No Right to Say "NO"as a Patient Research Subject?
Autonomy is an ethical principle applied to patients to the effect that the patient can make their own medical decisions of the options available with regard to their medical care and management. The patient has an autonomous right to say "No!".This principle has been followed both by ethical consensus and law for many years in how patients should be and are treated in the healthcare system.
The April 2011 issue of American Journal of Bioethics has an article by Sarah J.L. Edwards (page 3) provides a complexity to the application of that autonomy in the case where a patient volunteers to become a research subject in a medical investigation. The suggestion is that medical research subjects should be denied full autonomy during participation particularly in removing themselves prematurely from further participation in the study or reject or fail to follow instructions about the protocol, fail taking the study drugs or failing to permit some non-invasive or harmless procedures. The argument presented is that this behavior may harm the study, “harm science” and potentially harm future patients. The idea is to have the study participants sign a contract which they must follow or otherwise be subjected to penalties. What this means is that the subjects who are patients have just lost part of their autonomy at the outset to prevent “harm”. Yet as volunteers for research a reasonable assumption to make is that the nature of the studies usually provide no practical self-benefit (including monetary) to the patient except for the subject being and feeling altruistic. The reason for the true absence of benefit is that good studies are usually performed in a blind and randomized way so that no subject knows what treatment they are receiving. Also, the study is devised because science has not yet established whether one treatment is more effective than the other. One could argue that participation in the study makes the individual no longer a patient but simply an experimental subject and no longer fully autonomous.
So, my question here is: do you think there is "harm" and should all subjects sign away their full autonomy as a patient with a contract not to leave the experiment and to follow fully its details otherwise subject to penalty of one sort or another? ..Maurice.
posted by Maurice Bernstein, M.D. @ 7:06:00 PM
4 comments
4 Comments:
Thank you for an interesting post, Maurice.
I have yet to read the article, and if the brief summary in this post is any indication its an article I would really want to read as well.
If I understand your question correctly it is (1) whether there is this "harm" to future patients that results from the various refusals that currently permissible for human research subjects, and (2) whether this harm is grounds for denying patients full autonomy when they become research subjects by means of contractually enforced penalties?
As to the first question, I would have to say it is almost trivially true that non-compliance and lack of participation on behalf of human research subjects leads to a kind of harm for other patients. The harm is not direct, but there is a definite sense of a significant "opportunity cost" that is operational here. Research is delayed, breakthroughs and new technologies are held back - for every treatment or technique that could be used today if it was not for the lack of research subject cooperation in trials past, every patient that could benefit from these developments is denied that benefit and thereby harmed.
Personally I find this argument for possible future harm unconvincing. To start, it is not at all clear to me that future patients that could potentially benefit from new research are in any robust way owed these benefits by the current research subjects. That is, I do not see how if my being a current research subject in a study incurs upon me an obligation to possible future recipients of whatever benefits that result from the study. Certainly this forms a prima facie reason for me to enter and complete the study, but I don't think it generates a duty or obligation to do so.
Moreover, it is not at all clear that on balance denying full autonomy to current research subjects for the greater benefit to future patients necessarily passes the implied utilitarian calculus. After all, even utilitarians will agree that denial of autonomy is itself a harm and thus whatever potential harms (in terms of benefits lost) this truncated autonomy policy seeks to prevent must be weighed against the actual harms incurred in terms of the loss of autonomy by the research subjects.
Therefore, even if there is a kind of harm that is involved here (answering Yes, there is, to your first question) it is doubtful if this is a strong enough reason to deny full autonomy to patients who seek to enroll in clinical trials.
If setting a contract is ethical and practical,the matter of contracting the relationship of a research volunteer and the investigator will revolve around setting penalties. I wonder if possibly an analogous situation involving a gestational contract (volunteering but in a non-research setting) would be of value in this regard.
Take for example the gestational surrogate who accepts to allow the fertilized egg of a couple to be implanted into her uterus, thus becoming pregnant and continuing the pregnancy to the delivery of a child who will then be returned to the parental responsibility of that couple?
This acceptance by the surrogate and the relationship between the surrogate and the couple is an example where the relationship is not informal but currently legally contracted and presumably there is set some penalty if the surrogate does not perform as to the contract. The question is what penalties are most reasonable and legal? And does the issue of setting penalties tell us something about any apparent need or difficulties to set penalties for a research subject?
Suppose the surrogate is physically suffering from the pregnancy or finds that it has been too disruptive emotionally for her life or for some other reason decides and does abort the pregnancy. How should the penalty be decided? What if during the pregnancy it is shown that the child will be defective and the surrogate refuses to abort? What should be the penalty?
Can anything be learned from the gestational surrogate situation about the value or futility of attempting to set penalties for the patient who volunteers for medical research? Or both examples totally non-comparable? ..Maurice.
Uh, two words "Nuremberg Code"
Specifically point #9, but point #1 could also come into play if it wasn't followed to the letter....
Unless the research subject is being paid to participate in the study, there is no way any contract with a "penalty clause" would hold up under legal scrutiny, and even then, the maximum liability would likely be the amount the subject was paid. There is no way that they could legally force a subject to continue to participate in a study against their will (I asked a friend who is a US Circuit Court Judge).
A system such as proposed would, in all likelihood, also have a chilling effect on the potential number of research subjects that may be willing to participate in studies. Good luck getting anyone to volunteer......
Even in community based research studies overseen by IRB's, such as are implemented with experimental EMS procedures, a consensus has emerged on two predominant policies in recent years:
1. Community members should be given a means of opting out of any IRB approved studies in advance
2. Even if initially enrolled, the patient or their PR must be given the option to remove them from further participation in the study at the earliest possible opportunity.
Bottom line - there are always going to be a small percentage of subjects who, for one reason or another, will not complete participation in any given research study. Those conducting the study should simply plan for this and make adjustments accordingly. If they see a significantly higher number than normal withdraw from any specific study, then my recommendation is they look in the mirror and figure out what they did wrong in setting it up in the first place.
IMHO the whole penalty idea should be DOA.
Hex
Let me start out by saying that I fully support the principle of autonomy in research and the problematic example I'm about to give does not and did not change the fact. But I wanted to put it out there as thought, particularly for anyone sitting on an IRB.
When I sat on an IRB we came across a trial that appeared it would be difficult to enroll, and particularly difficult to keep subjects in follow up. The study did have medical risk, and it's benefit was highly unlikely for the enrolling subjects. There was no honorarium or financial benefit. In studies like this then, it is typical to expect that one of the primary reasons for subject participation is beneficence, to potentially help others.
As the years wore on, they did manage to enroll on a reasonable schedule, but drop out due to non-study endpoints (ie un-related to safety endpoints or other study outcomes) and lost-to-follow-up was very high. Because of the high drop out rate and lack of outcome data, the protocol continued to have to be amended to increase sample size and ensure some statistical significance.
Ultimately, the researcher lost the race against the grant's time clock. Funding ran out. They'd enrolled 30% higher than their originally planned enrollment, but it was still not enough to meet their statistical plan...because of all of the drop outs.
When the study closed out, the IRB revisited the protocol in discussion and we all came to the conclusion that essentially all of the subjects that did participate had been subjected to a risk/benefit ratio that we would have found unacceptable had we known it at the outset. They had been subjected to risk, but there would be no benefit to anyone from the research, likely ever. Hindsight.
So, while I don't support a contract or anything that could even be slightly coercive, I do recognize that a subject, particularly too many subjects, dropping out of a study can effectively put other other research subjects at effectively greater risk because the risk/benefit changes. This is wholly separate issue from the potential benefits for others from the research.
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