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Should Ethics Committees in clinical research be mandatory?

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Hotu Matua
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Let me start by saying that I have worked for 13 years in clinical research for a pharmaceutical company, and I have been studying Objectivism for just a year.

International standards for clinical reseach require protocols to be approved by an Ethics Committee (EC), before being presented for potential participants.

The purpose is to saveguard the rights and well being of patients including, the theory goes, reviewing whether the principle of respect for patients as autonomous beings is being followed.

I have preached as part of my job the principles and norms derived from many international conferences, and stressed the importance of following them.

Now, under my new objectivist perspective, I am starting to see it in a very different light.

While I would thank a committe of experts to inform doctors and patients about their opinion on the ethical aspect of the investigation being proposed, I cannot understand why govenrments of most conutries have made this a legal requirement.

This basically means that if you fail to obtain approval from an Ethics Committee (EC) and dare to start a clinical research, you may go to jail, even if you can demostrate that a competent patient gave his consent in a free and informed way. You may go to jail even if there is no proof that the experimental intervention made any harm to the patient. You may go to jail even if you demostrate a benefit to the patient.

In short, no private agreement between patients and doctors, or doctors and Pharma could be implemented without the sanction of an Ethics Committee.

What do you think about this?

Should approval by an EC be enforced by the government?

In an ideal world, what is the role that EC should play? Who should be financing the EC? patients? Pharma industry? hospitals? doctors?

Edited by Hotu Matua
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The knowledge required for the average patient to make an informed decision to participate is way outside the educational norm. Someone informed, but uninterested in the commercial aspects of the project is needed. That is what the Ethics Committees you deal with represent, and it is wholly valid.

However, it needn't be, and shouldn't be, connected with government, as you intimate. Perhaps the experimenters would have their experiment rated by a professional organization, who insured the participant against certain adverse effects. The professional rating company would be something like an accounting firm. Potential participants would rely on the rating the experiment gets, knowing what financial penalties were agreed to if their rating proved incorrect.

One way or another, I think demand would soon be met with supply. The overall safety of the scheme depends just on our constitutionally-guaranteed rights, where fraud, reckless endangerment, etc., are grounds for criminal and civil penalties.

Mindy

Edited by softwareNerd
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Thanks for your response, mindy.

I have two questions:

Who sould be paying for the salaries and overall functioning of that professional, private organization (Ethics Committee)?

When you say that such an organization (Ethics Committee) is needed, are you hinting that no patient could take under his sole responsibility to participate in a clinical trial? Could a patient agree to participating even if the EC has rejected the trial?

Edited by softwareNerd
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While I would thank a committe of experts to inform doctors and patients about their opinion on the ethical aspect of the investigation being proposed, I cannot understand why govenrments of most conutries have made this a legal requirement.
The basic reason is that in the past, medical researchers have engaged in fraud and the initiation of force against unwitting experimental subjects.
This basically means that if you fail to obtain approval from an Ethics Committee (EC) and dare to start a clinical research, you may go to jail, even if you can demostrate that a competent patient gave his consent in a free and informed way.
Well, that's a problem about your country. And there, I think the issue comes down to the basic assumption of freedom that we, at least, presently enjoy.

It is proper that consent (in all matters) be appropriately informed. If a researcher injects or dopes a subject without consent, that's plainly initiation of force, and we need not add new laws to address the matter. Any supposed "consent" that is obtained fraudulently is not, in fact, consent. So the protections already exist in the law, the only problem was that they were not enforced, because it was "for the good of society".

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Thanks for your response, mindy.

I have two questions:

Who sould be paying for the salaries and overall functioning of that professional, private organization (Ethics Committee)?

When you say that such an organization (Ethics Committee) is needed, are you hinting that no patient could take under his sole responsibility to participate in a clinical trial? Could a patient agree to participating even if the EC has rejected the trial?

It is to the experimenters' advantage that subjects sign up, so it would ultimately be they who foot the bill. Certainly, some subjects would have the education and specific knowledge to evaluate participation themselves. About one in a million. When there are unknowns involved, which is always the case in experimentation, there is an added layer of danger and of complication to the process of evaluating danger.

Of course people would be legally allowed to participate even if "an" EC rejected the trial. My whole thought is about non-governmental evaluations and assurances. However, a wise organization wouldn't hold trials that reputable ECs had rejected. Just asking for law suits!

Obviously, the potential for an EC to be in the hospital/research lab/pharmaceutical company's pocket looms large. But as long as the government stays out of it, and suitable penalties are in place for misrepresentation, there is no reason such an organization couldn't succeed at the task.

I imagine a TV commercial soliciting people with A and B symptoms, bragging that their protocol had been approved by such-and-such Ethics Committee, like the Better Homes and Gardens Seal of Approval, on steroids.

Mindy

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The basic reason is that in the past, medical researchers have engaged in fraud and the initiation of force against unwitting experimental subjects.Well, that's a problem about your country. And there, I think the issue comes down to the basic assumption of freedom that we, at least, presently enjoy.

It is proper that consent (in all matters) be appropriately informed. If a researcher injects or dopes a subject without consent, that's plainly initiation of force, and we need not add new laws to address the matter. Any supposed "consent" that is obtained fraudulently is not, in fact, consent. So the protections already exist in the law, the only problem was that they were not enforced, because it was "for the good of society".

Thanks fo your comment, David.

Yeah, I understand why governments have enforced the use of Ethics Committees from a traditional statist perspective. But what I meant is that I don't see the reason from an Objectivist perspective. Just as in any other situation where a person has to exercise his autonomy, it is in the bes interest of the customer/client/patient to understand the risks and benefits of what is being offered, and demand the appropriate guarantees.

For example, in a normal non-investigational setting, when you go to a doctor and he makes a diagnosis and prescribes a treatment, you do not normally expect that an Ethics Committee or any institutional board meet and approve that specific diagnosis and treatment made/prescribed to you. You trust in the qualifications of the doctor based on a previous assesment of his competence by an academic board . You trust in a law system that will punish the doctor if he proves to be incompetent. You may also want to seek a second opinión, but that is your call as a patient and you must pay for that.

So, if governments do not enforce the use of EC for normal medical practice as a prerequisite of any patient decision, why would it enforce it in the context of a clinical trial?

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Yeah, I understand why governments have enforced the use of Ethics Committees from a traditional statist perspective. But what I meant is that I don't see the reason from an Objectivist perspective.
But it is related to the legitimate actions of government, namely protecting the rights of individuals. If a person goes to a doctor seeking treatment for a medical condition, then it is fraud and a violation of the patient's rights for the doctor to claim to treat the condition while not actually treating the condition. The problem with IRB as it actually exists is that it prohibits perfectly proper actions in the name of preventing improper actions, i.e. it is overkill by many orders of magnitude.
So, if governments do not enforce the use of EC for normal medical practice as a prerequisite of any patient decision, why would it enforce it in the context of a clinical trial?
Essentially, they do enforce the use of a kind of IRB, via medical school training and licensing. Thus there is no separate review for ordinary medical treatment (and when the medical treatment is not ordinary, it is subject to IRB review). For example, prescribing Norvasc for hypertension is a form of normal medical treatment and if a doctor were to do so (assuming no counter-indications) then his actions fall under the rubric "normal conduct". But testing new drugs is, by definition, not included in "normal medical conduct". If a doctor were to prescribe colchicine as treatment for hypertension, that would not be normal, and the patient would have a right to know that his doctor is nuts.

Basically, it reduces to the idea that in the context of our knowledge (including accumulated medical knowledge), certain actions pose no risk but others do. A patient trusts that his doctor will inform him of risks, in lieu of a warning, the patient makes a particular assessment that the doctor's recommendation carries no risk. IRB, ideally (and not in actual practice) is a means of independently assessing whether the assumption of being risk-free is valid. The requirement is not that you cannot recommend a risky course of action, but that you must inform the patient of that risk, and to withhold material information regarding risks is an example of fraud.

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When one consults his own doctor, there is no conflict of interest in receiving good advice and treatment. (Though there are abuses of this.) But in an experimental trial, the interests of the institution running subjects is different from those of the individuals who might participate. It takes some inducement to get people to participate.

It is the conflict of interest, occurring in a situation at the cutting edge of technical knowledge, that makes an outside agency necessary, for all but the rare individual.

Mindy

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But it is related to the legitimate actions of government, namely protecting the rights of individuals. If a person goes to a doctor seeking treatment for a medical condition, then it is fraud and a violation of the patient's rights for the doctor to claim to treat the condition while not actually treating the condition. The problem with IRB as it actually exists is that it prohibits perfectly proper actions in the name of preventing improper actions, i.e. it is overkill by many orders of magnitude.

I am not sure if I am following you.

Are you saying that the submission of a study protocol to an IRB should be enforced by the government as part of its legitimate actions?

We are not discussing here the value of an IRB (I must say, though, that sadly the majority of IRB reviews do not in fact add any meaningful insight to the ethical aspects of the trial but just delay the start of trials, sometimes depriving patients with life-threatening conditions from a real option).

What we are discussing here is the use of an IRB, as a way for the State to "protect" its citizens.

It is not a matter of my country.

In the USA, if an American doctor insists in conducting clinical trials without the approval of an IRB, he may lose his license, which means that he can't treat patients without going to jail.

I am not talking about fraud, damage to patients or deceiving patients. We are talking about following a procedure that entails a third party opinion, whether the two parties involved (doctor and patient) want it or not.

Essentially, they do enforce the use of a kind of IRB, via medical school training and licensing.

Then, what about having certified/licensed investigators and then dropping altogether the requirement of an IRB approval? A certified investigator would, in principle, be trusted for his ability to determine whether a protocol is scientifically sound and ethically accpetable to be presented to patients for their consent. IRBs would not have to review each protocol the investigator engages in. IRBs would only act as a third party to review complains of patients, doctors or Pharma representatives. And fraud or damages would be prosecuted by law, as any other crime.

Anyway, is it compatible with Objectivism to expect the government to prohibit a doctor to treat patients without a license?

I guess I either missed what you are meaning or I am misinterpreting Objectivism.

Thus there is no separate review for ordinary medical treatment (and when the medical treatment is not ordinary, it is subject to IRB review). For example, prescribing Norvasc for hypertension is a form of normal medical treatment and if a doctor were to do so (assuming no counter-indications) then his actions fall under the rubric "normal conduct". But testing new drugs is, by definition, not included in "normal medical conduct". If a doctor were to prescribe colchicine as treatment for hypertension, that would not be normal, and the patient would have a right to know that his doctor is nuts.

I don't see the distinction from a conceptual viewpoint.

If I am undergoing a "routine" surgical procedure, for example, I need to know the risks and potential benefits, not withstanding it is "normal" or "experimental". I need to know the alternatives, notwithstanding it is "normal" or "experimental". And I have to give an informed consent, notwithstanding it is "normal" or "experimental".

If no IRB is requested to review the doctor's proposal before I decide, why should it be requested in a clinical trial?

A clinical trial might be far less risky than a "normal" surgical procedure.

Basically, it reduces to the idea that in the context of our knowledge (including accumulated medical knowledge), certain actions pose no risk but others do.

I think it basically reduces to the idea of being free to choose a second opinion, or the opinion of a board of experts, versus taking my chances.

In my ideal world, Ethics Committees would exist, but they would be few and really good.

There would be certified investigators at the reseach sites, and that certification would be made by private professional organizations.

Pharma Industry would submit clinical trials to two or three highly reputed IRBs (say, one in Europe, one in the USA and one in an emerging country) not because it is forced to do it, but because it is in its best interest. Once Pharma had their approval, it would send it to individual doctors or institutions, alongside the approval, just to make more robust the case for the trial.

Doctors and patients would be free to choose another IRB opinion, or just go ahead right away with the trial.

The translation/verbiage of the informed consent would be checked by doctors and patients. If the wording is not proper for the level of education of the patients, the patients would be the first to protest. Since the investigator would be a certified one, he would understand how an informed consent process has to be handled and what elements of the informed consent form should never be missed. His reputation, certification, license and liberty would be at stake.

The State would not have to review any trial. No FDA or other government agency sanction would be needed.

Timelines would be significantly shorten startup timelines, reduce costs and improve access to promising drugs.

What do you think?

Edited by Hotu Matua
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Are you saying that the submission of a study protocol to an IRB should be enforced by the government as part of its legitimate actions?

No, I'm saying that there is something behind IRB law that reflects the proper interests of government, but that the actual law goes beyond that (therefore into improper law). That specific thing is the requirement that individuals not engage in fraud, and the specific form of fraud to be concerned with is withholding the material information that a certain treatment (in the medical context) is not usual, customary and ordinary.

IRB law does not directly limit a person's individual right to do whatever they want (The tentacles of IRB law extend beyond medicine: I run smack into IRB issues in my life). However, medical licensing law does. I was under the impression that you were refering to a feature of Mexican law such that failure to conform to the requirements of IRB law would lend you in prison. In the US that would only be true indirectly, if you fail to conform to IRB law, your medical license is suspended, and you still practice medicine. But there is no direct provision for jail that arises from IRB law.

I am not talking about fraud, damage to patients or deceiving patients. We are talking about following a procedure that entails a third party opinion, whether the two parties involved (doctor and patient) want it or not.
As a characterization of one of the absurd consequences of IRB, that could easily be the case. You asked why such law might properly exist, and therefore we are talking about fraud. The answer, wholely and entirely, is that whatever action the government takes in this domain is related to the criminality of fraud. It does not follow that everything done "in the name of fraud prevention" is therefore justified.

The principle is, I think, quite straightforward. All goods and services come with a defeasible warranty, so you either have to openly repudiate the warranty or you have to abide by it. The warranty that a doctor makes is that he provides the best service that he can, and follows usual and customary standards in his practice. (The same is true of accountants, lawyers, and so on). You have to let patients know that you're doing something unusual, if you do something unusual. If you do not do so, then you are liable for a fraud action.

So what is simply required is that doctors inform their patients of risks ("inform" here means "cause to grasp", not just "obtain a signature").

Anyway, is it compatible with Objectivism to expect the government to prohibit a doctor to treat patients without a license?
No, completely independent of IRB and prior to the invention of such rules, it was and still is improper to require state licensing of doctors in order to practice their craft -- doctors or anyone else.
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Now it is clear to me, David.

Thanks for your clarifications and patience.

Just one question out of curiosity (not directly linked with the arguments):

How is that a doctor in the USA can practice medicine if his license has been suspended? Did I understand correctly? If so, what would be the case for the license?

(i am not advocating government licensing, it just sounded weird to me)

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Just one question out of curiosity (not directly linked with the arguments):

How is that a doctor in the USA can practice medicine if his license has been suspended? Did I understand correctly? If so, what would be the case for the license?

(i am not advocating government licensing, it just sounded weird to me)

If an M.D. has his license suspended, he cannot continue to practice medicine.

Mindy

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The discussion here is fascinating and informative. As I told Hatu Matua privately, I just completed degrees in criminology and social science and my first and last courses for the bachelor's and master's were both in professional ethics. Beyond that, I read Atlas Shrugged in 1966 and then took the "Basic Principles of Objectivism" course in my town. Over the years, I have published over 300 newspaper and magazine articles, many of them profiles of innovative businesses and entrepreneurs. The point is, I have a lot background and nothing much to say that is better than I have read.

We agree on the fundamental principles. The problem is to put that in writing so that it is enforceable, at least as contract, if not criminal law. Ultimately, as a result of appeals to higher courts, the only applicable standard is the "reasonable man." What would the average reasonable person expect? That is not much of a standard. It is like awarding Olympic medals to people who seem pretty darned good at sports.

No, I'm saying that there is something behind IRB law that reflects the proper interests of government, but ...

You have to let patients know that you're doing something unusual, if you do something unusual. If you do not do so, then you are liable for a fraud action.

From the earliest days of professional medicine, the patient seldom understood what the doctor intended. I know from teaching robotics in factories that you can have a hardware crash that damages the workcell and when your boss asks you if you explained the procedure he knows full well that what you saw was six guys nodding their heads up and down and not understanding a word you said. Medicine is a lot like that for the patient. You get all the words, but you know there is some meaning you are missing. My last time in consultation, I asked the doctor for evidence and the doctor gave me 60 pages with 120 footnotes. I'm still working on it...

In business, we say that the customer is always right. In real estate, they say, "Buyers are liars."

So, the professional review boards serve a purpose intended by and requested by the doctors themselves. You cannot trust the patient. And such review boards exist in business, also, as for instance the local Board of Realtors™.

Whether or not these professional guidelines should have the force of law is not clear. The government has a duty to protect against fraud. We allow the police to proactively protect life and property. Do we not allow the government to proactively protect against fraud?

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The problem is to put that in writing so that it is enforceable, at least as contract, if not criminal law. Ultimately, as a result of appeals to higher courts, the only applicable standard is the "reasonable man." What would the average reasonable person expect? That is not much of a standard.
That's right -- I'd say that it's part of "the program" to make explicit -- to express as objective law -- what is allowed and what is disallowed.
Medicine is a lot like that for the patient. You get all the words, but you know there is some meaning you are missing.
This on one of the reasons that there is a review process, because there is a difference between obtaining a perfunctory signature and obtaining an actual agreement with the patient that they will undergo some procedure, thus there is a need to cause the patient to grasp what the doctor is providing.
Whether or not these professional guidelines should have the force of law is not clear. The government has a duty to protect against fraud. We allow the police to proactively protect life and property. Do we not allow the government to proactively protect against fraud?
The problem with peremptory protection is that it can elevate the imaginable to the state of the actual. IRB law is excessive in that it makes it utterly impossible to commit fraud, since it makes it impossible to do many things that are not fraud. A proper IRB law would be much more narrowly tailored.
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But is there any defined Objectivist position of peremptory protection of rights in principle?

We have heard about the concept of "objective threat" to evaluate many situations, but what is exactly an objective threat?

By its own nature, a "threat" involves likelihood, probability. A threat is not a happening. It is a prediction.

So, how objective law can be written based on probabilities?

If a short, thin man tells a big muscular man "I am going to kick your arse". Is this an objective threat? If it is the big man who says that, is it now an objective threat? If the short thin man is known to bear weapons, ¿is it now an objective threat?

I am worried with the overall concept, because someone could point it out as a weakness of Objectivism, that we will never be able to define the proper role of a government as it will be impossible to tell whether the government should or should not act to "protect" a citizen against a specific "threat".

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But is there any defined Objectivist position of peremptory protection of rights in principle?
The basic principle is this, from Rand's interview "Objective Law", that 'every man ahead of committing an action would be able to tell, is the crime forbidden, what penalty would he incur if he commits it, and can make a decision accordingly'. Peremptory protection then reduces to stating "these acts are forbidden, and if you perform the act, you will be punished in this manner".

What follows, next, is a specification of what acts are properly prohibited. The act of fraud, performed by a doctor, would be an instance of that which is prohibited. The difficult question is specifying which acts do in fact constitute fraud. We should not look at question of "threat" and probabilities. For one thing, "threat" refers to two distinct things, the initiation of force ("he threatened me") and an indication that some negative outcome is probable ("it's threatening to rain today"). Only the actual initiation of force is to be prohibited by law -- risk is not something that should be prohibited by law.

Fraud is obtaining a value by omitting material information or providing false material information. The principle is that the exchange of value is conditional, i.e. "I give you A on the condition that you give me B", and fraud is violation of one of the conditions. Thus if you give C rather than A, that is fraud. With respect to what doctors provide, they provide a service, and it is a rather abstract service. They do not sell guaranteed results (well, usually), instead they sell a promise to act in the patients best interest according to certain professional principles. When they violate those principles, they have violated the fundamental material condition that the patient relies on in agreeing to the exchange. As a concrete example, a doctor who (silently) prescribes colchicine (or sugar pills) as an anti-hypertensive has committed fraud. However: the doctor can avoid the fraud by simply informing the patient that his suggestion is medically irrational and that there is no evidence to support the conclusion that colchicine (or sugar pills) are an effective anti-hypertensive.

The patient must be the one who decides what risks to take, therefore it is not proper for the government to decide "That risk is too great for you to take". But the patient must know that there are risks, when there are, because that is essential in his decision to accept or decline the treatment. So the relationship to "risk" or "threat" is indirect, and the only legally relevant question is whether the patient was told the truth.

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The difficult question is specifying which acts do in fact constitute fraud.

Yeah, that's the difficult part.

I suppose that the State should forbid acts that do not constitute by themselves a violation of a right when all these conditions are met:



  • The act is very likely to result in the violation of a right
  • This violation is very likely to be associated with significant damage to the victim's health, properties or freedom
  • The potential victim has no reasonable way to escape /avoid that damage

These criteria could be used to forbid, for example, a drunk from driving a car.

However, some people could argue that throwing a banana peel on the floor, or marketing a drug without thorough review by an independent agency, would also meet these criteria.

I have used in my criteria the words "very likely", "significant" and "reasonable". These would be either defined objectively, or left to subjective judgement by the lawmaker in turn!

Edited by Hotu Matua
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