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Informed Consent bites the dust.
Topic Started: Jun 8 2006, 09:01 AM (233 Views)
Jolly
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Geaux Tigers!
Do with the patient what you will....

http://seattlepi.nwsource.com/health/1500A...ed_Consent.html
The main obstacle to a stable and just world order is the United States.- George Soros
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Axtremus
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HOLY CARP!!!
Jolly,

Do you yourself have an opinion on this?
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Jolly
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Geaux Tigers!
I've got an opinion on just about everything. :biggrin:

Informed or Expressed Consent is a cornerstone of modern medicine. The patient has the right of refusal, except in instances of extreme detriment to public health.

The $64 question is where do we place the tripwire?
The main obstacle to a stable and just world order is the United States.- George Soros
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Steve Miller
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Bull-Carp
The'ye talking about running blood tests on blood already obtained, right?

Or am I missing something?
Wag more
Bark less
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DivaDeb
HOLY CARP!!!
I can't be judicious on this one. Too much Michael Palmer, Michael Crichton and Robin Cook.
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Jolly
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Geaux Tigers!
Steve Miller
Jun 8 2006, 11:17 AM
The'ye talking about running blood tests on blood already obtained, right?

Or am I missing something?

No.

If the health provider suspects you of having been exposed to a harmful agent, they can take your blood and perform tests without your permission.

The easy way or the hard way...
The main obstacle to a stable and just world order is the United States.- George Soros
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QuirtEvans
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I Owe It All To John D'Oh
Quote:
 
The rule lays out a scenario where a laboratory discovers what appears to be an unusual bug in a sample taken from a patient before a public health emergency was even suspected. With the apparent bug in the lab but the patient gone, going back for permission to use a confirmatory but experimental test - often the only type of test available - would introduce "unacceptable delays," the FDA said.


That example, from the article (and apparently from the rule), does not involve forced acquisition of a blood sample. It's pretty explicit that they are talking about a situation where the blood sample was already taken, but the patient is no longer on the premises.

Now, since I haven't read the rule itself, I can't say whether the rule extends beyond this example.

Have you read the rule itself, Jolly?
It would be unwise to underestimate what large groups of ill-informed people acting together can achieve. -- John D'Oh, January 14, 2010.
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Axtremus
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HOLY CARP!!!
It's still in the "public comment" period, right?
Where are the rules published?
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Jolly
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QuirtEvans
Jun 8 2006, 11:34 AM
Quote:
 
The rule lays out a scenario where a laboratory discovers what appears to be an unusual bug in a sample taken from a patient before a public health emergency was even suspected. With the apparent bug in the lab but the patient gone, going back for permission to use a confirmatory but experimental test - often the only type of test available - would introduce "unacceptable delays," the FDA said.


That example, from the article (and apparently from the rule), does not involve forced acquisition of a blood sample. It's pretty explicit that they are talking about a situation where the blood sample was already taken, but the patient is no longer on the premises.

Now, since I haven't read the rule itself, I can't say whether the rule extends beyond this example.

Have you read the rule itself, Jolly?

I've not read the rule, but your assumption about "add-on" testing is not quite correct. It's pretty common for a doctor to call the guys down in the lab, and add on tests to samples already obtained during treatment of the patient.

I read this more in the realm of public health...say the guys in the lab get a positive syphilis test on Mary Doe and they kick it over to PH. A VD Chaser runs Mary to ground and obtains all sexual contacts for the last X number of days. They in turn trace down her contacts, and these people are coming in for testing and treatment if needed.

They can go voluntarily, or the State Police will be happy to "cuff 'em, and bounce their butts into the back of a squad car.

But you are going, one way, or another.

EDIT - Unless this delves off into the FDA stuff, where any nonapproved test is considered more of a clinical trial...but why the emergent Public Health citation?
The main obstacle to a stable and just world order is the United States.- George Soros
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Mark
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HOLY CARP!!!
The feds are out of control people!

___.___
(_]===*
o 0
When I see an adult on a bicycle, I do not despair for the future of the human race. H.G. Wells
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ivorythumper
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I am so adjective that I verb nouns!
Hey, it worked for the Tuskegee Experiment-- one of the darling medical advances under utilitarian social policy that taught us so much about syphilis-- so what's the problem?
The dogma lives loudly within me.
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QuirtEvans
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I Owe It All To John D'Oh
Based solely on the news story, and the example it used, nothing more, you're misreading the rule, Jolly. I suppose it's possible that the rule does what you worry it does, but I don't think so, and that example is quite to the contrary. They make it pretty clear that they are testing the existing sample rather than waiting for the patient to be found and contacted. That, it seems to me, strikes the right public health balance.

If they were tracking people down and dragging them in and poking them without consent, I'd analyze it very differently, but I don't see evidence of that here.

Again, if you have information beyond the story, that would be interesting, but the story itself does not support that analysis.
It would be unwise to underestimate what large groups of ill-informed people acting together can achieve. -- John D'Oh, January 14, 2010.
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Nina
Senior Carp
This is an interesting case. They're not talking about experimental procedures, as far as I can tell. They're talking about experimental tests.

Yet in a worldwide epidemic, a bioterror attack, whatever, would you really want to limit yourself to only tests that have undergone full FDA review and approval, which can take years?

If you're in a car accident and unable to give informed consent, you will still get life saving medical treatment.

For me, the question would be how "life-threatening emergency" is defined. I'd also like to see a limit on the types of samples that could be taken without my permission. I mean, harvesting eggs is technically taking a sample.

If it were carefully written, I'm not 100% positive I'd oppose it. I'd need to know more.
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ivorythumper
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I am so adjective that I verb nouns!
Nina
Jun 8 2006, 12:56 PM
This is an interesting case.  They're not talking about experimental procedures, as far as I can tell.  They're talking about experimental tests.

I think this is a key point, Nina.
Quote:
 
Health care workers will be free to run experimental tests on blood and other samples taken from people who have fallen sick as a result of a bioterrorist attack, bird flu outbreak, detonation of a dirty bomb or any other life-threatening public health emergency, according to the rule issued by the Food and Drug Administration.

In all other cases, the use of an experimental test still requires the informed consent of a patient, as well as the review and approval of an outside panel.


We are not discussing experimental procedures. It seems that one the patient has agreed to treatment and say, had blood drawn, there is no serious ethical question about how that blood will be analyzed. Although this sort of ethic is regularly invoked on "House" which is where I get my most authoritative information. :wink:
The dogma lives loudly within me.
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Jolly
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Geaux Tigers!
ivorythumper
Jun 8 2006, 02:06 PM
Nina
Jun 8 2006, 12:56 PM
This is an interesting case.  They're not talking about experimental procedures, as far as I can tell.  They're talking about experimental tests.

I think this is a key point, Nina.
Quote:
 
Health care workers will be free to run experimental tests on blood and other samples taken from people who have fallen sick as a result of a bioterrorist attack, bird flu outbreak, detonation of a dirty bomb or any other life-threatening public health emergency, according to the rule issued by the Food and Drug Administration.

In all other cases, the use of an experimental test still requires the informed consent of a patient, as well as the review and approval of an outside panel.


We are not discussing experimental procedures. It seems that one the patient has agreed to treatment and say, had blood drawn, there is no serious ethical question about how that blood will be analyzed. Although this sort of ethic is regularly invoked on "House" which is where I get my most authoritative information. :wink:

Would you care to have your blood routinely screened for HIV? A lot of states require written consent to do so.

Or maybe once we get your blood, we decide to run a DOA panel for chuckles and grins...always nice to have on your medical record that positive result for THC, even if not from a NIDA lab.

Here's what I don't understand...in experimental tests, or FDA non-approved tests, there may be a problem with reimbursement, but if a patient agrees to medical treatment and the physician writes the order, a lab will do pretty much whatever they can do - no questions asked. Even the most esoteric of tests.

In a public health emergency - which is what they are referencing - why worry about informed consent?

The main obstacle to a stable and just world order is the United States.- George Soros
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ivorythumper
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I am so adjective that I verb nouns!
Jolly
Jun 8 2006, 02:15 PM
ivorythumper
Jun 8 2006, 02:06 PM
Nina
Jun 8 2006, 12:56 PM
This is an interesting case.  They're not talking about experimental procedures, as far as I can tell.  They're talking about experimental tests.

I think this is a key point, Nina.
Quote:
 
Health care workers will be free to run experimental tests on blood and other samples taken from people who have fallen sick as a result of a bioterrorist attack, bird flu outbreak, detonation of a dirty bomb or any other life-threatening public health emergency, according to the rule issued by the Food and Drug Administration.

In all other cases, the use of an experimental test still requires the informed consent of a patient, as well as the review and approval of an outside panel.


We are not discussing experimental procedures. It seems that one the patient has agreed to treatment and say, had blood drawn, there is no serious ethical question about how that blood will be analyzed. Although this sort of ethic is regularly invoked on "House" which is where I get my most authoritative information. :wink:

Would you care to have your blood routinely screened for HIV? A lot of states require written consent to do so.

Or maybe once we get your blood, we decide to run a DOA panel for chuckles and grins...always nice to have on your medical record that positive result for THC, even if not from a NIDA lab.

Here's what I don't understand...in experimental tests, or FDA non-approved tests, there may be a problem with reimbursement, but if a patient agrees to medical treatment and the physician writes the order, a lab will do pretty much whatever they can do - no questions asked. Even the most esoteric of tests.

In a public health emergency - which is what they are referencing - why worry about informed consent?

I agree with you that patients' rights to privacy are at stake. The question of how my blood could be routinely screened for HIV without my presenting myself for treatment (or perhaps life insurance, etc) is unclear to me. Would drug testing be a reasonable thing diagnostically? Is it necessary for me to be informed as to all the tests if my blood is being drawn diagnostically in order to determine what the cause is of my lack of health? I don't know any of the regulations involved, so I am just asking to determine what seems reasonable and what is at stake with this ruling.
The dogma lives loudly within me.
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