November 21, 2005
Since the EPA has been made toothless, what does it honestly matter what research it collects on the effects of treating children with pesticides? The EPA can't won't do anything about it anyway.
posted by Rothko at 7:42 AM on November 21, 2005
posted by Rothko at 7:42 AM on November 21, 2005
I don't think it says that, ROU. It allows for waivers and exceptions and determination of the importance of the study.
It will fund intentional dosing of children if they fall under those waivers and someone gives permission (see the AIDS drugs/orphans thing--that was funded and permission was granted by the city, something that will continue to happen)
posted by amberglow at 7:48 AM on November 21, 2005
It will fund intentional dosing of children if they fall under those waivers and someone gives permission (see the AIDS drugs/orphans thing--that was funded and permission was granted by the city, something that will continue to happen)
posted by amberglow at 7:48 AM on November 21, 2005
taz: yeah. If they're just asking families who use pesticide anyway for permission to observe their kids, it's not like the kids would receive any additional dosing. The fear is that a family who doesn't use bug bombs in the house might start using them to get into the study.
Which seems a bad study design. Ask people to behave normally, using bug bombs as they usually do, but to document their use. Then you have a useful control in those families that don't use pesticides, but live in an environment where other families do.
posted by ROU_Xenophobe at 7:48 AM on November 21, 2005
Which seems a bad study design. Ask people to behave normally, using bug bombs as they usually do, but to document their use. Then you have a useful control in those families that don't use pesticides, but live in an environment where other families do.
posted by ROU_Xenophobe at 7:48 AM on November 21, 2005
"Notwithstanding any other provision of this part, under no circumstances shall EPA or a person when covered by Sec. 26.101(j) conduct or support research involving intentional dosing of any child."
What that says is that you have to read the waivers to disallow dosing studies, not that dosing studies might be allowed by the waivers. This seems a pretty normal formulation. Here are some general rules. Here are some grounds for exceptions or waivers. Here is an uber-rule saying "No exceptions or waivers for this, even if it looks to you like the waivers section says there is one."
The AIDS study didn't follow the rules, so that's hardly relevant to a question of what the rules ought to be. But very relevant to a question of how you get researchers to actually abide by the rules in a more-than-lawyerly fashion.
posted by ROU_Xenophobe at 8:00 AM on November 21, 2005
What that says is that you have to read the waivers to disallow dosing studies, not that dosing studies might be allowed by the waivers. This seems a pretty normal formulation. Here are some general rules. Here are some grounds for exceptions or waivers. Here is an uber-rule saying "No exceptions or waivers for this, even if it looks to you like the waivers section says there is one."
The AIDS study didn't follow the rules, so that's hardly relevant to a question of what the rules ought to be. But very relevant to a question of how you get researchers to actually abide by the rules in a more-than-lawyerly fashion.
posted by ROU_Xenophobe at 8:00 AM on November 21, 2005
related? In its first restructuring under Administrator Stephen Johnson, the U.S. Environmental Protection Agency is creating a new “national security and intelligence” operation, according to an agency email released today by Public Employees for Environmental Responsibility (PEER). At the same time, EPA would eliminate the Office of Children’s Health Protection and bury its function inside an environmental education bureau. ... (11/3/05)
posted by amberglow at 8:01 AM on November 21, 2005
posted by amberglow at 8:01 AM on November 21, 2005
from that link: Johnson’s own role in childhood health issues was brought into stark relief during his confirmation hearings over his advocacy of using children in pesticide dosing experiments. Although Johnson cancelled one controversial study (with the anomalous acronym of CHEERS) in which parents were to be paid to spray pesticides in the room primarily occupied by their infant children, he did so in the face of threats by Democratic senators to block his confirmation. Since then, Johnson has heatedly defended CHEERS and is pushing a plan to allow children to be used in other chemical dosing experiments.
posted by amberglow at 8:02 AM on November 21, 2005
posted by amberglow at 8:02 AM on November 21, 2005
(Intervention, Mar. 05) EPA Nominee Advocates Human Guinea Pigs ... During President Bush’s first term, Johnson was a strong supporter of pesticide testing on humans. ...
posted by amberglow at 8:08 AM on November 21, 2005
posted by amberglow at 8:08 AM on November 21, 2005
amberglow, creepy, yes, but not allowed by the EPA guidelines doc under discussion. If he tries to change it, uncool.
It's odd how so many US federal agencies seem to get headed up by absolute idiots. Well, maybe it's just the idiots that make the news.
posted by GuyZero at 8:09 AM on November 21, 2005
It's odd how so many US federal agencies seem to get headed up by absolute idiots. Well, maybe it's just the idiots that make the news.
posted by GuyZero at 8:09 AM on November 21, 2005
All you need are idiots in the electorate.
Then idiots in the counties.
Then idiots as governors.
Then an idiot as a congressman.
You see where I'm going. If you don't, hard cheese.
posted by malusmoriendumest at 8:22 AM on November 21, 2005
Then idiots in the counties.
Then idiots as governors.
Then an idiot as a congressman.
You see where I'm going. If you don't, hard cheese.
posted by malusmoriendumest at 8:22 AM on November 21, 2005
Fortunately if anyone were to try using children as guinea pigs using this policy as a blanket they would soon learn that the EPA has limited regulatory jurisdiction. If the EPA claims something is permissible by its own policies that same behavior could still be illegal by other statutes outside of EPA jurisdiction.
posted by StarForce5 at 8:55 AM on November 21, 2005
posted by StarForce5 at 8:55 AM on November 21, 2005
What ROU_Xenophobe said; he read it correctly and explicated the provision properly. This is pretty easy to read... assuming you take the time to do it and understand the broader legislation. Taking selected provisions out of context will result in mistakes.
This "interpretation" in the FPP reminds me of the morons who said the Texas Constitutional amendment might ban all marriage in Texas... unqualified people opining on statutory interpretation without understanding how to interpret statutes. Taking a sentence out of the broader context is Mistake #1 in statutory interpretation, and will more times than not, lead to the opposite conclusion of what the law actually says. We had another FPP like this were some outraged poster made some post about a closed door super secret piece of legislation having to do with the Canadian boarder... only to find out that the clause explicitly rejected the bozo's interpretation.
Read the provisions as a whole, understand what the point of the statute is, and it makes it easier to parse out the words and clauses.
posted by dios at 9:07 AM on November 21, 2005
This "interpretation" in the FPP reminds me of the morons who said the Texas Constitutional amendment might ban all marriage in Texas... unqualified people opining on statutory interpretation without understanding how to interpret statutes. Taking a sentence out of the broader context is Mistake #1 in statutory interpretation, and will more times than not, lead to the opposite conclusion of what the law actually says. We had another FPP like this were some outraged poster made some post about a closed door super secret piece of legislation having to do with the Canadian boarder... only to find out that the clause explicitly rejected the bozo's interpretation.
Read the provisions as a whole, understand what the point of the statute is, and it makes it easier to parse out the words and clauses.
posted by dios at 9:07 AM on November 21, 2005
Also good piece of advice: don't rely on single issue interest groups to interpret the meaning of technical statutes that effect that single interest. It is easy to offer a ridiculously slanted view of the statute to drum up opposition.
posted by dios at 9:10 AM on November 21, 2005
posted by dios at 9:10 AM on November 21, 2005
You have to love the note on this oranizations front page right under their "alert" that says something to the effect "the snopes debunking of our last alert doesn't have anything to do with this alert. And snopes is biased."
posted by dios at 9:12 AM on November 21, 2005
posted by dios at 9:12 AM on November 21, 2005
Tempest in a teacup.
The only possible "controversy" that could be manufactured here is that inadvertent dosing (through accident, environmental exposure, etc.) could now be a desirable outcome for affected children thanks to 26.420. And even that's grasping at straws to find a "controversy."
Folks should be more worried about the current pharmaceutical shield laws for vaccines.
posted by FormlessOne at 9:59 AM on November 21, 2005
The only possible "controversy" that could be manufactured here is that inadvertent dosing (through accident, environmental exposure, etc.) could now be a desirable outcome for affected children thanks to 26.420. And even that's grasping at straws to find a "controversy."
Folks should be more worried about the current pharmaceutical shield laws for vaccines.
posted by FormlessOne at 9:59 AM on November 21, 2005
Aww. And here I was thinking the PETA guys finally got what they wanted.
Taking selected provisions out of context will result in mistakes.
Hey, there's no time for context when there's Righteous Outrage to be had!
posted by darukaru at 11:08 AM on November 21, 2005
Taking selected provisions out of context will result in mistakes.
Hey, there's no time for context when there's Righteous Outrage to be had!
posted by darukaru at 11:08 AM on November 21, 2005
Taking selected provisions out of context will result in mistakes.
Naming policies and rule changes one thing when they in fact result in the exact opposite is a specialty of the current government.
Allowing any exemptions and waivers when you repeatedly call for "categorical prohibition" renders any categorical prohibition null and void. The EPA was involved in the AIDS drugs to orphans horror here in NYC--show me where they prohibit intentionally giving children experimental and unapproved drugs. Talking about pesticides alone is not the whole story, especially given the head's explicit interest in human testing.
posted by amberglow at 11:24 AM on November 21, 2005
Naming policies and rule changes one thing when they in fact result in the exact opposite is a specialty of the current government.
Allowing any exemptions and waivers when you repeatedly call for "categorical prohibition" renders any categorical prohibition null and void. The EPA was involved in the AIDS drugs to orphans horror here in NYC--show me where they prohibit intentionally giving children experimental and unapproved drugs. Talking about pesticides alone is not the whole story, especially given the head's explicit interest in human testing.
posted by amberglow at 11:24 AM on November 21, 2005
The EPA was involved in the AIDS drugs to orphans horror here in NYC--show me where they prohibit intentionally giving children experimental and unapproved drugs.
Well, testing like that wouldn't be under the EPA anyway, that's the FDA. And there's a brief description of the process of children's consent here.
Young children aren't allowed to consent because they are considered too easily manipulated. But the fear there is that they would agree to testing, not that they would refuse it. And informed consent is always required from their guardian.
If you can convince an Institution Review Board that a drug specifically needs to be tested in children, you're only allowed to do so after a Phase I trial in adults.
posted by iron chef morimoto at 12:55 PM on November 21, 2005
Well, testing like that wouldn't be under the EPA anyway, that's the FDA. And there's a brief description of the process of children's consent here.
Young children aren't allowed to consent because they are considered too easily manipulated. But the fear there is that they would agree to testing, not that they would refuse it. And informed consent is always required from their guardian.
If you can convince an Institution Review Board that a drug specifically needs to be tested in children, you're only allowed to do so after a Phase I trial in adults.
posted by iron chef morimoto at 12:55 PM on November 21, 2005
I responded too quickly. I didn't notice that you had already mentioned IRB's. The FDA was involved in the AIDS drug testing you mentioned, and they have much more stringent guidelines than the EPA (the EPA has been involved in very stupid things).
posted by iron chef morimoto at 1:13 PM on November 21, 2005
posted by iron chef morimoto at 1:13 PM on November 21, 2005
Also:
the AIDS drugs to orphans horror here in NYC
I don't think it's a "horror" to give children an experimental drug when they have a fatal disease with no available treatment (which was the case with AIDS in the '80's). In fact, I'm in favor of it, since the alternative was doing nothing while they slowly die. The issue was getting the kids a proper legal advocate when they don't have a guardian.
posted by iron chef morimoto at 1:23 PM on November 21, 2005
the AIDS drugs to orphans horror here in NYC
I don't think it's a "horror" to give children an experimental drug when they have a fatal disease with no available treatment (which was the case with AIDS in the '80's). In fact, I'm in favor of it, since the alternative was doing nothing while they slowly die. The issue was getting the kids a proper legal advocate when they don't have a guardian.
posted by iron chef morimoto at 1:23 PM on November 21, 2005
The AIDS drug issue is completely irrelevant. This piece of legislation allows only studies performed on children who have already or are currently being exposed to these chemicals through indirect means. Such as: the exposure of children on a farm to pesticides used regularly ON THE CROPS. Not the kids. Are you suggesting we shouldn't study the effects of these pesticides on children who are, as a part of everyday life, exposed to these chemicals?
Just to run these tests, which parents who are aware of such proximity should embrace wholeheartedly, requires parental permission except in cases (the child abuse clause) a child has been removed from the home and there is suspicion that they've been exposed to aforementioned chemicals.
You get the idea.
posted by IronLizard at 3:20 PM on November 21, 2005
Just to run these tests, which parents who are aware of such proximity should embrace wholeheartedly, requires parental permission except in cases (the child abuse clause) a child has been removed from the home and there is suspicion that they've been exposed to aforementioned chemicals.
You get the idea.
posted by IronLizard at 3:20 PM on November 21, 2005
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posted by jsavimbi at 6:54 AM on November 21, 2005