Research involving the recently deceased: ethics questions that must be answered.

Research involving recently deceased humans that are physiologically maintained following declaration of death by neurologic criteria-or 'research involving the recently deceased'-can fill a translational research gap while reducing harm to animals and living human subjects. It also creates new challenges for honouring the donor's legacy, respecting the rights of donor loved ones, resource allocation and public health. As this research model gains traction, new empirical ethics questions must be answered to preserve public trust in all forms of tissue donation and in the practice of medicine while respecting the legacy of the deceased and the rights of donor loved ones. This article suggests several topics for immediate investigation to understand the attitudes and experiences of researchers, clinical collaborators, donor loved ones and the public to ensure research involving the recently deceased advances ethically.

Ethics of Health Information Sharing and Social Relationships at End of Life in Assisted Living.

Given an observed tension between perceived privacy restrictions and meaningful social connection in assisted living (AL) and using a relational perspective, we conducted a secondary thematic analysis of health information sharing practices among residents and their care partners in one large urban AL community in metropolitan Atlanta. Data included in-depth interviews with residents (n = 26), family members (n = 20), AL staff (n = 11), and external care workers (n = 4) as well as ethnographic data from observations and informal conversations conducted with these participants and others. Findings showed that health information sharing among residents was helpful in building social relationships; barriers to this communication contributed to isolation. Inappropriate public exchange of residents' healthcare information hindered building these relationships. Negotiating privacy boundaries for health information sharing was an ongoing confusing process across the community. Based on the findings, we propose new guidelines for health information sharing and additional privacy training for residents and care partners.

Disparities in communication among the inpatient homeless population at a safety-net hospital.

OBJECTIVE: To determine whether the homeless population experiences disparities in care and communication during inpatient hospitalizations in a safety-net hospital. METHODS: We administered a modified Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey to 112 age-sex- and education matched homeless and non-homeless adults at a university-affiliated-safety-net hospital from December 2017 through March 2018 and performed a retrospective review of medical records. Linear regression models were used to assess differences in responses to survey subscales, length of stay and other measures. RESULTS: Homeless participants trended toward poorer ratings for all HCAHPS subscales, reaching significance for the Communication about Medications subscale, with a mean score 1.2 (95% CI 0.48-1.76) points lower compared to non-homeless sample. Length of stay was not significantly different between homeless and non-homeless participants. CONCLUSION: In an urban safety-net hospital, disparities in communications regarding medications between hospital staff and patients were found based on housing status.

Withholding or withdrawing life-sustaining treatment in extremely low gestational age neonates.

OBJECTIVE: To identify sociodemographic and clinical factors associated with withholding or withdrawing life-sustaining treatment (WWLST) for extremely low gestational age neonates. DESIGN: Observational study of prospectively collected registry data from 19 National Institute of Child Health and Human Development Neonatal Research Network centres on neonates born at 22-28 weeks gestation who died >12 hours through 120 days of age during 2011-2016. Sociodemographic and clinical factors were compared between infants who died following WWLST and without WWLST. RESULTS: Of 1168 deaths, 67.1% occurred following WWLST. Withdrawal of assisted ventilation (97.4%) was the primary modality. WWLST rates were inversely proportional to gestational age. Life-sustaining treatment was withheld or withdrawn more often for non-Hispanic white infants than for non-Hispanic black infants (72.7% vs 60.4%; 95% CI 1.00 to 1.92) or Hispanic infants (72.7% vs 67.2%; 95% CI 1.32 to 3.72). WWLST rates varied across centres (38.6-92.6%; p<0.001). The centre with the highest rate had adjusted odds 4.89 times greater than the average (95% CI 1.18 to 20.18). The adjusted odds of WWLST were higher for infants with necrotiing enterocolitis (OR 1.77, 95% CI 1.21 to 2.59) and severe brain injury (OR 1.98, 95% CI 1.44 to 2.74). CONCLUSIONS: Among infants who died, WWLST rates varied widely across centres and were associated with gestational age, race, ethnicity, necrotiing enterocolitis, and severe brain injury. Further exploration is needed into how race, centre, and approaches to care of infants with necrotiing enterocolitis and severe brain injury influence WWLST.

The Advisory Committee on Immunization Practices' Ethical Principles for Allocating Initial Supplies of COVID-19 Vaccine - United States, 2020.

To reduce the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19) and its associated impacts on health and society, COVID-19 vaccines are essential. The U.S. government is working to produce and deliver safe and effective COVID-19 vaccines for the entire U.S. population. The Advisory Committee on Immunization Practices (ACIP)* has broadly outlined its approach for developing recommendations for the use of each COVID-19 vaccine authorized or approved by the Food and Drug Administration (FDA) for Emergency Use Authorization or licensure (1). ACIP's recommendation process includes an explicit and transparent evidence-based method for assessing a vaccine's safety and efficacy as well as consideration of other factors, including implementation (2). Because the initial supply of vaccine will likely be limited, ACIP will also recommend which groups should receive the earliest allocations of vaccine. The ACIP COVID-19 Vaccines Work Group and consultants with expertise in ethics and health equity considered external expert committee reports and published literature and deliberated the ethical issues associated with COVID-19 vaccine allocation decisions. The purpose of this report is to describe the four ethical principles that will assist ACIP in formulating recommendations for the allocation of COVID-19 vaccine while supply is limited, in addition to scientific data and implementation feasibility: 1) maximize benefits and minimize harms; 2) promote justice; 3) mitigate health inequities; and 4) promote transparency. These principles can also aid state, tribal, local, and territorial public health authorities as they develop vaccine implementation strategies within their own communities based on ACIP recommendations.

Perspective: The promise of multi-cellular engineered living systems.

Recent technological breakthroughs in our ability to derive and differentiate induced pluripotent stem cells, organoid biology, organ-on-chip assays, and 3-D bioprinting have all contributed to a heightened interest in the design, assembly, and manufacture of living systems with a broad range of potential uses. This white paper summarizes the state of the emerging field of "multi-cellular engineered living systems," which are composed of interacting cell populations. Recent accomplishments are described, focusing on current and potential applications, as well as barriers to future advances, and the outlook for longer term benefits and potential ethical issues that need to be considered.

The DREAMS Team: Creating community partnerships through research advocacy training for diverse older adults.

The DREAMS Team research advocacy training program helps clinical faculty and health students introduce basic clinical research concepts to diverse older adults to galvanize their active involvement in the research process. Older adults are frequently underrepresented in clinical research, due to barriers to participation including distrust, historical mistreatment, and their lack of health literacy. The DREAMS Team program aims to involve diverse older adults throughout all phases of research and increase research participation, thereby contributing to the growth of quality patient-centered, evidence-based health care. This course was developed for clinical faculty to deliver to diverse adults aged 55+ in eight 50-minute lectures, followed by half-hour small group discussions moderated by health students. A pilot cohort of 24 individuals was assessed for satisfaction post-program, and self-efficacy before and after the program. Older adult participants improved on a survey measure of self-efficacy, and indicated satisfaction on a post-program questionnaire. All agreed or strongly agreed that they enjoyed participating, and that classes enhanced knowledge/skills about the topics, were high quality, and provided useful information. Twenty-two out of 24 individuals who completed the program indicated they planned to get involved as research advocates. The DREAMS Team program can be offered either on its own, or as a follow-up program to a general health education course led by health students and/or professional researchers or clinicians. Educating older adults about the research process and advocacy through interactive seminars led by congenial and respectful researchers and health students may remove some barriers to research participation and involvement among diverse older adults.

Ethical guidelines in pandemic influenza: recommendations of the Ethics Subcommittee of the Advisory Committee of the Director, Centers for Disease Control and Prevention.

Because of the importance of including ethical considerations in planning efforts for pandemic influenza, in February 2005 the Centers for Disease Control and Prevention requested that the Ethics Subcommittee of the Advisory Committee to the Director develop guidance that would serve as a foundation for decision making in preparing for and responding to pandemic influenza. Specifically, the ethics subcommittee was asked to make recommendations regarding ethical considerations relevant to decision making about vaccine and antiviral drug distribution prioritization and development of interventions that would limit individual freedom and create social distancing. The ethics subcommittee identified a number of general ethical considerations including identification of clear goals for pandemic planning, responsibility to maximize preparedness, transparency and public engagement, sound science, commitment to the global community, balancing individual liberty and community interests, diversity in ethical decision making, and commitment to justice. These general ethical considerations are applied to the issues of vaccine and antiviral drug distribution and use of community mitigation interventions.

Policies on donation after cardiac death at children's hospitals: a mixed-methods analysis of variation.

CONTEXT: Although authoritative bodies have promulgated guidelines for donation after cardiac death (DCD) and the Joint Commission requires hospitals to address DCD, little is known about actual hospital policies. OBJECTIVE: To characterize DCD policies in children's hospitals and evaluate variation among policies. DESIGN, SETTING, AND PARTICIPANTS: Mixed-methods analysis of policies collected between November 2007 and January 2008 from hospitals in the United States, Puerto Rico, and Canada in 2 membership categories of the National Association of Children's Hospitals and Related Institutions. MAIN OUTCOME MEASURES: Status of DCD policy development and content of the policies based on coding categories developed in part from authoritative statements. RESULTS: One hundred five of 124 eligible hospitals responded, a response rate of 85%. Seventy-six institutions (72%; 95% confidence interval [CI], 64%-82%) had DCD policies, 20 (19%; 95% CI, 12%-28%) were developing policies; and 7 (7%; 95% CI, 3%-14%) neither had nor were developing policies. We received and analyzed 73 unique, approved policies. Sixty-one policies (84%; 95% CI, 73%-91%) specify criteria or tests for declaring death. Four policies require total waiting periods prior to organ recovery at variance with professional guidelines: 1 less than 2 minutes and 3 longer than 5 minutes. Sixty-four policies (88%; 95% CI, 78%-94%) preclude transplant personnel from declaring death and 37 (51%; 95% CI, 39%-63%) prohibit them from involvement in premortem management. While 65 policies (89%; 95% CI, 80%-95%) indicate the importance of palliative care, only 5 (7%; 95% CI, 2%-15%) recommend or require palliative care consultation. Of 68 policies that indicate where withdrawal of life-sustaining treatment can or should take place, 37 policies (54%; 95% CI, 42%-67%) require it to occur in the operating room and 3 policies (4%; 95% CI, 1%-12%) require it to occur in the intensive care unit. CONCLUSIONS: Most children's hospitals have developed or are developing DCD policies. There is, however, considerable variation among policies.

Theory can be relevant: an overview of bioethics for the practicing child and adolescent psychiatrist.

Familiarity with medical ethical theory and the history of bioethics is helpful for the understanding of the current state of bioethics, as well as possible future developments that will affect physicians and patients alike. This article reviews major schools of thought in bioethics and their relevance to clinical work with children, adolescents, and families. Child and adolescent psychiatrists need to be familiar with major ethical issues in general medicine, psychiatry, and pediatrics, in addition to those controversies that are more specific to their subspecialty. Employing a systematic approach for the identification and analysis of ethical concerns, such as the Four Topics Model of Jonsen and colleagues, improves child and adolescent psychiatrists' confidence that they are aware of ethical quandaries in practice and are addressing these issues in a transparent, well-informed manner.

Ethics guidelines for research with the recently dead.

The objective of the multidisciplinary expert Consensus Panel on Research with the Recently Dead (CPRRD) was to craft ethics guidelines for research with the recently dead. The CPRRD recommends that research with the recently dead: (i) receive scientific and ethical review and oversight; (ii) involve the community of potential research subjects; (iii) be coordinated with organ procurement organizations; (iv) not conflict with organ donation or required autopsy; (v) use procedures respectful of the dead; (vi) be restricted to one procedure per day; (vii) preferably be authorized by first-person consent, though both general advance research directives and surrogate consent are acceptable; (viii) protect confidentiality; (ix) not impose costs on subjects' estates or next of kin and not involve payment; (x) clearly explain ultimate disposition of the body.

Ethical issues in palliative care.

OBJECTIVES: To review important issues that address respect for patient autonomy, beneficnce, non-maleficence, and justice, which are included in communication surrounding the determination of decision-making capacity, informed consent, breaking bad news, and creating shared goals of care. DATA SOURCES: Review articles, and government and organizational reports. CONCLUSION: Palliative care and its proximity to end-of-life care issues frequently raises ethical issues for patients, their families, and the clinicians caring for them. Supporting the identification and honoring the patient's preferences for treatment are central components of ethical behavior. IMPLICATIONS FOR NURSING PRACTICE: Advance care planning provides an important opportunity for respecting patient autonomy and may be helpful when discussing care options surrounding resuscitation, withholding or withdrawal of treatment, or the determination of medical futility.

A workshop to teach medical students communication skills and clinical knowledge about end-of-life care.

We describe a half-day workshop to teach third-year medical students three focused end-of-life care skills: breaking bad news, discussing advance directives, and assessing and managing pain. Our workshop included a readers' theater exercise and three role-play exercises. In two of the workshops, faculty members played the role of patients. We used readers' theater to engage the students on an emotional level and set a reflective tone for the workshop. Evaluations reflected that most respondents felt that the workshop enhanced their understanding and ability to address these skills with patients. By 6 months, many students reported applying these skills to patient care in a way they thought was effective.