Rationalizing And Circumventing Federal Law Regarding Uninformed And Unconsented Medical Treatments

There was a study undertaken in February 2007 which sought to ascertain the reactions of people towards uninformed and unconsented medical treatment in research studeies, essentially attempting to grasp public attitude towards using patients as guinea pigs without their knowledge.

OBJECTIVES: To explore attitudes surrounding exception from informed consent enrollment into research studies. In addition, the authors sought to determine the level of awareness of such an ongoing study among potential subjects, as [defined by their presence in an emergency department (ED). Exception from informed consent enrollment in emergency medical research: attitudes and awareness.

METHODS: A convenience sample of urban academic ED patients and visitors was surveyed during a visit regarding their attitudes and awareness of an emergency exception from informed consent, blood-substitute trial ongoing in the community.

People were also questioned regarding their awareness of the existence of the study. These questions were posed to people visiting a hospital.
I find the fact that the questions were asked of people visiting the hospital to be a relevant aspect of this survey as it seems that the hospital environment would invoke within people more of a reactive inclination to the questions as opposed to a rational consideration. I contend that such a 'vulnerable' physiological state would bias the objective relevance of the results.

The conclusions of the study showed that the acceptance of uniformed and unconsented treatment was generally low (with certain demographics being inclined to a greater liklihod of acceptance), indicating that my thoughts on the subjectivity of the environment are not necessarily warranted. However the most interesting part of this study was the fact that the awareness of the practice/study/policy was low and that the results of this survey was to be used as follows:


These differences may guide institutional review boards and investigators in community-consultation strategies for future waiver of or exception from informed consent studies.

The survey was relevant to determine how a strategy to circumvent the informing and obtaining consent of future patients!

While I would like to further look into the specific results of the survey and as well learn more about the referenced blood substitution trial, this thread is meant to show that there is an active and intended effort to justify the negation of the first point of the Nuremberg Code:

1. The voluntary consent of the human subject is absolutely essential.

And also federal law regarding the protection of experimentees.

Federal Law Regarding Informed Consent

We here on these boards are daily interacting with political issues and scandals, new government policies designed to infringe upon the privacy of citizens and various other conspiracies.

What we don't do very much of on ATS is look towards the less obvious examples of conspiracy as they are undertaken with noble intention and are thusly not necessarily malicious. But the precedence of complicity and inattention to the negotiation of what should be non negotiable rights is one that is potentially more dangerous than allowing unaccountable access to our personal information.

The open admission to being motivated to strategize effieciently in obtaining acceptance of the "future waiver of or exception from informed consent studies" is a huge red flag in my opinion as it seems to open the door to a retroactive rationalization of submitting people to experimental medical treatments through a general community consensus without any kind of adequate comprehension of the specifics of future procedures.

So I ask ATS the following...
Are Federal Laws regarding Informed Consent negotiable?

Is it ethical for individuals to actively seek ways to gain the complicity of lesser educated and contextually ignorant individuals regarding the withholding of information as pertaining to the use of their bodies?

[edit on Wed, 25 Mar 2009 13:40:02 -0500 by MemoryShock]

This is the same type of 'legal obfuscation' we see so many other places in society. Look at financial contracts, 'service agreements', etc., all with impossible to understand clauses, vague phrasing, ambiguities; sometimes even clauses that let the contractual terms be changed without notification or prior consent.

This is the type of thing that is considered 'informed consent' and 'agreement', in the postmodern legal culture.

The concept of 'meeting of the minds', as a valid basis for agreement, is worth revisiting. It seems to have been totally abandoned; skewed to the agenda of the commercially expedient. Lawyers haven't helped this process, of course.

And what alternatives are people given? Sign a bunch of forms, sight unseen or ununderstood, or bleed to death? How can 'consent' be given if such coercion exists?

It only makes sense that there are attempts to further erode these rights, with the abandonment of even the pretense of an equal relationship between the medical-industrial establishment and their 'service-receivers'.

And let's not blame doctors in this, either - they're in as much of a tight squeeze, between malpractice, HMO requirements, insurance and administrative procedures, as the patients are. It's the system of human care-giving, ironically, that is becoming distinctly inhuman.

reply to post by MemoryShock

Is it ethical for individuals to actively seek ways to gain the complicity of lesser educated and contextually ignorant individuals regarding the withholding of information as pertaining to the use of their bodies?

No.

But, then again, personal responsibility shouldn't be negotiable, either. Don't sign something without reading it. Don't agree to something without getting all the facts.

Originally posted by skeptic1
But, then again, personal responsibility shouldn't be negotiable, either. Don't sign something without reading it. Don't agree to something without getting all the facts.

But how can personal responsibility be a valid onus for an individual if they are unaware of all the factors?

The point of this thread was to show a study that is seeking to strategize ways to bypass public concern over being subjegated to treatment that wasn't in the papers they were signing.

While I do think that personal responsibility is a valid point, I think that an under educated population kind of makes it moot. Afterall, most people do not comprehend medical procedure having not gone through the requisite schooling.

So there is an implicit trust placed in the hospital to treat people in such a way as that the implicit trust is honoured.

The practice of intentionally withholding information betrays this trust and could potentially, if not definitely, emphasize a dichotomy between medical professionals and the layman.

Some interesting information on this topic can also be found, here:

United States Department of Health And Human Resources: Office for Human Research Protections (OHRP)

Federalwide Assurance FAQ
Informed Consent FAQ

Where applicable, various federal regulations are also cited.

I would like to see any organization doing things like this being brought before an international tribunal, with punishments for contravening human rights. With heavy fines assessed for organizations involved.

reply to post by MemoryShock


I am speaking of the people who agree just to agree or sign just to sign. The people who don't bother to read what they sign.

And, education level cannot be a valid argument here. I don't care if I didn't graduate highschool. If someone is giving me medication, I am going to ask what it is, what it is for, and what it does. That is personal responsibility. Most people no longer have blind faith (or shouldn't), no matter their education level.

No, pharmaceutical companies, hospitals, doctors, any health-care organization should not perform experiments on people without their knowledge. But, on the flip side of that, if a person agrees to "something", then they better make the effort to know what they are agreeing to.

While reading your post there was the constant urge to rewind the tape and ask: How and Who the hell is considering the question in the first place, and Why? Not only is it not negotiable its not even a question to be raised in an open society to begin with.

And to rewind the tape even more: What is this "small percentage of people" supposedly willing to be experimented on without their consent?

[edit on 25-3-2009 by Skyfloating]

reply to post by skeptic1


I hear what you are saying.

The study was to gauge reaction from people about how they would react to being placed (or relatives) in an experimental treatment without their knowledge.

As well, awareness of the treatment/study was also gauged...indicating that a lack of popular awareness, either intentionally or not, would be a factor in future efforts of this nature.

More on this particular topic...

The statistics: There was a significantly higher death rate for people who got the blood substitute than for those who didn’t.

The results come as the Portland area soon will be part of another national medical study that, like the recent study of the artificial blood substitute called PolyHeme, is unusual for what it doesn’t do: It doesn’t inform people they will be part of the study.

An alert sounds on ‘waived consent’

The peculiarity of these cases that is allowing for research without informed consent is that the studies are of emergency medical treatments -- the patients are presumably either unconscious or simply not capable of making an informed decision at that time. Understandably, it is difficult to find people who can make an informed decision about whether or not to participate in a research program while bleeding out after flying through a windshield. So if what you want to find out is whether a new blood product will work when given in the ambulance on the way to the ER, it's hard to know how to go about it without breaching patients' rights. Perhaps a mark on drivers' licenses like there is for organ donation, so that you can think about it in advance? But that still doesn't allow for informed consent, since you have no way to know what kind of study you might be signing up for.

BTW, I'm not reading that abstract as looking for ways around informed consent, but I haven't been able to find the full text of the article online so I could be wrong. I'm reading it as simply trying to find out whether people know about the legal loophole that allows for waiver of informed consent in emergency situations, and what they think of it.

Still, interesting article and an important topic for the public to know about. Because when it comes down to it, I don't believe that the need to develop new and better emergency procedures or treatments justifies possibly violating an uninformed or unconscious patients' desire not to volunteer for such research.

Originally posted by americandingbat
The peculiarity of these cases that is allowing for research without informed consent is that the studies are of emergency medical treatments -- the patients are presumably either unconscious or simply not capable of making an informed decision at that time.

Good point but the study seems to be also bypassing the informing and gaining of consent from family etc.

Granted, the emergency situation does call for immediate action, which could be effected by the need for informed consent but it is a sticky situation that could potentially allow for a more lax approach to informed consent...such as the religious will of a patient against professional medical advice.

Some very interesting grey area situations...

BTW, I'm not reading that abstract as looking for ways around informed consent,

Really?

These differences may guide institutional review boards and investigators in community-consultation strategies for future waiver of or exception from informed consent studies.

An informed strategist is one who can more easily persuade...at the least, it is a bit suspicious to me...dressing up the lingo as "community-consultation" is an interesting point in mine eyes...

Iwould be interested in what the other criteria the study included. I doubt that physicians would be for performing medical treatments/procedures without consent, their liability insurances would never go for something like that. In cases of threat of immediate death, is the only situation that an informed consent can be ommitted prior to that treatment. Did the study involve any patients that were patients in such a crisis situation? If not, the study is sort of biased. It is really doubtful a physician would be worried about research on informed consent while in a patient emergency situation. Paramedics should never participate in administering research medicine, puhleez. Also, it is the physicians responsibilbity to explain the informed consent in laymans terms to the patient or guardian of patient and I don't think that ---I am going to cut an incision in your stomach right here and open up your belly and remove the gallbladder and then sew you back up--for cholecystectomy, would be to hard for anyone to understand less a child. You are not giving the general public a very nice intelligence level.
One last thing, regarding a low percent, who decided what per cent was low?