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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.

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.

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.

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.

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 polices 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.

ObjectiveTo identify sociodemographic and clinical factors associated with withholding or withdrawing life-sustaining treatment (WWLST) for extremely low gestational age neonates.DesignObservational 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.ResultsOf 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).ConclusionsAmong 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.

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