Background: Dr. Sandra Selleck is conducting a clinical research trial sponsored by the Alzheimer’s Society, to test a new drug that can possibly slow down the progression of Alzheimer’s disease. This research requires the inclusion of patients with mild Alzheimer’s, which is why Dr. Selleck has reached out to the director of St. Mary’s Nursing Home for Alzheimer’s patients, Ann Wilson, asking for residents to become participants in this study. Dr. Selleck has specified though that in order for these patients to participate, there must be no objection by any of the staff at the nursing home of the patient’s participation, and that the patients need to provide written consent or have their closest relative provide written consent. After hearing these conditions, Ann rejected Dr. Selleck’s request deeming this research trial as an exploitation of “extremely vulnerable people” (Thomas, Waluchow, and Gedge 116-117). The primary moral dilemma in this situation is the question of whether or not Ann actually has the right to reject Dr. Selleck’s request.
Discussion: I think Ann should not have rejected the subjects’ participation in this research trial on the basis of respect for autonomy. Firstly, the concept of autonomy is a person’s right to make their own decisions as long as they are deemed legally competent, and if they are not competent, then they will have a medical proxy to make those decisions for them. In this case, Ann is simply the director of the nursing home and not a medical proxy for any of these patients indicating that she lacks the right to make this decision for any of these patients. Secondly, as a health care professional, Ann must abide by the principle of respect for autonomy, which obligates her to disclose information; because Ann responds to Dr. Selleck’s request without disclosing even the existence of the research trial with any of the patients or the patients’ families, she is failing to uphold this obligation. Without giving the patients and their families information about said research trial, they do not even have the opportunity to bring about their own decisions (Beauchamp and Childress 106-107).
Concurrently, a secondary moral dilemma of this case is whether or not human subjects should be participants in research studies. According to Ann, this research should not be conducted on the residents because these patients are not at their best and “have been through enough in their lives” (Thomas, Waluchow, and Gedge 116-117). While some people may believe in this statement, I disagree because of the support this research has already acquired. The Alzheimer’s Society, which often partners with research programs to further knowledge about the disease and ways to aid patients, has sponsored this specific research suggesting its wholehearted support for this research. Additionally, two ethics committees which are probably similar or related to the roles of the Department of Bioethics’ Clinical Center Ethics Committee and Institutional Review Boards, have carefully reviewed all aspects of the research approving it on the grounds of having one of the major focal virtues—moral integrity; the committees’ thorough examination of the research has ensured that it is being done for the right reasons. Thus, Dr. Selleck should be able to have patients from the St. Mary’s Nursing Home participate in the research study should they choose to do so.
Works Cited:
“Alzheimer Society Research Program.” Alzheimer Society, http://www.alzheimer.ca/en/Research/Alzheimer-Society-Research-Program
Beauchamp, Tom L., and James F. Childress. Principles of Biomedical Ethics. New York, NY: Oxford University Press, 2001.
“The Department of Bioethics.” National Institutes of Health, https://www.bioethics.nih.gov/clinical/index.shtml
Thomas, John E., and Wilfrid J. Waluchow. Well and Good: Case Studies in Biomedical Ethics. Ontario: Broadview Press, 1987.
Hey Laura!
I agree with you that Ann should not have total veto power in whether or not subjects are allowed to participate in the clinical research trial. Autonomy can play a factor in this decision, but another issue in this case is whether or not the patients are considered legally competent. Adults are considered competent until shown to be otherwise, yet mental competency has varying levels related to displays of lucidity, alertness, and the like (Thomas, et al. 119). For this case, what is the cutoff of competency? Is everyone who is considered competent permitted to participate in the study if they choose to do so and everyone considered incompetent forbidden? It may be the obligation of the healthcare professional to keep the best interest of the patient in mind, but that does not necessarily mean that the patient or the patient’s family should not hear about potential opportunities or be forbidden from participating in prospective research.
In some situations, a family member might know more about what a patient would want to do, whether participating in research or not, based on the relationship they have established over time as compared to a health care professional who only recently started seeing the patient. For example, my grandmother passed away almost two years ago and was suffering from dementia. While she still remembered who I was and memories we shared, she was a diabetic and would forget to take her insulin. Eventually she needed to move into a full time assisted living facility since she was unable to take care of herself. After visiting with my grandmother one day, my mother explained to me how she hoped to never reach this stage in her life. She talked about how she would not want to live in a world where she could not remember in the short term or long term or was unable to care for herself. If my mother were in this situation, I would not want Ann to immediately reject participation in the research without talking to me first because I would give consent for my mother to be a part of this research study since she expressed numerous times, while competent, how undesirable and depressing her life would be with Alzheimer’s disease.
Works Cited:
Thomas, John E, et al. “Case 3.2: Nonconsensual Electroconvulsive Therapy.” Well and Good: Case Studies in Biomedical Ethics, Broadview P, 1987.
Accidentally put the citation for the wrong case…whoops.
Works Cited:
Thomas, John E, et al. “Case 3.1: Research Involving Alzheimer Patients” Well and Good: Case Studies in Biomedical Ethics, Broadview P, 1987.
Hi Riley,
Thank you for your comment. I agree with you on your mentioning of competency because that is a major determining factor when considering the concept of autonomy. In an answer to the several questions you posed, I would say that competency is not a black and white situation since sometimes patients demonstrate what is known as intermittent competency where they are not fully competent but not fully incompetent; yet, at the same time, according to the law one can only be labeled competent or incompetent, as it is an “all or nothing affair” (Thomas, Waluchow, and Gedge 119). Also, it appears that anyone who is competent would be able to participate in the research since this patient can sign their consent to Dr. Selleck per her wishes. Lastly, incompetent patients can also participate in the research study since family members of the patients can sign consent for them (Thomas, Waluchow, and Gedge 116).
Additionally, with regards to the story of your grandmother and mother, I agree that family members should always be consulted when it comes to decisions regarding their loved ones because they usually know more about the situation than the people who work at the nursing home. Also, the staff at the nursing home may have ulterior motives for their decisions because if they allow their patients to be subjects in research, the nursing home will be known to be associated with research, which could deter other patients from wanting to live there; thus, the nursing home would lose out on financial benefits. Also, if the patients with Alzheimer’s disease participate in the research study and the drug is actually effective, then the patient may be in a different cognitive state where they are well-enough to live on their own or with family instead of paying for assisted living; thus, again taking away possible financial benefits from the nursing home.
Work Cited:
Thomas, John E., and Wilfrid J. Waluchow. Well and Good: Case Studies in Biomedical Ethics. Ontario: Broadview Press, 1987.