The number of national bioethics commissions has burgeoned since the establishment of the first one in 1983. They provide an arena in which stakeholders with widely differing moral views can discuss, interact and negotiate about controversial matters. The establishment of the Brazilian committee is used as an example of how such bodies can be introduced. If such councils are to be implemented effectively and regarded as legitimate, the society as a whole should be included in the construction (...) of the proposal and represented on the council, the council should have the benefit of specialist advice when that is needed, and the council should be linked to the elected government in an official advisory capacity. The article describes long process of planning and consultation to establish Brazil's National Bioethics Council and of eventually defining its task as advising the president on matters relating to bioethics. (shrink)

Context: Although ethics consultation is commonplace in United States (U.S.) hospitals, descriptive data about this health service are lacking. Objective: To describe the prevalence, practitioners, and processes of ethics consultation in U.S. hospitals. Design: A 56-item phone or questionnaire survey of the "best informant" within each hospital. Participants: Random sample of 600 U.S. general hospitals, stratified by bed size. Results: The response rate was 87.4%. Ethics consultation services (ECSs) were found in 81% of all general hospitals in the U.S., and (...) in 100% of hospitals with more than 400 beds. The median number of consults performed by ECSs in the year prior to survey was 3. Most individuals performing ethics consultation were physicians (34%), nurses (31%), social workers (11%), or chaplains (10%). Only 41% had formal supervised training in ethics consultation. Consultation practices varied widely both within and between ECSs. For example, 65% of ECSs always made recommendations, whereas 6% never did. These findings highlight a need to clarify standards for ethics consultation practices. (shrink)

A 1999–2000 national study of U.S. hospitals raised concerns about ethics consultation (EC) practices and catalyzed improvement efforts. To assess how practices have changed since 2000, we administered a 105-item survey to “best informants” in a stratified random sample of 600 U.S. general hospitals. This primary article details the methods for the entire study, then focuses on the 16 items from the prior study. Compared with 2000, the estimated number of case consultations performed annually rose by 94% to 68,000. (...) The median number of consults per hospital was unchanged at 3, but more than doubled for hospitals with 400+ beds. The level of education of EC practitioners was unchanged, while the percentage of hospitals formally evaluating their ECS decreased from 28.0% to 19.1%. The gap between large, teaching hospitals and small, nonteaching hospitals widened since the prior study. We suggest targeting future improvement efforts to hospitals where needs are not being met by current approaches to EC. (shrink)

Background The American Society for Bioethics and Humanities (ASBH), a professional organization that certifies ethics consultants who pass the qualifying examination, published standards for the conduct of ethics consultations (EC). A national survey of adult hospital ethics consultants identified adherence to these standards, but no assessment of pediatric hospitals’ adherence has been done.Methods In this cross-sectional study, a national questionnaire was distributed electronically in 2022 to pediatric ethics consultants at children’s hospitals, collecting information about adherence to the (...) ASBH standards. Hospital characteristics were extracted from the Children’s Hospital Association Annual Benchmark Report. Quantitative analysis included descriptive statistics to assess adherence and analyses of variance to investigate associations between hospital characteristics and the time taken to respond to consultations.Results Of the 181 eligible pediatric hospitals, we received 104 completed surveys (57%) from 45 states. Pediatric EC have similar adherence rates to ASBH standards as adult hospitals. High-adherence (>75%) areas included having an expert available for EC and permitting any staff member to request EC. Low-adherence areas included having comprehensive policies covering all aspects of EC activities, having a response plan for egregious violations, and the elicitation of formal feedback after EC. There is an increased average response time for ethics consultation services in smaller pediatric hospitals and church-operated hospitals.Conclusions Pediatric hospitals overall have moderate adherence to the ASBH EC standards, with the highest rates occurring for standards that are shared by the American Academy of Pediatrics. Additional research into the barriers to standard adherence and the effectiveness of standards is warranted with emphasis on the impact of adherence on consultation quality. (shrink)

Conceived as a solution to clinical dilemmas, and now required by organizations for hospital accreditation, ethics committees have been subject only to small-scale studies. The wide use of ethics committees and the diverse roles they play compel study. In 1999 the University of Pennsylvania Ethics Committee Research Group (ECRG) completed the first national survey of the presence, composition, and activities of U.S. healthcare ethics committees (HECs). Ethics committees are relatively young, on average seven years in operation. Eighty-six percent (...) of ethics committees report that they play a role in ongoing clinical decision making through clinical ethics consultation. All are engaged in developing institutional clinical policy. Although 4.5% of HECs write policy on managed care, 50% of HEC chairs feel inadequately prepared to address managed care. The power and activity of ethics committees parallels the composition of those committees and the relationship of members to their institutions. The role of ethics committees across the nation in making policies about clinical care is greater than was known, and ethics committees will likely continue to play an important role in the debate and resolution of clinical cases and clinical policies. (shrink)

Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade (...) moral disagreement, conflict, and ‘outsiders’ are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well‐known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper. (shrink)

Much has been written about the role of hospital ethics committees. Ethics committees may have begun in Seattle in the early 1960s, but they were reified in. New Jersey by the Quinlan Court in the 1970s and thrived in the national bioethics movement of the 1980s.In this flurry of ethics activity, several new forms of ethics committees have evolved. New forms of ethics committees include patient care-oriented ethics committees. Many ethicists are familiar with mission-oriented ethics committees. Such committees (...) have taken on new roles, and Include PROs, IPCs, and HREAPs. In general, these committees are regulatory in nature and may often rely on rules and regulations to assess patient cases, research protocols, and health professional practices. (shrink)

The article examines reasons and features of the Italian bioethics movement in itself and in relationship to that in the U.S.A. Research, consultation, teaching are the most requested professional activities. Ethics committees are now established in several places and at different level: national (National Italian Committee for Bioethics), regional (Italy has about twenty regions with some political power), and institutional (research centers, university, main hospitals).

Context: Although ethics consultation is commonplace in United States hospitals, descriptive data about this health service are lacking. Objective: To describe the prevalence, practitioners, and processes of ethics consultation in U.S. hospitals. Design: A 56-item phone or questionnaire survey of the “best informant” within each hospital. Participants: Random sample of 600 U.S. general hospitals, stratified by bed size. Results: The response rate was 87.4%. Ethics consultation services were found in 81% of all general hospitals in the U.S., and in 100% (...) of hospitals with more than 400 beds. The median number of consults performed by ECSs in the year prior to survey was 3. Most individuals performing ethics consultation were physicians, nurses, social workers, or chaplains. Only 41% had formal supervised training in ethics consultation. Consultation practices varied widely both within and between ECSs. For example, 65% of ECSs always made recommendations, whereas 6% never did. These findings highlight a need to clarify standards for ethics consultation practices. (shrink)

Presidential commissions come and go by design, and it is reasonable to wonder about the impact of their recommendations. I have been involved in the work of two presidential commissions: as a member of the Advisory Committee on Human Radiation Experiments (from 1994 to 1995) and as senior consultant to the National Bioethics Advisory Commission (from 1999 to 2000) for its report on multinational research. I continue to reflect on and look for the impact of both these (...) commissions.ACHRE's charter included the review of experiments with ionizing radiation sponsored or conducted by the United States government since the 1940s. The committee was also charged with investigating specific intentional releases of radiation into the environment. ACHRE had a somewhat unique difficulty built into its work: the need to make retrospective ethical judgments. With the National Bioethics Advisory Commission, my main role as senior consultant consisted of writing chapters of the report on multinational research for the commissioners’ approval. A more important concern for me as a hired consultant was how to maintain intellectual and moral integrity. Unlike when writing scholarly papers, where I can express my own views, when I was drafting text for a presidential commission, the commissioners’ views took precedence over my own when we disagreed. I wondered, how much could I comply with the commissioners’ positions without compromising my own integrity? (shrink)

The annual volume of ethics consultations (ECs) has been a topic of interest in the bioethics literature, in part because of its presumed relationship to quality. To better understand factors associated with EC volume, we used multiple linear regression to model the number of case consultations performed in the last year based on a national survey. We found that hospital bed size, academic affiliation, and urban/rural location were all associated with EC volume, but were not the primary drivers. (...) Instead, these variables affected EC volume through three other variables, all of which relate to ethics staffing: the percentage of case consultations performed by a single individual; whether the survey respondent’s main role at the hospital contained the word “ethics”; and especially, the number of full-time ethics program staff. We conclude that EC is an example of supply-sensitive care, and further research is needed to determine the optimal level of EC activity. (shrink)

As part of a project to examine health care ethics consultation in Canada, we surveyed individuals who were considered by themselves or others to play a significant role in health care ethics consultation. Since one goal of the project was to examine the education and abilities necessary for consultants, we sought to determine the qualifications and skills currently possessed by persons considered to be ethics consultants. For the purposes of the questionnaire, health care ethics consultation was defined broadly to include (...) consultation on ethical issues in clinical care or in clinical research, ethics consultation to Clinical Ethics Committees, Research Ethics Committees, and policy formulation committees in health care institutions; clinical ethics work was defined more broadly still to include, in addition to the above, ethics education, administration, research and writing on bioethics other than the above, and public speaking.Three hundred and fifty questionnaires were sent to individuals and institutions across Canada that were thought to have some involvement in health care ethics consultation. Two hundred and fifty-three questionnaires were returned for a response rate of 72%. This report presents initial findings of the study and attempts to provide a comprehensive overview of the current state of ethics consultation within Canada. The survey examines demographics, educational background, time spent on ethics, institutional affiliations, approaches to the role of consultation, research related issues, and attitudes toward certification. (shrink)

Clinical ethics consultation service remains undeveloped in developing countries. It is recognised that its introduction poses challenges. Malaysia, a multicultural society with diverse religions, values and perceptions further complicate the introduction of formal clinical ethics consultation service. Clinicians attending a national congress workshop completed a Strengths–Weaknesses–Opportunities–Threats analysis. The aim was to gain insight into clinician’s expectations and promote initiatives leading to the introduction of clinical ethics consultation service. Clinicians agree that clinical ethics consultation service can improve quality of care, (...) reduce healthcare costs and advocate for patients and providers. The analysis highlighted constraints in sufficient critical mass of relevant expertise and restricted opportunities for training. The opportunities lie in education, curriculum development and availability of dedicated proponents. Cultural barriers, limited resources, lack of awareness, differenc... (shrink)

The purpose of this article is to provide a short overview of the condition of clinical ethics committees (CECs) and other forms of the so-called "ethics support" infrastructure. This includes but is not limited to CECs because some countries also have ethics consultation services that function independently from the CECs. It seems that properly structured CECs and other types of ethics support have a potential to act as facilitators of ethically sensitive healthcare decision-making. This goal can be achieved if the (...) ethics support infrastructure becomes an integral part of the healthcare institution where the majority of ethical dilemmas and the need for ethical debate arise. At the same time, CECs can become a useful tool for implementing bioethical standards developed at both national and international levels, including those established by the Council of Europe instruments. This is the main reason why the issue of developing clinical ethics support services might be very important for the Steering Committee on Bioethics (CDBI) of the Council of Europe. More specifically, the question is what special role ethics support services can play in the context of the follow up to the Council of Europe Symposium in the decision-making process regarding medical treatment in end-of-life situations (Strasbourg, 30 November-1 December). Very often, cases to be considered by the CECs and ethics consultants deal with the difficult end-of-life treatment choices. (shrink)

Research ethics review is a critical aspect of the research governance framework for human subjects research. This usually requires that research protocols be submitted to a research ethics committee for review and approval. This has led to very rapid developments in the domain of research ethics, as RECs proliferate all over the globe in rhyme with the explosion in human subjects research. The work of RECs has increasingly become elaborate, complex, and in many cases urgent, necessitating supporting rules and (...) procedures of operation. Guidelines for elaborating standard operating procedures for the functioning of RECs have also been proposed. The SOPs of well-placed and well-resourced RECs have tended to pay much attention to details, resulting, as a consequence, in generally long, elaborate, intricate and complex SOPs; a model that can hardly be replicated by other committees, equally under ethics review pressures, but working under much more constraining conditions in resource-destitute environments. In this paper, we looked at the content and length of SOPs from African RECs and compared them to the World Health Organization ’s guidelines as the gold standard. We also looked at the SOPs from the Ethics Review and Consultancy Committee of the Cameroon Bioethics Initiative that we elaborated in a simplified way in 2013, and compared them to the WHO’s guidelines and to the other SOPs. Sixteen SOPs from 14 African countries were collected from various sources. Their average length was of 30 pages. By comparison to the guidance of the WHO, only six of them were found acceptable with more than 70 % of the criteria from the gold standard that were fully described. Among those six, two of them were very long and detailed, while the four remaining SOPs ranged from 16 to 24 pages. The ERCC SOPs are seven pages long but maintain all that is of essence for the rigorous, efficient and timely review of protocols. We are convinced that, because of their brevity, simplicity, clarity and user-friendliness, the ERCC SOPs recommend themselves as a model template to, at least, committees similarly situated and/or circumstanced as the ERCC of the Cameroon Bioethics Initiative is. In fact, brevity, clarity, simplicity and user-friendliness are recognized values. Whatever is brief and clear is better than what is not and saves time. What is simple and user-friendly is better than what is not even though the two have the same aims because it saves both time and mental energy. And if this be true in general, it is even truer of the context and its peculiar constraints that we are addressing. (shrink)

Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods: Data on the descriptive characteristics of bioethics (...) consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results: Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions: Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues. (shrink)

This contribution addresses some bioethical and medico-legal issues of the opinion formulated by the Italian National Bioethics Committee (CNB) in response to the dilemma between the State’s duty to protect the life and health of the prisoner entrusted to its care and the prisoner’s right to exercise his freedom of expression. The prisoner hunger strike is a form of protest frequently encountered in prison and it is a form of communication but also a language used by the (...) prisoner in order to provoke changes in the prison condition. There are no rules in the prison regulations, nor in the laws governing the legal status of prisoners, that allow the conscious will of the capable and informed subject to be opposed and forced nutrition to be carried out. However, this can in no manner make therapeutic abandonment legitimate: the medical doctor should promote every action to support the patient. In the recent opinion formulated by the CNB it was remarked how self-determination is a central concept in human rights and refers to an individual’s ability to make autonomous and free decisions about his or her life and body. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Bioethics ConsultationPat Milmoe McCarrick (bio)(John La Puma, M.D., from the Department of Medicine at Lutheran General Hospital in Chicago, contacted the National Reference Center for Bioethics Literature and suggested bioethics consultation as a topic for the Scope Note Series. He provided an extensive list of citations about ethics consultations collected by him and by David Schiedermayer, M.D., for their new book Ethics Consultation: A Practical (...) Guide.)In Ethics Consultation in Health Care, editors John Fletcher, Norman Quist, and Albert R. Jonsen (I, 1989) define ethics consultation as "the provision of specialized help in identifying, analyzing, and resolving ethical problems that arise in clinical care. In medical ethics the area of consultation has grown rapidly since 1978 when Edmund D. Pellegrino (II, 1978) noted, "we cannot separate technical-moral decisions from the philosophic principles we use to justify them. Medicine and ethics must be engaged with each other at every level."In 1980 Albert Jonsen raised the question of whether an ethicist could be a consultant and said that the ethicist as consultant is a casuist, one whose moral reasoning is based on a system of reasoning that is applied to particular cases. He describes historical casuistry in Western culture, comparing it to modern moral philosophy, and suggests that a "new casuistry seems timely" for ethics consultation (II, Jonsen 1980). By 1984 ethicist Ruth Purtilo recorded her thoughts following an ethics consultation. She raised questions about the ethicist's place on a hospital staff and how to make that role appropriate and beneficial to all concerned, saying that "the ethicist retreats after the consultation; under no circumstances would the outcome of an ethics consultation be that the ethicist became the primary care giver or assumed ongoing responsibility for the clinical management of a case" (II, Purtilo 1984). Nevertheless, in 1992 two physician-ethicists who had been called as ethics consultants for a patient who had requested that he be removed from his ventilator reported that they became the persons who turned off the ventilator and administered the drugs that eased his dying (II, Edwards and Tolle 1992).In recognition of the growing number of persons identifying themselves as [End Page 433] consultants, the Society for Bioethics Consultation was founded in October 1985 as a professional society of persons engaged in bioethics consultation. It encourages and supports consultation, assists in establishing clinical education programs, and raises funds for consultation education. Although the Society has no permanent office, the president (currently, George Kanoti in the Cleveland Clinic Foundation's Bioethics Department) conducts its work and plans an annual meeting.The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) established new criteria concerning ethics in its 1992 Manual (III, JCAHO 1992) and in a special issue of QRB devoted to ethics consultation (I, Defining Quality 1992). These publications undoubtedly have contributed to the increased use of experts in medical ethics. The Manual notes that all organizations seeking accreditation should have some sort of "mechanism for the consideration of ethical issues arising in the care of patients and to provide education to care givers and patients on ethical issues in health care." A health care institution's eligibility for JCAHO accreditation, which is required for federal reimbursement, requires adherence to this specification (III, JCAHO 1992).The new International Directory of Bioethics Organizations provides an index of 129 different groups that indicated to the authors that they offer bioethics consultations. Of these, 83 are in the United States and 46 are in other countries. The ethics consultants included in the directory encompass a broad group of professionals who will assist patients, families, and primary care medical staff in finding solutions to ethical dilemmas resulting from use of new technologies or new treatments in health care. Consultants often come from the health fields: physicians, nurses, and other health personnel, but other professionals are also active as ethics consultants. Lawyers, pastoral counselors, philosophers, and social workers also offer bioethics consultation services (III, Nolen and Coutts 1993).Drs. Siegler, Pellegrino, and Singer wrote in 1990 that "Physician-ethicists and professional ethicists will continue to work side by side in the future. One is not likely to replace the other, nor is this desirable, because... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Clinical Bioethics at NIH:History and A New VisionJohn C. Fletcher (bio)On July 3, 1995, Dr. John I. Gallin, Director of the Magnuson Clinical Center of the National Institutes of Health (NIH), convened a one-day "Conference on the Future of Clinical Bioethics at the National Institutes of Health Intramural Program." Conferees included NIH officials and a panel of consultants from bioethics programs around the nation.1 (...) The subject was the future of NIH's intramural bioethics program and specifically a vision of a new multi-component program, presented by Dr. Gallin, the first speaker. Dr. Harold Varmus, Director of NIH, was there to assure his support for Dr. Gallin's vision. This author, honored to be second speaker, was invited to sketch a brief history of bioethics at NIH. The present article reviews some of this history and then reports on Dr. Gallin's proposal, points of consensus among speakers and conferees, and the search for a Chief of the Clinical Bioethics Program.History of Bioethics at NIHIt is often said that NIH is a well-kept secret as the nation's leading biomedical research facility. Also, few people know that NIH has a long history in bioethics. Some key events in that history are shown in Figure 1, beginning with two that occurred prior to the birth of bioethics. NIH made an early policy response to protect human subjects of research and to find acceptable limits for scientific freedom. The Clinical Center (CC), a 550-bed research hospital, opened in 1953. A subcommittee of the Medical Board, the Clinical Research Committee (CRC), was formed for prior group review of all studies with normal volunteers. The traditional practice was for researchers themselves to decide when studies would begin, which subjects to recruit, and whether informed consent would be sought. The CRC intervention bit into this tradition. In addition, patient studies that posed significant risks or departed widely from medical practice were reviewed by referral from the Clinical Directors of the various Institutes. Was this CRC an early institutional review [End Page 355] board (IRB)? As a guest researcher, I was permitted to observe the CRCs meetings between 1966 and 1969. It functioned much like an IRB but had no community or non-scientist members. Other IRB-like review groups undoubtedly existed prior to the CRC. Robert Levine (personal communication, September 7, 1995) recalls that Beth Israel Hospital in Boston had one in 1938. Historical research is clearly needed on the earliest forms of research review.Table 1. Bioethics at NIHEventYearClinical Research Committee1953Surgeon-General's PPO #1291966NIGMS funds Hastings Genetics Group1973OPRR's Mission1974NLM's grant to KennedyInstitute for Bibliography of Bioethics1974Recombinant DNA Advisory Committee1974STEP Series Bioethics Speakers1975Pre-IRBs at the CC1975-76Assistant for Bioethics to Director, CC1977RAC-Human Gene Therapy Subcommittee1983Lipsett Proposal (ICD)1983Liaison Group, CC1983Bioethics Program, CC1985Durable Power of Attorney for Researchwith Incapacitated Subjects1985-86NLM funds National Reference Centerfor Bioethics Literature1985National Institute for Nursing Research1986Bioethics Post-Doctoral Fellows Program1989ELSI Program1989Bioethicists on CC-IRBs1989CC-Ethics Committee1990Office of Human Subjects Research1992 [End Page 356]Between 1963 and 1967, the media exposed instances of ethically troubling research, and Beecher (1966) and Pappworth (1967) published sharp criticisms of the weak state of research ethics. In 1966, Surgeon-General William Stewart and NIH Director James Shannon issued a policy requiring local group review of all research involving human subjects before making an application for NIH peer review (Surgeon General 1966). The policy was the first in any nation to mandate ethics committees for clinical research. However, it did not apply to the NIH intramural program until Congress passed the National Research Act in 1974 (Public Law 93-348; 202, 88 Stat. 342, 1974). This lag permitted NIH intramural investigators the luxury of feeling above the norms imposed on ordinary mortals and guaranteed more resistance to the inevitable change to come. Resistance to change marked the intramural program from the mid-1960s to the mid-1970s... (shrink)

Background: The rapid pace of progress in medical research, the consequent need for the timely transfer of new knowledge into practice, and the increasing need for ethics support, is making the work of Ethics Committees (ECs) ever more complex and demanding. As a response, ECs in many countries exhibit large variation in number, mandate, organization and member competences. This cross-sectional study aims to give an overview of the different types of activities of Italian ECs and favour discussion at a European (...) level.Methods: A questionnaire was emailed to all Italian Ethics Committees contained in the national Registry of the Ministry of Health, enquiring whether the EC was conducting, or planning to conduct, 4 specific activities. A telephone interview was conducted to determine reasons for failure to respond.Results: Response rate was 53% (101 respondents out of 191). 20% of ECs restrict their responsibilities to research protocol review, 25% also offer ethical consultation to institutions, support on individual health care decisions and promotes educational initiatives, while the remaining 50% conduct a few of the examined activities to varying degrees. Large variation was observed across different types of hosting institutions and geographical locations.Conclusions: A common European model should be developed, defining EC functions, member selection modalities, necessary member competences, decision-making criteria and measures for work verification. In the absence of sound empirical evidence, it would be interesting to study the effectiveness and efficiency of the different existing models. (shrink)

During the last two decades, national bioethics committees have been established in many countries all over the world. They vary with respect to their structure, composition, and working methods, but the main functions are similar. They are supposed to facilitate public debate on controversial bioethical issues and produce opinions and recommendations that can help inform the public and policy‐makers. The dialogue among national bioethics committees is also increasingly important in the globalized world, where biomedical technologies raise (...) ethical dilemmas that traverse national borders. It is not surprising, therefore, that the committees are established and active in the technologically advanced countries. There have also been a few international capacity‐building initiatives in bioethics that have had a dual task: networking among existing national bioethics committees and helping establish such committees in those countries that still lack them. The problem is that, due to a lack of information, it is not clear what problems and challenges committees face in the transitioning societies often characterized as low‐ and middle‐income countries. (shrink)

Ethics committees in Catholic health care are responsible for con­sultation, education, and policy development and review. Historically, ethics committees were reactive and had no articulated goals. This article argues that the essential goals of Catholic ethics committees are (1) to promote the human dignity of patients and staff; (2) to promote the common good; (3) to promote institutional identity, integrity, and ethical climate; and (4) to improve quality of care. These goals are most effectively met when ethics committees are proactive (...) and integrated in the institution, embrace systems thinking, and utilize professional ethicists locally or regionally. (shrink)

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. (shrink)

As has become tradition, executive directors of United States’ presidential bioethics committees offer reflections about their experience shortly after the orderly shutdown of the commission staff. After the records are filed according to government records regulations; after all the staff members, who are hired into temporary positions that must be renewed every two years, have secured permanent employment; after preparations are made to ensure that the next commission staff (should there be one) has a budget and standard operating procedures (...) in order to begin its work in a timely manner; after the lights are turned out for the last time, the executive director makes the final climb up the stairs into the sunlight and reflects on the whirlwind. There is much about my work with the Presidential Commission for the Study of Bioethical Issues that deserves comment, but one aspect of the commission that has been especially valuable to me is its work to educate the nation on bioethical issues. This is, moreover, a contribution in which the commission staff was central, and it is one that, as an ethics educator myself, I will cherish deeply. (shrink)

The emergence of the ethics consultation as a means to resolve moral crises in clinical medicine has revealed the need for a worksheet that would facilitate intake and analysis. The author developed the Bioethics Consultation Form as an attempt to remedy this need. The form is arranged in an outline format and is a useful asset to ethics committee discussions and record keeping. The first section covers basic intake data concerning the patient's medical and personal information, advance directives, (...) and values, as well as the values of the physician and family. After the intake section is completed with the above data, the ethics consultant then turns to the analysis section. This second section allows for (1) the discussion of conflicting values, (2) the identification of priorities, and (3) the elucidation of ethical norms relevant to the case.The Bioethics Consultation Form was adopted by the Patient Care Advisory committee of the Franklin Square Hospital Center in Baltimore, Maryland in 1986. The methodology in the use of the form will be discussed. Further, the potential spectrum of consultative cases that can be analyzed using the form will be highlighted. (shrink)

The American Society for Bioethics and Humanities promulgated standards for clinical ethics consultants and is currently developing a national Quality Attestation in Clinical Ethics Consultation to assist facilities in ensuring that those performing clinical ethics consultations meet minimum standards. As the field moves towards such professionalization, there is a need to provide access to qualified clinical ethicists at a broad range of medical facilities. Currently, however, there are insufficient numbers of trained clinical ethicists to staff all healthcare facilities, (...) and many facilities lack the necessary resources to hire staff clinical ethicists. In this review, we describe several models for providing expert clinical ethics support to remote facilities that lack access to qualified clinical ethicists. Based on this analysis, we recommend telemedicine as the optimal model providing expert support to local ethics committee members tasked with providing clinical ethics consultation services. (shrink)

Technological advances in veterinary medicine have produced considerable progress in the diagnosis and treatment of numerous diseases in animals. At the same time, veterinarians, veterinary technicians, and owners of animals face increasingly complex situations that raise questions about goals of care and correct or reasonable courses of action. These dilemmas are frequently controversial and can generate conflicts between clients and health care providers. In many ways they resemble the ethical challenges confronted by human medicine and that spawned the creation of (...) clinical ethics committees as a mechanism to analyze, discuss, and resolve disagreements. The staff of the North Carolina State University Veterinary Hospital, a specialty academic teaching institution, wanted to investigate whether similar success could be achieved in the tertiary care veterinary setting. We discuss the background and rationale for this method, as well as the approach that was taken to create a clinical ethics committee. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:An Egg Takes Flight: The Once and Future Life of the National Bioethics Advisory Commission*Alexander Morgan Capron (bio)Attempting to describe the National Bioethics Advisory Commission (NBAC) is comparable to the surreal feat performed by the artist in a famous painting by René Magritte. The artist (Magritte himself) sits with his back to the viewer, a palette in his left hand. The brush in his right (...) hand is raised to a canvas, blank except for a bird in flight that he is in the process of painting. The artist is looking to his left at a tabletop, bare except for a single, plain egg.Having held its second formal meeting in mid-January, NBAC is certainly still embryonic, its future mysterious within its shell. Yet answers to four major questions that will determine not just what kind of bird the Commission turns out to be but the heights to which it will fly should be evident by April or May 1997. First, will the White House take the sort of interest in NBAC that is needed if it is to succeed? Second, will the Commission’s term be extended beyond October 1997—and will the decision come early enough to allow it to start soon on projects that will take more than a single year to complete? Third, will the Commission take a broad view of the issues it addresses, reexamining widely accepted assumptions and going back to basic premises, or will it respond primarily in bureaucratic terms, guided by its charter’s focus on improving the policies and practices of federal departments and agencies? Fourth, will the Commission move beyond its initially mandated topics—the rights and welfare of human research subjects and the management and use of genetic information—and become what its name promises, the nation’s advisory body on the full range of bioethical issues that arise in the organization and management of health services and research?The Origins of the Egg: NBAC’s PredecessorsThe creation of a national bioethics commission has been demanded for years, at the least since its most recent predecessor, the Biomedical Ethics [End Page 63] Advisory Committee (BEAC) finally expired in 1990. BEAC’s statutory authority lapsed after the hapless committee had spent several years itself like an in vitro embryo in a vat of liquid nitrogen. BEAC’s opponents in Congress froze its appropriation and forbad it to meet until the Biomedical Ethics Board of six senators and six representatives to which it was supposed to report resolved the chaos resulting from the Board members’ ideological differences and personal distrust; this never occurred, and the Board proved unable even to choose its chairman. 1 BEAC, which met only twice, had laid preliminary plans to study the issues raised by the new genetics, but the politics of abortion—which had greatly complicated and slowed the Board’s naming of the BEAC members—was strong enough to interfere even with the topic of genetics, on which the difference among committee members actually gave no sign of dividing on pro-life/pro-choice grounds.The disappearance of BEAC left the nation without a mechanism for “public bioethics,” and several efforts were undertaken in the early 1990s to generate a new commission that could carry on in the tradition of the two previous, successful bioethics commissions. (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research operated under a Congressional mandate in the Department of Health, Education, and Welfare from 1974 to 1978, and the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which had been authorized by Congress in 1978, actually operated as an independent body with government-wide purview from January 1980 to March 1983.) The Institute of Medicine established a committee to assess the mechanisms available not only to the federal government but also to states, professional bodies, and the public for deliberating about and resolving ethical issues stemming from developments in biomedicine (Bulger, Bobby, and Fineberg 1995). In September 1992, Senators Mark O. Hatfield (R-OR), Edward M. Kennedy (D-MA), and Dennis DeConcini (D-AZ) requested that the Office of Technology Assessment (OTA) evaluate the... (shrink)

Since Clinical Ethics Consultation has become important in the public health sector in the last decade in Germany, there are on-going questions about effectiveness. Targets have been established by the Ethics Committees, in regard to assisting patients, families and health care teams at times of ethical conflicts during the decision-making process in medical care. Of all the ethics consultations over the last eight years at Erlangen University Hospital the consultations carried out in the pediatric department were chosen to be reviewed (...) by a pediatrician and an ethicist. These were evaluated on the basis of team formation, interdisciplinary orientation, ethical criteria, completeness and methods of documentation. Results of the analysis of those records show a well-organized consultation team with regard to its personnel composition. Discrepancies with ethical questions posed in the literature are revealed, and also some partially incomplete documentation regarding medical facts and descriptions of the patients' or parents' opinion. (shrink)

The disability viewpoint is the fundamental for understanding social justice in a given population. Disability rights need to be obeyed in the inclusive preparedness and response to all the disasters or during the crisis period including COVID-19 pandemic. COVID-19 pandemic jeopardized the health and rehabilitation services globally. The impact is much more in low resource developing countries like Bangladesh. In general, people with disability (PWD) suffer from multiple medical and rehabilitation complications and they need frequent rehabilitation consultations or hospital admissions (...) in comparison to people without disability. As a developing country, Bangladesh has poor ratios of doctors, nurses and technologists of 1:0.4:0.24 (WHO: 1:3:5) to face the COVID-19 challenge. Rehabilitation services have been disrupted in almost two-thirds (63%) of countries of the world. Even though rehabilitation is the key to recovery following severe illness from COVID-19. There are many concerns and debates about the preparedness, response and mitigation the process of COVID-19 on the part of the national government. According to recent study reports, the lives of about 100% of PWD have been impacted by the COVID-19 pandemic. COVID-19 National Technical Advisory Committee is working for strategic planning, response and mitigation process but omission of a representative of PWD or a rehabilitation physician in the committee has created much dissatisfaction. The difficult COVID-19 testing process due to country wide shutdown of rehabilitation essential services and central pulling of rehabilitation physicians have side lined the PWD inclusiveness. It is expected that the rehabilitation preparedness, response and mitigation of the pandemic should be based on an ethics driven process. (shrink)

The establishment of Mexico's National Bioethics Commission (Comisión Nacional de Bioética), in 1992, was conceived within the context of a global movement aimed at raising awareness of the ethical implications of technological and scientific development, especially in biomedicine. In 2005, a new decree put the commission under the scope of the Secretariat of Health and granted it technical and operational autonomy, allowing it to become a regulatory agency aimed at promoting a culture of bioethics, encouraging reflection on (...) human health, and developing guidelines for health care, research, and education, through a global, secular, and democratic perspective. The commission became the leading actor in the strategy for institutionalizing bioethics in Mexico after reforms to the country's General Health Act in 2011, which required that public, social assistance, or private health care facilities establish a hospital bioethics committee to address bioethical dilemmas or issues and, when relevant, a research ethics committee to address research with human subjects. This assignment has shifted the focus of the activities and goals of the National Bioethics Commission toward establishing these committees in line with current regulations and developing mechanisms to ensure that they operate with the highest standards of ethical conduct, performance, and accountability. (shrink)

Background The Regional Committee for Africa of the World Health Organization (WHO) in 2001 expressed concern that some health-related studies undertaken in the Region were not subjected to any form of ethics review. In 2003, the study reported in this paper was conducted to determine which Member country did not have a national research ethics committee (REC) with a view to guiding the WHO Regional Office in developing practical strategies for supporting those countries. Methods This is a (...) descriptive study. The questionnaire was prepared and sent by diplomatic pouch to all the 46 Member States in the WHO African Region, through the WHO country representatives, for facilitation and follow up. The data were entered in Excel spreadsheet and subsequently exported to STATA for analysis. A Chi-Squared test (χ 2) for independence was undertaken to test the relationship between presence/absence of Research Ethics Committee (REC) and selected individual socioeconomic and health variables. Results The main findings were as follows: the response rate was 61% (28/46); 64% (18/28) confirmed the existence of RECs; 36% (10/28) of the respondent countries did not have a REC (although 80% of them reported that they had in place an ad hoc ethical review mechanism); 85% (22/26) of the countries that responded to this question indicated that ethical approval of research proposals was, in principle, required; and although 59% of the countries that had a REC expected it to meet every month, only 44% of them reported that the REC actually met on a monthly basis. In the Chi-Squared test, only the average population in the group of countries with a REC was statistically different (at 5% level of significance) from that of the group of countries without a REC. Conclusion In the current era of globalized biomedical research, good ethics stewardship demands that every country, irrespective of its level of economic development, should have in place a functional research ethics review system in order to protect the dignity, integrity and safety of its citizens who participate in research. (shrink)

Background: The bioethics literature contains speculation but little data about sociodemographic differences between patients for whom ethics committees (EC) are consulted for conflict about life-sustaining treatment (LST) and the broader hospital population that these committees serve. To provide an empirical context for this discussion, we examined differences in five sociodemographic factors between patients for whom an EC was consulted for conflict over LST and the general inpatient population, hypothesizing that nonwhite patients were most likely to be disproportionately represented. Methods: (...) This was a retrospective cohort study comparing self-reported race/ethnicity, household income, insurance status, primary language, and religious affiliation between patients involved in EC consultations for conflict over LST and the general adult inpatient population at a large academic hospital from January 1, 2007, through December 31, 2013. Results: There were 169 EC consultations involving conflict over LST and 243,197 adult inpatient admissions over the study period. On bivariate analysis, patients for whom the EC was consulted for conflict over LST were more likely to be nonwhite, low-income, and to speak a primary language other than English. They were not more likely to be underinsured or to report a religious affiliation. On multivariate analysis, patients for whom the EC was consulted for conflict over LST were more likely to be nonwhite (odds ratio [OR], 2.5; 95% confidence interval [CI], 1.7–3.7; p <.001). They were also more likely to be low income (OR, 1.8; 95% CI, 1.1–3.0; p =.02). They were not more likely to speak a primary language other than English (OR, 1.4; 95% CI, 0.9–2.1; p =.17). None of the assessed variables were associated with conflict over LST requiring additional meetings beyond the first EC consultation. Conclusions: Nonwhite and low-income status patients are disproportionately represented in EC committee consultation for conflict over LST compared to the general inpatient population. (shrink)

This chapter contains sections titled: Origins and Development The Functions of Ethics Committees and Ethics Consultants The Significance of Ethics Committees and Ethics Consultation for Bioethics Conclusion Acknowledgments References Further reading.

Last year, the Joint Commission on Accreditation of Healthcare Organizations for the first time included provisions in its Hospital Accreditation Manual requiring institutions to have mechanisms in place to consider ethical issues arising in the care of patients and to educate care givers and patients on bioethical issues. This new requirement is notably vague. There is no indication of what type of mechanisms would be appropriate or how those involved in considering ethical issues should conduct themselves. This vagueness is by (...) no means accidental, but it reflects a recognition that clinical bioethics is still in its formative stages and that there are currently almost as many different mechanisms for dealing with bioethical issues in the healthcare setting as there are institutions that have such mechanisms. The Joint Commission's action, however, also implies that the time for experimentation will soon be over. (shrink)

Bioethical and bio‐political questions are increasingly tackled by committees, councils, and other advisory boards that work on different and often interrelated levels. Research ethics committees work on an institutional or clinical level; local advisory boards deal with biomedical topics on the level of particular political regions; national and international political advisory boards try to answer questions about morally problematic political decisions in medical research and practice. In accordance with the increasing number and importance of committees, the quality of their (...) work and their functional status are being subjected to more and more scrutiny. Besides overall criticism regarding the quality of their work, particular committees giving political advice are often suspected of being incompatible with democratic values, such as respect for affected parties, representation of diverse values and transparency in the decision‐making processes. Based on the example of the German National Ethics Council, whose inauguration caused a still ongoing debate on the aims and scopes of committees in general, this paper discusses: (1) the requirements of modern democratic societies in dealing with complex scientific‐technical problems; (2) the composition and organisation of committees working as political advisory boards; and (3) the appointment procedures and roles of laymen and experts, and here in particular of ethicists, who may legitimately be taken on by a committee. I will argue that bioethics committees do not necessarily endanger democratic values, but can considerably improve their realisation in democratic decision‐making procedures – if, and only if, they do not act as substitutes for parliamentarian processes, but help prepare parliamentarian processes to be organised as rationally as possible. (shrink)

The field of bioethics aims to ensure that modern scientific and technological advancements have been primarily developed for the benefits of humankind. This field is deeply rooted in the traditions of Western moral philosophy and socio-political theory. With respect to the view that the practice of bioethics in certain community should incorporate religious and cultural elements, this paper attempts to expound bioethical tradition of the Malay-Muslim community in Malaysia, with shedding light on the mechanism used by the (...) class='Hi'>National Fatwa Council to evaluate whether an application of biological sciences is ethical or not. By using the application of the genetically modified food as a case study, this study has found that the council had reviewed the basic guidelines in the main references of shari'ah in order to make decision on the permissibility of the application. The fatwa is made after having consultation with the experts in science field. The council has taken all factors into consideration and given priority to the general aim of shari'ah which to serve the interests of mankind and to save them from harm. (shrink)

In the clinical setting, questions of medical ethics raise a host of perplexing problems, often complicated by conflicting perspectives and the need to make immediate decisions. In this volume, bioethicists and physicians provide a nuanced, in-depth approach to the difficult issues involved in bioethics consultation. Addressing the needs of researchers, clinicians, and other health professionals on the front lines of bioethics practice, the contributors focus primarily on practical concerns -- whether ethics consultation is best done by individuals, teams, (...) or committees how an ethics consult service should be structured the need for institutional support and techniques and programs for educating and training staff -- without neglecting more theoretical considerations, such as the importance of character or the viability of organizational ethics. (shrink)

BackgroundThis study aims to quantitatively and qualitatively evaluate the activities of a Bioethics Unit (BU) 5 years since its implementation (2016–2020). The BU is a research unit providing empirical research on ethical issues related to clinical practice, clinical ethics consultation, and ethical education for health care professionals (HPS).MethodsWe performed an explanatory, sequential, mixed-method, observational study, using the subsequent qualitative data to explain the initial quantitative findings. Quantitative data were collected from an internal database and analyzed by descriptive analysis. Qualitative (...) evaluation was performed by semi-structured interviews with 18 HPs who were differently involved in the BU’s activities and analyzed by framework analysis.ResultsQuantitative results showed an extensive increment of the number of BU research projects over the years and the number of work collaborations with other units and wards. Qualitative findings revealed four main themes, concerning: 1. the reasons for contacting the BU and the type of collaboration; 2. the role of the bioethicist; 3. the impact of BU activities on HPs, in terms of developing deeper and more mature thinking; 4. the need to extend ethics support to other settings. Overall, our results showed that performing both empirical bioethics research and more traditional clinical ethics activities at the same unit would produce an impetus to increase collaboration and spread an 'ethical culture' among local HPs.ConclusionsOur findings contribute to a growing body of literature on the models of clinical ethics support services and the role of empirical research in bioethics internationally. They also prepare the ground for the implementation of a multidisciplinary Clinical Ethics Committee (CEC) that aims to support the BU’s ethics consultation service within the local context. (shrink)