[Doofy]

Didn't see this posted, so...

WTF?!?

http://abcnews.go.com/WNT/story?id=2166058&page=1

With the FDA's approval, Northfield Lab has recruited hospitals to participate in the trial study with exemption from informed consent requirements on study participants. Although Northfield Lab claims that extensive information on the study has been made public, a vast majority of the general public has never heard of the trial.

Basically, they're testing an new artificial blood on accident victims without their consent. You have a car crash and you're losing blood, you get in the ambulance and there's a random chance you could find yourself a guinea pig for their experiment. Nobody will ask you for your permission to include you in this test.

Apparently, last time they ran this type of test two people died from the experiment.

The only way you can not be a part of this experiment is to wear an opt-out bracelet (or not have an accident).

[RAILhead]

Huh.

[Doofy]

Originally Posted by RAILhead

Huh.

Do Americans not mind the FDA allowing them to be part of a medical trial without their permission?

[von Wrangell]

This is one of those very few instances where me and Doofy agree I think. You should never have to say that you don't want to be a part of an experiment. It's ethically wrong. You should sign an informed consent form that says you want to take part in the experiment.




ok, I have no idea if I got my point across.

[Doofy]

Originally Posted by von Wrangell

ok, I have no idea if I got my point across.

Sounded right to me.

It's like email lists - you should be on a list only if you choose to opt-in, not subscribed automatically until you choose to opt-out. Except email lists won't kill you - this could.

Heck, what if they were pulling this kind of thing with those drug trails that went wrong a few months back? No thanks!

[von Wrangell]

Originally Posted by Doofy

Sounded right to me.

It's like email lists - you should be on a list only if you choose to opt-in, not subscribed automatically until you choose to opt-out. Except email lists won't kill you - this could.

Heck, what if they were pulling this kind of thing with those drug trails that went wrong a few months back? No thanks!

Exactly.

We had a similar incident here on Iceland a few years back (and is still in effect). A research company (Decode Genetics) got the right to all bloodsamples and medical papers (have no idea what that is called in English) from every Icelander. The problem was that we (Icelanders) needed to go to either a hospital or to the ministry of health to tell the government/company that we didn't want to be a part of that. This is a serious breach of ethics and every single doctor and researcher were against this. But it still was pressed through congress.

Luckily other mechanisms are stalling it at the moment though.

What surprises me the most though are two things. Why are people so ignorant about these things that they actually think it's OK and even a good idea? And why does the governments allow this?

[Millennium]

Originally Posted by von Wrangell

What surprises me the most though are two things. Why are people so ignorant about these things that they actually think it's OK and even a good idea? And why does the governments allow this?

Strict utilitarianism: "The greatest good for the greatest number of people." It's the principle on which all modern liberal ideologies and most modern conservative ideologies are built, and this is nothing more than its logical conclusion.

It is also, incidentally, why I am not a liberal. The needs of the many do indeed outweigh the needs of the few, but I believe the needs of the one -individual rights- to be heaviest of all. It's probably the only thing I've ever agreed with Ayn Rand about.

[von Wrangell]

Originally Posted by Millennium

Strict utilitarianism: "The greatest good for the greatest number of people." It's the principle on which all modern liberal ideologies and most modern conservative ideologies are built, and this is nothing more than its logical conclusion.

It is also, incidentally, why I am not a liberal. The needs of the many do indeed outweigh the needs of the few, but I believe the needs of the one -individual rights- to be heaviest of all. It's probably the only thing I've ever agreed with Ayn Rand about.

This has nothing to do with liberalism or conservatism.

We have a conservative government here on Iceland and from the OP it's happening in the US as well. I wouldn't say the US is even close to being liberal.

This is simply the power of lobbyists on corrupt and ethically blind politicians. The political leaning of those politicians is irrelevant.

[vmarks]

The ethical principle here is this:

In a situation where the patient is unable to give consent (e.g. unconcious) the law presumes that the patient would want all measures taken to save his life.

That's it.

In a lot of situations, saline water is all that is available until the patient can arrive at hospital. This experiment provides the field with an oxygen-carrying-substance with the properties of blood, giving the patient a much better chance of survival.

Also, it has a shelf life of near 3 years when blood expires in 40 days.

[von Wrangell]

Originally Posted by vmarks

The ethical principle here is this:

In a situation where the patient is unable to give consent (e.g. unconcious) the law presumes that the patient would want all measures taken to save his life.

That's it.

In a lot of situations, saline water is all that is available until the patient can arrive at hospital. This experiment provides the field with an oxygen-carrying-substance with the properties of blood, giving the patient a much better chance of survival.

Also, it has a shelf life of near 3 years when blood expires in 40 days.

Maybe in the US but in civilised countries the law says that a patient unable to give his informed consent wants every government approved measure to save his life. And for something still not approved by the FDA (and their equivalents in the world) the patient needs to give his informed consent. That is you can't ask a patient in a state of shock if he wants to try something new.

Basically if the patient can't give his informed consent only approved measures may be taken to save his life, unless his relatives give their informed consent.

It's simply ethically wrong to force people to take part in a study they don't know about.

[vmarks]

Maybe you're missing something: The trial isn't just because the company wants to do a trial.

The trial was approved by the FDA to be held. There are a lot of experiments and trials that take place prior to the step we're at now, and those results have to be shown and accounted for to the FDA, who then approves going forward with a trial like the one we're discussing now.

So where is the difference between what you're saying about so-called-civilised countries of the world and the US?

This is approved for trial, and so fits what you're saying about the rest of the world.

[von Wrangell]

Originally Posted by vmarks

Maybe you're missing something: The trial isn't just because the company wants to do a trial.

The trial was approved by the FDA to be held. There are a lot of experiments and trials that take place prior to the step we're at now, and those results have to be shown and accounted for to the FDA, who then approves going forward with a trial like the one we're discussing now.

So where is the difference between what you're saying about so-called-civilised countries of the world and the US?

This is approved for trial, and so fits what you're saying about the rest of the world.

No. It's just like you said (don't see the problem in understanding it though).

This has been approved for trial. Not as a legitimate substitude for blood transfusion.

There is a reason it's called a trial. And that is why it would be illegal in civilised countries to use it on patients that have no say in whether they want to take part in this trial or not.

[von Wrangell]

Here's a short summary on what informed consent is:

http://www.socialpsychology.org/consent.htm

[vmarks]

Except that it has been approved for use in the circumstances laid out.

And again, the principle and law is, where no consent is available, consent is presumed in favor of saving the life.

You don't have to tell me what informed consent is. Rather, tell me how patients suffering shock or unconciousness can voice their consent.

[von Wrangell]

Originally Posted by vmarks

Except that it has been approved for use in the circumstances laid out.

And again, the principle and law is, where no consent is available, consent is presumed in favor of saving the life.

You don't have to tell me what informed consent is. Rather, tell me how patients suffering shock or unconciousness can voice their consent.

It seems like I have to tell you what informed consent is.

No, it's been approved for trials. Trials is not something you force people to take part in. And no, consent is not presumed in anything. If you are having a trial you have to get informed consent from the participants. If they are in shock or unconcious you need to get informed consent from their relatives.

This might be legal in the US but I don't really care about that. This would be illegal in civilised countries.

[Millennium]

Originally Posted by vmarks

You don't have to tell me what informed consent is. Rather, tell me how patients suffering shock or unconciousness can voice their consent.

They can't, which is why the ethical thing to do is to only do things which can be reversed. This way, if the patient turns out to have not wanted the procedure, then a terrible mistake has been made but at least it can be undone.

When they find a way to reverse a transfusion, then I might agree to experimenting with these artificial blood substitutes. But I'm not holding my breath for that one.

[moodymonster]

so... they're using an experimental 'product' operationally.

If it's the only option then that's what you have to use. But, it's not the only option (unless the blood banks are severly depleted), therefore it seems like people are being experimented on without their knowledge.

Which in my eyes is a bad thing.

experimenting with peoples' consent can go wrong:

Six men remain in intensive care after being taken ill during a clinical drugs trial in north-west London.
The healthy volunteers were testing an anti-inflammatory drug at a research unit based at Northwick Park Hospital when they suffered a reaction.

Relatives are with the patients, who suffered multiple organ failure. Two men are said to be critically ill.

http://news.bbc.co.uk/1/hi/england/london/4807042.stm

experimenting without consent is wrong.

[BRussell]

Sorry for the length, but here are the regulations for an exemption from informed consent.

It's part Title 21, 50.24, and can be found here.

(BTW, I have no doubt von Wrangell that Iceland, as civilized as it is, has some provision like the following for an exemption from informed consent. Wanna bet?)

Subpart B--Informed Consent of Human Subjects Sec. 50.24 Exception from informed consent requirements for emergency research.
(a) The IRB responsible for the review, approval, and continuing review of the clinical investigation described in this section may approve that investigation without requiring that informed consent of all research subjects be obtained if the IRB (with the concurrence of a licensed physician who is a member of or consultant to the IRB and who is not otherwise participating in the clinical investigation) finds and documents each of the following:
(1) The human subjects are in a life-threatening situation, available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.

(2) Obtaining informed consent is not feasible because:

(i) The subjects will not be able to give their informed consent as a result of their medical condition;

(ii) The intervention under investigation must be administered before consent from the subjects' legally authorized representatives is feasible; and

(iii) There is no reasonable way to identify prospectively the individuals likely to become eligible for participation in the clinical investigation.

(3) Participation in the research holds out the prospect of direct benefit to the subjects because:

(i) Subjects are facing a life-threatening situation that necessitates intervention;

(ii) Appropriate animal and other preclinical studies have been conducted, and the information derived from those studies and related evidence support the potential for the intervention to provide a direct benefit to the individual subjects; and

(iii) Risks associated with the investigation are reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.

(4) The clinical investigation could not practicably be carried out without the waiver.

(5) The proposed investigational plan defines the length of the potential therapeutic window based on scientific evidence, and the investigator has committed to attempting to contact a legally authorized representative for each subject within that window of time and, if feasible, to asking the legally authorized representative contacted for consent within that window rather than proceeding without consent. The investigator will summarize efforts made to contact legally authorized representatives and make this information available to the IRB at the time of continuing review.

(6) The IRB has reviewed and approved informed consent procedures and an informed consent document consistent with 50.25. These procedures and the informed consent document are to be used with subjects or their legally authorized representatives in situations where use of such procedures and documents is feasible. The IRB has reviewed and approved procedures and information to be used when providing an opportunity for a family member to object to a subject's participation in the clinical investigation consistent with paragraph (a)(7)(v) of this section.

(7) Additional protections of the rights and welfare of the subjects will be provided, including, at least:

(i) Consultation (including, where appropriate, consultation carried out by the IRB) with representatives of the communities in which the clinical investigation will be conducted and from which the subjects will be drawn;

(ii) Public disclosure to the communities in which the clinical investigation will be conducted and from which the subjects will be drawn, prior to initiation of the clinical investigation, of plans for the investigation and its risks and expected benefits;

(iii) Public disclosure of sufficient information following completion of the clinical investigation to apprise the community and researchers of the study, including the demographic characteristics of the research population, and its results;

(iv) Establishment of an independent data monitoring committee to exercise oversight of the clinical investigation; and

(v) If obtaining informed consent is not feasible and a legally authorized representative is not reasonably available, the investigator has committed, if feasible, to attempting to contact within the therapeutic window the subject's family member who is not a legally authorized representative, and asking whether he or she objects to the subject's participation in the clinical investigation. The investigator will summarize efforts made to contact family members and make this information available to the IRB at the time of continuing review.

(b) The IRB is responsible for ensuring that procedures are in place to inform, at the earliest feasible opportunity, each subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, of the subject's inclusion in the clinical investigation, the details of the investigation and other information contained in the informed consent document. The IRB shall also ensure that there is a procedure to inform the subject, or if the subject remains incapacitated, a legally authorized representative of the subject, or if such a representative is not reasonably available, a family member, that he or she may discontinue the subject's participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If a legally authorized representative or family member is told about the clinical investigation and the subject's condition improves, the subject is also to be informed as soon as feasible. If a subject is entered into a clinical investigation with waived consent and the subject dies before a legally authorized representative or family member can be contacted, information about the clinical investigation is to be provided to the subject's legally authorized representative or family member, if feasible.

(c) The IRB determinations required by paragraph (a) of this section and the documentation required by paragraph (e) of this section are to be retained by the IRB for at least 3 years after completion of the clinical investigation, and the records shall be accessible for inspection and copying by FDA in accordance with 56.115(b) of this chapter.

(d) Protocols involving an exception to the informed consent requirement under this section must be performed under a separate investigational new drug application (IND) or investigational device exemption (IDE) that clearly identifies such protocols as protocols that may include subjects who are unable to consent. The submission of those protocols in a separate IND/IDE is required even if an IND for the same drug product or an IDE for the same device already exists. Applications for investigations under this section may not be submitted as amendments under 312.30 or 812.35 of this chapter.

(e) If an IRB determines that it cannot approve a clinical investigation because the investigation does not meet the criteria in the exception provided under paragraph (a) of this section or because of other relevant ethical concerns, the IRB must document its findings and provide these findings promptly in writing to the clinical investigator and to the sponsor of the clinical investigation. The sponsor of the clinical investigation must promptly disclose this information to FDA and to the sponsor's clinical investigators who are participating or are asked to participate in this or a substantially equivalent clinical investigation of the sponsor, and to other IRB's that have been, or are, asked to review this or a substantially equivalent investigation by that sponsor.

[Kevin]

Originally Posted by von Wrangell

This might be legal in the US but I don't really care about that. This would be illegal in civilised countries.

What a lame attack.

Yeah Iceland is so much more civilized than the US.

Give me a break.



You seriously need to get off your pretentious high horse.

[medicineman]

Originally Posted by von Wrangell

Maybe in the US but in civilised countries the law says that a patient unable to give his informed consent wants every government approved measure to save his life. And for something still not approved by the FDA (and their equivalents in the world) the patient needs to give his informed consent. That is you can't ask a patient in a state of shock if he wants to try something new.

Basically if the patient can't give his informed consent only approved measures may be taken to save his life, unless his relatives give their informed consent.

It's simply ethically wrong to force people to take part in a study they don't know about.

The FDA is the nominal authority in the United States. Yet, depending on which study you read, more that 50% of meds are dispensed and dosed off label.

And by civilized countries, do you mean those in the middle east and African continent? Those that have such admiral records of human rights, women's rights and religious tolerence?

[hey!_Zeus]

Originally Posted by Kevin

What a lame attack.

Yeah Iceland is so much more civilized than the US.

Give me a break.



You seriously need to get off your pretentious high horse.

I don't think they have "drive by's" in Iceland or the kind of **** that mucks up the sh!t hole you live in.

You have to get off your hobby horse buddy.

And change your underwear for gods's sake!!

[SimeyTheLimey]

BRussell is correct (I took food and drug law in school, so have some idea what this is about). For many decades now there has been a special provision to the normal informed consent rules for emergency procedures. If you think about it, it makes perfect sense.

Generally, trials of new drugs and medical devices are tested on human subjects in clinical trials (after earlier testing on animals, etc). The last stage of testing necessarily involves real people with real illnesses or injuries. It has to be that way if you want to develop new medical technologies and ensure that they are safe and effective for use. As a general rule, each subject to the trial gives informed consent. However, if you always required informed consent, you could never do trials for emergency procedures and drugs used in emergencies. During an emergency, the patient is usually unconcious or so hurt that you can't really get informed consent because the patient is not in a position to give it. But on the other hand, you can't manufacture an emergency just for the sake of testing a procedure. Unnecessary treatment is unethical.

So the compromise is the exception to the informed consent rules where the medical decision is made by an independent panel of physicians rather than the patient (who can't give informed consent in this situation). It's necessary to do this if medical technology for use in emergencies is to improve. It's either this, or you don't test the products at all. And because we require new medical products be tested before going on the market, you either do this, or you give up improved medical techniques altogether.

Oh, and yes, I understand that other countries with medical industries do exactly the same thing. And those countries that don't have drug industries use drugs tested in countries that do.

[Chuckit]

Originally Posted by Kevin

What a lame attack.

Yeah Iceland is so much more civilized than the US.

Give me a break.



You seriously need to get off your pretentious high horse.

He was criticizing Iceland for a similar lack of ethics in his post just before that, wasn't he?

[Doofy]

Originally Posted by SimeyTheLimey

So the compromise is the exception to the informed consent rules where the medical decision is made by an independent panel of physicians rather than the patient (who can't give informed consent in this situation).

What's actually happening is that in the back of the ambulance there's a bunch of sealed envelopes. Once a patient is in there, the crew take one of these envelopes and break it open. It'll say "use new experimental synthetic blood" or "don't use new experimental synthetic blood". Completely random - not an independent panel of physicians anywhere in sight.

[SimeyTheLimey]

Originally Posted by Doofy

What's actually happening is that in the back of the ambulance there's a bunch of sealed envelopes. Once a patient is in there, the crew take one of these envelopes and break it open. It'll say "use new experimental synthetic blood" or "don't use new experimental synthetic blood". Completely random - not an independent panel of physicians anywhere in sight.

The independent panel is called an Institutional Review Board. It is described in BRussell's post. The IRB oversees the trial. It is an independent panel of physicians and researchers -- including people from outside the hospital conducting the trial.

The point stands, either you allow research into drugs and devices used in emergency proceedures or you don't. If you want medicine to progress, you have to have a rule such as this. That is why your country has (to the best of my knowledge) very similar rules. If you are opposed to the advancement of science, that is fine (you have posted before that you have a phobia of anything "synthetic"). But this is a public policy matter that has been decided by our respective elected governments. This is a narrow exception to a general rule, and one completely justified by the circumstances.

[von Wrangell]

Originally Posted by SimeyTheLimey

The independent panel is called an Institutional Review Board. It is described in BRussell's post. The IRB oversees the trial. It is an independent panel of physicians and researchers -- including people from outside the hospital conducting the trial.

The point stands, either you allow research into drugs and devices used in emergency proceedures or you don't. If you want medicine to progress, you have to have a rule such as this. That is why your country has (to the best of my knowledge) very similar rules. If you are opposed to the advancement of science, that is fine (you have posted before that you have a phobia of anything "synthetic"). But this is a public policy matter that has been decided by our respective elected governments. This is a narrow exception to a general rule, and one completely justified by the circumstances.

This synthetic heme could be tested in most surgeries. They don't need to do it on emergency cases.

[von Wrangell]

Originally Posted by BRussell

Sorry for the length, but here are the regulations for an exemption from informed consent.

It's part Title 21, 50.24, and can be found here.

(BTW, I have no doubt von Wrangell that Iceland, as civilized as it is, has some provision like the following for an exemption from informed consent. Wanna bet?)

Been browsing through the laws and found no such parts. The most interesting thing I found was this little line (translated from Icelandic):

• Benefits for science and community should never be valued more than the right of the individual in a study.

So, liberal Iceland protects the individual more than conservative US.

[BRussell]

Originally Posted by von Wrangell

Been browsing through the laws and found no such parts. The most interesting thing I found was this little line (translated from Icelandic):

• Benefits for science and community should never be valued more than the right of the individual in a study.

So, liberal Iceland protects the individual more than conservative US.

Check out these Regulations on clinical trials of medicinal products in humans and look at Article 19: Clinical trials on children and individuals with reduced capacity to give their informed consent. The regulations are much less specific than the long conditions in those US regulations.

Are you familiar with the genetic database project in Iceland? That uses presumed consent, where you have to opt out, or you're in. So Iceland is internationally famous for its lack of respect for informed consent. How you can live there under such conditions I don't know.

[Kevin]

Originally Posted by hey!_Zeus

I don't think they have "drive by's" in Iceland or the kind of **** that mucks up the sh!t hole you live in.

Don't have em where I live either Zeus.

See America is a lot like Europe. Different parts of it are completely different.

You learned something today.

[von Wrangell]

Originally Posted by BRussell

Check out these Regulations on clinical trials of medicinal products in humans and look at Article 19: Clinical trials on children and individuals with reduced capacity to give their informed consent. The regulations are much less specific than the long conditions in those US regulations.

But it's a bit more complex than that.

Basically everyone has a legal guardian here on Iceland. It's either a relative or the justice system. The laws are very similar to how they deal with mentally "disturbed" persons. If no relatives or legal guardians want to decide the state has the right to take away that persons right to decide how he is treated if it is proven that the person is so ill that he cannot make that decision on his own. But that is where the legal guardian system comes into play. When that happens 2-3 doctors need to ask a judge if they are allowed to keep the person in the hospital against the patients wish. When they do that they need to show that the patient is a danger to himself. Then the judge has to decide if the benefit of whatever treatment the doctors are proposing justifies taking away the patients right to decide.

In clinical trials the same system is in play. If the patient cannot give his informed consent the hospital has to talk to their relatives. If the relatives aren't in reach or cannot say yes or no (and their opinion is prioratised depending on how they are related to the patient) the hospital has to get a couple of doctors to give their opinion on the trial. After that they have to contact a judge and say what they think. The judge is then the legal guardian who decides. Which means that a trial like the one mentioned in this thread would never be allowed here on Iceland.

Perhaps I'll just ask my father if a trial like this would be allowed. Just to make sure I'm not talking about of my arse here. (he's the head of the national science ethics committee that decides if clinical trials on Iceland get their permits)

Are you familiar with the genetic database project in Iceland? That uses presumed consent, where you have to opt out, or you're in. So Iceland is internationally famous for its lack of respect for informed consent. How you can live there under such conditions I don't know.

Take a look at my second post in this thread. Just want to add one thing to what I already said about it. deCode got special laws written just for them. They are the only ones who have that right.

But like I said, fortunately this project is stalling in the system and deCode has basically given up on it.

[sek929]

Originally Posted by Kevin

Don't have em where I live either Zeus.

See America is a lot like Europe. Different parts of it are completely different.

You learned something today.

I wonder why he didn't know that in the first place, civilized indeed

[Doofy]

WTF is wrong with you people?

A discussion intended to be a cross between a heads-up and an "is this ethical?" question is turned into (once again) a discussion about the US vs the World.

The only reason I mention Americans in my second post in this thread is because:

1) It's happening in America (I caught it while watching a BBC relay of ABC news).

2) I thought Americans were supposed to be particularly opposed to this sort of thing, being the land of the free and all that.

Get a grip, people.

[BRussell]

Originally Posted by von Wrangell

Take a look at my second post in this thread. Just want to add one thing to what I already said about it. deCode got special laws written just for them. They are the only ones who have that right.

But like I said, fortunately this project is stalling in the system and deCode has basically given up on it.

Uh, you expect me to actually read the threads I post in?

I'm just trying to point out that, in any system for protecting human subjects, there are mechanisms for special cases like this. I don't know if this blood study fits - these things of course can always be debated. But the general regulation - and this exception - seems reasonable to me. Otherwise you either can't do the research or you have to do it in unnecessary circumstances, both of which are less desirable than this, IMO.