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PubMed2005

[Reorganization of the procedures and the tasks of the responsible ethics committees after the 12th AMG amendment. Concepts of the permanent working group of the medical ethics committees in Germany].

Since 12(th) of August 2004 the EU Directive 2001/20/EG has been implemented into the national law. The 12th AMG amendment of 30 July 2004 and the good clinical practice decree on the conduct of clinical trials on drugs for human use of 9 August 2004 have been authorized and must be considered for new clinical trials with investigational medical products (drugs). The scope of the changes are to increase the quality of clinical trials and to continue the process of harmonization within the European Community. Based on the new law the sponsor has to apply for approval by the competent authority and for a favourable opinion by the responsible ethics committee. Both procedures are independent; a favourable opinion of the responsible ethics committee is a necessary condition before starting the trial. Thus, the role of the ethics committees has been changed; the committees are considered as an institution comparable to an authority to protect the rights and safety of human subjects involved in clinical trials. The permanent working group of the medical ethics committees in Germany has established a procedure to meet these requirements, particularly in the case of multicentre clinical trials, where only a single opinion shall be given for each member state. This article describes this procedure (application, process of ethical consideration among the leading and local ethics committees in multicentre trials, responsibilities during the trial).

Clinical Trials as Topic↗
PubMed2002

The impact of three years' ethics teaching, in an integrated medical curriculum, on students' proposed behaviour on meeting ethical dilemmas.

OBJECTIVE: To evaluate the impact of 3 years' ethics teaching (30 hours mainly small group teaching in year 1, 14 hours mainly lecture-type teaching in years 2 and 3) on students' proposed behaviour on encountering ethical dilemmas. DESIGN: Cohort design. SETTING: University of Glasgow Medical School. SUBJECTS: A cohort of 111 students entering Glasgow University's new learner-centred, integrated medical curriculum; where ethics learning is formally assessed in years 1 and 5 only; in October 1996. MAIN OUTCOME MEASURE: Student answers consistent with consensus professional judgement on the ethical dilemmas posed by the vignettes of the Ethics and Health Care Survey Instrument. RESULTS: The instrument was completed pre- and post- year 1 and post- year 3 by 77%(85) of the cohort. There is a significant increase in the number of consensus answers given following the first year of the curriculum, but no further improvement was found. The odds ratio for giving the consensus answer post- year 1 relative to pre- year 1 was 1.42, 95% Confidence Interval (1.19, 1.71), P = 0.0001. Comparing post- year 3 to pre- year 1, odds ratio 1.30 (1.08, 1.57), P = 0.0062. Post- year 3 compared to post- year 1, odds ratio 0.91 (0.76, 1.10), P = 0.34. CONCLUSIONS: While small group ethics teaching can be effective in developing students' normative identification with the profession of medicine, its effectiveness is dependent on the amount of small group teaching provided. The lack of formal assessment in years 2 and 3 is also felt to contribute to the lack of impact. This information will inform future curriculum development.

Curriculum↗
PubMed2006

Bringing ethics education to the clinical years: ward ethics sessions at the University of Washington.

PURPOSE: Although most medical schools teach medical ethics during preclinical years, incorporating these ethics into clinical training remains challenging. During clinical rotations, students' professional behaviors and attitudes are profoundly affected. This project was intended to develop an educational intervention to incorporate medical ethics training as a part of students' professional development within the context of clinical training. METHOD: "Ward Ethics" is a series of peer discussions guided by clinical faculty mentors trained in fostering issue identification and strategy development. The sessions described here were conducted during medicine and surgery rotations for third-year medical students at the University of Washington School of Medicine from 1998 to 2003. Thirty clinical faculty participated as facilitators. Written evaluations were collected from students and faculty at each session, and faculty interviews were conducted in 2001. RESULTS: The data reported are from 24 sessions and 15 faculty interviews from 1999 to 2001. The topics were consistent with prior reports of ethical issues that students encountered. Students reported a variety of learned strategies such as knowing how and when to speak up and transitioning from prioritizing evaluations to focusing on patient care, resulting in their feeling more confident. Faculty reported noticing positive results to their professional development as well. CONCLUSIONS: Medical students in the clinical years face ethically challenging situations. Some circumstances, if left unexamined, may erode students' abilities to maintain and develop appropriate professional behaviors. Students participating in this activity agreed that it served as a way to fight isolation, share stories, and exchange ideas for future problem solving.

Academic Medical Centers↗
PubMed2002

Law, ethics and research ethics committees.

This paper examines the view of the operational management of the UK Research Ethics Committee (REC) system that RECs may not reject applications on purely legal grounds. Two arguments are offered for this view: the first rests on the contention that being lawful and being ethical are not the same thing; the second is that RECs lack expertise and authority to base their decisions on legal considerations. However, whatever the philosophical standing of the first argument, it is contrary to published guidance, the basis of RECs' official authority, unethical, and politically imprudent to permit RECs not to consider conformity with the law to be at least a necessary condition for REC approval. In any event, RECs can obtain competent and authoritative advice on the law (though the Department of Health has been remiss in this regard), and they do not exceed their authority by applying the law, because this is within their ethical remit. When current guidance to RECs about advising researchers on whether or not breaches of confidence are permissible in the public interest is linked to the view of the REC management that the role of RECs is to facilitate research (albeit ethical research), this raises serious doubts about the integrity of the system of ethical review currently in place, which is illustrated by a recent "agreement" of the Chairmen of the MRECs not to consider the Data Protection Act 1998 in their ethical review.

Confidentiality↗
PubMedDate not supplied

Ethics consultation in Portland. Providence Health's Oregon Region has created an ethics consult service.

In response to the need for a more structured approach toward the enhancement of and preparation for case consultation, the Portland Service Area (PSA) of the Providence Health System Oregon Region implemented a "special team" system. These teams--an extension of the ethics committees already in place--underwent training in areas such as an overview of ethics, patient decision making, professionalism, organizational ethics, and palliative and end-of-life care. Moving ethics consultation away from the purview of ethics committees generally, and into the realm of these trained special teams, has improved PSA's ability to respond to ethics needs in the region.

Ethics Consultation↗
PubMedDate not supplied

St. Louis system has Corporate Ethics Committee. Sisters of Mercy Health System has developed an approach for assisting in the integration of ethics and operations.

Despite the relatively recent advent of organizational ethics committees--created to address operational concerns that are not always appropriate for a clinical ethics committee to take on--there remain impediments (such as time constraints, limited ethical expertise, lack of senior leaders at the table, and waning interest of members) to the impact such a group might have. Committed to addressing operational concerns in a meaningful and "value-added" way, and mindful of the challenges that can limit the effectiveness of organizational ethics committees, the St. Louis-based Sisters of Mercy Health System developed an approach that has proven successful. Without changing the committee's goals-education, policy, and consultation-Mercy's renewed Corporate Ethics Committee was restructured to include ethical experts, people knowledgeable about particular issues, and people with authority.

Ethics Committees↗
PubMed1990

[Discussion forum on medical ethics. A1. Basic forms in ethics].

Medical ethics should not be subsumed under the classical types of ethical reasoning (e.g. Aristotle, Kant) nor the modern ethical versions of utilitarianism, deontology or ethics of discourse. All of them may contribute to medical ethics; but these should be goaled by general ethics in the meaning of how to lead a senseful life in its whole.

Ethics↗
PubMed1995

The Consortium Ethics Program: an approach to establishing a permanent regional ethics network.

This paper describes the first three-year experience of the Consortium Ethics Program (CEP-1) of the University of Pittsburgh Center for Medical Ethics, and also outlines plans for the second three-year phase (CEP-2) of this experiment in continuing ethics education. In existence since 1990, the CEP has the primary goal of creating a cost-effective, permanent ethics resource network, by utilizing the educational resources of a university bioethics center and the practical expertise of a regional hospital council. The CEP's conception and specific components stem from recognition of the need to make each hospital a major focus of educational efforts, and to provide academic support for the in-house activities of the representatives from each institution.

Cost-Benefit Analysis↗
PubMed1996

Of ethics committees, protocols, and behaving ethically in the field: a case study of research with elderly residents in a nursing home.

In this paper we discuss differing discourses of research ethics committees and the clinical research field. Reflections on our experience of conducting research in a nursing home are used to highlight the tensions and inconsistencies that arise from these discourses and the need to behave ethically in the field. While accepting the need for adherence to guiding principles of duty based ethics, we have found that practical moral decisions in the field required that, as individual researchers, we needed to exercise discretionary judgement, informed by the ethic of care and the concern for the well-being of research participants.

Aged↗
PubMedDate not supplied

An ethic of analysis: an argument for critical analysis of research interviews as an ethical practice.

Nursing literature is replete with discussions about the ethics of research interviews. These largely involve questions of method, and how careful study design and data collection technique can render studies more ethical. Analysis, the perennial black box of the research process, is rarely discussed as an ethical practice. In this paper, I introduce the idea that analysis itself is an ethical practice. Specifically, I argue that political discourse analysis of research interviews is an ethical practice. I use examples from my own research in a prison control unit to illustrate what this might look like, and what is at stake.

Clinical Nursing Research↗
PubMed2000

Applied ethics: what kind of ethics and what kind of ethicist?

Types of ethics are classified as more or less holistic in three respects. Current forms of applied ethics (among them reflective equilibrium) are criticized for being reductionist rather than holistic. It is claimed that applied ethics ought to be of a holistic kind. Two examples (tracing of hereditary cancer and active euthanasia) are used for maintaining that a reductionist ethic is of limited use for solving practical moral problems. Some possible roles of the ethicist are discussed. It is maintained that the ethicist ought to be a life philosopher mapping the moral landscape or a personal mentor rather than being a policeman or an ethics engineer.

Ethical Theory↗
PubMed2001

What makes a problem an ethical problem? An empirical perspective on the nature of ethical problems in general practice.

Whilst there has been considerable debate about the fit between moral theory and moral reasoning in everyday life, the way in which moral problems are defined has rarely been questioned. This paper presents a qualitative analysis of interviews conducted with 15 general practitioners (GPs) in South Australia to argue that the way in which the bioethics literature defines an ethical dilemma captures only some of the range of lay views about the nature of ethical problems. The bioethics literature has defined ethical dilemmas in terms of conflict and choice between values, beliefs and options for action. While some of the views of some of the GPs in this study about the nature of their ethical dilemmas certainly accorded with this definition, other explanations of the ethical nature of their problems revolved around the publicity associated with the issues they were discussing, concern about their relationships with patients, and anxiety about threats to their integrity and reputation. The variety of views about what makes a problem a moral problem indicates that the moral domain is perhaps wider and richer than mainstream bioethics would generally allow.

Attitude of Health Personnel↗
PubMedDate not supplied

Independent ethical review of studies involving personal medical records. Report of a working group to the Royal College of Physicians Committee on Ethical Issues in Medicine.

There is a duty to use available information for the general good where this can be done without detriment. It is, in principle, ethically acceptable to use personal medical records without approaching or involving the patients concerned, provided that confidentiality and anonymity are preserved; such use does not require independent ethical approval provided that confidentiality is assured and subject to safeguards described below. Epidemiologists have a special interest in the use of personal medical records in their work (in this context the use of health-related registers and existing biological samples may be included), though access to such data involves professional staff in all medical specialties, not only those in epidemiology. The following guidance is based on a report of a working group (which included non-medical members) to the Royal College of Physicians Committee on Ethical Issues in Medicine. Activities such as medical audit, epidemiological surveillance, inquiries designed to establish indices of morbidity and mortality and outbreak investigations all constitute medical practice and as such do not require independent ethical review. Research involving access to medical records, health-related registers, or existing biological samples only, without direct patient involvement, requires neither explicit individual patient consent nor independent ethical review provided that: a) explicit consent to access a person's records is obtained either from official custodians of the records (who have a duty to satisfy themselves as to the bona fides and competence of the investigator) or from the patient's clinician: the decision to access personal medical information should not be left to the sole discretion of the investigator.(ABSTRACT TRUNCATED AT 250 WORDS)

Confidentiality↗
PubMed2005

Ethical considerations in the early composite tissue allograft experience: a review of the Louisville Ethics Program.

This paper reviews the formulation and evolution of the ethical component in one of the earliest clinical composite tissue allograft (CTA) programs, the hand transplantation program in Louisville, Kentucky, USA. The purpose was to derive lessons and define principles to give guidance for future programs and introduction of new CTA. We reviewed the initial ethical considerations, including input from respected ethical scholars, guidelines for innovative procedures transparency in public and professional scrutiny, and compliance with human studies regulations (IRB approval). We found the initial focus on ethics, scholarly input, guidelines for innovative procedures, and human studies protection regulations to be valid. Moreover, we noted the effect of autonomy in subjective, quality-of-life benefits on equipoise and effective risk-benefit analysis in effective informed consent. We found that psychiatric screening and support to be exceptionally valuable in protecting autonomy, suitability for participation, assessing personality organization, and determining compliance ability. We conclude that the program ethical principles were validated. For future CTA programs and procedures, we recommend an ethical emphasis with adherence to high standards and transpire to independence to scrutiny and oversight. We recommend protection of autonomy judgments in equipoise judgment and informed consent. We recommend skilled psychiatric screening and support. We endorse scholarship, scientific accuracy, and data sharing.

Humans↗
PubMed1999

The European Biomedical Ethics Practitioner Education Project: an experiential approach to philosophy and ethics in health care education.

The European Biomedical Ethics Practitioner Education Project (EBEPE), funded by the BIOMED programme of the European Commission, is a five-nation partnership to produce open learning materials for healthcare ethics education. Papers and case studies from a series of twelve conferences throughout the European Union, reflecting the 'burning issues' in the participants' healthcare systems, have been collected by a team based at Imperial College, London, where they are now being edited into a series of seven activity-based workbooks for individual or group study. These draft workbooks are now being read by a network of critical readers across Europe, whose comments will be incorporated into the final versions of the workbooks. The result will be the first European-wide and Europe-centred resource for teaching students, practitioners, and members of ethics committees. Topics covered include: Resource allocation and rationing The rights of children and young people Long-term care of the elderly Mental health and mental illness Autonomy and patient choice Decisions at the end of life A study guide to using the workbooks. The collaborative nature of the project has highlighted differentiated national approaches in medical ethics. Against the British and Dutch rights-orientated approach have emerged two other alternative models: the Nordic preference for administrative resolution of entitlement disputes, and the southern European emphasis on deontological codes. A genuinely European reconstruction of autonomy and rights, using hermeneutic, feminist and narrative approaches to counterbalance individualistic models, is emerging across the workbooks. The programme has also uncovered national differences in how ethics should be taught, with the workbooks' style being an experiential approach. Thus the EBEPE project is developing new models in both substantive and pedagogic senses, about both what should be taught and how it should be presented.

Bioethics↗
PubMed1993

Ethics in a short white coat: the ethical dilemmas that medical students confront.

Many existing ethics curricula fail to address the subtle yet critical ethical issues that medical students confront daily. The authors report on the kinds of dilemmas students face as clinical clerks, using cases that students submitted in 1991-92 during an innovative and well-received ethics class given at a tertiary care hospital as part of the internal medicine clerkship. Analysis of these cases reveals that many dilemmas are intimately tied to the student's unique role on the medical health care team. Recurring themes included the student's pursuit of experience, differing degrees of knowledge and ignorance among team members, and dealing with disagreement within the hierarchical authority structure of the medical team. The authors conclude that some components of ethical education must be participant-driven and developmentally stage-specific, focusing more attention on the kinds of ethical decisions made by medical students as opposed to those made by residents or practicing physicians.

Aged↗