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Reporting of ethical standards: differences between complementary and orthodox medicine journals?

OBJECTIVES: This study aimed at assessing whether there are differences in the reporting of ethical aspects of complementary and alternative medicine (CAM) and mainstream medical research. DESIGN: Review of published literature. SETTING: Research department of medical school. MAIN OUTCOME MEASURES: Reports of ethical aspects including adherence to clinical guidelines, ethical approval from ethics committees, consent of the patient, declaration of conflict of interest, and declaration of funding for a study. RESULTS: We included 21 articles from CAM journals, as well as 16 from equal impact factor mainstream (EIF) journals and 27 from high impact factor (HIF) journals. A statistically significant difference was found in the reporting of ethical approval: 62% of all CAM articles, 75% of the EIF and 93% of the HIF journal articles reported approval from ethics committees [chi2 = (2, n = 64) 6.631, p<0.05]. Regarding the reporting of obtaining patients' consent there were no statistically significant differences: 48% of all CAM articles, 38% of the EIF mainstream and 67% of the HIF mainstream journal articles explicitly stated that patients signed a consent form [chi2 = (2, n = 64) 3.813, p>.05]. High impact factor journals were more likely to report on ethical standards than other journals on conflicts of interests and sponsorship. However, they were less likely to report a reference to ethical guidelines. Articles from CAM journals had more strict reporting requirements than mainstream medicine journals with comparable impact factors. CONCLUSIONS: Differences exist between complementary and orthodox medical journals in the reporting of ethical aspects of trial design.

Codes of Ethics↗

The forms and limits of medical ethics.

As medical ethics has evolved over the past several decades, it has come to be regarded as a domain of applied ethics, that is, the application of a rationally based, philosophical theory to moral problems in health care. But an array of difficulties arise in the attempt to apply general moral theories or norms to concrete problems, difficulties that expose the incompleteness and indeterminacy of philosophical moral theory. The doubtful ability of applied ethics to be practically helpful has led to the development of two main competitors. One is the attempt to reprise and rehabilitate the tradition of moral casuistry, which focuses on the analysis of specific cases rather than on the defense and application of theories and norms. The second is the search for moral insight and guidance in narratives or stories. These alternatives suffer from some of the same difficulties that plague applied ethics, however. Another trend in medical ethics rejects the theoretical preoccupation of applied ethics in favour of contextualism--an insistence on situating moral problems in institutional and organizational structures and in social and cultural backgrounds. Social science investigations of medical ethics pay attention to the former, while feminist critiques of medical ethics are concerned with exposing and eradicating cultural biases against women. Contemporary work in medical ethics is diverse, but these manifold approaches hold out the promise of improving our understanding of morality as a truly practical enterprise.

Ethics, Medical↗

Ethical process in human research published in thoracic surgery journals.

BACKGROUND: Media reports of ethical transgressions in research with human subjects have increasingly focused attention on clinical investigators and have served to undermine public confidence in medical research. A series of editorials in The Annals of Thoracic Surgery and The Journal of Thoracic and Cardiovascular Surgery in 2002 and 2003 emphasized integrity in research publication. We investigated the extent to which the ethical process was mentioned in reports of thoracic surgical research with human subjects since 2002. METHODS: We reviewed all reports of research involving human subjects published in these journals during the first 6 months of 2002, the first 6 months of 2003, and the last 6 months of 2004 (n = 273, 291 and 288 for each time period, respectively with a total of 852). RESULTS: Ethical process was mentioned in 346 of 852 (41%) investigations. Comparing US and non-US studies, the rates of mentioning ethical process for prospective studies were 76 of 83 (92%) and 178 of 216 (82%), respectively, and for retrospective studies were 75 of 220 (34%) and 18 of 334 (5%), respectively. Between 2002 and 2004, the rates of mentioning ethical process for prospective studies increased from 79 of 101 (78%) to 80 of 89 (90%), and for retrospective studies it increased from 17 of 172 (10%) to 59 of 199 (30%). CONCLUSIONS: There was a significant increase in mention of ethical process from early 2002 to late 2004; however, documentation of appropriate ethical process in human research published in cardiothoracic journals remains less than ideal. The main burden of ensuring ethical process in human investigations rests with researchers, their institutions, and institutional review boards; however, editors can help rectify this problem by requiring adherence to national and international standards in the human subjects' research studies they publish. In adhering to ethical standards, investigators respect the research subjects' right of self-determination and foster public confidence in human research.

Bibliometrics↗

Ethical implications of genetic analysis of individual susceptibility to diseases.

Ethics can be regarded as a reflection or reconsideration of existing moral codes in the search of good and goes beyond moral conduct. This means that ethics is a never-ending process, which in science must develop with the development of science itself. Thus, the process of seeking better ethics is as integral within science as the development of new methods. Along these lines of thought it can be argued that (1) poor science cannot be ethically sound, (2) every scientist has a personal responsibility to develop ethics in his area of expertise, (3) the development of solid ethical background in science requires education in ethics as well as in methodology and scientific thinking and (4) research ethics cannot develop in solitude, but needs input from other scientists, other fields (including philosophy) and society. Several burning questions can be identified within genetic analysis for individual susceptibility. These ethical aspects can be viewed from three different perspectives: practice of research, patient/research subject personally and long-term implications in society. This paper tries more to awaken thoughts than give clear answers.

Biological Science Disciplines↗

Role of the research ethics committee.

Research ethics committees have an important role to play in ensuring the ethical standards and scientific merit of research involving human subjects. There are three important obligations placed on the ethics committee. Firstly, and most importantly, the ethics committee must ensure that the rights of research participants are protected. This is achieved by ensuring that individuals receive sufficient information, which can be easily understood, and ensuring that appropriate strategies are in place to protect participants from potential adverse consequences of the research. Secondly, the research ethics committee has an obligation to society which provides the resources for research and will ultimately be affected by the results. Thirdly, the research ethics committee has an obligation to the researcher. The research proposal should be treated with respect and consideration. The research ethics committee should strive to meet each of these obligations. All researchers should welcome the contribution made by research ethics committees to the research process because they help to ensure that research meets the high ethical and scientific standards expected by society.

Ethics Committees↗

Ethics of early prevention in schizophrenia.

OBJECTIVE: To represent a cross-section of current thinking on the ethics of early (primary) prevention in schizophrenia. METHOD: Ethical considerations presented at the First Australian Schizophrenia Prevention Conference, Sydney, March 1999, particularly from the final session on 'Ethics', are recorded here together with complementary referenced material. RESULTS: Ethical concerns arise in the arenas of research over clinical priorities; screening ethics, including stigma, confidentiality, informed consent and support required through waiting periods; and the ethics of prolonged assessments in the absence of disorder, the right not to know and the possible ethical prematurity or otherwise of screening for schizophrenia. CONCLUSIONS: There are several legitimate ethical concerns that must be understood and addressed by those undertaking the developing of primary preventive measures in schizophrenia. Such measures must still be regarded as more experimental the further ahead the measures are undertaken from the onset of the disorder. Anticipatory ethical guidelines should be developed to inform such research.

Ethics, Medical↗

Ethically-based clinical decision-making in physical therapy: process and issues.

The identification and consideration of relevant ethical issues in clinical decision-making, and the education of health care professionals (HCPs) in these skills are key factors in providing quality health care. This qualitative study explores the way in which physical therapists (PTs) integrate ethical issues into clinical practice decisions and identifies ethical themes used by PTs. A purposive sample of eight PTs was asked to describe a recent ethically-based clinical decision. Transcribed interviews were coded and themes identified related to the following categories: 1) the integration of ethical issues in the clinical decision-making process, 2) patient welfare, 3) professional ethos of the PT, and 4) health care economics and business practices. Participants readily described clinical situations involving ethical issues but rarely identified specific conflicting ethical issues in their description. Ethical dilemmas were more frequently resolved when there were fewer emotional sequelae associated with the dilemma, and the PT had a clear understanding of professional ethos, valued patient autonomy, and explored a variety of alternative actions before implementing one. HCP students need to develop a clear professional ethos and an increased understanding of the economic factors that will present ethical issues in practice.

Adult↗

Ethical benefits and costs of coercion in short-term inpatient psychiatric care.

OBJECTIVE: The study examined the outcome of psychiatric inpatient care in terms of patients' reports of ethical benefits, which were defined as fulfillment of the ethical principles of beneficence and autonomy, and ethical costs, which were defined as any violation of those principles. METHODS: A consecutive sample of 84 committed patients and a random sample of 84 voluntarily admitted patients in psychiatric care in two Swedish counties were studied. The patients were assessed twice by a psychiatrist, at admission and at discharge or after three weeks of care. They were also interviewed by a clinical psychologist at discharge or after three weeks. Four aspects of the ethical benefits or costs of their care were examined--whether they reported improvement in mental health, being treated with respect, not being violated as a person, and not being exposed to measures against their will (aside from commitment). RESULTS: The great majority of all patients reported improvement as a result of the psychiatric care. A third of the committed patients and more than half of the voluntarily admitted patients experienced ethical benefits only, without ethical costs. Twenty-three percent of the committed patients and 13 percent of the voluntary patients experienced ethical costs only, without ethical benefits. Some of the patients who experienced ethical costs only were also rated by a psychiatrist as not improved. CONCLUSIONS: Few patients had no measurable benefits of care. For committed as well as voluntary patients, an association was found between perceived respect for autonomy and self-reported improvement in mental health.

Adolescent↗

Ethics and the AIDS pandemic in the developing world.

Traditional ethics provide insight, but often fall short of guiding the complex biomedical ethical concerns of research conducted in developing countries. The need to create research within a framework that is appropriate to the social, medical, and political context of developing countries is examined through the current AIDS pandemic in sub-Saharan Africa. A specific case study focuses on this issue. Over 70 percent of the 40 million people with HIV/AIDS live in sub-Saharan Africa. With at least one in five African adults infected with the disease, sub-Saharan Africa is now acknowledged as the epicenter of HIV/AIDS. The scale and scope of the disease in the environment of a developing economy presents unique issues that challenge the role and practices of traditional ethics in healthcare research programs. Medical research within developing countries, particularly for HIV/AIDS, requires a distinctive approach. For these populations, investigators must incorporate new thinking into traditional biomedical research ethics which will address the role of innovation; access to treatment; the impact of fear, stigma, and denial; concerns around autonomy for vulnerable populations; capacity building; and sustainable care to communities. Since May 1999, Secure the Future, a philanthropic program that focuses on care and support for women and children infected and affected by HIV/AIDS, has attempted to fulfill these ethical concepts in its processes. The program is a public and private sector partnership between governments, communities, practitioners, academia, and Bristol-Myers Squibb Company to respond to AIDS in five countries in sub-Saharan African countries: Botswana, Lesotho, Namibia, South Africa, and Swaziland. To ensure symmetry between ethical principles and local context, collaborative projects undergo a comprehensive review process. This includes review and approval by a national secretariat to ensure projects support objectives of national policies and local communities; approval by an ethics committee comprised of participating institutions; blinded peer review; and an examination by an external advisory board comprised of local and international medical experts, persons living with AIDS (PLWA), religious communities, governments, and nongovernmental organizations (NGOs). An independent monitor also oversees the approved programs. Cost-effective and practical interventions against HIV/AIDS must encompass ethical approaches appropriate to the contexts of the respective developing countries. Lessons learned to date are to focus on innovation; establish unassailable ethical standards that are sensitive to local contexts; ensure transparent communications among partners and the broader community; and build sustainable capacity.

Acquired Immunodeficiency Syndrome↗

Sensitivity to ethical issues confronted by Korean hospital staff nurses.

This descriptive study was undertaken to identify the degree of ethical sensitivity of staff nurses and to analyze the differences in ethical sensitivity in terms of both general and ethics-related characteristics. Participants were 236 staff nurses working in general hospitals in Korea. Ethical sensitivity was measured by means of an instrument developed by the researchers. The results showed that the mean score for the degree of ethical sensitivity was 0.71 out of a possible maximum score of 1 (range 0.30 to 0.97). For general characteristics, there was a significant difference in ethical sensitivity according to age (F (df 2233) = 3.99, P = 0.02). For characteristics related to ethics, there was a significant difference in ethical sensitivity according to attitude towards the nursing profession (F (df 4231) = 2.94, P = 0.03). It is therefore recommended that a training program reflecting these variables be developed to enhance staff nurses' ethical sensitivity.

Adult↗

Psychoanalysis and ethics--relevant then, essential now.

The general concepts of morality and ethics are presented followed by an overview of the history of medical ethics from Hippocrates to the founding of the American Medical Association, whose Code of Ethics psychiatrists follow. The particular relevance of these topics to the founding of psychoanalysis is explored utilizing a 50-year review of the professional literature. The ethical underpinnings of Freud's theory and practice are highlighted revealing Freud to be anything but anti-ethics. The ethical dimension of contemporary ethical theory and practice is also presented together with a discussion of the developmental acquisition of an ethical attitude. The article concludes with a discussion of the current relevance and future importance of morality and ethics if medicine (including psychiatry and psychoanalysis) is to survive as a profession.

Ethics, Professional↗

Ethical considerations for biomedical scientists and engineers: issues for the rank and file.

Biomedical science and engineering is inextricably linked with the fields of medicine and surgery. Yet, while physicians and surgeons, nurses, and other medical professionals receive instruction in ethics during their training and must abide by certain codes of ethics during their practice, those engaged in biomedical science and engineering typically receive no formal training in ethics. In fact, the little contact that many biomedical science and engineering professionals have with ethics occurs either when they participate in government-funded research or submit articles for publication in certain journals. Thus, there is a need for biomedical scientists and engineers as a group to become more aware of ethics. Moreover, recent advances in biomedical technology and the ever-increasing use of new devices virtually guarantee that biomedical science and engineering will become even more important in the future. Although they are rarely in direct contact with patients, biomedical scientists and engineers must become aware of ethics in order to be able to deal with the complex ethical issues that arise from our society's increasing reliance on biomedical technology. In this brief communication, the need for ethical awareness among workers in biomedical science and engineering is discussed in terms of certain conflicts that arise in the workaday world of the biomedical scientist in a complex, modern society. It is also recognized that inasmuch as workers in the many branches of bioengineering are not regulated like their counterparts in medicine and surgery, perhaps academic institutions and professional societies are best equipped to heighten ethical awareness among workers in this important field.

Authorship↗

Business Ethics 101 for the biotech industry.

Biotechnology companies face ethical challenges of two distinct types: bioethical challenges faced on account of the nature of work in the life sciences, and corporate ethical challenges on account of their nature as commercial entities. The latter set of challenges has received almost no attention at all in the academic literature or media. This paper begins to remedy that lacuna, examining ethical issues that arise specifically on account of the status of biotech companies as commercial entities. The focus here is on three representative issues: product safety, corporate social responsibility, and corporate governance. It is argued that each of these issues poses particular ethical challenges for companies in the biotech sector. In the area of product safety, it is noted that biotech companies face particular challenges in determining what counts as a "safe" product, given the contentious nature of what might count as a "harm" in the biotech field. In the area of corporate social responsibility, the adoption of a "stakeholder approach" and an attempt to manage the social consequences of products pose special challenges for biotech companies. This is due to the enormous range of groups and individuals claiming to have a stake in the doings of such companies, and the trenchant controversies over just what the social consequences of various biotechnologies might be. In the area of corporate governance, biotech companies need to seek out and follow best practices regarding the ways in which information, authority, and influence flow between a company's shareholders, managers, and Board of Directors, if they are to avoid duplicating the ethical and financial scandal that brought down ImClone. An important meta-issue, here--one that renders each of these corporate ethical challenges more vexing--is the difficulty of finding the appropriate benchmarks for ethical corporate behavior in a field as controversial, and as rapidly evolving, as biotechnology. Three programmatic suggestions can be made: Firstly, scholars and others interested in the ethical performance of the biotech sector must seek out and build opportunities for richer interdisciplinary collaboration. Secondly, companies within the biotech sector must seek out expertise and build capacity and competency in dealing with the corporate ethical issues that arise in their sector. Finally, companies in the biotech sector should explore the opportunities for collective problem solving afforded by the existence of local, national, and international industry associations such as the Biotechnology Industry Organization, BIOTECanada, and EuropaBio.

Benchmarking↗

Gastroenterology in the last decennia and initiatives in medical ethics: coincidence or linkage?

A quarter of a century ago ethics was an esoteric term, known to theologians and philosophers, but unknown as a discipline to the majority of doctors. Since then, however, ethics has become a substantial part of clinical medicine and health research. Ethics as an area of interest for Danish gastroenterologists appeared from several foci in the early days. One angle was an almost revival-like interest in research methodology and its ethical dimensions. Other angles were derived from Danish gastroenterologists' experiences transferred from other disciplines before the birth of Danish gastroenterology. From the time of these early incentives Danish gastroenterologists have constituted a platform for the implementation of the basic principles, lying behind medical ethics, now in collaboration with other parts of the medical profession. The topics are reflected in a number of publications and in the various practical diversions. An interest in information of patients appeared at an early stage. Publication ethics as a subdiscipline involved Danish gastroenterologists and has led to contributions within the framework of the International Group of Medical Journal Editors. Research ethics, a central topic throughout all years, has led to such important initiatives as the Second Helsinki Declaration and the establishment of a national control system for medical research in man. A further ramification of ethics is scientific dishonesty and good clinical practice. Here a recent initiative has led to the establishment of a national Committee on Scientific Dishonesty. Under the auspices of the OMGE (Organisation Mondiale de Gastroentérologie) Danish gastroenterologists have investigated transnational and transcultural differences in gastroenterologists' attitudes to information of patients and relatives and have unmasked considerable and important differences throughout the world. Medical ethics has, together with scientific methodology, to some extent reunited the sub-specialized fragments of the mother disciplines medicine and surgery and in this way has acted as partes pro toto.

Attitude of Health Personnel↗

Ethics education at the engineering/medicine interface.

There is a functioning interface between engineering and medicine. There are also wide-spread indications in the scientific community that there is increased concern for ethical matters in science and that the time has arrived for more instruction in this area. One reason for this in bioengineering is the rapidly growing complexity of technology in both engineering and medical biology. The ensuing difficulty in communication cannot be remedied just with more technical information. Instead bioengineers need an improved understanding of medical education and practice, and medical ethics is fundamental to this. Ethical considerations are crucial to decision making and therefore to all areas of professional endeavor in bioengineering. As a framework for ethics education, bioengineers need to gain a better understanding both of medical education in general and of medical practice, particularly the case study method in education and the nature of decision making in medical practice. Key subject areas in medical ethics for bioengineers include rights and duties of physicians, determination of death, team ethics, patient privacy and informed consent, research ethics, and malpractice. An ethics curriculum for bioengineers should be taught using both informal but regular exposure to clinical activities and clinicians, and formal classroom work. In the medical ethics classroom setting, writing assignments are essential to provoke each student to the introspection and commitment needed to form a personal professional ethos.

Biomedical Engineering↗

Perceptions of nursing faculty regarding ethical issues in nursing research.

A major premise of any research activity is that ethical conduct will be identified and observed during the research process. Yet a comprehensive review of the nursing literature failed to find any research assessing nurses' perceptions of ethical issues related to authorship, publication, reporting results, or funding. This study assessed nursing faculty members' perceptions of ethical scenarios related to the areas of authorship, publication, reporting results, and funding. A 34-item questionnaire, consisting of ethical issues related to research, was mailed to a national random sample of nursing faculty who were teaching at graduate degree-granting institutions. A three-wave mailing was used to maximize response rate. A total of 388 nurses responded to the survey (77.6% response rate). Less than half of the respondents reported that content included in their curriculum was related to the issues under study. Respondents' perceptions of the ethical scenarios varied. A majority of the respondents considered six of the scenarios ethical, eight unethical, one questionable, and one not an ethical issue. Five of the scenarios received widely varied responses. Faculty members who had chaired student dissertations found three questionnaire items significantly (p < .05) more unethical than faculty members who had not chaired dissertations. Faculty teaching in programs in which the highest degree offered was a doctorate found two items unethical significantly more often than faculty teaching at programs in which the highest degree offered was a master's degree. Results of this study demonstrate the potential that students are not being taught necessary issues related to ethical authorship and publication practices. Faculty members themselves may not have had the education needed to educate their own students in the area of research ethics.

Analysis of Variance↗

What's the matter with business ethics?

The more business ethics secures its status in campuses across the country, the more bewildering it appears to actual managers. It's not that managers dislike the idea of doing the right thing. As University of Toronto Assistant Professor Andrew Stark argues, far too many business ethicists just haven't offered them the practical advice they need. Before business ethics became a formal discipline, advocates of corporate social responsibility claimed that the market would ultimately reward ethical behavior. But ethics and interests did not always intersect so fruitfully in the real world. And when they did not, managers were left in the dark to grope for the right ethical course. In the 1970s, the brand-new field of business ethics came onto the scene to address this issue. Critical of the "ethics pays" approach, academics held that ethics and interests can and do conflict. Still, scholars took an equally unrealistic line. To them, a manager's motivation could be either altruistic or self-interested, but never both. In short, ethicists still weren't addressing the difficult moral dilemmas that managers face on a day-to-day basis, and only recently have they begun to do so. After some initial stumbles, ethicists are getting their hands dirty and seriously considering the costs of doing the right thing. Finally, a new business ethics is emerging that acknowledges and accepts the messy world of mixed motives. As a result, novel concepts are springing up: moderation, pragmatism, minimalism, among others.(ABSTRACT TRUNCATED AT 250 WORDS)

Administrative Personnel↗

[Health care resource allocation in Chile. Ethical considerations in decision making].

BACKGROUND: The inclusion of ethical aspects in the world health care reform is currently being discussed. AIM: To analyze the ethical component of health care decision making in Chile. MATERIAL AND METHODS: A qualitative analysis of interviews with 4 health service directors, 4 public hospital directors and 1 sub director. Inquiries to 16 public hospital ethics committees, about importance of ethical components in decision making, role of ethics committees in financial issues and the feasibility of incorporation explicit ethical considerations in decision making. RESULTS: There is an absence of explicit ethical criteria in decision making. There is little participation of directors in these issues and lack of information. Although ethical aspects are considered relevant, they are not taken into account. Ethics committees are mostly dedicated to evaluate research protocols. The community is not mentioned as a relevant actor in decision making about resource allocation. CONCLUSIONS: Health service directors and all health care personnel should be trained in bioethics. These aspects should be incorporated to their daily work.

Adult↗