Reimagining Thriving Ethics Programs without Ethics Committees.

With the increasing professionalization of clinical ethics, some hospitals and health systems utilize both ethics committees and professional clinical ethicists to address their ethics needs. Drawing upon historical critiques of ethics committees and their own experiences, the authors argue that, in ethics programs with one or more professional clinical ethicists, ethics committees should be dissolved when they fail to meet minimum standards of effectiveness. The authors outline several criteria for assessing effectiveness, describe the benefits of a model that places primary responsibility for ethics work with professional clinical ethicists-the PCE-primary model, and offer suggestions for alternative ethics program structures that empower healthcare professionals to contribute to ethics work in ways more tailored to their strengths and skills while minimizing the shortcomings of ethics committees.

Answering the Call for Standardized Reporting of Clinical Ethics Consultation Data.

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.

Building an Organizational Ethics Program on a Clinical Ethics Foundation.

Organizational ethics programs often are created to address tensions in organizational values that have been identified through repeated clinical ethics consultation requests. Clinical ethicists possess some core competencies that are suitable for the leadership of high-quality organizational ethics programs, but they may need to develop new skills to build these programs, such as familiarity with healthcare delivery science, healthcare financing, and quality improvement methodology. To this end, we suggest that clinical ethicists build organizational ethics programs incrementally and via quality improvement projects undertaken in collaboration with senior clinical leaders. Organizational ethics programs often differ from clinical ethics programs in their membership and processes, and likely will require ethicists to forge new partnerships with a wide array of organizational leaders. With attention to the ways that organizational ethics programs differ from clinical ethics programs, and investment in quality improvement methodology and formal institutional needs assessments, clinical ethics leaders can position an organizational ethics program to advocate effectively for visible and compelling alignment of leadership decision making with the values of the organization.

Comprehensive Quality Assessment in Clinical Ethics.

Scholars and professional organizations in bioethics describe various approaches to "quality assessment" in clinical ethics. Although much of this work represents significant contributions to the literature, it is not clear that there is a robust and shared understanding of what constitutes "quality" in clinical ethics, what activities should be measured when tracking clinical ethics work, and what metrics should be used when measuring those activities. Further, even the most robust quality assessment efforts to date are idiosyncratic, in that they represent evaluation of single activities or domains of clinical ethics activities, or a range of activities at a single hospital or healthcare system. Countering this trend, iin this article we propose a framework for moving beyond our current ways of understanding clinical ethics quality, toward comprehensive quality assessment. We first describe a way to conceptualize quality assessment as a process of measuring disparate, isolated work activities; then, we describe quality assessment in terms of tracking interconnected work activities holistically, across different levels of assessment. We conclude by inviting future efforts in quality improvement to adopt a comprehensive approach to quality assessment into their improvement practices, and offer recommendations for how the field might move in this direction.

Unrealistic optimism and the ethics of phase I cancer research.

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.

Development of clinical trials in a cooperative group setting: the eastern cooperative oncology group.

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.

Phase III clinical trial development: a process of chutes and ladders.

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 <21 accruals. 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.

Steps and time to process clinical trials at the Cancer Therapy Evaluation Program.

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.