The content on or accessible through Medpedia.com is for informational purposes only. Medpedia is not a substitute for professional advice or expert medical services from a qualified health professional.
Read more
Medpedia Answers
(Other)Medpedia Answers is a platform for asking and answering questions about health and medicine. Read more.
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 on Medpedia 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? Does the patient no longer have the right to say "No!" ..Maurice.
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 on Medpedia 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? Does the patient no longer have the right to say "No!" ..Maurice.
asked May 18, 2011 at 09:06PM in Other
-
0Votes
answered May 19, 2011 at 11:03AMThe patient should always have the right to remove themselves from the study as frustrating as it might be to the researcher and study team. Having patients drop out of a study is just as important to study as why those that stayed in stayed in. Patients start and stop medications all the time and I don't fire them as patients becuase they don't always follow what I say. -
1Votesanswered May 19, 2011 at 11:03AMThe patient should always have the right to remove themselves from the study as frustrating as it might be to the researcher and study team. Having patients drop out of a study is just as important to study as why those that stayed in stayed in. Patients start and stop medications all the time and I don't fire them as patients becuase they don't always follow what I say.
-
0Votesanswered May 19, 2011 at 09:47PMI would agree with those who would challenge the concern that there is sufficient statistical evidence to show that significant numbers of subjects either leave a research project prematurely or fail to cooperate with the protocol to cause "harm" to the study. And then in well constructed study if there were some losses, in what way would the harm be expressed and how would that affect future patients. All of this has to be made clear to all including the subject if one is to remove their autonomous decision-making capacity. ..Maurice.
-
1Votes
answered May 21, 2011 at 07:12AMMaurice, no person should be deprived of their right to say "no" to anything done to their bodies or minds. Since the results of experimental treatments are, by definition, unknown, it would be absurd to penalize someone for dropping out of a study that was making them sick. Moreover, all studies with which I have ever been associated with have a predicted dropout rate built into them, to that is statistically taken into account when the results are published.
Finally, even in the usual course of contract law, courts have frequently imposed only reduced penalties on those in breach where the breach is seen as more "efficient" than completion of the contract, or where little harm is done to the party against whom the breach has occurred. That is one reason why restrictive covenants are becoming more difficult to enforce.
SHORT ANSWER: No. No one should be required to sign away their autonomy in order to participate as a research subject. -
1Votes
answered May 23, 2011 at 08:51AMI think there should be legislation that forbids the assessment of penalties in research studies or clinical trials, for those who withdraw. Why should a patient give up his or her rights for a future benefit to others, without choice? That is what was done, albeitly in a twisted way, in the twin studies by Dr. Mengele in WWII concentration/death camps. If there aren't enough patients as a result of withdrawal(s) by patient(s), then postpone the study/trial and review the incentives for participation. Also, there have been a number of toxic reactions to experimental substances, especially in cancer research, resulting in Grade 3/4 reactions. Patients often know that something weird is happening in their body, and they have a right to put a stop to that, or even something as mundane as just changing their mind. Ironically, the assessment of penalties for changing one's mind will drive more people away from participating in the first place, than anything else, especially in these hard economic times. That is my opinion, for what it is worth.
Here is the journal abstract link:
http://bioethics.net/journal/j_articles.php?aid=2502&display=abstract -
1Votes
answered May 23, 2011 at 10:49AMRespect for research participants must be maintained, and this is done by providing autonomous decision-making. To deny this would be in direct violation of any standard of medical ethics and should not be tolerated.
I will say that complete data is essential for the results of a research study. When a participant expresses interest to withdraw or does not follow-up, I feel it is appropriate to explain the negative impact on the study. Explanations should be provided as to allow a fully informed decision and not to be manipulative or coercive. -
0Votesanswered May 24, 2011 at 04:19PMThanks for all the comments,
Now, how would you all look at the differences in responsibility, ethics and the need for contracts in a different medical situation of "volunteering" but in a non-research setting? 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?
The matter of contracting the relationship of a research volunteer and the investigator will revolve around setting penalties. In this regard, again, 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.
Sign-in
to post an answer to this question.
Related Questions
in
Other
- What are the limits of patient autonomy in medical decision making?
- How much, as a patient, would you NOT want to know about your medical illness and treatment?
- In the doctor-patient relationship, who is the "boss"?
- Are IV steroid injections harmful when a woman is pregnant?
- Are excessive calcium supplements harmful for someone with heart disease?
- Should health care institutions comply with a patient's request for racial preferences in care?
- Is it OK for patients to lie to their doctor?
- Is sheesha (also spelled shisha) harmful or not?
- Should the 4 Ethical Principles (Autonomy, Beneficence, Non-Maleficence and Justice) be applied differently in the elderly compared to those who are younger?
- Are there harmful side effects from using sweetener?
- »» See All
The content on or accessible through Medpedia.com is for informational purposes only. Medpedia is not a substitute for professional advice or expert medical services from a qualified health professional.
Read more