Informed Consent Waived in Public Crisis

Informed Consent Waived in Public Crisis
By ANDREW BRIDGES, Associated Press Writer

Wednesday, June 7, 2006
(06-07) 16:01 PDT WASHINGTON, (AP) --

In a public health emergency, suspected victims would no longer have to give permission before experimental tests could be run to determine why they're sick, under a federal rule published Wednesday. Privacy experts called the exception unnecessary, ripe for abuse and an override of state informed-consent laws.

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.

"To be candid, I hope it is a hypothetical problem. I hope we spent a lot of time creating a rule we never have to invoke," said Dr. Steve Gutman, director of the FDA's in-vitro diagnostics office.
(snip/...)

http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2006/06/07/national/w160152D89.DTL&type=politics

this truly is no longer my country, not one I recognized.

surgery, for example?/

They can evoke an emergency and start shooting stuff into people.

I can only guess how the bloodsoaked bush administration would use this if they got a real mandate.

Wouldn't it be easy and quiet to kill anti-war people with needles.

They can evoke an emergency and start shooting stuff into people.

Where did you get this notion??

Certainly not from the article linked, or the excerpt from it posted.

Here's a little more, that probably should have been part of the original post, given how this

Health care workers will be free to run experimental tests on blood and other samples taken from people who have fallen sick ...

seems to have been so easily missed:

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.

There is an evident violation of privacy here -- one that could arguably be justified.

But really. Nobody is going to be getting shot full of any stuff. Really.

I can't find any of the articles. Lousy searcher, I guess.

I think it's been the past 2 years that OHSU has
been pushing to use substitute blood on people
who are unconscious.

The idea has not gone over very well and, as
far as I know, they are not giving it to people. Then
again, the only way I would know would be IF
it is in the newspaper.

the choice would be- do you give them something that might save their lives- or do you let them die with their rights on.

frickin' nazis :grr: :scared: :puke:

The same people who get to declare "terra" alerts? Very scary!

count on it.

Ok....what's an "experimental test" ???

I understand...someone is sick, you draw blood, then you test blood. That's a test. It's not an "experimental test" is it?

"Experimental test" sounds like something that's not FDA approved...something that's new. Maybe I'm misunderstanding.

What is an "experimental test" as far as the medical community is concerned?

procedures were only going to be covered if the recipient agreed to be in experimental medical trials.

in this case means any test that isn't specifically FDA approved for detecting a certain disease.

Lab tests -- just like drugs -- have to go through an FDA approval process.

For this law to take effect, a public health emergency has to be declared, and the physician staff and hospital would have to approve the use of the test (expiriments of any type can't be run w/o staff approval).

This only applies to tests that look at blood, vomits, stool, urine, etc. Nothing invasive (other than a blood draw).

OK - Healthcare providers, this sounds like an opportunity for a mail flood.

I know a member of a DMAT team, and I've asked for that individual's opinion and response. Will that individual "do no harm" or stick it to us for the sake of an emergency declared by some shill laboratory? What if a Lot of reagent is corrupted; what if the CEO is corrupted?

Paging Dr. Josef Mengele: pick up the house phone please.

The Model State Emergency Health Powers ACT





Very scary stuff. If I recall, many states were initially refusing to adopt it, but I don't know which ones or where all stand on it now.

the draft of the MSEHPA in pdf:
http://www.publichealthlaw.net/MSEHPA/MSEHPA.pdf

http://www.publichealthlaw.net/MSEHPA/MSEHPA2.pdf

Lots of older past writeups by various medical and civic groups here

http://www.aapsonline.org/testimony/emerpind.htm

aclu: http://www.aclu.org/privacy/medical/14857res20020101.html

to adopt it or wanted to water it down. Bushco wasn't having any of that so it got passed intact under HS. It's truly scary stuff. Even doctors can't refuse to give untested vaccines or take chronic illness under consideration during a "health crisis" declared by gov't lay people with no medical experience.

in cases where the patient is uncocious, and there is no relative or anyone else authorised to give consent?

Say for example a sick homeless man is brought into a hospital unconcious and suffering from some disease. No one knows his identity, and thus can not trace any relatives. How do doctors get consent to run tests or treat him?

if the public knew what goes on with medical situations -- folks would rather expire rather than seek help from medical.
it is not only tests -
i've had friends in "tests" allowed to suffer because the test is more important than the patient

fearless one, the decider, made it leagl for drs in his state to euthanize without permission from family and with out consulting family. they do not withhold life support. they kill with an injection just like dogs in the pound or criminals in the death chamber. it is called the "comfort dose."
this is not about indigence or inability to pay - it is not about right to die -- it is not about immediate relief from suffering --- it IS freedom for the meds to kill because of convenience. it happens all the time people just don't know about it.

to this we've come.

:nuke:


"If they don't have the time to get it, at least inform them retroactively what's been done, so people can keep track of what information has been collected from them," Blevins said.

EXACTLY!


The rule took effect Wednesday but remains subject to public comment until Aug. 7. The FDA said it published the rule without first seeking comments because it would hinder the response to an outbreak of bird flu or other public health emergency.

Huh? They didn't seek comments because that would hinder a response to something that hasn't happened? Who writes this crap?!


"Nobody said two airplanes would fly into the World Trade Center, did they? We wouldn't have written the rule unless we thought it was a possibility," Gutman said.

YES THEY DID, YOU FREAKIN MORON!


The FDA said the lack of such an exemption impeded the public health response to the Severe Acute Respiratory Syndrome, or SARS, epidemic of 2003.

Huh? The FDA had to deal with a SARS epidemic? In which alternate universe?

:wtf: