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.