Lessons learned from implementing a responsive quality assessment of clinical ethics support.

BACKGROUND: Various forms of Clinical Ethics Support (CES) have been developed in health care organizations. Over the past years, increasing attention has been paid to the question of how to foster the quality of ethics support. In the Netherlands, a CES quality assessment project based on a responsive evaluation design has been implemented. CES practitioners themselves reflected upon the quality of ethics support within each other's health care organizations. This study presents a qualitative evaluation of this Responsive Quality Assessment (RQA) project. METHODS: CES practitioners' experiences with and perspectives on the RQA project were collected by means of ten semi-structured interviews. Both the data collection and the qualitative data analysis followed a stepwise approach, including continuous peer review and careful documentation of the decisions. RESULTS: The main findings illustrate the relevance of the RQA with regard to fostering the quality of CES by connecting to context specific issues, such as gaining support from upper management and to solidify CES services within health care organizations. Based on their participation in the RQA, CES practitioners perceived a number of changes regarding CES in Dutch health care organizations after the RQA: acknowledgement of the relevance of CES for the quality of care; CES practices being more formalized; inspiration for developing new CES-related activities and more self-reflection on existing CES practices. CONCLUSIONS: The evaluation of the RQA shows that this method facilitates an open learning process by actively involving CES practitioners and their concrete practices. Lessons learned include that "servant leadership" and more intensive guidance of RQA participants may help to further enhance both the critical dimension and the learning process within RQA.

Objectives and outcomes of clinical ethics services: a Delphi study.

OBJECTIVES: To explore the objectives and outcomes most appropriate for evaluating clinical ethics support services (CESs) in the USA. METHODS: A three-round e-Delphi was sent to two professional medical ethics listservs (Medical College of Wisconsin-Bioethics and American Society for Bioethics and Humanities) as well as 19 individual experts. The survey originally contained 15 objectives and 9 outcomes. In round 1, participants were asked to validate the content of these lists. In round 2, we had 17 objectives and 10 outcomes, and participants were asked to rank them for appropriateness in a top 10 list of objectives and a top 5 list of outcomes. RESULTS: Participants came to a high(at least 70%) level of agreement on seven objectives: mediate, educate, develop policy, improve the moral quality of a decision or action, counsel, create a moral space and manage moral distress. Participants came to a moderate (at least 51%) level of agreement on three objectives: empower, awareness of ethics and preventative ethics. Participants also came to a moderate (at least 51%) level of agreement on five outcomes: ethical justification, transformation of institution, improvement of quality of life, principled consensus and satisfaction with the expertise of a CES. CONCLUSION: This e-Delphi identified 10 objectives and 5 outcomes that are a good starting point for developing outcome measures to evaluate CESs in the USA, while reminding us of the diversity of perspectives still evident in the field.

Do we understand the intervention? What complex intervention research can teach us for the evaluation of clinical ethics support services (CESS).

BACKGROUND: Evaluating clinical ethics support services (CESS) has been hailed as important research task. At the same time, there is considerable debate about how to evaluate CESS appropriately. The criticism, which has been aired, refers to normative as well as empirical aspects of evaluating CESS. MAIN BODY: In this paper, we argue that a first necessary step for progress is to better understand the intervention(s) in CESS. Tools of complex intervention research methodology may provide relevant means in this respect. In a first step, we introduce principles of "complex intervention research" and show how CESS fulfil the criteria of "complex interventions". In a second step, we develop a generic "conceptual framework" for "ethics consultation on request" as standard for many forms of ethics consultation in clinical ethics practice. We apply this conceptual framework to the model of "bioethics mediation" to make explicit the specific structural and procedural elements of this form of ethics consultation on request. In a final step we conduct a comparative analysis of two different types of CESS, which have been subject to evaluation research: "proactive ethics consultation" and "moral case deliberation" and discuss implications for evaluating both types of CESS. CONCLUSION: To make explicit different premises of implemented CESS interventions by means of conceptual frameworks can inform the search for sound empirical evaluation of CESS. In addition, such work provides a starting point for further reflection about what it means to offer "good" CESS.

Institutional Ethics Committees.

In hospitals throughout the United States, institutional ethics committees (IECs) have become a standard vehicle for the education of health professionals about biomedical ethics, for the drafting and review of hospital policy, and for clinical ethics case consultation. In addition, there is increasing interest in a role for the IEC in organizational ethics. Recommendations are made about the membership and structure of an IEC, and guidance is provided for those serving on an IEC.

An overview of trends in the regulation of clinical ethics committees: an opinion from the Italian National Bioethics Committee article / Una visión general de las tendencias en la regulación por los comités de ética clínica: una opinión del Comité Nacional Italiano de Bioética

In 2017, the Italian National Bioethics Committee (INBC) released an opinion paper titled "Clinical ethics committees". Said document advocates for the creation of "clinical bioethics committees" in every suitable setting and lays out a set of guidelines aimed at regulating such committees' functions. The recommendations deal primarily with the independence, requirements for counselling, structures, composition, tasks, placement, coordination, requisite competences, regulations. In the opinion's contents there are: a) the need to entrust counselling and training on ethical issues within clinical practice to different committees than those that deal with ethical assessments of scientific trials and experimentation; b) the laying out of all the various functions and related competencies required of the ethics committees' members; c) the necessity that all counselling practices be carried out by each committee as a whole, rather than by a single expert member; d) Committee's independence. The authors elaborate on each one of the above mentioned aspects and highlight the importance of INBC's recommendations in order to improve the quality standards of care delivered "to each patient's bed"

En el 2017, el Comité Nacional Italiano de Bioética (CNIB) publicó un artículo de opinión titulado "Comités de Ética Clínica". Dicho documento aboga por la creación de "comités clínicos de bioética" en cada entorno adecuado, y establece un conjunto de directrices destinadas a regular las funciones de tales comités. Las recomendaciones se refieren principalmente a la independencia, los requisitos para el asesoramiento, las estructuras, la composición, las tareas, la ubicación, la coordinación, las competencias requeridas, las regulaciones. En los contenidos de la opinión se plantean: a) la necesidad de confiar el asesoramiento y la capacitación en cuestiones éticas dentro de la práctica clínica a diferentes comités que aquellos que se ocupan de las evaluaciones éticas de los ensayos científicos y la experimentación; b) la presentación de las diversas funciones y competencias requeridas por los miembros de los comités de ética; c) la necesidad de que todas las prácticas de asesoramiento sean llevadas a cabo por cada comité como un todo, y no por un solo miembro experto; d) independencia del comité. Los autores detallan cada uno de los aspectos mencionados anteriormente y resaltan la importancia de las recomendaciones de CNIB para mejorar los estándares de calidad de la atención brindada "a la cabecera de la cama de cada paciente"

El internista como consultor de ética clínica: un antídoto contra "la barbarie delespecialismo" en la práctica hospitalaria / The internist as clinical ethics consultant: An antidote to "the barbarism of specialization" in hospital practice

El desarrollo de la ética clínica hospitalaria en España depende casi exclusivamente de los comités de ética asistencial. Estos han sido criticados por su falta de cercanía a la cabecera del paciente en los conflictos éticos cotidianos y por su escasa operatividad práctica, que se refleja en el escaso número de consultas que reciben. En el presente trabajo reflexionamos sobre la necesidad de modificar el modelo actual de atención en ética clínica para reactivarlo y llamar la atención sobre el papel primordial del internista como motor de dicho cambio. Para ello proponemos un modelo en que los comités de ética asistencial incorporen consultores de ética, mejor posicionados para la discusión de casos a la cabecera del enfermo. Seguidamente analizamos las características que dichos consultores deberían poseer

The development of hospital clinical ethics in Spain depends almost exclusively on the healthcare ethics committees, which have been criticized for a lack of proximity to the patient's bedside in day-to-day ethical conflicts and for their scarce practical operation, reflected in the low number of consultations they receive. In this study, we reflect on the need to change the current healthcare model in clinical ethics so as to reactivate it and call attention to the essential role of internists as the engine for this change. To this end, we propose a model in which the healthcare ethics committees incorporate ethics consultants, who are better positioned to discuss cases at the patient's bedside. We then analyse the characteristics that these consultants should have

\How Can Clinical Ethics Committees Take on Organizational Ethics? Some Practical Suggestions.

Although leaders in the field of ethics have for many years pointed to the crucial role that organizations play in shaping healthcare ethics, organizational ethics remains a relatively undeveloped area of ethics activity. Clinical ethics committees are an important source of potential expertise, but new skills will be required. Clinical ethics committees seeking to extend their purview to organizational issues will have to respond to three challenges-how to gain sanction and support for addressing controversial and sensitive issues, how to develop an acceptable process, and how to make a difference on the ground. The article presents practical suggestions for how clinical ethics committees meet these challenges.

Expertise, Ethics Expertise, and Clinical Ethics Consultation: Achieving Terminological Clarity.

The language of ethics expertise has become particularly important in bioethics in light of efforts to establish the value of the clinical ethics consultation (CEC), to specify who is qualified to function as a clinical ethics consultant, and to characterize how one should evaluate whether or not a person is so qualified. Supporters and skeptics about the possibility of ethics expertise use the language of ethics expertise in ways that reflect competing views about what ethics expertise entails. We argue for clarity in understanding the nature of expertise and ethics expertise. To be an ethics expert, we argue, is to be an expert in knowing what ought to be done. Any attempt to articulate expertise with respect to knowing what ought to be done must include an account of ethics that specifies the nature of moral truth and the means by which we access this truth or a theoretical account of ethics such that expertise in another domain is linked to knowing or being better at judging what ought to be done and the standards by which this "knowing" or "being better at judging" is determined. We conclude with a discussion of the implications of our analysis for the literature on ethics expertise in CEC. We do think that there are clear domains in which a clinical ethics consultant might be expert but we are skeptical about the possibility that this includes ethics expertise. Clinical ethics consultants should not be referred to as ethics experts.

Human somatic cell nuclear transfer and reproductive cloning: an Ethics Committee opinion.

This document presents arguments that conclude that it is unethical to use somatic cell nuclear transfer (SCNT) for infertility treatment due to concerns about safety; the unknown impact of SCNT on children, families, and society; and the availability of other ethically acceptable means of assisted reproduction. This document replaces the ASRM Ethics Committee report titled, "Human somatic cell nuclear transfer and cloning," last published in Fertil Steril 2012;98:804-7.

Moral Reasoning among HEC Members: An Empirical Evaluation of the Relationship of Theory and Practice in Clinical Ethics Consultation.

In light of the ongoing development and implementation of core competencies in bioethics, it is important to proceed with a clear sense of how bioethics knowledge is utilized in the functioning of hospital ethics committees (HECs). Without such an understanding, we risk building a costly edifice on a foundation that is ambiguous at best. This article examines the empirical relationship between traditional paradigms of bioethics theory and actual decision making by HEC members using survey data from HEC members. The assumption underlying the standardization of qualifications and corresponding call for increased education of HEC members is that they will base imminent case decisions on inculcated knowledge. Our data suggest, however, that HEC members first decide intuitively and then look for justification, thereby highlighting the need to re-examine the pedagogical processes of ethics education in the process of standardizing and improving competencies.

The European "clinical trial" regulation; relationship with the Jardé Act: a Giens workshop.

In May 2014, the European Union Parliament and Council published a new regulation on clinical trials on medicinal products for human use, which is designed to replace Directive 2001/20/EC. It will not come into effect until 2016. Nevertheless, it is essential to examine its relationship with national legislation, i.e. the Jardé Act, whose implementation has been delayed pending publication of the European regulation. The Giens workshop identified and examined the various issues that this relationship is bound to raise. In particular, it looked at trial methodology assessment procedures, the working relationship between the French National Agency of Drug Safety and Health Products (Agence Nationale de Sécurité du Médicament et des Produits de Santé, ANSM) and ethics committees during the authorization application evaluation phase, review of post-authorization/registration studies on medicinal products and medical devices, and data transparency.

Assessing Awareness and Implementation of a Recommendation for Surgical Innovation Committees: A Survey of Academic Institutions.

OBJECTIVE: In 2008, a Position Statement of the Society of University Surgeons (SUS) recommended the creation of institutional surgical innovation committees (SICs) to ensure appropriate oversight of surgical innovations. The purpose of this study was to determine the level of awareness of the position statement, and how innovations are handled in academic departments of surgery. METHODS: An electronic survey was designed to determine the level of awareness of the SUS recommendations among members of the Society of Surgical Chairs; the existence and characteristics of SICs; and alternative means of oversight of surgical innovations. RESULTS: The survey was distributed to 150 persons, and 65 (43%) surveys were returned; 84% reported their institution promoted innovative surgery as a strength, but 55% were unaware of the SUS recommendations; 23% reported that their institution has an SIC, and 20% said their institution has discussed or plans an SIC. Existing SICs have a median of 7 members; 57% reviewed 3 or fewer procedures in the prior year; and only 7% reviewed 10 or more. The majority of respondents reported alternative mechanisms of oversight, including morbidity/mortality conferences (88%), peer review (77%), and outcomes registries (51%). CONCLUSIONS: A minority of Surgery Department Chairs is aware of the SUS Position Statement. Although most reported surgical innovation was an institutional strength, only 23% had an SIC and most rely on other mechanisms of oversight. It is unclear whether academic surgical departments are committed to providing education and awareness of the appropriate development and implementation of surgical innovations.

Hospital Ethics Committees in Poland.

According to UNESCO guidelines, one of the four forms of bioethics committees in medicine are the Hospital Ethics Committees (HECs). The purpose of this study was to evaluate how the above guidelines are implemented in real practice. There were 111 hospitals selected out of 176 Polish clinical hospitals and hospitals accredited by Center of Monitoring Quality in Health System. The study was conducted by the survey method. There were 56 (50%) hospitals that responded to the survey. The number of HECs members fluctuated between 3 and 16 members, where usually 5 (22% of HECs) members were part of the board committee. The composition of the HECs for professions other than physicians was diverse and non-standardized (nurses-in 86% of HECs, clergy-42%, lawyers-38%, psychologists-28%, hospital management-23%, rehab staff-7 %, patient representatives-3%, ethicists-2%). Only 55% of HECs had a professional set of standards. 98% of HECs had specific tasks. 62% of HECs were asked for their expertise, and 55% prepared <6.88% of the opinions were related to interpersonal relations between hospital personnel, patients and their families with emphasis on the interactions between superiors and their inferiors or hospital staff and patients and their families. Only 12% of the opinions were reported by the respondents as related to ethical dilemmas. In conclusion, few Polish hospitals have HECs, and the structure, services and workload are not always adequate. To ensure a reliable operation of HECs requires the development of relevant legislation, standard operating procedures and well trained members.

A protocol and ethical framework for the distribution of rationed chemotherapy.

Shortages of generic, injectable chemotherapeutics have been increasing in prevalence since 2006. Due to the lack of access to first-line, lifesaving treatments, physicians have been forced to ration chemotherapy between patients. Although the scarcity has been managed with good intentions, it has been done in an ad hoc manner, without the benefit of an ethically grounded and standardized schema. Using an approach based on the "accountability for reasonableness" method by Daniel and Sabin, I establish a framework and protocol for rationing that is specific to chemotherapy. Prior to the state of true shortage, I present guidelines for the use of an adequate supply of chemotherapy with knowledge of upcoming scarcity. Within the rationing framework itself, I first prioritize emergency use of chemotherapeutics and those already receiving treatment at the time of shortage. I advocate for stratifying patients based on the prognostic indicators of their cancer type, using a combination of clinical-trial-based initial response and longer term survival, followed by the patients' line of treatment. All patients who are not able to receive their "best" treatment must receive a sequent, next-best treatment, and their treatment team must have the ability to appeal to a rationing committee in special circumstances. I reject the ideas of stratification based on the intention of the treatment, perceived quality of life, pre-existing condition not impacting performance status, the classical "sickest first" argument, and giving preference to pediatric cases. Lastly, I advocate for any system of rationing to be transparent to those it affects and acknowledge the difficulties it presents to patients and physicians alike.

Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

Sources of bias in clinical ethics case deliberation.

A central task for clinical ethics consultants and committees (CEC) is providing analysis of, and advice on, prospective or retrospective clinical cases. However, several kinds of biases may threaten the integrity, relevance or quality of the CEC's deliberation. Bias should be identified and, if possible, reduced or counteracted. This paper provides a systematic classification of kinds of bias that may be present in a CEC's case deliberation. Six kinds of bias are discussed, with examples, as to their significance and risk factors. Possible remedies are suggested. The potential for bias is greater when the case deliberation is performed by an individual ethics consultant than when an entire clinical ethics committee is involved.