Background The literature on the ethics of biobanking often overlooks the practical operations of biobanks. The ethics of stewardship requires that biobank resources are used to conduct beneficial science. Networked biobanks have emerged to increase the scientific benefit of biobank resources, but little is known about whether and how operations of networking may accomplish this goal.Methods As part of a larger study on the ethical, legal, and social implications (ELSI) of networked biobanking, we conducted 38 interviews with representatives of 31 (...) networked biobanks. Interviews explored operations of the networks. We used thematic analysis to examine how respondents describe three topics associated with stewarding biobank resources—funding, utilization, and sustainability.Results Our results highlight that funding, utilization, and sustainability are critical not only to the operation of biobanks, but also to the ethical obligations that biobankers owe to stakeholders to steward the resources. Based on prior research, we hypothesized that respondents would describe networking as beneficial to increasing funding, utilization, and sustainability of the network. Respondents generally found value in networked biobanking, but networking did not necessarily increase funding, utilization, and sustainability.Conclusion The results presented here support inclusion of funding, utilization, and sustainability as topics of ethical concern in the practice of biobanking and networked biobanking. These issues are rooted in the stewardship obligations that biobankers feel to their partners, client investigators, and participants. The goal of promoting stewardship through networking requires significant time and effort to build governance models that honor the obligations of each individual biobank to their donors and advance the collective goals of the network. We conclude with suggestions offered by respondents to address improving these aspects of stewardship. (shrink)

Introduction Deep brain stimulation (DBS) is approved under a humanitarian device exemption to manage treatment-resistant obsessive-compulsive disorder (TR-OCD) in adults. It is possible that DBS may be trialed or used clinically off-label in children and adolescents with TR-OCD in the future. DBS is already used to manage treatment-resistant childhood dystonia. Evidence suggests it is a safe and effective intervention for certain types of dystonia. Important questions remain unanswered about the use of DBS in children and adolescents with TR-OCD, including whether (...) mental health clinicians would refer pediatric patients for DBS, and who would be a good candidate for DBS.Objectives To explore mental health clinicians’ views on what clinical and psychosocial factors they would consider when determining which children with OCD would be good DBS candidates.Materials and Methods In depth, semi-structured interviews were conducted with n = 25 mental health clinicians who treat pediatric patients with OCD. The interviews were transcribed, coded, and analyzed using thematic content analysis. Three questions focused on key, clinical, and psychosocial factors for assessing candidacy were analyzed to explore respondent views on candidacy factors. Our analysis details nine overarching themes expressed by clinicians, namely the patient’s previous OCD treatment, OCD severity, motivation to commit to treatment, presence of comorbid conditions, family environment, education on DBS, quality of life, accessibility to treatment, and patient age and maturity.Conclusions Clinicians generally saw considering DBS treatment in youth as a last resort and only for very specific cases. DBS referral was predominantly viewed as acceptable for children with severe TR-OCD who have undertaken intensive, appropriate treatment without success, whose OCD has significantly reduced their quality of life, and who exhibit strong motivation to continue treatment given the right environment. Appropriate safeguards, eligibility criteria, and procedures should be discussed and identified before DBS for childhood TR-OCD becomes practice. (shrink)

Background Implementation science presents ethical issues not well addressed by traditional research ethics frameworks. There is little empirical work examining how clinicians whose work is affected by implementation studies view these issues. Accordingly, we interviewed clinicians working at sites participating in an implementation study seeking to improve patient handoffs to the intensive care unit (ICU).Methods We performed semi-structured interviews with 32 clinicians working at sites participating in an implementation study aiming to improve patient handoffs from the operating room to the (...) ICU. We analyzed the interviews using an iterative coding process following a conventional content analysis approach.Results Clinicians’ greatest concern about involvement was possible damage to interpersonal relations with more senior clinicians. They were divided about whether informed consent from clinicians was necessary but were satisfied with the study’s approach of sending out mass communications about the study. They did not think opting out of the implementation portion of the study was feasible but saw this inability to opt out as unproblematic because they equated the study with routine quality improvement. Those clinicians who helped launch the study at their sites recounted several different ways of doing so beyond simply facilitating access.Conclusions The risks that clinicians identified stemmed more from their general status as employees than their specific work as clinicians. Implementation researchers should be attuned to the ethical ramifications of involving employees of varying ranks. Implementation researchers using hybrid designs should also be sensitive to the possibility that practitioners affected by a study will equate it with quality improvement and overlook its research component. Finally, the interactions that go into facilitating an implementation study are more various than the “gatekeeping” typically discussed by research ethicists. More research is needed on the ethics of the myriad interactions that are involved in making implementation studies happen. (shrink)

To succeed, an accreditation process for clinical ethics fellowship programs (CEFPs) would need support from CEFP directors. To assess CEFP directors’ opinions, we surveyed all 36 CEFP directors in the United States and Canada, achieving a 100% response rate. We found that support for accreditation is strong, with 30.6% strongly supportive, 44.4% supportive, 22.2% neutral, 2.8% opposed, and 0% strongly opposed. Most directors (77.8%) would be likely to apply for accreditation within the next five years regardless of the availability of (...) government funding; even more (86.1%) would apply if government funding became available for accredited programs. Most directors thought that lack of a national accreditation process (75.0%), lack of agreed-upon standards (90.0%), and lack of funding for CEFPs (91.7%) were at least moderate problems for the field. When directors were asked what they thought was the greatest challenge or barrier to developing an accreditation process, many mentioned the diversity of programs and the challenge of achieving consensus on accreditation standards. Directors offered a variety of suggestions for how to overcome or manage challenges or barriers, including collecting data on existing programs, mirroring standards established for other health professions, and setting clear expectations on the need for compromise. When directors were asked how they expected that accreditation and government funding would affect their own programs, the field of clinical ethics, and patient care, directors mostly had very positive expectations; no director expected negative effects in any of these areas. Overall, this study provides evidence that developing an accreditation process for CEFPs would be both possible and desirable. Our findings have immediate practical implications for the field and will inform efforts that are already underway to establish an accreditation process for CEFPs. (shrink)

Background Some have hypothesized that talk about suffering can be used by clinicians to motivate difficult decisions, especially to argue for reducing treatment at the end of life. We examined how talk about suffering is related to decision-making for critically ill patients, by evaluating transcripts of conversations between clinicians and patients’ families.Methods We conducted a secondary qualitative content analysis of audio-recorded family meetings from a multicenter trial conducted in the adult intensive care units of five hospitals from 2012–2017 to look (...) at how the term “suffering” and its variants were used. A coding guide was developed by consensus-oriented discussion by four members of the research team. Two coders independently evaluated each transcript. We followed an inductive approach to data analysis in reviewing transcripts; findings were iteratively discussed among study authors until consensus on key themes was reached.Results Of 146 available transcripts, 34 (23%) contained the word “suffer” or “suffering” at least once, with 58 distinct uses. Clinicians contributed 62% of first uses. Among uses describing the suffering of persons, 57% (n = 24) were related to a decision, but only 42% (n = 10) of decision-relevant uses accompanied a proposal to limit treatment, and only half of treatment-limiting uses (n = 5) were initiated by clinicians. The target terms had a variety of implicit meanings, including poor prognosis, reduced functioning, pain, discomfort, low quality of life, and emotional distress. Suffering was frequently attributed to persons who were unconscious.Conclusions Our results did not support the claim that the term “suffering” and its variants are used primarily by clinicians to justify limiting treatment, and the terms were not commonly used in our sample when decisions were requested. Still, when these terms were used, they were often used in a decision-relevant fashion. (shrink)

Background Potential clinical interventions to mitigate or eliminate symptoms of Down syndrome (DS) continue to be an active area of pre-clinical and clinical research. However, views of members of the DS community have yet to be fully explored.Methods We conducted a survey with parents/caregivers of people with DS (n = 532) to explore interest in potential therapeutic approaches during fetal development or childhood that may improve neurocognition and modulate the DS phenotype. We qualitatively analyzed open-ended responses.Results Some respondents rejected the (...) development of therapies for DS categorically as being fundamentally ableist and promoting the erasure of diverse individuals. Many reflected tensions between the desire to improve quality of life and an aversion to erasure of a child’s personality.Conclusion Findings suggest that views on identity, personality, and disability may influence the acceptance of new interventions, especially if they are thought to mitigate positive attributes of the phenotype or negatively influence social acceptance of people with DS. (shrink)