Fins and colleagues rightly note that “clinical ethics consultation is a high-stakes endeavor with an increasing prominence in health care systems” for which “progress in developing standards for q...

Objectives: The official implementation of clinical pharmacy in Vietnam has arrived relatively late, resulting in various stressors. This study aims to evaluate job stress level and suggest viable solutions.Methods: A cross-sectional study was conducted on clinical pharmacists in 128 hospitals in Ho Chi Minh City. Job stress questions were derived from the Healthcare Profession Stress Inventory.Results: A total of 197 CPs participated, giving a response rate of 82.4%. Participants were found to have moderate job stress with an overall (...) mean stress score of 1.5 and stress rate of 52.8%. The sample size was statistically adequate and the HPSI was valid and reliable. Patient care responsibility was the main stressor, especially in public hospitals, followed by job conflicts. Lack of experience, low income, and inability to participate in clinical ward rounds caused significant stress to CPs regarding job recognition and job uncertainty. More practice-oriented training programs in bachelor curricula and clinical practice should be applied to help CPs gain more experience, self-confidence, and diminish job stress.Conclusion: CPs in HCMC have moderate stress. More practice-oriented training programs should be prioritized to lessen stress for CPs. (shrink)

A subcategory of medical tourism, reproductive tourism has been the subject of much public and policy debate in recent years. Specific concerns include: the exploitation of individuals and communities, access to needed health care services, fair allocation of limited resources, and the quality and safety of services provided by private clinics. To date, the focus of attention has been on the thriving medical and reproductive tourism sectors in Asia and Eastern Europe; there has been much less consideration given to more (...) recent ‘players’ in Latin America, notably fertility clinics in Chile, Brazil, Mexico and Argentina. In this paper, we examine the context-specific ethical and policy implications of private Argentinean fertility clinics that market reproductive services via the internet. Whether or not one agrees that reproductive services should be made available as consumer goods, the fact is that they are provided as such by private clinics around the world. We argue that basic national regulatory mechanisms are required in countries such as Argentina that are marketing fertility services to local and international publics. Specifically, regular oversight of all fertility clinics is essential to ensure that consumer information is accurate and that marketed services are safe and effective. It is in the best interests of consumers, health professionals and policy makers that the reproductive tourism industry adopts safe and responsible medical practices. (shrink)

The review system on research with human participants in the Netherlands is characterised as a decentralised controlled and integrated peer review system. It consists of an independent governmental body, the Central Committee on Research Involving Human Subjects (or Central Committee), which regulates the review of research proposals by accredited Medical Research Ethics Committees (MRECs). The legal basis was founded in 1999 with the Medical Research Involving Human Subjects Act. The review system is a decentralised arrangement since most research proposal (...) are reviewed by the 30 accredited MRECs in the country. It is a controlled system in which the Central Committee is responsible for the accreditation and oversight of the MRECs and can make legally binding directives for these committees. The assessment of research proposals is an integrated peer review process in which all documents of the research file are reviewed by experts in one committee only. A small number of research proposals are assessed by the Central Committee and not by accredited MRECs. These proposals are on specific research categories such as gene therapy, cell therapy and embryo research. The review of research with surplus human embryos is regulated separately in the Embryos Act. The Central Committee provides support to the accredited MRECs and to researchers and sponsors. It is currently developing an internet portal to reduce the bureaucracy and make the review process more efficient and transparent. The Central Committee stimulates confidence on medical research in society by providing a public trial registry with core data on reviewed research proposals. (shrink)

This article explores whether the bioethical performance and trustworthiness of pharmaceutical companies can be improved by harnessing market forces through the use of accreditation, certification, or rating. Other industries have used such systems to define best practices, set standards, and assess and signal the quality of services, processes, and products. These systems have also informed decisions in other industries about where to invest, what to buy, where to work, and when to regulate. Similarly, accreditation, certification, and rating programs can help (...) drug companies address stakeholder concerns in four areas: clinical trial design and management, dissemination of clinical trial results, marketing practices, and the accessibility of medicines. To illuminate processes — such as conflicts of interests and revolving-door policies — that can jeopardize the integrity of accreditation, certification, and ratings systems, the article concludes with a consideration of recent failures of credit-rating agencies and a review of the regulatory capture literature. (shrink)

IntroductionRheumatologists are the primary healthcare professionals responsible for patients with rheumatic diseases and should acquire medical ethical competencies, such as the informed consent process. The objective clinical structured examination is a valuable tool for assessing clinical competencies. We report the performance of 90 rheumatologist trainees participating in a station designed to evaluate the ICP during the 2018 and 2019 national accreditations.MethodsThe station was validated and represented a medical encounter in which the rheumatologist informed a patient with systemic lupus (...) erythematosus with clinically active nephritis about renal biopsy. A trained patient–actor and an evaluator were instructed to assess ICP skills in obtaining formal informed consent, delivering bad news and overall communication with patients. The evaluator used a tailored checklist and form.ResultsCandidate performance varied with ICP content and was superior for potential benefit information but significantly reduced for potential complications and biopsy description. Only 17.8% of the candidates mentioned the legal perspective of ICP. Death was omitted by the majority of the candidates ; after the patient–actor challenged candidates, only 57.1% of them gave a clear and positive answer. Evaluators frequently rated candidate communications skills as superior, but ≥1 negative aspect was identified in 69% of the candidates.ConclusionsEthical competencies are mandatory for professional rheumatologists. It seems necessary to include an ethics competency framework in the curriculum throughout the rheumatology residency. (shrink)

Introduction Currently, The nature and scope of Clinical Ethics Protocols in Madrid are not well understood.Objectives The main objective is to describe the features of ‘guideline/recommendation’ type CEPs that have been or are being developed by existing Clinical Ethics Committees in Madrid. Secondary objectives include characterisation of those CECs that have been the most prolific in reference to CEP creation and implementation and identification of any trends in future CEP development.Methods We collected CEPs produced and in process by (...) CECs accredited in the public hospitals in Madrid, Spain, from 1996 to 2008.Results CECs developed 30 CEPs, with 10 more in process. The most common topic is refusal of treatment . If CEPs addressing terminal illness, Do-Not-Resuscitate orders and advance directives are placed into a separate ‘ethical problems at the end of life’ category, this CEP subject emerges as the most common . There is a relationship between the age of the CEC and the development of CEPs . CECs now seem to be more likely to engage in CEP development.Conclusions The CECs in Madrid, Spain, have developed a significant number of CEPs and there is a trend towards continued development. The most frequent topics are ethical problems at the end of life and refusal of treatment by the patient. (shrink)

The movement advocating the formal certification of clinical ethics consultants may result in major changes to the field of clinical ethics consultation by creating a new standard of care. The actual certification process is still in the development phase, but unanswered questions include: What will certification cost, and, Who will pay? Currently there is little salary support for ethics consultants and no regulation requiring healthcare institutions to offer clinical ethics consultation. Without the support of healthcare administrators and (...) accreditation bodies, this may remain unchanged.Healthcare administrators may be unwilling to pay for certification or professional services if accreditation bodies do not require healthcare institutions to provide certified ethics consultants’ services. If consultants will not be reimbursed or paid, they may not seek certification. If certified consultants are required, healthcare administrators may look for ways to cover the costs for providing this service, including insurance or third-party reimbursement and direct billing of patients for consultations, which may affect who performs and who participates in ethics consultation. However, this is less than ideal, as bioethicists believe ethics consultation should be available to all as part of providing safe, quality ethical care and support and guidance for patients, families, and healthcare staff.Going forward, bioethicists should study quality improvement, patient safety, and cost-savings resulting from certification-eligible clinical ethics consultants’ activities. Administrators and financial personnel can be surveyed regarding their support for the certification process. Bioethicists should enlist the help of patient rights and safety advocacy groups, professional medical associations, and healthcare administrators. Bioethicists should invite accreditation bodies, healthcare administrators, and financial personnel to collaborate in the development of the certification process. Without their support, certification may be of value only to the bioethics community, and may have little standing in actual clinical healthcare institution settings. (shrink)

The past decade has witnessed a shift in the ambitions of pharmacists away from the core role of dispensing medicines towards more interesting and rewarding relationships and responsibilities with other healthcare providers and patients. The patient-centred role of pharmacists has allowed ethical issues experienced in medical practice to surface in pharmacy practice, resulting in an increase in the number and variety of ethical dilemmas that pharmacists face in their routine pharmacy practice. Pharmacy education prepares pharmacy students for practice and must (...) be in tune with the professional dynamics. Many countries that provide patient-centered pharmacy services have redesigned pharmacy ethics education while others are in various stages of revision of their curriculum in order to adequately equip future pharmacists with the rudiments required to handle ethical issues in clinical pharmacy practice. In contrast, in Nigeria, little or no pharmacy ethics is taught to pharmacy students and the challenge lies with the curriculum design and method of teaching. (shrink)

The federal government is funding a sea change in health care by investing in interventions targeting social determinants of health, which are significant contributors to illness and health inequity. This funding power has encouraged states, professional and accreditation organizations, health care entities, and providers to focus heavily on social determinants. We examine how this shift in focus affects clinical practice in the fields of oncology and emergency medicine, and highlight potential areas of reform.

Clinical ethics consultation has become an important resource, but unlike other health care disciplines, it has no accreditation or accepted curriculum for training programs, no standards for practice, and no way to measure effectiveness. The Clinical Ethics Credentialing Project was launched to pilot‐test approaches to train, credential, privilege, and evaluate consultants.

Background: Undergraduate nursing students have been documented to experience ethical distress during their clinical training and felt poorly supported in discussing the ethical issues they encountered. Research aims: This study was aimed at exploring nursing students’ perceived opportunity to discuss ethical issues that emerged during their clinical learning experience and associated factors. Research design: An Italian national cross-sectional study design was performed in 2015–2016. Participants were invited to answer a questionnaire composed of four sections regarding: socio-demographic data, previous (...) clinical learning experiences, current clinical learning experience quality and outcomes, and the opportunity to discuss ethical issues with nurses in the last clinical learning experience. Participants and research context: Participants were 9607 undergraduate nursing students who were attending 95 different three-year Italian baccalaureate nursing programmes, located at 27 universities in 15 Italian regions. Ethical considerations: This study was conducted in accordance with the Human Subject Research Ethics Committee guidelines after the research protocol was approved by an ethics committee. Findings: Overall, 4707 perceived to have discussed ethical issues ‘much’ or ‘very much’; among the remaining, 3683 and 1217 students reported the perception of having discussed, respectively, ‘enough’ or ‘never’ ethical issues emerged in the clinical practice. At the multivariate logistic regression analysis explaining 38.1% of the overall variance, the factors promoting ethical discussion were mainly set at the clinical learning environment levels. In contrast, being male was associated with a perception of less opportunity to discuss ethical issues. Conclusion: Nursing faculties should assess the clinical environment prerequisites of the settings as a context of student experience before deciding on their accreditation. Moreover, the nursing faculty and nurse managers should also enhance competence with regard to discussing ethical issues with students among clinical nurses by identifying factors that hinder this learning opportunity in daily practice. (shrink)

The development of ethics case consultation over the past 30 years, initially in North America and recently in Western Europe, has primarily taken place in the secondary or tertiary healthcare settings. The predominant model for ethics consultation, in some countries overwhelmingly so, is a hospital-based clinical ethics committee. In the United States, accreditation boards suggest the ethics committee model as a way of meeting the ethics component of the accreditation requirement for payment by Health Maintenance Organizations, and in some (...) European countries, there are legislatory requirements or government recommendations for hospitals to have clinical ethics committees. There is no corresponding pressure for primary care services to have ethics committees or ethics consultants to advise clinicians, patients, and families on the difficult ethical decisions that arise in clinical practice. (shrink)

Hospital ethics committees have become widespread over the last 25 years, stimulated by the Quinlan decision of the New Jersey Supreme Court, the report of a President's Commission, and most recently by the Joint Commission on Accreditation of Health Care Organizations , which now man dates that each hospital seeking accreditation have a functioning process for the consideration of ethical issues in patient care. Laws and regulations in several states require that hospitals establish ethics committees, and some states stipulate that (...) certain types of cases and disputes be taken to such committees. At least one state grants legal immunity to those who implement recommendations of an ethics committee. (shrink)

Hospital ethics committees have become widespread over the last 25 years, stimulated by the Quinlan decision of the New Jersey Supreme Court, the report of a President's Commission, and most recently by the Joint Commission on Accreditation of Health Care Organizations, which now man dates that each hospital seeking accreditation have a functioning process for the consideration of ethical issues in patient care. Laws and regulations in several states require that hospitals establish ethics committees, and some states stipulate that certain (...) types of cases and disputes be taken to such committees. At least one state grants legal immunity to those who implement recommendations of an ethics committee. (shrink)

The analysis of a dispute can focus on either interests, rights, or power. Commentators often frame the conflict over conscience in clinical practice as a dispute between a patient’s right to legally available medical treatment and a clinician’s right to refuse to provide interventions the clinician finds morally objectionable. Multiple sources of unresolvable moral disagreement make resolution in these terms unlikely. One should instead focus on the parties’ interests and the different ways in which the health care delivery system (...) can accommodate them. In the specific case of pharmacists refusing to dispense emergency contraception, alternative systems such as advanced prescription, pharmacist provision, and over-the-counter sales may better reconcile the client’s interest in preventing unintended pregnancy and the pharmacist’s interest in not contravening his or her conscience. Within such an analysis, the ethicist’s role becomes identifying and clarifying the parties’ morally relevant interests. (shrink)

This collection addresses whether ethicists, like authorities in other fields, can speak as experts in their subject matter. Though ethics consultation is a growing practice in medical contexts, there remain difficult questions about the role of ethicists in professional decision-making. Contributors examine the nature and plausibility of moral expertise, the relationship between character and expertise, the nature and limits of moral authority, how one might become a moral expert, and the trustworthiness of moral testimony. This volume engages with the growing (...) literature in these debates and offers new perspectives from both academics and practitioners. The readings will be of particular interest to bioethicists, clinicians, ethics committees, and students of social epistemology. These new essays promise to advance discussions in the professionalization and accreditation of ethics consultation. (shrink)

For decades a debate has played out in the literature about who bioethicists are, what they do, whether they can be considered professionals qua bioethicists, and, if so, what professional responsibilities they are called to uphold. Health care ethics consultants are bioethicists who work in health care settings. They have been seeking guidance documents that speak to their special relationships/duties toward those they serve. By approving a Code of Ethics and Professional Responsibilities for Health Care Ethics Consultants, the American Society (...) for Bioethics and Humanities (ASBH) has moved the professionalization debate forward in a significant way. This first code of ethics focuses on individuals who provide health care ethics consultation (HCEC) in clinical settings. The evolution of the code's development, implications for the field of HCEC and bioethics, and considerations for future directions are presented here. (shrink)

Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict (...) or come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

Recollections of humanistic and transpersonal psychology’s origin’s morph into the pros and cons of humanistic/transpersonal oriented schools developing APA accredited clinical programs. This discussion dovetails with the question will ATP ever become an APA division, raising an interesting alternative for those of us considering a career in counseling: becoming a spiritual coach. Enter the issue of psychedelic therapy and the Supreme Courts decision to allow ayahuasca as a sacrament by the Uniao Do Vegetal Church, and the importance of (...) why humanistic and transpersonal psychology need to clearly map out the territories and sub-divisions of science and religion. Finally this conversation raises a concern, that Maslow’s call for a “trans-human” psychology sought to encourage creating what we now call ecopsychology. (shrink)

Clinical ethics consultation has become an important resource, but unlike other health care disciplines, it has no accreditation or accepted curriculum for training programs, no standards for practice, and no way to measure effectiveness. The Clinical Ethics Credentialing Project was launched to pilot‐test approaches to train, credential, privilege, and evaluate consultants.

As clinical ethics consultants move toward professionalization, the process of certifying individual consultants or accrediting programs will be discussed and debated. With certification, some entity must be established or ordained to oversee the standards and procedures. If the process evolves like other professions, it seems plausible that it will eventually include a written examination to evaluate the core knowledge competencies that individual practitioners should possess to meet peer practice standards. The American Society for Bioethics and Humanities has published core (...) knowledge competencies for many years that are accepted by experts as the prevailing standard. Probably any written examination will be based upon the ASBH core knowledge competencies. However, much remains to be done before any examination may be offered. In particular, it seems likely that a recognized examining board must create and validate examination questions and structure the examination so as to establish meaningful, defensible parameters after dealing with such challenging questions as: Should the certifying examination be multiple choice or short-answer essay? How should the test be graded? What should the pass rate be? How may the examination be best administered? To advance the field of health care ethics consultation, thought leaders should start to focus on the written examination possibilities, to date unaddressed carefully in the literature. Examination models—both objective and written—must be explored as a viable strategy about how the field of health care ethics consultations can grow toward professionalization. (shrink)

Every pharmacist, aware or not, is constantly making ethical choices. Sometimes these choices are dramatic, life-and-death decisions, but often they will be more subtle, less conspicuous choices that are nonetheless important. Assisted suicide, conscientious refusal, pain management, equitable and efficacious distribution of drug resources within institutions and managed care plans, confidentiality, and alternative and non-traditional therapies are among the issues that are of unique concern to pharmacists. One way of seeing the implications of such issues and the moral choices (...) they pose is to look at the experiences of practitioners and the kinds of choices they have had to make in situations typically faced by pharmacists. This book is a collection of those situations based on the real experiences of practicing pharmacists. The use of case studies in health care ethics is not new, but in pharmacy it is. This text is an important teaching tool that will help pharmacy students and pharmacists address the increasing number of ethical problems arising in their profession. It is not merely a compilation of cases, but rather is organized for the systematic study of applied ethics. Part I shows how to distinguish ethical problems from other kinds of evaluative judgments and examines the sources of values in pharmacy, posing basic questions about the meaning and justification of ethical claims. Part II explores the basic principles of ethics as they have an impact on pharmacy. Specific cases from clinical settings present in a systematic way the various questions raised by each of the major ethical principles -- benefiting the patient, distributing resources justly, respecting autonomy, dealing honestly with patients, keeping promises of confidentiality, and avoiding harm. Part II examines some of the special problems of contemporary pharmacy such as the linkages between pharmaceutical care and professional practice, human experimentation, reproductive issues, genetic technology, death and dying, and mental health. (shrink)

Clinical ethics training programs are responsible for preparing their trainees to be competent ethics consultants worthy of the trust of patients, families, surrogates, and healthcare professionals. While the American Society for Bioethics and Humanities (ASBH) offers a certification examination for healthcare ethics consultants, no tools exist for the formal evaluation of ethics trainees to assess their progress toward competency. Medical specialties accredited by the Accreditation Council for Graduate Medical Education (ACGME) use milestones to report trainees’ progress along a (...) continuum of professional development as a means of “operationalizing and implementing” medical competencies. Utilizing the Core Competencies for Healthcare Ethics Consultation and the ACGME and American Board of Pediatrics’ (ABP) Pediatric Milestones Project, we developed milestones for 17 subcompetencies in clinical ethics consultation and academic bioethics. As the field of clinical ethics becomes more standardized, such tools will be needed to promote the development of robust training programs and to certify that their graduates are competent practitioners. (shrink)

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) requires as a condition of accreditation that every health care institution -- hospital, nursing home, or home care agency -- have a standing mechanism to address ethical issues. Most organizations have chosen to fulfill this requirement with an interdisciplinary ethics committee. The best of these committees are knowledgeable, creative, and effective resources in their institutions. Many are wellmeaning but lack the information, experience, and skills to negotiate adequately the complex ethical (...) issues that arise in clinical and organizational settings. Handbook for Health Care Ethics Committees is the first resource designed to address the range of work performed by ethics committees as part of their multiple responsibilities, including education, case consultation, and policy development. It features an eight-chapter curriculum reviewing the content of contemporary health care bioethics and discussing the ethical foundations of clinical practice, with each subsequent section focusing on a set of ethical issues that commonly arise in the clinical setting. Through case studies, the authors explore issues such as informed consent and refusal, decision making and decisional capacity, truth telling, decision-making concerns of minors, end-of-life issues, palliation, justice in and access to health care services, and organizational ethics. They offer sample policies and procedures, draft guidelines and protocols, and key legal cases. Providing both a strong theoretical foundation and practical applications, this handbook will be essential reading for every member of a health care ethics committee. (shrink)

According to UNESCO guidelines, one of the four forms of bioethics committees in medicine are the Hospital Ethics Committees. 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 hospitals that responded to the survey. The number of HECs (...) members fluctuated between 3 and 16 members, where usually 5 members were part of the board committee. The composition of the HECs for professions other than physicians was diverse and non-standardized. 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. (shrink)

The topic of professionalism has dominated the content of major academic medicine publications during the past decade and continues to do so. The message of this current wave of professionalism is that medical educators need to be more attentive to the moral sensibilities of trainees, to their interpersonal and affective dimensions, and to their social conscience, all to the end of skilled, humanistic physicians. Urgent calls to address professionalism from such groups as the Association of American Medical Colleges, the American (...) Board of Internal Medicine, and the Accreditation Council for Graduate Medical Education, among others. In fact, at the 2004 annual meeting of the AAMC six separate presentations addressed professionalism with such titles as "Evaluating Humanism and Professionalism," Professionalism: Expectation, Education, Evaluation," or "Toward Assessing Professional Behaviors of Medical Students through Peer Observations". Professionalism, then, has become part of the current academic medicine parlance, used by administrators, clinical faculty, residency programs, and professional organizations with an expectation of shared meanings and goals. All of these stakeholders focus on what has become a consistent list of attributes deemed to be the essence of professionalism, which usually include variations on altruism, duty, excellence, honor and integrity, accountability, and respect. In fact, most of the scholarly work to date has been listing, describing, decrying, and measuring/evaluating it. In this collection of essays, we don’t argue with these attributes. Instead, we ask questions of the discourse from which they arise, how the specialized language of academic medicine disciplines has defined, organized, contained, and made seemingly immutable a group of attitudes, values, and behaviors subsumed under the label "professional" or "professionalism." This collection aims to be a critical text, one that questions the profession’s beliefs about the nature of its work and how such beliefs are enacted in medical education, particularly as they fuel the professionalism discourse. In addition, we will scrutinize how the discourse is enacted in both the formal and hidden curriculum, and in the larger medical environment. (shrink)

Background. Africa has seen an increase in the number of health research projects being conducted on the continent, particularly clinical trials. Ideally, this should be accompanied by a commensurate improvement in research ethics review capacity to competently provide the much-required research ethics oversight. Unfortunately, this is not the case in many African countries, which are still grappling with weak research ethics oversight capacity, not only at national level but also at institutional level. Objectives. To describe the proposal by Kenya’s (...) national research ethics regulatory authority, the National Commission for Science Technology and Innovation (NACOSTI), to build the capacity of its National Scientific and Ethics Committee (NSEC), tasked with providing the required research ethics oversight in the country. Methods. This is the proposal submitted by NACOSTI to the European and Developing Countries Clinical Trials Partnership for funding of a project entitled ‘Strengthening Research Ethics and Oversight in Kenya’ (STReK). It describes the activities involved to strengthen the NSEC to provide the required research ethics in the country, and to build the research ethics capacity of research ethics committees (RECs) it has accredited, through training and mentorship programmes, to enable them to efficiently review research proposals. Results. Proposed activities of the project are presented. Implementation of the activities described is ongoing. Conclusion. Lessons learnt in this regard may be of benefit to other research ethics regulatory authorities in resource-constrained countries aiming to strengthen their research ethics oversight capacity. (shrink)

This article discusses clinical ethics consultation (CEC), and thereby ethics support services in the Canadian context. Commonalities and differences between the three models of ethics support and CEC shared in this article are identified, set within the broader context of the Canadian healthcare system, accreditation, and professionalization of practicing healthcare ethicists.

With the Accreditation Council for GraduateMedical Education''s designation of professionalism as one of six corecompetencies in residency medical education,some educators of residents and medicalstudents believe that the concept ofprofessional role is too restrictive and narrowfor grappling with the complex dynamics ofprofessional–patient relationships. The ethicalquandaries of abortion and physician assistedsuicide illustrate how individual personalvalues cannot be ignored in the dynamicrelationship between health care professionaland patient. This article describes a medicalschool course where students are paired with patient mentors. Within the dynamic andintimate (...) relationship that unfolds over severalmonths, students explore the experience ofboundaries, and are invited to use thisexperience to consider their evolvingprofessional identity. (shrink)

Background The globalization of clinical research in the last two decades has led to a significant increase in the volume of clinical research in developing countries. As of 2016, Uganda was the third largest destination for clinical trials in Africa. This requires adequate capacity and systems to facilitate ethical practice. Methods This was a retrospective study involving review of laws, guidelines, policies and records from 1896 to date. Results Modern medicine evolved from 1896 and by the time (...) of Uganda's independence in 1962, a 1500 bed national referral hospital was in place and a fully‐fledged medical school was established at the Makerere University. As the practice of medicine evolved in the country, so did medical research that addressed priority health issues. The growth in modern medicine was not matched with development of research infrastructure and regulatory systems. The first documented regulation of research activities was in 1970 while the first research ethics committee established in 1986 was to facilitate review of research related to the HIV/AIDs pandemic. In 1990 an Act of Parliament was passed to facilitate development and implementation of policies, hence the development of the national guidelines in 1997, training, establishment and accreditation of research ethics committees, conferences and research site monitoring. Conclusion Over the past 120 years, the implementation and structural aspects of research ethics in Uganda have evolved through 70 years of no regulation, followed by 30 years of rudimentary regulation while the last 20 years have shown significant growth in the regulatory system associated with supportive laws, institutionalization of regulatory and training processes. (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)

Currently, there is no authoritative credentialing process for individuals engaged in ethics practice, no accreditation system that sets minimum education standards for programs aiming to prepare these individuals for their work, and little evidence available that any particular training model is actually achieving its pedagogical goals. At the same time, a number of healthcare organizations and universities now routinely offer post-graduate programs, clinical fellowships and in-house training specifically devised to prepare graduates for ethics practice. However, while their numbers appear (...) to be growing, information about these programs is limited. In this paper, we describe the goals, content and strategies of three educational programs offered in Ontario, Canada. These case studies highlight the diversity of ethics education available to those who engage in ethics practice and underscore the need to take this variety into account in the development of future education standards that would specify minimally acceptable educational requirements. (shrink)