Blood substitude trials

The FDA has approved trials for a new blood substitute on the public.

But the general public was not told about it. A badly injured person could be randomly selected for use. (An EMT opens an envelope which says yes or no) To opt out a person needs to wear a special blue braclet, which no one in the general public, knew about.

This is going on in 20 cities.

Link to ABC News

It just gets deeper and deeper...

[edit on 7/7/2006 by roadgravel]

The lack of informed consent is creepy, no doubt.

But this substance is being used in situations where the patient is in severe danger due to massive blood loss, and the current treatment for this level of blood loss (salt water infusion) is not particularly effective.

Consent would be waved because the subject would probably be incapacitated.

Again...creepy? Yes.
Am I going to blue-bracelet up? No.

Yes, I see the point in general.

It was stated that a person had no choice in refusing the trial, even if they were able to comunicate. Blue bracelet refusal only.

That would be lawsuit city!
(Although I have a hunch that personal injury lawyers are already lining up for this one, regardless...)

But no, if you have your wits about you and ask not to be involved in the study, they have to honor your wish.

This is too mind boggling to fathom. How could anything like this be sanctioned without consent?

What other things would fall into the same category where consent is not needed? This can't be the only thing being tested this way.

WTH IS GOING ON??????

Edit: Seriously - if it's not too late you should change the title of this thread to Unconsented Blood Substitute Trials or something.

[edit on 7/7/2006 by Relentless]

I found something similar from 1999.

1999 AP news article on HemAssist trial

Excerpt...

"The new 1996 regulations require a level of community notification that is higher than most scientific studies, including community meetings, press releases and post-study follow-up. "

Just wondering if anyone in the target cities ever heard any public notification about the trial that just occurred.


[edit on 7/7/2006 by roadgravel]