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PubMed1998

[The structure of meta-ethical reasoning and "paradigmatic instability" of medicine].

Meta-ethics is such a philosophical discipline that it analyses meaning and logical status of moral conceptions and arguments. Its scope of interest is focused on such problems, among others, as to what extent are moral values the intrinsic part of our reality and, on the other hand, to what extent are they merely the expression or certain conventions, emotions or directives. Codes of medical ethics and other legal acts concerning ethical commitments, both domestic and international (as, for example, Declaration of Helsinki), are based on a certain hidden meta-ethical presumption that morality is a human creation, and thus it belongs to a certain so-called "social realm". As such, medical ethics undergoes continuous transformations with regard to technological progress, which creates new moral challenges. This frequently leads to conflicts between moral, legal and praxiological norms under the absence of consensual conformity of utilitarian and deontological ways of moral reasoning. It may be useful for medical ethics to differentiate between axiological and thetic norms that are present in codes of medical ethics and in various international bioethical declarations and conventions.

Ethics, Medical↗
PubMed2000

[Controversies over the surgical placebo: legal issues and the ethical debate].

The debate on controlled surgery trials has had some rather "sensational" repercussions, enlivening the placebo issue. In France, there is a consensus on the ethical conditions necessary for proper protection of individual persons. This consensus has taken on a legal form with the promulgation of the Huriet law. For this reason, all studies and research protocols in medicine and surgery are examined by ethics committees (CCPPRB) who assess the inclusion conditions within the framework of biomedical research and in compliance with the concept that individual participants must be give proper protection. These committees are faced with increasingly complex situations, particularly concerning the pertinence of information give to the participant and the modalities of consent. In France, standard measures were established after a parliamentary debate issuing from a wider public debate. The issue has become a social transaction between biomedical research professionals and the society in general. The international debate over the surgery placebo is an interesting illustration of how mediation institutions, working along the principles of ethical committees, play a key role in social awareness of the ethical issues involved before an innovating practice is initiated. But how legitimate are sensational pieces published in the media, which as is clearly demonstrated with the debate over the surgical placebo, are almost always individual points of view? Shouldn't the debate take into account the contributions of ethical committees which integrate representatives of the social community as well as the importance of a legal framework for individual protection as proposed by the French law? Shouldn't personal points of view be counterbalanced by regularly expressed ethical committee opinions formed after appropriate ethics-oriented discussion going beyond the simple question of "should we do it", a question often dismissed by extreme theoretical arguments that leave unanswered the practical question of "how should we do it"?

Controlled Clinical Trials as Topic↗
PubMed2000

Arguing for a dynamic quality in professional codes of ethics.

Many professional organizations and healthcare institutions have developed codes of ethics for a number of reasons. Unlike legal mandates, codes of ethics provide professionals with a framework for ethical behavior within their specific discipline. Professionals today face challenges because the necessary ethical debates cannot keep pace with the rapidly changing environment in which ethical dilemmas quickly emerge. This article describes components of codes of ethics, outlines the evolving nature of ethics, and argues for a dynamic quality in these codes as a way to provide timely, sensitive guidance for professional practice.

American Nurses' Association↗
PubMed2001

[Scientific ethics and frozen embryos].

BACKGROUND: Scientific Ethics is the theory and praxis of decisions. Philosophical Ethics is presented as the theory and praxis of the good. As the good differs among cultures, Philosophical Ethics is dependent on the endo-cultural good conception. The decision (included that one of adhesion or not to a world vision) depends on neuro-psychic specific factors: i) cognitive factors that include mostly the knowledge of the alternatives and their consequences and the ideological or religious conception of good in relation to the alternatives; ii) affective factors that make alternatives pleasant, unpleasant or neutral, attractive, repulsive or neutral; iii) emotional factors that associate to alternatives anger, peace or neutrality, sadness, happiness or neutrality; iv) value factors that assign importance, triviality or neutrality to alternatives, or assign them significance, irrelevancy or neutrality. There are unspecific factors such as the psychic energy, desire or others. Mixed factors such as attitude, motivation, intention and others. Scientific Ethics deals with the mind as a materio-energetic process which is different from the soul, eggs and embryos of any species are full individuals of that species, because, they have initiated a copy of their genome that specify, give autonomy and define them as individuals. For Scientific Ethics to leave frozen embryos like that for ever, to defrost and get rid of them or to use their cells for science are synonymous of killing them. To defrost them to use their cells as stem cells for somatic cell therapy or to implant them into uteri to continue their development is to maintain alive their cells, but only the implantation allows their maintenance as individuals, thus, being the only compatible with the Christian ethics. The compatibility of these alternatives with other ethics is discussed.

Cryopreservation↗
PubMed2001

Research ethics committee: getting started.

Unanticipated questions arose when starting an institutional research ethics committee in Grenada. Research ethics committees are charged with the ethical review of research protocols. They serve to protect people who volunteer as research subjects from harm or wrong that may result from participating in research. The Caribbean has a rich history of medical research involving human subjects. There is a growing will in the region to establish effective and sustainable research ethics committees that adhere to international standards. This paper examines uncertainties and questions that arose in starting a research ethics committee in Grenada, and describes how uncertainties were resolved. The questions centre on which guidelines to follow, who to appoint as members, what procedures to follow, and how to train members. An additional question relates to the role of a Ministry of Health in founding a research ethics committee. Resolution of these uncertainties shows that ethical review of research can be both effective and sustainable in the Caribbean.

Clinical Protocols↗
PubMed2002

The establishment of a hospital clinical ethics committee.

In the Republic of Ireland the establishment of Clinical Ethics Committees (CECs) are relatively new. The need for such committees has occurred due to the fact that the consideration of ethical issues in healthcare has become an important and frequent part of discussions by individuals and institutions. A number of factors have contributed to this growth of ethical considerations. The Bon Secours Health System (BSHS) decided to establish a CEC and appointed a co-ordinating team to draw up terms of reference for such a committee. During this process the co-ordinating team drew on the experience of other countries and of its own staff. Potential criticisms of how such a committee would function were examined. A representative membership of the CEC was also arrived at. The following functions were identified for a CEC: the need to provide a mechanism for the identification, discussion and resolution of medical ethical issues; the need to identify medical ethical issues which may create challenges to the health system and to monitor the responses of the health system to these areas, and the provision of education. Policy development was seen as a primary function of the CEC. Ethical case review also emerged as one area of potential involvement by the CEC. During the staff consultation a large number of ethical issues emerged which the staff requested the CEC to address. A methodology necessary for coping with the differences within the BSHS was developed by the CEC. It is evident that CECs are here to stay and how they develop and function will have an impact on the quality of healthcare.

Ethics Committees, Clinical↗
PubMed2002

[Recent topics on ethical issues in psychiatry, mental care and welfare].

This lecture focuses on several ethical issues on psychiatry research and psychiatric practice. The most important issue in ethics is informed consent in both the national guidelines on ethics in genomic study and epidemiological studies determined by the Ministry of Health, Welfare and Labor, Ministry of Education, Culture, Sports, Science and Technology and Ministry of Economy, Trade and Industry. They recommend researchers to obtain consent from subjects making free voluntary decisions after they are fully provided with the necessary information and explanation. The guidelines on ethics in genomic study strongly recommend organizing an ethical committee committed by several extramural members from the fields of law, social or human sciences. On the other hand, the guidelines on ethics in epidemiological study provide how to obtain informed consent in detail according to how projects are carried out. Strict requirements of informed consent tend to inhibit medical research conduct, in particular a research on post-mortem brain, which is one of the important research areas for elucidation of pathogenesis and pathophysiology of mental disorders. Recently a new trend to organize a brain bank by donation of the patient who has given consent before death. This is a proper way to collect post-mortem brain overcoming the ethical problems and it is our hope that this trend will develop in our country. Disclosure of medical records to patients is one of the most recent and debated issues in psychiatric practices. In 1999, the Ministry of Health and Welfare started investigations on whether medical records should be disclosed to patients. The report of the committee strongly recommends accelerating the disclosure of medical records. Responding to this report, several medical organizations issued a guideline. Recently, we carried out a questionnaire survey on the disclosure rate of medical records in the psychiatric departments of both medical school hospitals and national mental hospitals, where special committees have been organized to determine the disclosure of the medical records when a patient demands it officially. Contrary to our expectation the rate of disclosure demands was very low in both medical schools and national mental hospitals. The average number was only less than one case in medical schools, and less than 0.5 cases in national mental hospitals. It was speculated that patient requests demanding the disclosure of the records are mostly managed by the doctor in charge without consulting the special committee. Looking back the process of debate on the disclosure of medical records, several important issues, such as notice of diagnosis, informed consent, management of records, standardization of medical records, financial support to establish management system of medical records and so on, remain to be further examined thoroughly.

Confidentiality↗
PubMed2006

[Encouragement and training of ethical competence in geriatric nursing. A pre-condition of high quality in professional caring process].

The article makes a case for the necessity of more intensive training in the ethics of geriatric care. It confronts the bias against too much ethical behaviour in daily practice, while also arguing for the liberating and enriching aspects of giving ethical care to the aged. Based on a differentiation between morals and ethics, the essay recognizes the endeavors to achieve moral behaviour in geriatric care, but questions whether in every case the caregivers have sufficient ethical core competence to determine either the appropriateness or the righteousness of their moral actions. The essay discusses what should be understood under "ethical competence" and how ethical competence can be acquired and advanced by schooling.

Clinical Competence↗
PubMed1991

Opinion survey of physicians on ethical issues in medical research.

A total of 3622 physicians registered in the Association of Physicians of India were contacted through mail and requested to respond to a semistructured questionnaire pertaining to different aspects of medical ethics, with particular focus on informed consent. Six hundred twenty-nine physicians (17.4%) responded to the questionnaire; 86% of the respondents reported having had no formal training in medical ethics; 49% of the subjects who undertook research obtained oral consent only. Majority of the respondents noted the relevance of ethics in different medical situations, though in certain areas like community health and research using animals ethical issues were felt to be less important. Patients' inability to come for regular follow-up and illiteracy were opined to be the main constraints in obtaining consent. Opinion on the amount of information to be imported to research participants as part of informed consent was at variance with standard guidelines. Physicians who reported having had an orientation course in medical ethics and those with prior research experience were more aware of ethical issues. Majority of the professionals desired for inclusion of ethics in medical curriculum.

Attitude of Health Personnel↗
PubMedDate not supplied

[Language and ethics].

The author proposes the hypothesis that there exists an essential link between language and ethics, beyond the obvious fact that the postulates of ethics have to be expressed in a verbal way. He chooses two ways for demonstrating his hypothesis: a phenomenological description of the substantive element of language, which is the word, and then an analysis of both the philo- and the ontogenetic origin of ethical experience. Making evident the essential characteristics of language, among which it is appropriate to outline its capacity to give existence to things (as it is deduced from the analysis of some poetic texts), the author gets to unveil its deep ethic sense in the religious word: gods show themselves through the revealed word, and men address to them with their prayers. Gods give norms that imitate afterwards. The second way allows the author to demonstrate that the step from nature to culture is done through the norm, and this is basically verbal; but at the same time it is possible to demonstrate how the word is found in the base of the individual ethical experience, in that very particular phenomenon that is the voice of the conscience. In short, language is in its essence ethical, and the ethical experience is indissolubly bound to the verb.

Ethics↗
PubMedDate not supplied

Teaching ethics to nursing students.

Ethical practice is the responsibility of all nurses. But if they are to understand the principles of ethics and carry them out in their work, nursing curricula must incorporate ethics into course content. Such content requires faculty who understand both ethical theories and their application to nursing. Appropriate methods of evaluating student learning are also needed. The growing complexity of our health care system demands that nurses assume increasing responsibility for ethical decision making. We can no longer ignore the link between ethics and nursing. Ethics education for nurses is mandatory, not elective.

Curriculum↗
PubMed1981

[Ethical questions in trials in humans as seen by the biometrician (author's transl)].

Ethical questions in trials in humans are particularly urgent today for many reasons. Basic concepts and recognized ethical requirements are presented. The role of medical statistics and planning of trials for ethical questions is discussed with the example of estimation of case numbers. Human suffering is kept as low as possible, the framework of thought for sophisticated ethical questions is first prepared by calculation, statistics contribute to the objectivation of facts and the obtaining of consent and open up new ethical problems. A check-list of questions that should be raised in a trial on humans and a compilation of the ethical problems to be expected nowadays are given. Theses on the ethics of human trials close the paper.

Biometry↗
PubMed1994

[Medical research and the ethics committee. A questionnaire study among project leaders in the health region 4].

All 159 principal investigators whose projects had been assessed by the biomedical research ethics committee in Health Region 4 (Central Norway) during 1986-92 were asked to complete a questionnaire about medical research ethics and the work of the ethics committee. Their answers about scientific fraud and misconduct have been published previously. This paper reports how the 119 respondents (70% of those addressed) regard the role and work of the ethics committees and how they perceived the committee's assessment of their own project. A majority agreed that medical ethics committees are an important part of the scientific community (90%), that scientific quality is an important ethical element of any project (85%), and that researchers put more effort into their study protocol as they knew it would be assessed by an ethics committee (85%). More than 70% agreed that the committee's comments were useful and relevant, but a majority of these agreed only partly. The results are discussed in relation to the characteristics of the investigators.

Attitude of Health Personnel↗
PubMed1993

Education in medical ethics.

Since ethics is an integral part of practice of medicine, its study should parallel that of study of medicine. It should proceed in an orderly fashion from undergraduate into postgraduate study, starting with an understanding of principal moral values governing medical ethics. It should subsequently develop awareness of frequent existence of ethical issues and dilemmas, help develop the capacity for resolution of these issues through ethical reasoning, and acquire understanding of the function of institutional bodies concerned with ethics. Clinical real life situations and case studies should be extensively used as an educational tool. The exact design of the curriculum may vary to reflect the medical curriculum of a particular institution, but common objectives to all systems must be to achieve familiarity with moral values underlying the practice of medicine and with methodology of ethical reasoning. Some form of examination and evaluation of the course should be a standard feature of all teaching programs of medical ethics.

Curriculum↗
PubMedDate not supplied

[Ethical principles of medical research using human subjects].

Medical research involving human beings has contributed to the advancement of knowledge about prevention, diagnosis, and treatment of the diseases. All researchers, independently of their working country, must always have in mind the international ethical principles as a guide in the solution for the ethical problems that they may face during the practice of research activities on human beings. Among the ethical principles more widely accepted in the western culture, three are of upstanding importance for clinical research in human subjects: a) the principle of respect for persons, based upon the conception of the individual as an autonomous being, capable of shaping and directing his own life; b) the principle of beneficence, that refers to the ethical obligation to maximize benefits and to minimize harms and wrongs; and c) the principle of justice, that refers to the ethical imperative to treat each person in accordance with what is morally right and proper. The application of these theoretical principles to the real life problems is not easy, especially in cases in which the research group belong to a developed country, and the group of participating subjects, to an underdeveloped one. It is worthy to ask if the three mentioned ethical principles are universally acknowledged, and whether in the Latin American and Caribbean region, these principles are recognized as the gold rules for the solution of the ethical problems of medical research involving human subjects.

Caribbean Region↗
PubMed1997

Implications of socio-cultural contexts for the ethics of clinical trials.

BACKGROUND: Health technology assesment (HTA) requires scientifically rigorous experimentation involving patients as subjects. HTA itself is required so that treatment given to patients will be both effective and efficient; this requirement is itself ethical in nature. At the same time it is essential that the methods used in HTA are ethically sound. Most healthcare researchers agree that the most effective and soundest method for assessing treatments is the randomised controlled trial (RCT). However, some researchers believe that the RCT is unethical, either in essence, or for use in some forms of medical research and HTA. Furthermore, many patients seem unable to understand the principles and purposes of the RCT, a factor which is highly detrimental for the validity of informed consent. Informed consent is the key to the ethics of medical research, both in most theories and in all codes of research conduct. Many RCTs therefore risk being unethical in practice, even if ethical in principle. AIM OF REPORT: To survey the main objections to the RCT and its alternatives. To assess the philosophical and methodological basis of these objections, and of the methods recommended for addressing them. To identify areas where objections are founded in social or cultural factors normally overlooked in ethical argument about the RCT methodology. To identify alternative arguments or methods which might resolve ethical conflicts in this area. HOW THE RESEARCH WAS CONDUCTED: The methods used were adapted from systematic reviews in medicine. Systematic searches of Medline, Psychlit and Sociofile CD-ROM databases; hand-searches of the major journals in general medicine and surgery, medical ethics and philosophy; and searches of books were carried out. The literature survey was restricted to articles published or abstracted in English. A database of the most relevant and useful materials was compiled, and is accessible on the Internet (http://www.liv.ac.uk/sdthomps/page1.html). RESEARCH FINDINGS: UNDERSTANDING RCTS AND THEIR ALTERNATIVES: There is some evidence of difficulty in understanding the aims and methods of RCTs, and some disquiet about elements of the RCT methodologies. These objections are well known and much discussed, and concern the use of placebo, the continuation of trials after significant differentials in benefit or harm are apparent, and randomisation. CULTURAL OR RELIGIOUS OBJECTIONS: There was an absence of evidence of cultural or religious objections to randomisation, placebo or other kinds of controlled prospective trials. This most likely reflects an absence of research rather than absence of objections. (ABSTRACT TRUNCATED)

Cultural Diversity↗
PubMed1998

[Current aspects and problems relating to medical ethics in oncology].

A case history of a breast cancer patient is used to exemplify ethical dilemmas in medical oncology: information of a cancer patient and his family, ethical problems with genetic testing, ethical issues with do-not-resuscitate-orders, ethical dilemmas with limited resources, problems with insurance companies, ethical issues in clinical trials and questions in dying patients including physician-assisted suicide and active euthanasia. Medical oncologists have to develop skills in recognizing ethical dilemmas in patient care and must prepare to cope with the many and complex ethical issues in the care of oncology patients.

Breast Neoplasms↗
PubMed1992

Clinical ethics consultations: reasons for optimism, but problems exist.

[The author identifies] five problems familiar to clinical ethicists. (1) Physicians often do not recognize important ethical issues. (2) Debate exists over whether such consultations should give specific management recommendations. (3) Principles of medical ethics cannot, by themselves, resolve real ethical issues. (4) The patient's interests sometimes conflict with the interests of the family, the health professionals, and the hospital. (5) Clinical ethics consultations take a toll on the consultant....[He] discuss[es] the implications of each problem for clinical ethics consultations and offer[s] a solution to it.

Aged↗