CLINICAL ETHICS COMMITTEES: OVERVIEW OF THE EUROPEAN EXPERIENCE.

Making appropriate medical decisions in the best interest of the patient and in a line with the patient's autonomy, rights, dignity and plurality of values, are very important. In order to reach those goals and develop patient-oriented health service, Clinical Ethics Committees (CECs) support could make a great contribution. European countries (Netherland, Belgium, Italy, Germany, Norway, UK) are experiencing an exponential rise in the number of CECs as a mechanism to address the new ethical dilemmas in clinical settings, however the practice of CECs are facing barriers in transitional countries in central, eastern, and southeastern Europe. Despite the differences across the European countries we have found many similarities in groundwork trends of CECs development in studied countries, which have the most important impetus on the implementation and development of CECs. The most important and common ones are: enforcement of human rights doctrine, pluralistic civil movement, progressive development of medical science and new technologies, transfer of human rights movement in health care, development of bioethics, CECs educational capacity building, arising of complex moral, legal and ethical dilemmas in physicians' daily clinical practice, shifting medical care paradigm from the physician's single obligation to the shared responsibilities with respect of patient's rights, autonomy and dignity. Exploring those trends will lead to the opportunity to identify the most important factors that impact on the strengthening of the CECs practice in transitional countries as well.

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.

Mediation Approaches at the Beginning or End of Life.

The approaches used in mediation may help ethics consultants, especially in difficult cases. In this piece, I primarily discuss these techniques. I also discuss how clinicians may be of the most help to parents of infants with severe genetic conditions, to research participants, and to patients who may be at risk for Alzheimer's disease and their surrogate decision makers.

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.

Legal briefing: Healthcare ethics committees.

This issue's "Legal Briefing" column covers recent legal developments involving institutional healthcare ethics committees. This topic has been the subject of recent articles in JCE. Healthcare ethics committees have also recently been the subject of significant public policy attention. Disturbingly, Bobby Schindler and others have described ethics committees as "death panels." But most of the recent attention has been positive. Over the past several months, legislatures and courts have expanded the use of ethics committees and clarified their roles concerning both end-of-life treatment and other issues. These developments are usefully grouped into the following eight categories: 1. Existence and availability. 2. Membership and composition. 3. Operating procedures. 4. Advisory roles. 5. Decision-making and gate-keeping roles. 6. Confidentiality. 7. Immunity. 8. Litigation and court cases.

Institutional challenges for clinical ethics committees.

Clinical ethics committees (CECs) have been developing in many countries since the 1980s, more recently in the transitional countries in Eastern Europe. With their increasing profile they are now faced with a range of questions and challenges regarding their position within the health care organizations in which they are situated: Should CECs be independent bodies with a critical role towards institutional management, or should they be an integral part of the hospital organization? In this paper, we discuss the organizational context in which CECs function in Europe focusing on five aspects. We conclude that in Europe clinical ethics committees need to maintain a critical independence while generating acceptance of the CEC and its potential benefit to both individuals and the organization. CECs, perhaps particularly in transitional countries, must counter the charge of "alibi ethics". CECs must define their contribution to in-house quality management in their respective health care organization, clarifying how ethical reflection on various levels serves the hospital and patient care in general. This last challenge is made more difficult by lack of consensus about appropriate quality outcomes for CECs internationally. These are daunting challenges, but the fact that CECs continue to develop suggests that we should make the effort to overcome them. We believe there is a need for further research that specifically addresses some of the institutional challenges facing CECs.

A pilot qualitative study of "conflicts of interests and/or conflicting interests" among Canadian bioethicists. Part 1: Five cases, experiences and lessons learned.

In this pilot qualitative study 13 clinical bioethicists from across Canada were interviewed about their experiences of conflicts of interest and/or conflicting interests in their professional roles. The interviews generated five composite cases. Participants reported being significantly impacted by these experiences both personally and professionally.

Survey on the function, structure and operation of hospital ethics committees in Shanghai.

OBJECTIVE: The objectives of this study are to understand the current functions, structure and operation of hospital ethics committees (HECs) in Shanghai and to facilitate their improvement. METHODS: (1) A questionnaire survey, (2) interviews with secretaries and (3) on-site document reviews of HECs in Shanghai were used in the study, which surveyed 33 hospitals. RESULTS: In Shanghai, 57.56% of the surveyed hospitals established HECs from 1998 to 2005. Most HECs used bioethical review of research involving human subjects as well as bioethical review or consultation regarding medical care services and administrative decision- making. Of the surveyed HECs, 14.3% did not provide any formal bioethical training to the HECs' members and many HECs had no standard operating procedures. Some HECs had no clear definition of what was "conflict of interest" that should be considered by the HECs, while 44.4% of the HECs did not perform continuing review. DISCUSSION: After the issues of related national regulations, more and more hospitals established HECs in Shanghai, but the functions of HECs need to be further developed and formal training on bioethics should be provided to HEC members. To assure the independence and good performance of HECs, the conflict of interest procedure, the standard operating procedures and bioethical review should be improved. CONCLUSION: HECs in Shanghai had developed in the preceding 10 years and they played great roles in protecting the rights and welfare of human subjects and patients; some areas need improvement.

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.

Who Makes Decisions for Incapacitated Patients Who Have No Surrogate or Advance Directive?

Unrepresented patients are those who have no surrogate or advance directive to guide medical decision making for them when they become incapacitated. While there is no perfect solution to the problem of making medical decisions for such vulnerable patients, 3 different approaches are noted in the literature: a physician approach, an ethics committee approach, and a guardianship approach. Recent policies and laws have required an approach that is "tiered" with respect to both who is involved and the gravity of the medical treatment questions at issue. In a general sense, some variant of a tiered approach is likely the best possible solution for jurisdictions and health institutions-both those already with and those without a tiered approach-to the challenging puzzle of treating unrepresented patients.

When there's a heartbeat: miscarriage management in Catholic-owned hospitals.

As Catholic-owned hospitals merge with or take over other facilities, they impose restrictions on reproductive health services, including abortion and contraceptive services. Our interviews with US obstetrician-gynecologists working in Catholic-owned hospitals revealed that they are also restricted in managing miscarriages. Catholic-owned hospital ethics committees denied approval of uterine evacuation while fetal heart tones were still present, forcing physicians to delay care or transport miscarrying patients to non-Catholic-owned facilities. Some physicians intentionally violated protocol because they felt patient safety was compromised. Although Catholic doctrine officially deems abortion permissible to preserve the life of the woman, Catholic-owned hospital ethics committees differ in their interpretation of how much health risk constitutes a threat to a woman's life and therefore how much risk must be present before they approve the intervention.

Clinical Bioethics Committees: a Brazilian experience.

Since its beginning, Bioethics has been related to medical decision making. In health settings, difficult dilemmas, critical situations, controversial decisions are problems that clinical Bioethics reflects on. Institutional Ethics Committees is a general and ambiguous denomination to many different activities. In Brazilian hospitals, we have three different kinds of ethics and bioethics committees: Medical Ethics Committees, Research Ethics Committees and Clinical Bioethics Committees. The first implemented committees were the Medical Ethics Committees, whose objective is to evaluate professional ethics conflicts. These committees were proposed by the Conselho Federal de Medicina (Brazilian Medicine Council). In 1988, the Brazilian government, through the Conselho Nacional de Saude (Brazilian National Health Council) proposed the first research guidelines: Resolucao 01/88, updated in 1996 by Resolucao 196/96. One of these guidelines created the Research Ethics Committees. The first one was created in the Hospital Sao Lucas and the second in the Hospital de Clinicas de Porto Alegre, both in Porto Alegre, Rio Grande do Sul. In 1993, the Hospital de Clinicas de Porto Alegre created the first Brazilian Clinical Bioethics Committee. A Clinical Bioethics Committee can be defined as an interdisciplinary group of health professionals and other persons, whose objective is to provide consultancy on ethical questions and suggest institutional ethical guidelines, in a transdisciplinary perspective. In healthcare institutions, especially in hospitals, Clinical Bioethics Committees can help different segments in critical decision-making that involves ethical, moral, legal or social issues. The activities of a Clinical Bioethics Committee can be reactive or proactive. Consultancy is the typical reactive activity. Clinical Bioethics rounds are the example of proactive activity. In this study, we will present two different Brazilian experiences in Clinical Bioethics Committees: Hospital Sao Lucas and Hospital de Clinicas de Porto Alegre.

Adverse effects of a multicentre system for ethics approval on the progress of a prospective multicentre trial of cancer treatment: how many patients die waiting?

BACKGROUND: As cancer survival is improving approximately by 1-2% per year, delays in the clinical trials that lead to that improvement could cost lives. AIMS: To review the process of ethics committee approval for a multicentre clinical trial of cancer treatment and to estimate the delay it will cause in obtaining the results and the effects of such delays on survival for all cancers in Australia. METHODS: A survey was sent to each of the 15 centres participating in the study to obtain details about submissions they had made to their ethics committees and the replies received from them. RESULTS: The survey response rate was 100%. The average time required to complete an ethics submission was 12 h, and the average length of time for a final reply was 70 days. Wide variation was noted in the replies, 40% were considered constructive. Most centres said the effort in ethics submissions is sufficient to limit participation in other clinical trials that are available. CONCLUSION: The multicentre system of ethics approval has significantly delayed this multicentre trial and may delay advances in cancer care. Extrapolating this delay to determine an influence on improvements in cancer survival suggests that it may be responsible for 60 cancer deaths per year. A method for measuring the effect on the shape of the accrual curve is defined, and the term DIABOLECAL (Delays in Accrual Brought On Largely by Ethics Committee Activity Lag-time) is proposed to describe it. Attempts to overcome this problem have been introduced overseas.

A Study on the Directed Living Non-Related Donor Kidney Transplantation Submitted to the Hospital Transplant Ethics Committee at the National Kidney and Transplant Institute.

BACKGROUND: In the latter part of 2009, the Department of Health of the Philippines prohibited kidney transplantation with non-related kidney donors. Hence, the National Kidney and Transplant Institute created a Hospital Transplant Ethics Committee. This study describes directed non-related kidney donation at the National Kidney and Transplant Institute. METHODS: This retrospective study reviewed the profiles of recipients and directed living non-related kidney transplant donors submitted to the Hospital Transplant Ethics Committee. RESULTS: A total 74 recipients and donors were reviewed by the Hospital Transplant Ethics Committee in 2014. Donors initiated the talks about being a donor (75%) to repay the good deeds that were done by the recipient for them or their families; examples of which are: sometime in their lives they needed financial assistance for hospitalization for their relatives and it was the patient who paid the hospital bill; or because they pitied the recipient, whom they found to be a good person, thus they would want to give one of their kidneys. Seventy-four (100%) said that they were not expecting anything in return for this act but wanted to be of help to the recipient. Of these 74 cases, 70 cases (95%) were approved and the others were disapproved. CONCLUSIONS: With a Hospital Transplant Ethics Committee in place, directed kidney donation is a valuable tool as an additional source of kidney donor without violating any ethical issues.

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.