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Ethical assessment of clinical research publications.

The ethical quality of research could be improved in four ways: increasing the expertise of research committees, encouraging the popularization of research in ethics, delivering medical training in ethics, and improving the a posteriori control of editorial committees. With regard to the last point, we propose ethical guidelines that may be used as a screening device for publication. Scientific publications have a duty to contribute to the diffusion and application of ethical principles. But too often pieces of research published in these journals do not adequately demonstrate their ethical reflections and chosen ethical procedures. Only scientific procedures are extensively discussed. We think it is essential to develop an assessment of the ethical value of research that is featured in journals, in the same way that the methodological value is assessed. This paper reports what motivated our group to create an ethical scheme, how we developed this scheme and what was our process of validation. In the same way that today a study can be refused publication for methodological inadequacies, in the future publication could more likely be refused for ethical shortcomings.

Ethics↗

[Ethics review committees for human research: the challenge of strengthening this process in Colombia].

INTRODUCTION: Ethics committees are a necessary resource to guarantee ethical integrity in human research; they must apply international standards in their ethical evaluation of research projects involving human subjects. OBJECTIVE: The ethics committees for human research of Colombia were characterized, and recommendations for strengthening them were formulated. MATERIALS AND METHODS: In 2003, 280 groups with research projects involving human subjects were selected from a list of research groups which form part of the science and technology network of Colciencias. (Colciencias is the Colombian national agency that promotes and funds science and technology.) Eighty percent (224) of the projects were associated with 40 institutions, consisting of universities, hospitals, and public or private research centers. Thirty of these institutions had at least one ethics committee for evaluating use of human subjects. A questionnaire was mailed to each of these Committees, requesting information concerning its their compostition, regulations, multidisciplinarity, plurality, representativity and independence. The World Health Organization's Operational Guidelines for Ethic Committees that Evaluate Biomedical Research (TDR/PRD/ETHICS/2000) was used as reference for the analysis. In 5 of the cities, supplemental information was obtained by direct discussions with members of the ethics committees. RESULTS: Twenty-six committees responded to the questionnaire. The results indicated that 47% of the committee members were physicians, but only 23% of the committees had representatives from the community. In 60% of the Committees, members were not independent from the organization in which it was based. Seventy percent had established operating procedures. Lack of national regulations and limited education in research ethics were mentioned as the main drawbacks in providing effective guidance. CONCLUSIONS: These observations led to the conclusion that national guidelines must be established for ethics committees that correspond to international standards. Committee members must be trained before accepting committee responsibilities. Finally, new committees must be created along with the improvement of the currently existing committees for reinforcing and promoting the importance of ethical integrity in research.

Biomedical Research↗

Ethics of research involving humans: uniform processes for disparate categories?

The Australian Health Ethics Committee's National Statement on Ethical Conduct in Research Involving Humans (1999) expanded the health and medical focus of preceding statements by including all disciplines of research. The Statement purports to promote a uniformly high ethical standard for this expanded range of research, and is endorsed by, inter alia, the Australian Academy of the Humanities, the Australian Academy of Science, and the Academy of Social Sciences in Australia. High ethical standards should apply to all research involving humans. However, uniformity in the review processes of disparate research endeavors is not a necessary condition for uniformly high ethical standards. Bringing the ethical review of all research under a model which has developed within the context of health and medical research ethics for over thirty years may be inappropriate and at times incoherent. The language, methods, nature and products of research in areas such as the Humanities are often very different from those of health, medical and other sciences. The Behavioral and Social Sciences Ethics Review Committee at The University of Queensland (UQ) had, since the mid-1980s, considered that the guidelines of the time did, in fact, cover all aspects of human experimentation. We describe the ways in which this position was implemented, how issues raised by the new wording in the National Statement have been recently managed by UQ's research ethics committees, and point to outstanding questions.

Advisory Committees↗

Ethical issues in hospital medicine.

The medical ethics of the new millennium will be fascinating and fast moving in our pluralistic Western society. This will be particularly true in ethics in the hospital setting and under hospitalist models. Ethical decisions are ubiquitous in medical practice, at the microlevel of the patient-physician relationship and at the macro-level of the allocation of resources and other ethical decisions. Hospitalists need to recognize that ethical issues are distinct from medical ones and need to utilize different techniques in their resolution. Ethics in the public sector, such as in hospitals and other health care organizations, cannot transcend politics completely, because the public sector is the political arena. For ethical guidelines to survive, however, they must be based not on political expediency but on sound ethical principles and reasoning. As the knowledge of medicine, technology, and science continues to grow, the challenges of regulation, policy, and ethical issues in the hospital setting and elsewhere in the health care system will occupy physicians for some time to come.

Clinical Competence↗

Ethical inquiry and the concept of research.

The place of scholarly research in nursing has not been well studied. Ethical inquiry, as scholarly research, has been included in this neglect. The concept of ethics research is defended and new research approaches to ethics are outlined. Forms of ethics research identified are scholarly, empirical, and dual mode. Questions considered are: Is ethics research research? What are the forms of ethics research? What is the role of empiricism in ethics research? And what is the relationship of ethics research to the moral concerns of nursing? Ethics research explores the basic moral norms undergirding nursing research, practice, and education.

Behavioral Research↗

Avoiding "Cloudcuckooland" in ethics committee case review: matching models to issues and concerns.

... The special concerns of families, patients, and caregivers are inevitably interwoven among the difficult ethical issues that ethics committees confront when they review individual cases. Certain of these ethical issues and special concerns can be addressed more effectively by the use of one particular case review model. This means that no one model for case review is suited to address every ethically difficult patient care situation. When one case review model is used exclusively by an ethics committee, some issues and concerns will not be resolved effectively. This difficulty cannot be ameliorated by switching to another exclusive model. To do so would be to trade an Athens for a "Cloudcuckooland." The case review model selected by ethics committees must vary from case to case. The model that is chosen should be geared to resolve the ethical issues central to that situation and the special concerns of patient, family, and caregivers. An examination of the three received models [the committee as a whole, teams, and individual members or consultants] will show that each is particularly suited to resolve certain kinds of ethical issues and special concerns. Because of this, ethics committees should develop a method for choosing the most appropriate model for reviewing specific cases.

Bioethical Issues↗

What triggers requests for ethics consultations?

OBJECTIVES: While clinical practice is complicated by many ethical dilemmas, clinicians do not often request ethics consultations. We therefore investigated what triggers clinicians' requests for ethics consultation. DESIGN: Cross-sectional telephone survey. SETTING: Internal medicine practices throughout the United States. PARTICIPANTS: Randomly selected physicians practising in internal medicine, oncology and critical care. MAIN MEASUREMENTS: Socio-demographic characteristics, training in medicine and ethics, and practice characteristics; types of ethical problems that prompt requests for consultation, and factors triggering consultation requests. RESULTS: One hundred and ninety of 344 responding physicians (55%) reported requesting ethics consultations. Physicians most commonly reported requesting ethics consultations for ethical dilemmas related to end-of-life decision making, patient autonomy issues, and conflict. The most common triggers that led to consultation requests were: 1) wanting help resolving a conflict; 2) wanting assistance interacting with a difficult family, patient, or surrogate; 3) wanting help making a decision or planning care, and 4) emotional triggers. Physicians who were ethnically in the minority, practised in communities under 500,000 population, or who were trained in the US were more likely to request consultations prompted by conflict. CONCLUSIONS: Conflicts and other emotionally charged concerns triggers consultation requests more commonly than other cognitively based concerns. Ethicists need to be prepared to mediate conflicts and handle sometimes difficult emotional situations when consulting. The data suggest that ethics consultants might serve clinicians well by consulting on a more proactive basis to avoid conflicts and by educating clinicians to develop mediation skills.

Attitude of Health Personnel↗

Ethical codes: between theory and health care practice.

Apart from legal norms, medicine is also governed by a broad array of ethical norms. Historically, ethical codes are a translation of these ethical norms. They are designed to assist the individual professional in the ethical aspects of his or her professional life. Ethical codes are however subject to different critiques. This contribution focuses on two critiques: (1) ethical codes neglect the pervasiveness of morality and the complexity of moral issues by presenting a set of specific ethical norms that need to be applied (outside in perspective); (2) ethical codes do not take into account the fragmentation of ethics and the decreasing homogeneity of the professional group (middle ground position).

Bioethics↗

Teaching ethics in nursing curricula. Traditional and contemporary models.

The teaching of ethics in nursing education has become increasingly important in recent years. While it was an important part of early nursing education, it nearly disappeared from the nursing curriculum during the 1950s and 1960s. The traditional method of ethics teaching, the Scientific Model, is no longer used in nursing education. However, the contemporary models of ethics teaching--the Moral Concepts Model, the Moral Issues Model, the Clinical Practice Model, and the Ethics Inquiry Model--are being implemented into baccalaureate, graduate, and doctoral education in nursing. Having different goals and employing different teaching methods, these models promise to achieve the overall goal for teaching ethics to nurses: to produce a morally accountable practitioner who is skilled in ethical decision making. The uses of these model are encouraged in all aspects of nursing education, regardless of type of curriculum and faculty preparation to teach ethics. Given the availability of ethics resources and faculty seminars/workshops on ethics teaching strategies, all or part of any of the models can be easily implemented in the majority of nursing education programs.

Bioethical Issues↗

Ethics committees in Croatia in the healthcare institutions: the first study about their structure and functions, and some reflections on the major issues and problems.

OBJECTIVES: In Croatia, ethics committees are legally required in all healthcare institutions by the Law on the Health Protection. This paper explores for the first time the structure and function of ethics committees in the healthcare institutions in Croatia. DESIGN: Cross-sectional survey of the healthcare institutions (excluding pharmacies and homecare institutions) to identify all ethics committees. SETTING: Croatia six years after the implementation of the Law on the Health Protection. MAIN MEASUREMENTS: Structure and function of ethic committees in the healthcare institutions. RESULTS: 46% of the healthcare institutions in Croatia (excluding pharmacies and homecare institutions) have an ethics committee; 89% of ethics committees have 5 members 3 of whom are from medical professions and 2 come from other fields; 49% of those committees stated that their main function is the analysis of research protocols. Only a small fraction of those ethics committees sent in standing orders, working guidelines or other documents that are connected with their work. CONCLUSIONS: Although there are legal provisions for ethics committees in the healthcare institutions in Croatia, there is an evidence of discrepancies between the practice and the "Law on the Health Protection," suggesting the need for revision of the law. There is a need for creating separate networks of HECs and IRBs in Croatia. In comparison with other countries, the development of ethics committees in Croatia has some similarities with other transitional societies in Europe. Additional research should be undertaken in the work of ethics committees in Croatia in order to understand committees' group dynamics, attitudes, and knowledge.

Croatia↗

Against over-estimating the role of ethics in technology development.

The role of ethics in technology development has been often questioned, especially in the early days of societal reflection of technology. However, the situation has changed dramatically. Ethical consideration now is generally declared to be indispensable in shaping technology in a socially acceptable and sustainable way. The expectations of ethics are large; often even a kind of "New Ethics" is postulated. In the present paper an over-estimation of the role of ethics for technology development is rejected. It is argued that ethical reflection is, indeed, indispensable in certain problem areas and situation types; but there is, on the other hand, space for technology development free from the requirement for ethical reflection. The absence of a requirement for ethical reflection, however, always has to be considered relative to some "morale provisoire" (provisional morality) as an accepted normative framework within which technology development may occur without explicit ethical reflection. If this framework, however, is doubted or is shown to be insufficient the situation changes completely. Ethical reflection in this case becomes necessary, to consider this normative framework in order to offer modifications or supplements.

Engineering↗

The ethical basis of psychiatric research: conceptual issues and empirical findings.

The study objective was to clarify the ethical basis of psychiatric research by outlining conceptual issues and empirical findings related to the ethics of human experimentation. A systematic review of scholarly and empirical literature covering three decades was performed. The ethics of human research has come to be understood in relation to the principles of respect for persons, beneficence, justice, and the ideal of informed consent. Subjects who cannot fully participate in informed-consent processes are especially vulnerable to exploitation. Current dilemmas stem from insufficient attention to the vulnerabilities of mentally ill research participants, problems in applying ethical concepts and guidelines to psychiatric research, and claims of research misconduct. Empirical studies indicate that (1) psychiatric symptoms significantly affect informed consent, (2) psychiatric patients may possess certain strengths with respect to research involvement, (3) proxy decision-making is problematic, (4) informed consent is also difficult to attain with the medically ill and others, (5) patients are motivated to participate in research by the hope of personal benefit, (6) ethical aspects of research are poorly documented, and (7) institutional review processes may not be adequate to protect vulnerable subjects. Psychiatric research can be performed ethically, according to standards set throughout the biomedical and behavioral sciences, so long as researchers and institutions are respectful of special ethical issues in human experimentation and strive to include vulnerable study participants fully in research decisions. However, many gaps in the empirical literature exist regarding the specific nature and implementation of ethics principles in psychiatric research. Efforts to advance both science and ethics, including the study of ethical dimensions of human research itself, are essential for the future of psychiatry.

Attitude to Health↗

Ethical considerations in home care of the oncology patient.

OBJECTIVES: To examine the context of home care and the values of providers and patients that lead to potential ethical conflicts. To discuss a normative model of ethical decision making, and to suggest resources for resolving ethical issues. DATA SOURCES: Published articles pertaining to ethical issues and home health care. CONCLUSIONS: Home care is a viable and beneficial alternative to hospital care for a variety of patients, yet home care can result in unique value conflicts between patients and their families, and patients and home care providers. Loss of privacy and determining who is in charge are several unique areas to home care that can lead to ethical problems. Policies, guidelines, value statements, and ethics committees are excellent resources to assist in ethical decision-making. IMPLICATIONS FOR NURSING PRACTICE: A workable method or model to resolve ethical problems, and resources to assist in ethical decision-making can provide home care providers with guidelines to analyze an ethical problem and the support to choose and act on the best option.

Decision Making↗

Evolutionary ethics from Darwin to Moore.

Evolutionary ethics has a long history, dating all the way back to Charles Darwin. Almost immediately after the publication of the Origin, an immense interest arose in the moral implications of Darwinism and whether the truth of Darwinism would undermine traditional ethics. Though the biological thesis was certainly exciting, nobody suspected that the impact of the Origin would be confined to the scientific arena. As one historian wrote, 'whether or not ancient populations of armadillos were transformed into the species that currently inhabit the new world was certainly a topic about which zoologists could disagree. But it was in discussing the broader implications of the theory...that tempers flared and statements were made which could transform what otherwise would have been a quiet scholarly meeting into a social scandal' (Farber 1994, 22). Some resistance to the biological thesis of Darwinism sprung from the thought that it was incompatible with traditional morality and, since one of them had to go, many thought that Darwinism should be rejected. However, some people did realize that a secular ethics was possible so, even if Darwinism did undermine traditional religious beliefs, it need not have any effects on moral thought. Before I begin my discussion of evolutionary ethics from Darwin to Moore, I would like to make some more general remarks about its development. There are three key events during this history of evolutionary ethics. First, Charles Darwin published On the Origin of the Species (Darwin 1859). Since one did not have a fully developed theory of evolution until 1859, there exists little work on evolutionary ethics until then. Shortly thereafter, Herbert Spencer (1898) penned the first systematic theory of evolutionary ethics, which was promptly attacked by T.H. Huxley (Huxley 1894). Second, at about the turn of the century, moral philosophers entered the fray and attempted to demonstrate logical errors in Spencer's work; such errors were alluded to but never fully brought to the fore by Huxley. These philosophers were the well known moralists from Cambridge: Henry Sidgwick (Sidgwick 1902, 1907) and G.E. Moore (Moore 1903), though their ideas hearkened back to David Hume (Hume 1960). These criticisms were so strong that the industry of evolutionary ethics was largely abandoned (though with some exceptions) for many years. Third, E.O. Wilson, a Harvard entomologist, published Sociobiology: The New Synthesis in 1975 (Wilson E.O. 1975), which sparked renewed interest in evolutionary ethics and offered new directions of investigation. These events suggest the following stages for the history of evolutionary ethics: development, criticism and abandonment, revival. In this paper, I shall focus on the first two stages, since those are the ones on which the philosophical merits have already been largely decided. The revival stage is still in progress and we shall eventually find out whether it was a success.

Biological Evolution↗

Methodological quality and reporting of ethical requirements in phase III cancer trials.

BACKGROUND: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD: Methodological quality (Jadad score) and ethical quality (Berdeu score) were assessed for all randomised controlled trials (RCTs) published in 10 international journals between 1999 and 2001 (n = 231). RESULTS: The mean Jadad score was 9.86 +/- 1.117. The methodological quality was poor in 75 RCTs (Jadad score <9). The mean Berdeu score was 0.42 +/- 0.133. The mean ethical quality score for poor methodological quality RCTs (n = 75) was 0.39 +/- 0.133; it was 0.43 +/- 0.133 for good (n = 156) methodological quality RCTs (p = 0.07). There was improvement in ethical quality according to the year of commencement of the trials (p < 0.001). There was no correlation between methodological quality and the number of participating patients (R2 = 0.003, p = 0.78), between ethical quality and the number of participating patients (R2 = 0.003, p = 0.76 ), or between ethical quality and methodological quality (R2 = 0.012, p = 0.1). ICP and REC approval were not obtained for 21 and 77 trials respectively. CONCLUSION: The association between methodological quality and the reporting of ethical requirements probably reflects the respect shown for patients during the whole research process. These results suggest that closer attention to the conduct of clinical research, as well as the reporting of its ethical aspects, is needed.

Clinical Trials, Phase III as Topic↗

Is there a future for clinical ethics services in Australia?

Clinical ethics refers to the consideration of ethical issues arising directly in the context of patient care. Health professionals are generally adept at effectively and sensitively managing ethical issues in clinical care. However, in some settings, multidisciplinary clinical ethics services may enhance clinical practice by assisting clinicians, patients and others to identify, understand and manage ethical issues. Clinical ethics services may be particularly valuable for situations in which moral perspectives diverge or communication has deteriorated. Such services may facilitate discussion and help the parties find mutually satisfactory solutions. Clinical ethics services may take various forms, including clinical ethics committees, ethics consultants, patient advocates or other mechanisms for responding to complaints and grievances. There is considerable disagreement about key aspects of clinical ethics services, including who should conduct them, how they should be run and what role they should play in decision-making.

Adult↗

[Ethical aspects of short health technology assessments--a systematic review].

Ethical aspects are of high relevance to Short Health Technology Assessments (HTAs). We therefore conducted a systematic review to find out to what extent ethical aspects have been considered in previous Short HTAs. We included articles whose title or abstract suggested that it was a "short", "rapid" or "brief" assessment published in German, English, or French. 272 out of 513 Short HTAs were included. Twenty-five publications (9%) explicitly mentioned ethical aspects, 32 publications (12%) dealt with ethical aspects without explicitly addressing them as 'ethical', 208 publications (76%) did not consider ethical aspects and in another 7 publications (3%) ethical aspects were not relevant. Short HTAs are regularly used to assess sparsely evaluated and/or emerging technologies for which a particular need for an ethical assessment can be assumed. However, the majority of the Short HTAs included in this review did not consider ethical aspects. In this article we therefore suggest a set of key words that will allow authors of Short HTAs to do a systematic literature search for ethical papers in their respective subject of investigation.

Biomedical Technology↗

[Ethical principles in medical practice].

In the present work, we present an analysis of ethics in the practice of medicine, as a fundamental element of the quality of medical care. We present a brief review of factors related to the development of ethics. In this paper we have shown different institutional and societal conditions for the definition and promotion of ethics. We present a conceptual analysis of the quality of medical care and how ethics interplays with the care given by medical practitioners and how that combination of quality medical care and adherence to ethical principles are used to solve health problems, with a high-degree of satisfaction to both patients and their families. Before entering into the conceptualization of each of the ethical principles of medical practice, the concepts of morality, ethics, bioethics, medical ethics, and ethical deontology are defined. We continue with the proposal of ten ethical principles of medical practice that include charity, fairness, autonomy, confidentiality, respect, dignity, solidarity, honesty, loyalty, and justice, and the concept of each of them, as well as the precepts that each principle contains.

Ethics, Medical↗