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Research ethics oversight systems have traditionally emphasized the informed consent process as the primary means by which to demonstrate respect for prospective subjects. Yet how researchers can best fulfill the ethical obligations of respect for persons in pragmatic clinical trials (PCTs)-particularly those that may alter or waive informed consent-remains unknown. We propose eight dimensions of demonstrating respect in PCTs: (1) engaging patients and communities in research design and execution, (2) promoting transparency and open communication, (3) maximizing agency, (4) minimizing burdens and promoting accessibility, (5) protecting privacy and confidentiality, (6) valuing interpersonal interactions with clinicians and study team members, (7) providing compensation, and (8) maximizing social value. While what respect requires in the context of PCTs will vary based on the nature of the PCT in question, the breadth of these dimensions demonstrates that respect obligations extend beyond informed consent processes.

Evidence suggests that Gaelic football (GF) players do not meet the recommended energy intake (EI) levels and therefore may be at risk of low energy availability (LEA). This study examined energy availability (EA) in 20 elite male GF players. At two stages during a season (2019-2020), repeated measures of EI, exercise energy expenditure (EEE), EA and body composition were performed. Sixty-five percent reported with LEA [30 kcal.kg Lean Body Mass (LBM)

Given that pediatric genomic sequencing (GS) may have implications for the health and well-being of both the child and family, a clearer understanding of the key drivers of the utility of GS from the family perspective is needed. The purpose of this study is to explore what is important to caregivers of pediatric patients regarding clinical GS, with a focus on family-level considerations. We conducted semi-structured interviews with caregivers (n=41) of pediatric patients who had been recommended for or completed GS that explored the scope of factors caregivers considered when deciding whether to pursue GS for their child. We analyzed the qualitative data in multiple rounds of coding using thematic analysis. Caregivers raised important family-level considerations, in addition to those specifically for their child, which included wanting the best chance at good quality of life for the family, the ability to learn about family health, the impact on the caregiver’s well-being, privacy concerns among family members, and the cost of testing to the family. We developed a framework of key drivers of utility consisting of four domains that influenced caregivers’ decision making: underlying values, perceived benefits, perceived risks, and other pragmatic considerations regarding GS. These findings can inform measurement approaches that better capture the utility of pediatric GS for families.

Genomic sequencing of healthy newborns to screen for medically important genetic information has long been anticipated but data around downstream medical consequences are lacking. Among 159 infants randomized to the sequencing arm in the BabySeq Project, an unanticipated monogenic disease risk (uMDR) was discovered in 18 (11.3%). We assessed uMDR actionability by visualizing scores from a modified ClinGen Actionability SemiQuantitative Metric and tracked medical outcomes in these infants for 3-5 years. All uMDRs scored as highly actionable (mean 9, range: 7-11 on a 0-12 scale) and had readily available clinical interventions. In 4 cases, uMDRs revealed unsuspected genetic etiologies for existing phenotypes, and in the remaining 14 cases provided risk stratification for future surveillance. In 8 cases, uMDRs prompted screening for multiple at-risk family members. These results suggest that actionable uMDRs are more common than previously thought and support ongoing efforts to evaluate population-based newborn genomic screening.

peer-reviewed The full text of this article will not be available in ULIR until the embargo expires on the 22/01/2022 The Female Athlete Triad has recently been suggested to be a threat to male athletes. This review aims to examine the evidence, and associated effects, of low energy availability (LEA) in male athletes. A comprehensive search of PubMed and SPORTDiscus was performed. Three RCT and seven CS studies were included that measured energy availability and included well‐trained males. Clinical LEA (

The capacity of next-generation closed-loop or adaptive deep brain stimulation devices (aDBS) to read (measure neural activity) and write (stimulate brain regions or circuits) shows great potential to effectively manage movement, seizure, and psychiatric disorders, and also raises the possibility of using aDBS to electively (non-therapeutically) modulate mood, cognition, and prosociality. What separates aDBS from most neurotechnologies (e.g. transcranial stimulation) currently used for enhancement is that aDBS remains an invasive, surgically-implanted technology with a risk-benefit ratio significantly different when applied to diseased versus non-diseased individuals. Despite a large discourse about the ethics of enhancement, no empirical studies yet examine perspectives on enhancement from within the aDBS research community. We interviewed 23 aDBS researchers about their attitudes toward expanding aDBS use for enhancement. A thematic content analysis revealed that researchers share ethical concerns related to (1) safety and security; (2) enhancement as unnecessary, unnatural or aberrant; and (3) fairness, equality, and distributive justice. Most (70%) researchers felt that enhancement applications for DBS will eventually be technically feasible and that attempts to develop such applications for DBS are already happening (particularly for military purposes). However, researchers unanimously (100%) felt that DBS ideally should not be considered for enhancement until researchers better understand brain target localization and functioning. While many researchers acknowledged controversies highlighted by scholars and ethicists, such as potential impacts on personhood, authenticity, autonomy and privacy, their ethical concerns reflect considerations of both gravity and perceived near-term likelihood.

Hospital administrators may lack familiarity with what clinical ethicists do (and do not do), and many clinical ethicists report receiving inadequate financial support for their clinical ethics consultation services (CECSs). Ethics consultation is distinct in that it is not reimbursable by third parties, and its financial benefit to the hospital may not be quantifiable. These peculiarities make it difficult for clinical ethicists to resort to tried-and-true outcome-centered evaluative strategies, like cost reduction or shortened length of stay for patients, to show a "need" for ethics consultation. Likewise, it can be difficult for clinical ethicists to "speak the same language" as healthcare administrators and managers, which, in turn, means that CECSs run the risk of being unable to demonstrate value to those who pay for the service. The purpose of this descriptive article is to provide practical guidance to clinical ethicists and program directors on how to cultivate administrative support for a CECS. Specifically, we discuss two elements that clinical ethics leaders must critically appraise and successfully argue to meet the expectations of administrators-the value of a CECS and its fit in clinical workflow.

Despite rapid technical progress and demonstrable effectiveness for some types of diagnosis and therapy, much remains to be learned about clinical genome and exome sequencing (CGES) and its role within the practice of medicine. The Clinical Sequencing Exploratory Research (CSER) consortium includes 18 extramural research projects, one National Human Genome Research Institute (NHGRI) intramural project, and a coordinating center funded by the NHGRI and National Cancer Institute. The consortium is exploring analytic and clinical validity and utility, as well as the ethical, legal, and social implications of sequencing via multidisciplinary approaches; it has thus far recruited 5,577 participants across a spectrum of symptomatic and healthy children and adults by utilizing both germline and cancer sequencing. The CSER consortium is analyzing data and creating publically available procedures and tools related to participant preferences and consent, variant classification, disclosure and management of primary and secondary findings, health outcomes, and integration with electronic health records. Future research directions will refine measures of clinical utility of CGES in both germline and somatic testing, evaluate the use of CGES for screening in healthy individuals, explore the penetrance of pathogenic variants through extensive phenotyping, reduce discordances in public databases of genes and variants, examine social and ethnic disparities in the provision of genomics services, explore regulatory issues, and estimate the value and downstream costs of sequencing. The CSER consortium has established a shared community of research sites by using diverse approaches to pursue the evidence-based development of best practices in genomic medicine.

As more research studies incorporate next-generation sequencing (including whole-genome or whole-exome sequencing), investigators and institutional review boards face difficult questions regarding which genomic results to return to research participants and how. An American College of Medical Genetics and Genomics 2013 policy paper suggesting that pathogenic mutations in 56 specified genes should be returned in the clinical setting has raised the question of whether comparable recommendations should be considered in research settings. The Clinical Sequencing Exploratory Research (CSER) Consortium and the Electronic Medical Records and Genomics (eMERGE) Network are multisite research programs that aim to develop practical strategies for addressing questions concerning the return of results in genomic research. CSER and eMERGE committees have identified areas of consensus regarding the return of genomic results to research participants. In most circumstances, if results meet an actionability threshold for return and the research participant has consented to return, genomic results, along with referral for appropriate clinical follow-up, should be offered to participants. However, participants have a right to decline the receipt of genomic results, even when doing so might be viewed as a threat to the participants’ health. Research investigators should be prepared to return research results and incidental findings discovered in the course of their research and meeting an actionability threshold, but they have no ethical obligation to actively search for such results. These positions are consistent with the recognition that clinical research is distinct from medical care in both its aims and its guiding moral principles.

Newborn Care Poster Presentation Purpose for the Program In December 2011, a report generated from the online‐incident reporting system indicated that three infant falls (6.6 falls per 10,000 births) had occurred in 2011. Two infants falls (4.4 falls per 10,000 births) were reported in 2009 and no infant falls were reported in 2010. All incidents took place during the night shift and infant falls were due to the mother falling asleep. None of the newborns suffered serious injury. The mother–baby unit had just completed a project to increase exclusive breastfeeding and more infants (>70%) were rooming‐in with their mothers. There was concern on the part of the staff that the new mother–baby care delivery model would be blamed for the increased rate in falls. The hospital had also recently purchased new beds that may have been contributory to the increased rate in falls because the side rails were not as high when the head of the bed was elevated. Proposed Change To fully evaluate contributory factors related to infant falls in the mother–baby unit and develop safety strategies to reduce/eliminate infant falls by instituting a Newborn Safety Partnering Agreement for Parents. Implementation, Outcomes, and Evaluation An increased rate of infant falls in the mother–baby unit prompted review to identify potential contributory factors, which included exhaustion of the mother after delivery, bedside rail position, too many pillows, timing and type of pain medication, cultural issues, and unsafe parental behaviors. A query was sent out to the NY Organization of Nurse Executives list serve, which requested any infant fall prevention programs that were successful. The query and literature review yielded minimal results. An infant safety checklist was developed to include awareness for potential falls. Based on feedback, the checklist evolved into a Newborn Safety Partnering Agreement for Parents and fall debrief tool to be used after a fall to immediately identify contributing factors. The premise behind the partnering agreement was to increase parents' awareness of the potential of an infant fall beyond traditional patient education. The tool is used to educate and ask parents to partner with staff to keep their infant safe. A pilot to evaluate effectiveness was conducted. Minor changes to the tool and implementation of the agreement in the delivery room before delivery proved successful. Since the implementation of the Newborn Safety Partnering Agreement for Parents there have been no infant falls to date. Implications for Nursing Practice Implementation of a Newborn Safety Partnering Agreement for Parents on the mother–baby unit raises awareness to prevent infant falls and injury.

Professional Issues Poster Presentation Implementation, Outcomes, and Evaluation A trimmed identification band with the bar code is attached to the lead wires before the leads are placed on the infant. The band will stay between the infant and the cable juncture, which lies outside the infant nesting area. This allows the label to be scanned and the patient identification can be made without disturbing the infant. Prior to implementation, identification errors were erratic and often exceeded those of the hospital as a whole. Since implementing the new identification system in the neonatal intensive care unit, patientidentification errors for neonatal intensive care unit admissions were reduced to zero for a 4-month period. During the following month, one error was discovered as a result of failure to follow the new identification procedure. Retraining and reinforcement continues.