The moral dilemma in this case revolves around the issue of autonomy. The Alzheimer residents at St. Mary’s suffer from mental impairment, as a result of their disease, and tend to experience “intermittent competency”. Dr. Selleck is proposing to conduct a clinical trial in order to test the efficacy of the drug Tetrahydroaminoacridine in dramatically decreasing the “progression rate of Alzheimer’s disease” (Thomas & Waluchow, 129). Participants in the trial would include individuals who maintain some control over their mental capacities and are in the middle stages of Alzheimer’s. To qualify for participation in the study, “formal, written consent” must be obtained from both the patient and their closest relative, and the healthcare staff at St. Mary’s must agree. If a patient is deemed “legally incompetent”, then consent from the patient is not necessary, but consent from a relative is required for participation (Thomas & Waluchow, 129). The director of St. Mary’s, Ann Wilson, objects to these patients participating in the clinical trial. She argues that the residents at St. Mary’s are elderly, institutionalized, and impaired, and should not be victimized through scientific examination (Thomas & Waluchow, 129-130). The proposed clinical trial cannot access a large enough sample size without the assistance of St. Mary’s residents. The dilemma is whether a resident at St. Mary’s Nursing Home, who meets the appropriate qualifications, should be allowed to participate in the clinical trial or precluded from participating for the reasons stated by Wilson. While objections from a healthcare staff member at St. Mary’s may prevent residents from participating in the clinical trial, I argue that Wilson is obstructing the notion of a resident’s autonomy by denying the resident and their family the opportunity to decide to engage in a trial that could be beneficial in reducing the progression of Alzheimer’s.
Beauchamp and Childress (2013) define respect for autonomy as a moral principle involving “a norm of respecting and supporting autonomous decisions” (13). Patients suffering from Alzheimer’s disease may be only intermittently competent, but withholding participation of such patients from clinical trials on grounds of autonomy prevents future progression in combating this tragic disease. The patients fulfilling the criteria for this trial still maintain some mental capacities, and denying such patients the liberty to consent to participate in the trial is not respecting the autonomy of these individuals. A close relative may grant consent for the patient if they are legally incompetent. The residents at St. Mary’s who are eligible to participate in the trial should be granted the opportunity to express autonomy and such autonomy should be supported.
The director at St. Mary’s may express her concern for the Alzheimer patient’s wellbeing, but denying them the opportunity to receive a drug that has promising effects in helping to combat the progression of their chronic disease is further reducing what little autonomy they have left. Participation in the trial is not proposed to have any negative effects on the participants and has been cleared by multiple Research Ethics Boards. Participation in the trial will either benefit participants or leave them to carry out the projected course of the disease. A drug for Alzheimer’s can only truly be tested by trials involving individuals with Alzheimer’s and with Alzheimer’s disease comes questions of competency. If the patient and a close family member consent to the trial, participation should not be denied. Preventing this clinical trial not only affects the participants in the trial, but also impedes possible advances in treatment for other individuals with Alzheimer’s.
A study was conducted by Kim et al. (2001) to determine the competency of individuals with Alzheimer’s in giving informed consent. Results of the study address the controversy in gaining consent from such individuals. More information regarding the study can be found through the following link: http://ajp.psychiatryonline.org.proxy.library.emory.edu/doi/full/10.1176/appi.ajp.158.5.712
Works Cited
Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. New York:
Oxford UP, 2009. Print.
Thomas, John and Wilfrid Waluchow. Well and Good: A Case Study Approach to Biomedical
Ethics. 3rd ed. Broadview Press Ltd., n.d. Print.
Michelle’s blog post brings up a really interesting dilemma. Although difficult to know if someone will develop Alzheimer’s Disease, I believe that once a person is diagnosis, and the likely prognosis is known, the individual should be asked then and there if they would be interested in participating in studies down the road. It does not seem fair to allow someone who is currently not in the normal state of mind to make a decision that while may benefit others may also harm themselves. Also, asking relatives is not giving the individual autonomy, and thus I believe is not an appropriate solution. If the individual did not make the choice in the right state of mind then they should not be denied medication due to being put in a study.
Michelle brings up a lot of interesting points. I agree that there is definitely a concern surrounding autonomy with regard to even not allowing the patients consent if they want to. However, I think Wilson is abiding by the oath she took to do no harm. According to the case, the drug will slow the progression of Alzheimer’s, not reverse the process. It may seem like semantics, but from the perspective of the patient and his/her family, they may be given false hope if they are presented with this opportunity. Also, even consenting would have to be very carefully monitored to ensure there is no coercion occurring for the patients to undergo the experimental trials. So then, which is more important: autonomy or protection from harm (including that of emotional harm)?
While Michelle brings up many valid points, I believe that the autonomy behind patients who are considered to be “only intermittently competent” is something that can be further elaborated upon. According to the Alzheimer’s association, competence is the “capacity to understand the relevant options and consequences of a particular task or decision in light of one’s own values” (Respect for autonomy). Furthermore, the Association claims that people with Alzheimer’s should be allowed to exercise their remaining capacities in regards to their choice. In denying this “free exercise,” one is challenging the patient’s independence and dignity (Respect for autonomy). I would also like to point out the Association’s point in highlighting that “neither law nor ethics allows interference with a competent person’s choices purely on the grounds that the caregiver or another individual knows what is best for the person” (Respect for autonomy).. This statement is important in the sense that it prevents patients with Alzheimer’s from feeling worthless and hopeless. In order to be considered competent, according to the Alzheimer’s association, a patient with Alzheimer’s maintains the ability to understand the nature, purpose, risks, benefits and alternatives of the proposed treatment. However, I am curious as to who has the responsibility to decide whether or not a patient is considered to be confident. Are there categories that a patient is rated on and then measured along a scale?
“Respect for autonomy .” Alzheimer’s Association. N.p., Sept. 2011. Web. 25 Jan. 2015. .
I like the balance between autonomy and non-maleficence that Michelle suggests in her discussion of the article. I think Dr. Wilson is within her rights to express concern for patients’ well-being and stand up generally for such a vulnerable population and one could say it is her duty to do so under the principles of beneficence and non-maleficence, but the ethics surrounding research and medical procedures really revolve around individual choice. The study seems to have levels of consent in place by testing competency and allowing for both surrogate and patient consent. Participation in this study should be determined on a case by case basis between the patient and their family. Personally, I think saying otherwise serves as an example of paternalistic medicine.