So much for patient rights.

[Graebel]

My mom emailed me this story. It also showed up on 20/20. Just an FYI for anybody who makes frequent trips to American emergency rooms.

http://www.rawstory.com/news/2006/Blood_substitute_to_be_tested_on_0707.html

Here are the hospitals participating. http://www.clinicaltrials.gov/ct/show/NCT00076648?order=1

And this totally violates the Helsinki Declaration but the FDA doesn't seem to care.:(

[zombiegirl]

Are these all teaching hospitals that are conducting the trials. I know the one in Kansas is.
It's ridiculous that they do not need permission to try this when they have no idea what some of the side effects could be. It would just really suck to have my life saved and find out they used this crap and I need a new liver because of it. :(

[MikePizzoff]

I saw this on the news last night. It's really ****ed up. I really can't believe this **** is being allowed.

[panic]

One thing to remember, is that critical trauma patients are often so incapacitated that they lack the capacity to provide consent. If you ONLY included patients able to provide consent, you wouldn't be able to evaluate the product in the sickest subset. Think about it, if you're getting a blood transfusion on ED arrival, you're pretty jacked up. As an emergency physician that works in a level 1 trauma center, I'll tell you that less than 5% of trauma patients require transfusion in the ED.

Also, remember that we're talking about phase 3 clinical trials here, the product has already passed toxicity and dosing tests in phases 1 and 2. The question is not "Is this a dangerous product?" but rather "Is it as good as packed red cells?"

[Graebel]

Also, remember that we're talking about phase 3 clinical trials here, the product has already passed toxicity and dosing tests in phases 1 and 2. The question is not "Is this a dangerous product?" but rather "Is it as good as packed red cells?"

"In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed consent, preferably in writing."

IMO, unconcious or not, you are violating a person's body space without their consent. And they were very sneaky about how they informed the communities. I work in research and I would not want this in myself or my son. Especially not without my express permission.

[Philly_SWAT]

Unfortunately, I think this is another result of the way our society acts about money. Doctors/hospitals are "entrepreneurs" first, "healers" second. It would "cost" too much money to run this trial with only consenting patients, with legal rights as to free medical treatment after the fact for the rest of their lives if there was a problem with the treatment. Therefore, just do it, hope for the best, and take your chance with possible lawsuits after the fact. The all-mighty dollar is God here in America, death or medical problems for human beings be damned. This report scares me, but does not surprise me at all.

[panic]

Unfortunately, I think this is another result of the way our society acts about money. Doctors/hospitals are "entrepreneurs" first, "healers" second. It would "cost" too much money to run this trial with only consenting patients, with legal rights as to free medical treatment after the fact for the rest of their lives if there was a problem with the treatment. Therefore, just do it, hope for the best, and take your chance with possible lawsuits after the fact. The all-mighty dollar is God here in America, death or medical problems for human beings be damned. This report scares me, but does not surprise me at all.

This is nonsense. Its not about how much it would cost to consent people, its about the fact that many of the people who need the treatment (blood or the study product) can't give consent because they are too sick. In EVERY institution in the country that performs any sort of scientific or medical research involving human subjects researchers are required to obtain informed consent unless they get a waiver of the requiremnt from the Institutional Review Board (IRB) which is charged with the protection of human subjects. The researchers performing this study obtained a waiver on the merits of the study and the inability to obtain consent. It had NOTHING TO DO with consent being too costly to obtain. Jesus people, this isn't Germany in 1941.


"In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed consent, preferably in writing."

IMO, unconcious or not, you are violating a person's body space without their consent. And they were very sneaky about how they informed the communities. I work in research and I would not want this in myself or my son. Especially not without my express permission.

IRBs grant waivers for informed consent all the time. (See above post.) Its uncommon for waivers to be granted for investigation of new drugs, products and devices (waivers are most often granted for other types of research such as those involving medical records, existing stores of human tissue, and so forth) but its not unheard of when the intervention being evaluated is expected to benefit a group that is not expected to be able to provide consent at the time of treatment.

A perfect examples is the study of drugs for refractory cardiac arrest such as Amiodarone. These studies were done on people that sustained out-of-hospital cardiac arrest -- they lacked the ability to provide consent because they were dead -- and the IRBs granted waivers because the drug show promise compared to the existing standard drug.

Next time, do a little research before you get all alarmist.

[Graebel]

Next time, do a little research before you get all alarmist.

Panic, it doesn't matter what it is. Some people don't want things put in their bodies without them knowing about it. Course I don't really expect anyone to honor my DNR either.

[panic]

Panic, it doesn't matter what it is. Some people don't want things put in their bodies without them knowing about it. Course I don't really expect anyone to honor my DNR either.

I understand Graebel, but some research that society has decided needs to be done (like the Amiodarone example) can't be done with your consent on an individual basis.