Decision-Making for Adolescents with Gender Dysphoria.

Legislation banning gender-affirming medical care (GAMC) for minors is inconsistent with the Consensus Recommendations for Pediatric Decision-Making (Salter et al. 2023). Gender dysphoria is a medical condition, and GAMC promotes adolescents' health interests. The evidence for GAMC is comparable to the evidence for other types of pediatric medical care. Parents are permitted to consent for similar risks in the treatment of other conditions. Evaluation of the potential benefits, risks, and treatment alternatives is contingent on individual patients' clinical conditions and adolescents' and their parents' values and preferences. Such decisions are within the scope of parental discretion and should be made through shared decision-making with health-care providers. Parents' declining GAMC does not inherently create a significant risk of serious imminent harm required to justify state intervention. Usurping parental discretion for GAMC is unjust: it treats this medical care differently than other comparable types of medical care without sufficient justification.

Adverse Events During Apnea Testing for the Determination of Death by Neurologic Criteria: A Single-Center, Retrospective Pediatric Cohort.

OBJECTIVES: To report the prevalence of adverse events in children undergoing apnea testing as part of the determination of death by neurologic criteria (DNC). DESIGN: Single-center, retrospective study. SETTING: Academic children's hospital that is a Level I Trauma Center. PATIENTS: All children who underwent apnea testing to determine DNC from July 2013 to June 2020. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We abstracted the medical history, blood gases, ventilator settings, blood pressures, vasoactive infusions, intracranial pressures, chest radiographs, and echocardiograms for all apnea tests as well as any ancillary test. Adverse events were defined as hypotension, hypoxia, pneumothorax, arrhythmia, intracranial hypertension, and cardiac arrest. Fifty-eight patients had 105 apnea tests. Adverse events occurred in 21 of 105 apnea tests (20%), the most common being hypotension (15/105 [14%]) and hypoxia (4/105 [4%]). Five of 21 apnea tests (24%) with adverse events were terminated prematurely (three for hypoxia, one for hypotension, and one for both hypoxia and hypotension) but the patients did not require persistent escalation in care. In the other 16 of 21 apnea tests (76%) with adverse events, clinical changes were transient and managed by titrating vasoactive infusions or completing the apnea test. CONCLUSIONS: In our center, 20% of all apnea tests were associated with adverse events. Only 5% of all apnea tests required premature termination and the remaining 15% were completed and the adverse events resolved with medical care.

Experiences of reproductive genetic counselors with abortion regulations in Ohio.

Since 2010, Ohio legislators have passed more than 15 legislative changes related to abortion and abortion providers, and nine procedural abortion clinics have closed. We investigated reproductive genetic counselors' perceptions, attitudes and self-reported practices regarding Ohio's current and proposed abortion regulations. We conducted five focus groups and two telephone interviews in 2019-2020, with a total of 19 reproductive genetic counselors. Participants discussed difficulties keeping current on abortion legislation and clinics' and hospitals' policies, resulting in anticipatory anxiety and leading to additional work to discuss the laws with patients. Participants articulated that practices of reproductive genetic counseling-and patient advocacy-are impeded by the legislation. Genetic counselors perceive negative impacts on patients' autonomy, particularly reflective of healthcare disparities of marginalized groups, which may contribute to frustration and anger. Ultimately, the mental and emotional burden on genetic counselors created by abortion legislation contributes to compassion fatigue and burnout. Our findings show that Ohio's abortion regulations negatively impact reproductive genetic counselors and their relationships with their patients. Repealing existing abortion regulations and preventing future restrictive legislation may ameliorate the negative effects of regulations on reproductive genetic counselors and their patients. In the event that these laws remain, innovative communication tools and proactive professional society advocacy are potential means to mitigate the negative impact on reproductive genetic counselors.

Ventilator Triage Policies During the COVID-19 Pandemic at U.S. Hospitals Associated With Members of the Association of Bioethics Program Directors.

BACKGROUND: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies. OBJECTIVE: To characterize the development of ventilator triage policies and compare policy content. DESIGN: Survey and mixed-methods content analysis. SETTING: North American hospitals associated with members of the Association of Bioethics Program Directors. PARTICIPANTS: Program directors. MEASUREMENTS: Characteristics of institutions and policies, including triage criteria and triage committee membership. RESULTS: Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend that those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations. LIMITATION: The results may not be generalizable to institutions without academic bioethics programs. CONCLUSION: Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation. PRIMARY FUNDING SOURCE: None.

An Ethical Analysis of Hospital Visitor Restrictions and Masking Requirements During the COVID-19 Pandemic

Nonpharmaceutical interventions to minimize the transmission of the severe acute respiratory syndrome coronavirus 2 are necessary because we currently lack a vaccine or specific treatments. Healthcare facilities have adopted visitor restrictions and masking requirements. These interventions should be evaluated as public health measures, focusing on their efficacy, the availability of less-restrictive alternatives, and the minimization of the burdens and their balance with the benefits. These interventions, as well as exceptions, can be justified by the same analysis. For example, visitor restrictions are sound, as are exceptions for women in labor, adults with disabilities, minor children, and individuals who are dying. In implementing these policies, specific rules are preferable to general principles because they are more efficient and reduce possible bias. There should, however, be appeal mechanisms and retrospective review processes. Evaluating requests for medical exemptions to masking requirements is particularly difficult, given the prevalence of nonmedical objections, false claims of medical exemptions, and a lack of objective medical criteria. Requiring written statements by licensed healthcare providers that undergo subsequent substantive review may therefore be justified.

Public Attitudes toward Consent and Data Sharing in Biobank Research: A Large Multi-site Experimental Survey in the US.

Individuals participating in biobanks and other large research projects are increasingly asked to provide broad consent for open-ended research use and widespread sharing of their biosamples and data. We assessed willingness to participate in a biobank using different consent and data sharing models, hypothesizing that willingness would be higher under more restrictive scenarios. Perceived benefits, concerns, and information needs were also assessed. In this experimental survey, individuals from 11 US healthcare systems in the Electronic Medical Records and Genomics (eMERGE) Network were randomly allocated to one of three hypothetical scenarios: tiered consent and controlled data sharing; broad consent and controlled data sharing; or broad consent and open data sharing. Of 82,328 eligible individuals, exactly 13,000 (15.8%) completed the survey. Overall, 66% (95% CI: 63%-69%) of population-weighted respondents stated they would be willing to participate in a biobank; willingness and attitudes did not differ between respondents in the three scenarios. Willingness to participate was associated with self-identified white race, higher educational attainment, lower religiosity, perceiving more research benefits, fewer concerns, and fewer information needs. Most (86%, CI: 84%-87%) participants would want to know what would happen if a researcher misused their health information; fewer (51%, CI: 47%-55%) would worry about their privacy. The concern that the use of broad consent and open data sharing could adversely affect participant recruitment is not supported by these findings. Addressing potential participants' concerns and information needs and building trust and relationships with communities may increase acceptance of broad consent and wide data sharing in biobank research.

Content analysis of requests for religious exemptions from a mandatory influenza vaccination program for healthcare personnel.

OBJECTIVE: Having failed to achieve adequate influenza vaccination rates among employees through voluntary programmes, healthcare organisations have adopted mandatory ones. Some programmes permit religious exemptions, but little is known about who requests religious objections or why. METHODS: Content analysis of applications for religious exemptions from influenza vaccination at a free-standing children's hospital in Cincinnati, Ohio, USA during the 2014-2015 influenza season. RESULTS: Twelve of 15 260 (0.08%) employees submitted applications requesting religious exemptions. Requestors included both clinical and non-clinical employees. All requestors voluntarily identified their religious affiliation, and most were Christian (n=9). Content analysis identified six categories of reasons used to justify an exemption: risks/benefits, ethical/political, lack of direct patient contact, providence, purity and sanctity of life. Individuals articulated reasons in 1-5 (mean 2.6) categories. The most frequently cited category (n=9) was purity; the vaccine and/or its mode of administration were impure, or receiving the vaccine would make the individual impure. Two individuals asserted that the vaccine contained cells derived from aborted human fetuses. Individuals (n=6) also volunteered information supporting the sincerity of their beliefs including distress over previous vaccination and examples of behaviour consistent with their specific objection or their general religious commitment. All requests were approved. CONCLUSIONS: Less than 0.1% of employees requested religious exemptions. Partnering with religious leaders and carefully correcting erroneous information may help address requestors' concerns.

Systematic Review of Typologies Used to Characterize Clinical Ethics Consultations.

INTRODUCTION: Classifying the ethical issues in clinical ethics consultations is important to clinical practice and scholarship. We conducted a systematic review to characterize the typologies used to analyze clinical ethics consultations. METHODS: We identified empirical studies of clinical ethics consultation that report types of ethical issues using PubMed. We screened these articles based on their titles and abstracts, and then by a review of their full text. We extracted study characteristics and typologies and coded the typologies. RESULTS: We reviewed 438 articles; 30 of the articles fulfilled our inclusion criteria. We identified 27 unique typologies. Each typology contained five to 47 categories (mean was 18). The most common categories were DNAR (do-not-attempt-resuscitation) orders (19 of the 27 typologies, or 70 percent), capacity (18 of the typologies, or 67 percent), withholding (18 of the typologies, or 67 percent), withdrawing (17 of the typologies, or 63 percent), and surrogate or proxy (16 of the typologies, or 59 percent). Only seven (26 percent) of the typologies contained all five of the most common categories. The typologies we used to characterize clinical ethics consultation exhibit significant heterogeneity and several conceptual limitations. A common typology is needed whose development may require multi-institutional collaboration and could be facilitated by professional organizations.

A qualitative study of adolescents' understanding of biobanks and their attitudes toward participation, re-contact, and data sharing.

While biobanks have become more prevalent, little is known about adolescents' views of key governance issues. We conducted semi-structured interviews with adolescents between 15 and 17 years old to solicit their views. All interviews were audiotaped and transcribed. Two investigators coded the transcripts and resolved any discrepancies through consensus. We conducted 18 interviews before reaching data saturation. Four participants (22%) had previously heard of a biobank. Many participants had misunderstandings about biobanks, some of which persisted after education. Participants believed that enrolling in a biobank would benefit others through scientific research. Many study participants were unable to identify risks of biobank participation. Thirteen participants (72%) were willing to enroll in a biobank and only one (6%) initially was not. Participants believed that if they were unable to provide assent when enrolled, then they should be re-contacted at the age of majority and their data should not be shared until that time. Participants emphasized the importance of being aware of their enrollment and the possibility of disagreeing with their parents. Participants' misunderstanding of biobanks suggests that assent may not be adequately informed without additional education. While adolescents had positive attitudes toward biobanks, they emphasized the importance of awareness of and involvement in the decision to enroll.

May Medical Centers Give Nonresident Patients Priority in Scheduling Outpatient Follow-Up Appointments?

Many academic medical centers are seeking to attract patients from outside their historical catchment areas for economic and programmatic reasons, and patients are traveling for treatment that is unavailable, of poorer quality, or more expensive at home. Treatment of these patients raises a number of ethical issues including whether they may be given priority in scheduling outpatient follow-up appointments in order to reduce the period of time they are away from home. Granting them priority is potentially unjust because medical treatment is generally allocated based on medical need and resource utilization, and then on a first-come, first-served basis. While it is difficult to compare the opportunity cost of waiting for an appointment to different patients, nonresident patients incur higher expenditures for travel, room, and board than resident patients. Giving them priority in scheduling to reduce these costs may be justifiable. Preferentially scheduling nonresident patients may also indirectly benefit resident patients consistent with Rawls's difference principle. This potential justification, however, rests on several empirical claims that should be demonstrated. In addition to reducing resident patients' waiting times, medical centers should not prioritize nonresident patients over resident patients with more urgent medical needs. There is, therefore, a limited and circumscribed justification for prioritizing nonresident patients in scheduling follow-up appointments.

A systematic literature review of individuals' perspectives on broad consent and data sharing in the United States.

PURPOSE: In 2011, an Advanced Notice of Proposed Rulemaking proposed that de-identified human data and specimens be included in biobanks only if patients provide consent. The National Institutes of Health Genomic Data Sharing policy went into effect in 2015, requiring broad consent from almost all research participants. METHODS: We conducted a systematic literature review of attitudes toward biobanking, broad consent, and data sharing. Bibliographic databases included MEDLINE, Web of Science, EthxWeb, and GenETHX. Study screening was conducted using DistillerSR. RESULTS: The final 48 studies included surveys (n = 23), focus groups (n = 8), mixed methods (n = 14), interviews (n = 1), and consent form analyses (n = 2). Study quality was characterized as good (n = 19), fair (n = 27), and poor (n = 2). Although many participants objected, broad consent was often preferred over tiered or study-specific consent, particularly when broad consent was the only option, samples were de-identified, logistics of biobanks were communicated, and privacy was addressed. Willingness for data to be shared was high, but it was lower among individuals from under-represented minorities, individuals with privacy and confidentiality concerns, and when pharmaceutical companies had access to data. CONCLUSIONS: Additional research is needed to understand factors affecting willingness to give broad consent for biobank research and data sharing in order to address concerns to enhance acceptability.Genet Med 18 7, 663-671.

Adolescents' preferences regarding disclosure of incidental findings in genomic sequencing that are not medically actionable in childhood.

Next-generation sequencing has challenged the consensus that predictive testing should not be performed on asymptomatic minors for conditions that are not medically actionable in childhood. While the available literature suggests that most parents want access to incidental findings discovered in genomic sequencing, there is little information regarding adolescents' views. This study's goal is to determine adolescent views regarding the disclosure of incidental findings for adult onset conditions that are not medically actionable in childhood. We conducted a cross-sectional survey of students enrolled in 7-12th grade science classes in three Cincinnati public schools. Most (235 of 282, 83%) students wanted access to non-actionable incidental findings. These participants most frequently (38%) endorsed future planning as the reason for disclosure. Seventy-two percent of students believed they should participate in the decision making process. Seventy-three percent of students believed that parents of children less than 12 years old should have access to this information. Adolescents want to have access to and participate in decisions about incidental findings. © 2016 Wiley Periodicals, Inc.

Conducting a large, multi-site survey about patients' views on broad consent: challenges and solutions.

BACKGROUND: As biobanks play an increasing role in the genomic research that will lead to precision medicine, input from diverse and large populations of patients in a variety of health care settings will be important in order to successfully carry out such studies. One important topic is participants' views towards consent and data sharing, especially since the 2011 Advanced Notice of Proposed Rulemaking (ANPRM), and subsequently the 2015 Notice of Proposed Rulemaking (NPRM) were issued by the Department of Health and Human Services (HHS) and Office of Science and Technology Policy (OSTP). These notices required that participants consent to research uses of their de-identified tissue samples and most clinical data, and allowing such consent be obtained in a one-time, open-ended or "broad" fashion. Conducting a survey across multiple sites provides clear advantages to either a single site survey or using a large online database, and is a potentially powerful way of understanding the views of diverse populations on this topic. METHODS: A workgroup of the Electronic Medical Records and Genomics (eMERGE) Network, a national consortium of 9 sites (13 separate institutions, 11 clinical centers) supported by the National Human Genome Research Institute (NHGRI) that combines DNA biorepositories with electronic medical record (EMR) systems for large-scale genetic research, conducted a survey to understand patients' views on consent, sample and data sharing for future research, biobank governance, data protection, and return of research results. RESULTS: Working across 9 sites to design and conduct a national survey presented challenges in organization, meeting human subjects guidelines at each institution, and survey development and implementation. The challenges were met through a committee structure to address each aspect of the project with representatives from all sites. Each committee's output was integrated into the overall survey plan. A number of site-specific issues were successfully managed allowing the survey to be developed and implemented uniformly across 11 clinical centers. CONCLUSIONS: Conducting a survey across a number of institutions with different cultures and practices is a methodological and logistical challenge. With a clear infrastructure, collaborative attitudes, excellent lines of communication, and the right expertise, this can be accomplished successfully.

Obtaining consensus regarding international transplantation continues to be difficult for pediatric centers in the United States.

Organ transplant is life-saving and any given organ may be valuable to a multitude of potential recipients. An allocation system must be used to reconcile the difference between supply and demand, and this system must take into account the impact that accepting international patients may have on the local system. The principles for allocation must be clear, equitable, provide utility and must be monitored so as to maintain public trust. The impact of the system on metrics deemed to be critical must be measured. Finally, strategies must take into account the local culture, size of the region to be supported, the number and experience of transplant centers, and the resources of the healthcare delivery system. Our focus is on the United States, recognizing that strategies and challenges may vary across countries.

Inducing HIV Remission in Neonates: Child Rights and Research Ethics.

The U.N. Convention on the Rights of the Child (CRC) recognizes children as independent rights holders and articulates 38 substantive rights, including four general principles. It obligates states parties to realize these rights. The U.N. Committee on the Rights of the Child (Committee) oversees implementation of the CRC and can draw attention to areas requiring improvement. Many of the CRC's rights have implications for clinical research. While they justify some nontherapeutic research, they also require participants' protection. The Committee's guidance that decision-makers justify their decisions by reference to child rights has the potential to enrich the deliberations of research ethics committees. The CRC is consistent with requirements that low- and middle-income countries ensure that domestic research is relevant to the health needs of their populations and that resulting products and services are available to their populations. The CRC provides strong recognition of the role of parents and families and duties of states parties to support them in fulfilling their role. This could include support to improve informed consent processes.

Conscientious Objection: Widening the Temporal and Organizational Horizons.

Conscience can influence physicians' interactions with patients in myriad ways and, by extension, can influence the interactions and internal dynamics of a health care team. The AMA's opinion around physicians' exercise of conscience appropriately balance the obligations physicians have to their patients and profession, and the rights of physicians as moral agents to exercise their conscience. While the opinion is an effective starting point, further guidance is necessary to clarify the process by which physicians should identify, manage, and, if necessary, report their conscientious refusals to patients, supervisors, or colleagues. In addition to laying out a proposed process for identifying and managing issues of conscience, this article will use relevant and timely examples to help clarify how a physician could apply this process in an instance of conscientious refusal.