Exploring the Impact of COVID-19 Restrictions on Nursing Home Residents', Families', and Staff's Perceptions of Bioethical Principles: A Qualitative Study.

In this study, we employed a pre-interview survey and conducted interviews with nursing home staff members and residents/family members to understand their perceptions of whether the COVID-19 restrictions fulfilled obligations to nursing home residents under various principles, including autonomy, beneficence, nonmaleficence, justice, and privacy. We conducted 20 semi-structured interviews with staff members from 14 facilities, and 20 with residents and/or family members from 13 facilities. We used a qualitative descriptive study design and thematic analysis methodology to analyze the interviews. Findings from the pre-interview survey indicated that, compared to nursing home staff, residents and their families perceived lower adherence to bioethics principles during the pandemic. Qualitative analysis themes included specific restrictions, challenges, facility notifications, consequences, communication, and relationships between staff and residents/family members. Our study exposes the struggle to balance infection control with respecting bioethical principles in nursing homes, suggesting avenues for improving processes and policies during public health emergencies.

Knowledge gaps in heart and lung donation after the circulatory determination of death: Report of a workshop of the National Heart, Lung, and Blood Institute.

In a workshop sponsored by the U.S. National Heart, Lung, and Blood Institute, experts identified current knowledge gaps and research opportunities in the scientific, conceptual, and ethical understanding of organ donation after the circulatory determination of death and its technologies. To minimize organ injury from warm ischemia and produce better recipient outcomes, innovative techniques to perfuse and oxygenate organs postmortem in situ, such as thoracoabdominal normothermic regional perfusion, are being implemented in several medical centers in the US and elsewhere. These technologies have improved organ outcomes but have raised ethical and legal questions. Re-establishing donor circulation postmortem can be viewed as invalidating the condition of permanent cessation of circulation on which the earlier death determination was made and clamping arch vessels to exclude brain circulation can be viewed as inducing brain death. Alternatively, TA-NRP can be viewed as localized in-situ organ perfusion, not whole-body resuscitation, that does not invalidate death determination. Further scientific, conceptual, and ethical studies, such as those identified in this workshop, can inform and help resolve controversies raised by this practice.

The ubiquity of 'self-care' in health: Why specificity matters.

Despite increased interest in self-care for health, little consensus exists around its definition and scope. The World Health Organization has published several definitions of self-care, including in a 2019 Global Guideline rooted in sexual and reproductive health and rights (SRHR), later expanded to encompass health more generally. To establish a robust understanding of self-care, this exploratory study inventorises, consolidates, presents and analyses definitions of self-care beyond the SRHR field. A pragmatic review identified definitions and conceptualisations of self-care from peer-reviewed and grey literature published between 2009 and 2021. The search identified 91 definitions of self-care from 116 relevant publications. Data extraction informed analysis to identify recurring themes and approaches, revealing three key areas of variation: self-care being: (1) defined directly or descriptively; (2) situated within individual, interpersonal or structural contexts; (3) defined broadly or topic-specifically. A multilevel conceptualisation can guide a more broadly applicable understanding of self-care: first, as an aspect of healthcare; second, as a concept operating at individual, interpersonal and institutional levels; third, as a concept that impacts specific health fields and contexts differently. A comprehensive but adaptable framework works in service of improving health and wellbeing for all, acknowledging the linkages between self-care and health-related human rights.

Voucher-Based Kidney Donation and Redemption for Future Transplant.

Importance: Policy makers, transplant professionals, and patient organizations agree that there is a need to increase the number of kidney transplants by facilitating living donation. Vouchers for future transplant provide a means of overcoming the chronological incompatibility that occurs when the ideal time for living donation differs from the time at which the intended recipient actually needs a transplant. However, uncertainty remains regarding the actual change in the number of living kidney donors associated with voucher programs and the capability of voucher redemptions to produce timely transplants. Objective: To examine the consequences of voucher-based kidney donation and the capability of voucher redemptions to provide timely kidney allografts. Design, Setting, and Participants: This multicenter cohort study of 79 transplant centers across the US used data from the National Kidney Registry from January 1, 2014, to January 31, 2021, to identify all family vouchers and patterns in downstream kidney-paired donations. The analysis included living kidney donors and recipients participating in the National Kidney Registry family voucher program. Exposures: A voucher was provided to the intended recipient at the time of donation. Vouchers had no cash value and could not be sold, bartered, or transferred to another person. When a voucher was redeemed, a living donation chain was used to return a kidney to the voucher holder. Main Outcomes and Measures: Deidentified demographic and clinical data from each kidney donation were evaluated, including the downstream patterns in kidney-paired donation. Voucher redemptions were separately evaluated and analyzed. Results: Between 2014 and 2021, 250 family voucher-based donations were facilitated. Each donation precipitated a transplant chain with a mean (SD) length of 2.3 (1.6) downstream kidney transplants, facilitating 573 total transplants. Of those, 111 transplants (19.4%) were performed in highly sensitized recipients. Among 250 voucher donors, the median age was 46 years (range, 19-78 years), and 157 donors (62.8%) were female, 241 (96.4%) were White, and 104 (41.6%) had blood type O. Over a 7-year period, the waiting time for those in the National Kidney Registry exchange pool decreased by more than 3 months. Six vouchers were redeemed, and 3 of those redemptions were among individuals with blood type O. The time from voucher redemption to kidney transplant ranged from 36 to 155 days. Conclusions and Relevance: In this study, the family voucher program appeared to mitigate a major disincentive to living kidney donation, namely the reluctance to donate a kidney in the present that could be redeemed in the future if needed. The program facilitated kidney donations that may not otherwise have occurred. All 6 of the redeemed vouchers produced timely kidney transplants, indicating the capability of the voucher program.

Expanding controlled donation after the circulatory determination of death: statement from an international collaborative.

A decision to withdraw life-sustaining treatment (WLST) is derived by a conclusion that further treatment will not enable a patient to survive or will not produce a functional outcome with acceptable quality of life that the patient and the treating team regard as beneficial. Although many hospitalized patients die under such circumstances, controlled donation after the circulatory determination of death (cDCDD) programs have been developed only in a reduced number of countries. This International Collaborative Statement aims at expanding cDCDD in the world to help countries progress towards self-sufficiency in transplantation and offer more patients the opportunity of organ donation. The Statement addresses three fundamental aspects of the cDCDD pathway. First, it describes the process of determining a prognosis that justifies the WLST, a decision that should be prior to and independent of any consideration of organ donation and in which transplant professionals must not participate. Second, the Statement establishes the permanent cessation of circulation to the brain as the standard to determine death by circulatory criteria. Death may be declared after an elapsed observation period of 5 min without circulation to the brain, which confirms that the absence of circulation to the brain is permanent. Finally, the Statement highlights the value of perfusion repair for increasing the success of cDCDD organ transplantation. cDCDD protocols may utilize either in situ or ex situ perfusion consistent with the practice of each country. Methods to accomplish the in situ normothermic reperfusion of organs must preclude the restoration of brain perfusion to not invalidate the determination of death.

Strengthening Global Efforts to Combat Organ Trafficking and Transplant Tourism: Implications of the 2018 Edition of the Declaration of Istanbul.

The 2018 Edition of the Declaration of Istanbul on Organ Trafficking and Transplant Tourism (DoI) provides an updated set of principles and definitions to guide policymakers and health professionals working in organ donation and transplantation. A draft of the new edition was circulated to the public and transplant professionals through an online consultation process, which also sought feedback on a draft explanatory article that explained the principles and discussed some of their practical implications. Both drafts were revised in response to feedback from participants in the consultation. We present here the discussion article, which is intended to assist stakeholders in applying the principles of the DoI by providing more detailed information about the meaning and potential implications of implementing the DoI in various contexts.

Beecher Dépassé: Fifty Years of Determining Death, Legally.

Five decades ago, Henry Knowles Beecher, a renowned professor of research anesthesiology, sought to solve a problem created by modern medicine. The solution proposed by Beecher and his colleagues on the Ad Hoc Committee of the Harvard Medical School to Examine the Definition of Brain Death proved very influential.1 Indeed, other contemporaneous medical developments magnified its significance yet also made the solution it offered somewhat problematic. As we mark this fiftieth anniversary, at a time when concerns about the conceptual model on which its recommendations rested are being voiced by critics from medicine as well as philosophy, it is worthwhile to view the committee's report in relation to the problem that prompted its existence as well as the one to which it was quickly applied.

At Last! Aye, and There's the Rub.

Mea culpa. In 1981 the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, of which I was the Executive Director, recommended to the President and Congress that all federal departments and agencies that conduct or support human subjects research adopt "as a common core" the HHS regulations, "while permitting additions needed by any department or agency that are not inconsistent with these core provisions." The commission believed-rightly, I still think-that having uniformity would ease administration, reduce regulatory burdens, simplify oversight, and make research more efficient. Yet our naïve expectation the task could be accomplished in 180 days meant that we failed to anticipate that if it took much longer-namely, the 10 years that passed before the Common Rule was issued-federal officials would thereafter be reluctant to change the regulations and that when they tried to do so twenty years later, with the issuance of the ANPRM in 2011, they would propose comprehensive revisions. I argue that was the wrong conclusion to draw from the difficulties in issuing the first Common Rule, and that the process of producing the new "final rule" on January 19, 2017-during which many of the proposed changes were either dumped or promulgated without being adequately vetted-reinforces the conclusion that a more incremental process, with ongoing involvement of the public through an advisory body like the President's Commission, would be a much better way to proceed.

Building the Next Bioethics Commission.

At every moment, somewhere in the world, a group of men and women are sitting around a table deliberating about an ethical issue posed by medicine and research, whether as a research ethics committee; a hospital or clinical ethics committee; a stem-cell review committee; a gene transfer research committee; a biobank ethics committee; an ethics advisory committee for a medical or nursing association or nongovernmental organization; a state, provincial, national, or intergovernmental bioethics committee; or an ad hoc panel examining a particular development or case. However, the last national committee in the United States, the Presidential Commission for the Study of Bioethical Issues, held its final meeting at the end of August 2016 and closed its doors. Should we regret its departure? I believe that the United States would benefit from having another national bioethics advisory body, but I do not think that the commission should simply have continued under a new president in the same form. Instead, looking at the experience of that commission and its six predecessors-who they were, how they worked, the functions they served, and the problems they experienced-we can derive some useful ideas for anyone planning to build the next commission.

Vouchers for Future Kidney Transplants to Overcome "Chronological Incompatibility" Between Living Donors and Recipients.

BACKGROUND: The waiting list for kidney transplantation is long. The creation of "vouchers" for future kidney transplants enables living donation to occur when optimal for the donor and transplantation to occur later, when and if needed by the recipient. METHODS: The donation of a kidney at a time that is optimal for the donor generates a "voucher" that only a specified recipient may redeem later when needed. The voucher provides the recipient with priority in being matched with a living donor from the end of a future transplantation chain. Besides its use in persons of advancing age with a limited window for donation, vouchers remove a disincentive to kidney donation, namely, a reluctance to donate now lest one's family member should need a transplant in the future. RESULTS: We describe the first three voucher cases, in which advancing age might otherwise have deprived the donors the opportunity to provide a kidney to a family member. These 3 voucher donations functioned in a nondirected fashion and triggered 25 transplants through kidney paired donation across the United States. CONCLUSIONS: The provision of a voucher to potential recipients whose need for a transplant makes them "chronologically incompatible" with their donors may increase the number of living donor transplants.

Research on Medical Practices: Why Patients Consider Participating and the Investigational Misconception.

Understanding how patients decide whether to enroll in research can help improve educational materials, protocols, and recruitment rates. However, little is known about patients' willingness to participate in research on medical practices (ROMP), or studies comparing interventions within usual care. We assessed willingness to consider participating in ROMP by surveying 1095 adults in the United States, of whom 834 answered at least one open-ended question about their reasons for being willing or unwilling to consider participating in two scenarios involving ROMP. Most respondents were willing to consider participating in the research scenarios. The most commonly cited reasons for being willing to consider participating included benefit to others and oneself; the top reasons for being unwilling to consider participating included belief that the research was unsafe and an unfavorable view of experimentation. Responses also revealed misconceptions about ROMP among both those who were willing and unwilling to consider participating. Because these misconceptions may present an obstacle to recruiting participants in ROMP, there may be a need for educational initiatives to clarify the nature of these types of studies.

Adrift in the Gray Zone: IRB Perspectives on Research in the Learning Health System.

BACKGROUND: Human subjects protection in healthcare contexts rests on the premise that a principled boundary distinguishes clinical research and clinical practice. However, growing use of evidence-based clinical practices by health systems makes it increasingly difficult to disentangle research from a wide range of clinical activities that are sometimes called "research on medical practice" (ROMP), including quality improvement activities and comparative effectiveness research. The recent growth of ROMP activities has created an ethical and regulatory gray zone with significant implications for the oversight of human subjects research. METHODS: We conducted six semi-structured, open-ended focus group discussions with IRB members to understand their experiences and perspectives on ethical oversight of ROMP, including randomization of patients to standard treatments. RESULTS: Our study revealed that IRB members are unclear or divided on the central questions at stake in the current policy debate over ethical oversight of ROMP: IRB members struggle to make a clear distinction between clinical research and medical practice improvement, lack consensus on when ROMP requires IRB review and oversight, and are uncertain about what constitutes incremental risk when patients are randomized to different treatments, any of which may be offered in usual care. They characterized the central challenge as a balancing act, between, on the one hand, making information fully transparent to patients and providing adequate oversight, and on the other hand, avoiding a chilling effect on the research process or harming the physician-patient relationship. CONCLUSIONS: Evidence-based guidance that supports IRB members in providing adequate and effective oversight of ROMP without impeding the research process or harming the physician-patient relationship is necessary to realize the full benefits of the learning health system.