Clinical trials emerged in rapid succession as the COVID-19 pandemic created an unprecedented need for life-saving therapies. Fair and equitable subject selection in clinical trials offering investigational therapies ought to be an urgent moral concern. Subject selection determines the distribution of risks and benefits, and impacts the applicability of the study results for the larger population. While Research Ethics Committees monitor fair subject selection within each trial, no standard oversight exists for subject selection across multiple trials for the same disease. (...) Drawing on the experience of multiple clinical trials at a single academic medical centre in the USA, we posit that concurrent COVID-19 trials are liable to unfair and inequitable subject selection on account of scientific uncertainty, lack of transparency, scarcity and, lastly, structural barriers to equity compounded by implicit bias. To address the critical gap in the current literature and international regulation, we propose new ethical guidelines for research design and conduct that bolsters fair and equitable subject selection. Although the proposed guidelines are tailored to the research design and protocol of concurrent trials in the COVID-19 pandemic, they may have broader relevance to single COVID-19 trials. (shrink)

The commitment of transplant physicians to protect the physical and psychological health of potential donors is fundamental to the process of living donor organ transplantation. It is appropriate that strict regulations to govern an individual’s decision to donate have been developed. Some may argue that adherence to such regulations creates a doctor-patient relationship that is rooted in paternalism, which is in drastic contrast with a doctor-patient relationship that is rooted in patients’ autonomy, characteristic of most other operative interventions.In this article (...) we analyze the similarities between cosmetic plastic surgery and living donor surgery as examples of surgeries governed by different ethical principles. It is interesting that, while the prevailing ethical approach in living donor surgery is based on paternalism, the ethical principle guiding cosmetic surgery is respect for patients’ autonomy. The purpose of this article is not to criticize either practice, but to suggest that, given the similarities between the two procedures, both operative interventions should be guided by the same ethical principle: a respect for patients’ autonomy. We further suggest that if living organ donation valued donors’ autonomy as much as cosmetic plastic surgery does, we might witness a wider acceptance of and increase in living organ donation. (shrink)

Laspro et al. (2024) have articulated a number of important considerations in order for the first-in-human whole-eye transplant (WET) to be an ethically acceptable endeavor. These authors have clea...

The practice of surgery requires consideration of a number of specific aspects of clinical medical ethics that are different from those most influential in other areas of medical care. The nature of surgical care alters the sense of responsibility that surgeons feel for their actions and also alters the relationship between surgeons and patients. Because surgical care requires patients to place such great trust in their surgeons, surgical informed consent must emphasize the importance of that trust. Surgeons must use innovative (...) means to solve individual patient problems even if the result is a novel operation. Surgical procedures may be altered due to the unexpected findings in the operating room and therefore surgeons must have considered how to respond in such situations. The future of surgical practice will inevitably lead to increasing ethical concerns in maintaining the ethical dimension of surgery, in allowing autonomy for trainees while maintaining patients’ safety, and in balancing surgical risks of prophylactic surgery with the genetic predisposition to develop cancer. (shrink)

Clinical red blood cell transfusion guidelines have been widely adopted in clinical practice, resulting in standardized transfusion practices in hospitalized patients with anemia. Standardization of transfusion practice has been welcomed by clinicians and health systems as a mechanism for reducing unnecessary, harmful, and costly practice variation that results in healthcare disparities. However, overzealously applied guidelines can have deleterious consequences for individual patients, ultimately resulting in and/or exacerbating healthcare disparities, rather than resolving them. This article provides empirical examples of the adverse (...) consequences from the well-meaning attempt to standardize transfusion practice based on clinical practice guidelines and discusses the ethical implications of standardized transfusion practice. (shrink)

Volume 20, Issue 8, August 2020, Page 123-125.