experimentation WITHOUT consent!

[Brandon]

Why is George Orwell's nightmarish vision of the future becoming more a reality?

IF the FDA had it's way, it will allow doctors to perform "experimental research" without your informed consent.

What does everyone think of this?

http://www.worldnetdaily.com/news/article.asp?ARTICLE_ID=51880

 

[l99999us]

I think it raises many questions of ethics and is a very dangerous step especially as it could be endangering the lives of people without their concsent or even knowledge. This is especially true if their are already effective procedures for the treatement in question.

 

[tater03]

This is just plain wrong. They should not do anything without someones consent.

 

[dong]

I need a more complete knowledge of the perspectives and the policy in review. Any appreciation of medical ethics will teach you that the buzzword "informed consent" in fact entails far more complex consideration. If there's a source for it, I'd like to read through the proposed amendments to see exactly what part of this it addresses.

 

[framed]

I don't think it’s nearly as simple as "They should not do anything without someone’s consent." There are good reasons to require informed consent in most cases, but there are also very good exceptions. Consider cardiac defibrillators. No one questions that these have saved tens of thousands of lives since their being brought into service. If the inventors had to get informed consent to test one of these on a human, how would they ever have brought it to market? (You can't ask the unconscious and dying heart attack victim.)

A more current debate is around testing artificial blood. The stuff has a year long shelf life (vs less than a month for blood), doesn’t require a donor, doesn’t carry disease, doesn't require refrigeration (making it great for ambulances and the military), and may reduce the risk of heart attack compared to transfused blood. Of course, all the potential patients this product could help come in the hospital unconscious from severe bleeding. Should we sit them up and ask if they'd like to participate?

There definitely need to be rules around trials that legitimately cannot obtain consent, but if I read that article right that’s exactly the point of what the FDA is doing. They’re revising their rules for trails of emergency medical care where consent is impossible to obtain.

Please remember that patient consent is not the only safeguard against unethical medical research. Lab tests, animal trials, chemical studies, and consent-based testing are all in the FDAs bag of requirements among many others. These other methods are used whenever possible before the FDA allows clinical trials on humans, consent based or otherwise.

To read what the FDA is actually planning to do around supporting trials in emergency medicine check out:

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01439.html

 

[sarah]

I support this sort of testing, but only in situations where consent is impossible to attain.

 

[dong]

This reminds me that I have read novels and seen films that use this as the premise- the sentiment there is the usual "if you can't gain their consent then you shouldn't do it". Why? Because the specific scenarios would be something like some mad doctor's whimsical fancy for the advancement of treatment or something like that...

Anyway, my point is that the consideration of such would be definitely far more complex- among the fundamental things to consider would be the intention to treat, treatability or management plans of the patient, and implications on patient's health etc. I'll use an example to provide some perspective: patient's in a non-iatrogenic coma (i.e. the doctor didn't induce it) and the doctors don't know how to bring them out, for any number of reasons. There's something that might work, but it's not approved, and still in either the clinical trial stage or just finished lab testing...or it could be completely ad hoc. Now you tell the patient this...well that's useless- they're in a coma! What about if you tell the family? They don't have a clue what you're talking about. What to do then?

 

[Slashmire]

Interesting, I wouldn't think that it would end up going that far....but I'll try to stick to news of it, and see what's coming up next.

 

[capitalist_junkie]

I guess what bothers me is that I like to be in control. And if I'm in a situation where I cannot have control, I'd like to think there are people, such as family, who I can trust to make those decisions for me. I don't like the idea that doctors have more control over my body than I do.

 

[dong]

I think that's what drives much of the concern. Prima facie, it seems to be a direct violation of presumed human rights.

 

[harleysneak]

I think that consent is one of the most important parts of research and scientific experimentation as far as humans go. Without it, our rights as human beings to express our feelings and thoughts are being taken away.

 

[dong]

Funnily enough this is why there's a specific divide between being able to test scientifically (medically) with lab-raised animals but as far as people go, ethics committees usually disallow human experimentation in the form of double-blinded randomised-control trials (the strongest form of independent evidence). We thus usually have to rely on more epidemiological evidence which is more for retrospective analysis than for development of new treatments, medications etc.

Why this is particularly interesting is simply that the divide exists. I'm wondering, with the recent rise in significance (at least in the philosophy world) of animal philosophy and the notion of consent and animals as moral agents how this might affect even this kind of testing, if at all (for more detail refer to the "I declare thee man and cow" thread).

But that's all tangential. Essentially you're right as far as a medical perspective would dictate.