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Benchmarks against which healthcare ethics consultation (HCEC) services can assess their performance are needed. As first-generation benchmarks continue to be developed, it is the obligation of the field to continually evaluate how these measures reflect the performance of any single HCEC service. This will be possible only with widespread reporting of standardized data points. In their article in this issue of The Journal of Clinical Ethics, Glover and colleagues provide a valuable preliminary approach for assessing appropriate consult volumes for a HCEC service. The limitations of their study read as a call to action for the field of clinical ethics to expand and standardize data reporting so that more robust metrics can be developed. In response to this call by Glover and colleagues, the Cleveland Clinic HCEC service provides consult data from 2015 through 2019 for one of its medical centers, and offers an additional volume-based metric, consult-to-ICU-to-bed ratio (CiBR), that may add nuance to any normative assessment of HCEC service consult volume. Given that volume-based metrics are the native language of the clinical environment, efforts to improve such metrics in the field through transparency and standardization are warranted. However, the expositive power of volume- based metrics is limited; additional domains related to quality and outcomes are needed.

We agree with the assessment provided by Horner et al. that the current HEC-C certification process is imperfect and could better serve its advertised purpose if re-designed with targeted improveme...

INTRODUCTION: As the COVID19 pandemic persists across the globe, health care professionals and institutions continue to face ethical challenges and often are uncertain about their responses to those challenges While some of these ethical issues have been experienced before, e g , ventilator allocation during H1N1, refusing CPR during Ebola outbreak, similar and other unique ethical issues have developed during the COVID19 pandemic To better understand individual and institutional perspectives, we designed and distributed a survey to capture those working health care and others perceive issues surrounding institutional responses to COVID-19 Given the nature of COVID-19, and our interim analysis, it is likely that many of these issues will arise in the critical care setting METHODS: We sent a survey out weekly to two large bioethics listservs starting in April 2020 Members of the listserv were asked to complete the survey each week and to forward the survey to interdisciplinary colleagues who may not be members of these listservs At this point in our analysis we have completed basic descriptive statistics, including X-tabs and Fischer's exact test RESULTS: Using only 6 months of data for participants who complete the survey for the first time, we received 446 respondents since April 2020 The average age of participants was 47 6 and over 71% of participants identified as female 95% of the respondents work primarily in the US with 62% working in critical care setting at least part-time Overall, when asked about the extent to which it is ethically reasonable to limit CPR (during crisis standards of care) for patients with COVID-19, for the sake of conserving scarce resource, nearly 50% of respondents choose the response, ?Can be reasonable, but generally one should not limit CPR ? Relatedly, 64% of respondents believed it was always reasonable to require providers to don all PPE before initiating CPR on a patient with COVID This is especially relevant in light of the finding that over 78% of participants replied that their institution does not or that they were unsure whether or not their institution has a policy that limits CPR for COVID19 patients when there is insufficient PPE CONCLUSIONS: The survey identified the need for broadly collaborative efforts to resolve ethical issues during COVID-19

Mr. C is a twenty-two-year-old who was flown to a level-1 trauma center after diving headfirst into shallow water. Prior to this accident, he was in excellent health. At the scene, he had been conscious but was paralyzed and had no sensation below his neck. The emergency medical services team immobilized Mr. C's neck with a cervical collar and intubated him for airway protection before transport. As Mr. C's medical care proceeds, he expresses a desire for extubation, although it was not clear that he had the capacity to make this (or any other) decision. It also was unclear whether this desire reflected his authentic wishes to be allowed to die or stemmed from feelings of discomfort and agitation. Over a period of several days, Mr. C's sedation was lightened, and the psychiatry service conducted a formal decision-making capacity assessment. Mr. C continues to express a desire to withdraw life-sustaining medical treatment. However, the psychiatry service is concerned that Mr. C seems to lack adequate insight into what it would mean to die. What does it mean to respect Mr. C's autonomy?

One of the most pressing ethical challenges facing phase I cancer research centres is the process of informed consent. Historically, most scholarship has been devoted to redressing therapeutic misconception, that is, the conflation of the nature and goals of research with those of therapy. While therapeutic misconception continues to be a major ethical concern, recent scholarship has begun to recognise that the informed consent process is more complex than merely a transfer of information and therefore cannot be evaluated only according to how well an individual understands such information. Other components of decision-making operate independently of understanding and yet still may compromise the quality of informed consent. Notable among these components is unrealistic optimism, an event-specific belief that one has a better chance of receiving benefit than others similarly situated. In this article, we consider responses to interviews with parents who had recently completed an informed consent conference for enrolling their child in a phase I cancer clinical trial to examine how this influence manifests and how investigators might address it during informed consent.

As outlined in the case description already presented, efforts to collect patient-reported outcomes (PROs) may improve the quality of health care delivery by identifying relationships between curre...

As dermatology residency program director, Dr Duco recently reviewed the Accreditation Council for Graduate Medical Education (ACGME) guidelines for resident graduation. She noticed that performing or observing cosmetic procedures, such as botulinum toxin and soft tissue filler injections, are listed under surgical requirements. Currently, residents have a limited opportunity either to perform or to observe these procedures under faculty supervision. To fulfill accreditation requirements, the residency program started an after-hours clinic staffed with a full-time faculty member who supervises the cosmetic procedures performed by the residents. All patients are volunteers and receive cosmetic services at no charge. Pharmaceutical companies provide the products to the department free of charge through a company training grant. The cosmetic clinic recently came under scrutiny because the institution designated these cosmetic injectable products as samples, and sampling is prohibited by the hospital.

Purpose: The Institute of Medicine report on cooperative groups and the National Cancer Institute (NCI) report from the Operational Efficiency Working Group both recommend changes to the processes for opening a clinical trial. This article provides evidence for the need for such changes by completing the first comprehensive review of all the time and steps required to open a phase III oncology clinical trial and discusses the effect of time to protocol activation on subject accrual. Methods: The Dilts and Sandler method was used at four cancer centers, two cooperative groups, and the NCI Cancer Therapy Evaluation Program. Accrual data were also collected. Results: Opening a phase III cooperative group therapeutic trial requires 769 steps, 36 approvals, and a median of approximately 2.5 years from formal concept review to study opening. Time to activation at one group ranged from 435 to 1,604 days, and time to open at one cancer center ranged from 21 to 836 days. At centers, group trials are significantly more likely to have zero accruals (38.8%) than nongroup trials (20.6%; P < 0.0001). Of the closed NCI Cancer Therapy Evaluation Program–approved phase III clinical trials from 2000 to 2007, 39.1% resulted in Conclusions: The length, variability, and low accrual results demonstrate the need for the NCI clinical trials system to be reengineered. Improvements will be of only limited effectiveness if done in isolation; there is a need to return to the collaborative spirit with all parties creating an efficient and effective system. Recommendations put forth by the Institute of Medicine and Operational Efficiency Working Group reports, if implemented, will aid this renewal. Clin Cancer Res; 16(22); 5381–9. ©2010 AACR.

Purpose To examine the processes and document the calendar time required for the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) and Central Institutional Review Board (CIRB) to evaluate and approve phase III clinical trials. Methods Process steps were documented by (1) interviewing CTEP and CIRB staff regarding the steps required to activate a trial from initial concept submission to trial activation by a cooperative group, (2) reviewing standard operating procedures, and (3) inspecting trial records and documents for selected trials to identify any additional steps. Calendar time was collected from initial concept submission to activation using retrospective data from the CTEP Protocol and Information Office. Results At least 296 distinct processes are required for phase III trial activation: at least 239 working steps, 52 major decision points, 20 processing loops, and 11 stopping points. Of the 195 trials activated during the January 1, 2000, to December 31, 2007, study period, a sample of 167 (85.6%) was used for gathering timing data. Median calendar days from initial formal concept submission to CTEP to trial activation by a cooperative group was 602 days (interquartile range, 454 to 861 days). This time has not significantly changed over the past 8 years. There is a high variation in the time required to activate a clinical trial. Conclusion Because of their complexity, the overall development time for phase III clinical trials is lengthy, process laden, and highly variable. To streamline the process, a solution must be sought that includes all parties involved in developing trials.

Purpose: We examine the processes and document the calendar time required to activate phase II and III clinical trials by an oncology group: the Eastern Cooperative Oncology Group (ECOG). Methods: Setup steps were documented by (a) interviewing ECOG headquarters and statistical center staff, and committee chairs, (b) reviewing standard operating procedure manuals, and (c) inspecting study records, documents, and e-mails to identify additional steps. Calendar time was collected for each major process for each study in this set. Results: Twenty-eight phase III studies were activated by ECOG during the January 2000 to July 2006 study period. We examined a sample from 16 of those studies in detail. More than 481 distinct processes were required for study activation: 420 working steps, 61 major decision points, 26 processing loops, and 13 stopping points. Median calendar days to activate a trial in the phase III subset was 783 days (range, 285-1,542 days) from executive approval and 808 days (range, 435-1,604 days) from initial conception of the study. Data were collected for all phase II and phase III trials activated and completed during this time period (n = 52) for which development time represented 43.9% and 54.1% of the total trial time, respectively. Conclusion: The steps required to develop and activate a clinical trial may require as much or more time than the actual completion of a trial. The data shows that to improve the activation process, research should to be directed toward streamlining both internal and external groups and processes.

In their article, Drs. Ubel and Silbergleit (2011) present “behavioral equipoise” as a supplement to the notion of clinical equipoise (CE) as it pertains to the justification for conducting randomi...

Although Sokol never explicitly says that bioethicists (clinical ethics consultants) are bullies, his anthropomorphism of bioethics insinuates this.1 It would be a tragedy for readers to believe that Sokol accurately portrays the entire field. Clinical ethics straddles theoretical inquiry and practical application, but theoretical inquiry is not responsible …

CRA6509 Background: Post-activation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. Methods: National Cancer Institute Cancer Therapy Evaluation Program (NCI-CTEP) sponsored trials for all therapeutic, non-pediatric phase I,I/II, II, and III studies activated in an eight year period (2000–2007) were investigated (n=553). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trialactivation. Multivariable logistic regression analysis was used tocalculate unadjusted and adjusted odds ratios, controlling for study phase and size of expected accruals. Results: 40.0 percent (n=221) of CTEP-approved oncology trials failed to achieve minimum accrual goals, with 49.2 percent (n=30) of phase III trials failing to achieve at least 25 percent of accrual goals. A total of 8,723 patients (17.0% of accruals) accrued to those studies that were unable to achieve the projected minimum accrual goal. Trials requiring 9–12 months development were significantly more likely to achieve accrual goals (odds ratio, 1.94; 95% CI, 1.06 to 3.52, P=0.031) than trials requiring the median time (15–18 months); trials that exceeded 27 months of development time were significantly less likely of achieving accrual goals (odds ratio, 0.14; 95% CI, 0.04 to 0.54, P=0.004). Conclusions: A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. [Table: see text] No significant financial relationships to disclose.

6543 Background: To examine the accrual rates for all phases clinical trials opened at four selected comprehensive cancer centers (CCCs). Methods: Accrual data for the date ranges was collected for...