Ethical issues surrounding informed consent. Part I: a brief history and ethical foundations surrounding informed consent.
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In their commentary on the recent report on the ethics of managed care by the American Medical Association's (AMA) Council on Ethical and Judicial Affairs, Miles and Koepp offer two salient criticisms: For one thing, they fault the Council for not disclosing how intellectual, legal, and financial conflicts of interest may have influenced the Council's ethical opinions. Specifically, they point to the AMA's customary interest in preserving the fee-for-service system and in avoiding potential litigation that might arise from strictures imposed on rulings of the Council on Ethical and Judicial Affairs by the Federal Trade Commission (FTC). For another, Miles and Koepp decry the Council's focus on the ethical obligations of individual physicians to their own patients to the neglect of their obligations to the healthcare plan, the other patients in the plan, and to society at large. Specifically, they lament the lack of a well-developed ethic of distributive justice and collective governance suitable to the economic exigencies of allocating resources. In this commentary, I wish to examine more closely two issues raised by Miles and Koepp's critique. The first issue is the assumption that the existence of interests--and, therefore, the possibility of conflicts of interest--is relevant in assigning validity to the conclusions of an ethical deliberation and that full disclosure is helpful in determining that validity. The second issue is the proper ethical relationship that should obtain between the obligations of physicians, to their own patients with whom they have a covenant of trust, and the obligations they incur to a health plan or to society when they sign a contract as a participating physician. This is part of the more general question of the proper relationship between commutative and distributive justice when they are in conflict. A third issue, which neither Miles and Koepp nor I address is the ethical propriety or moral legitimacy of restraints imposed by the FTC on the ethical guidelines of a profession. Should the FTC's legal hegemony over competition overrule the integrity of professional ethics? Should it make any difference in the Council's ethical opinions? This is a subject for more extended treatment than I can give it here. Suffice it to say that the rulings of the FTC are legal, not ethical, rulings. As such, their validity must be subjected to the same critical examination as other ethical statements. The mere existence of an FTC ruling, its practical consequences notwithstanding, is no warrant for abandoning an ethical principle. This is particularly the case since the FTC has made the protection of competition its icon and endowed it with a quasi-ethical authority. My commentary is not an item-by-item apologia for the Council's report. I do agree with, and wish to defend, its emphasis on the primacy of the physician's obligation to his or her patient even in a managed-care system. But I also agree with Miles and Koepp that a fuller development of an ethic of distributive justice is in order. I suspect they would frame their ethic differently than would I. I do not agree with them, however, that disclosure of interests would help to judge the ethical validity of the Council's opinions, except in a limited way. Lest I be suspected of a conflict of interest, I must state at the outset that I had no part in drafting the Council's report and that I have no personal or intellectual commitment to fee-for-service per se. The report did cite a work of mine, however, and I do have an interest in clarifying its relevance to the issues in question.
BACKGROUND: In recent years there has been an increasing focus on human subject protection and on documentation of ethical review in published clinical research. The JAAD clearly states in its instructions to authors, which adhere to the guidelines set forth by the International Committee of Medical Journal Editors, "studies involving live human subjects must have been approved by the author's Institutional Review Board or its equivalent." OBJECTIVE: To determine what proportion of prospective studies on human subjects submitted to the clinical trials and therapeutics section lacked mention of review by an ethics board and to determine the outcome of these manuscripts. METHODS: We reviewed 150 prospective studies submitted from July 1, 2004 to January 16, 2006 to a single associate editor, who receives the majority of reports requiring ethics board review. RESULTS: Of 150 prospective studies, 36% (n = 54) had no mention of ethics review or consent, whereas 15% (n = 22) mentioned consent but not ethics review. Forty-two papers were returned asking for ethics information, and of these, 48% were resubmitted with confirmation of ethics review, 22% were withdrawn, 12% were never resubmitted, 12% responded that ethical review was not obtained, and 7% were clarified as exempt from review. Of the 150 papers, 45% were from US authors and 55% were from international authors. Sixty-seven percent of US papers and 35% of international papers included ethics board information (P <or= .001). Of the remaining authors who did not initially provide information on ethics review, 25% of US and 53% of international authors were able to provide documentation of ethics board review when asked. Of international authors asked for ethics information, 67% of European authors provided confirmation of ethical review, as compared with 48% of non-European authors. LIMITATIONS: It is not possible to know with certainty whether each study not citing ethics review actually did not undergo review by an ethics board. Additionally, other editors may have handled some studies requiring ethics review. CONCLUSIONS: One half of authors submitting papers on prospective clinical studies to the JAAD did not provide evidence of ethical review on initial submission. The reason for omission was likely oversight in half of the cases, but in others ethics review and approval were likely not obtained. International authors were more likely to omit mention of ethics review, but, although sample size was too small for statistical analysis, international authors were more often able to provide it when asked, suggesting oversight or misunderstanding as a reason for omission. Furthermore, ethics review may be more standard in the European Union, as European authors were more likely to be able to provide the information when asked, although small sample size precluded statistical analysis.
In medical ethics, business ethics, and some branches of political philosophy (multi-culturalism, issues of just allocation, and equitable distribution) the literature increasingly combines insights from ethics and the social sciences. Some authors in medical ethics even speak of a new phase in the history of ethics, hailing "empirical ethics" as a logical next step in the development of practical ethics after the turn to "applied ethics." The name empirical ethics is ill-chosen because of its associations with "descriptive ethics." Unlike descriptive ethics, however, empirical ethics aims to be both descriptive and normative. The first question on which I focus is what kind of empirical research is used by empirical ethics and for which purposes. I argue that the ultimate aim of all empirical ethics is to improve the context-sensitivity of ethics. The second question is whether empirical ethics is essentially connected with specific positions in meta-ethics. I show that in some kinds of meta-ethical theories, which I categorize as broad contextualist theories, there is an intrinsic need for connecting normative ethics with empirical social research. But context-sensitivity is a goal that can be aimed for from any meta-ethical position.
BACKGROUND: Changes in workplaces and work organizations represent a challenge for governments, social partners and occupational health professionals whose aim is to appropriately satisfy emerging requirements and needs. An increasing number of occupational health problems requires a high-quality standard practice supported by ethically consistent decisions. The ethical aspect of the practice is strictly linked to that of appropriateness, involving requirements of effectiveness, efficiency and respect of ethical principles of the individual, community and society. OBJECTIVES AND METHODS: The paper aims at focusing the ethical components of the quality of an occupational health program by taking a systematic approach to the ethical problems. The approach consists of a 2-step process. The first step consists of appraising the basic ethical principles of the dilemma ("to do good": to prevent or to remove evil and to do or to promote good; "not to do evil", implying not to inflict evil; to do no harm; autonomy implying respect of other's freedom and self-determination; justice implying equity, solidarity and non discrimination). The second step consists of detecting the stakeholders involved or interested in the decision. The alternatives are discussed according to the assessment of ethical costs (violating the consistentprinciple) and ethical benefits (fulfilment of the consistent principle) for the stakeholders. RESULTS: Systematic analysis of the ethical components of the dilemma according to ethical principles and their discussion within a framework involving different stakeholders makes it possible to recognise ethical costs and ethical benefits of the alternative decisions. The decisions may have different costs and benefits, which should be considered and weighed to take a proper decision. Although there is no certainty about the suitability of the decision, the assessment of the ethical components may be a valuable tool in decision-making based on the awareness that any ethical aspect has been considered. CONCLUSION: Occupational health professionals are requested to act with respect for general ethical principles and preferences of the individual, groups and setting. A high-quality practice will take into account the ethical content and the ethical conduct and any intervention will include analysis of ethical principles to compare alternative decisions and their consequences for the different stakeholders. This approach guarantees a practice based on, in addition to scientific evidence, the assessment of ethical costs and ethical benefits to favour decisions preventing conflicts.
BACKGROUND: Medical ethics is a required part of the curriculum in all medical schools in the United States, and an essential component of the educational guidelines for most postgraduate residency programs. Currently, general surgery does not specify ethics education in its essential curriculum for surgical training. This study was designed to determine the existing educational activities in ethics for residents in general surgery, as well as to characterize the attitudes of surgical educators about the role of ethics teaching in residency training. METHODS: An 80-item questionnaire was mailed to the program directors of all accredited general surgery residencies in the United States. They were requested to provide information about their teaching activities in ethics, their resources for ethics instruction, and their attitudes about the importance of education in clinical ethics for surgical residents. RESULTS: The survey had a 71% response rate with a representative distribution of programs based on size, geographic location, and community versus university affiliation. Fifty-six programs (28%) offered no formal ethics education, 94 (48%) held one teaching event in ethics, and 48 (24%) conducted two or more activities. The format for instruction in ethics included grand rounds (50%), resident conferences (41%), and ethics rounds (9%). Residencies with a faculty surgeon having expertise or special interest in ethics had a greater number of ethics teaching activities (P <0.05), whereas programs with a hospital ethicist were more likely to provide ethics rounds (P <0.01). A standardized curriculum in ethics was favored by 85% of respondents with critical content in end-of-life decisions, managing ethical conflict, and informed consent. The majority of program directors were opposed to (50%) or undecided (20%) about inclusion of ethics questions on the American Board of Surgery Inservice Training Examination (ABSITE) and Qualifying Examination in General Surgery. CONCLUSIONS: The majority of program directors of general surgery residencies support the teaching of clinical ethics and favor a standardized curriculum. However, most residencies in general surgery do not include ethics instruction as part of their on-going, regular educational schedule.
PURPOSE: The authors' primary goal was to provide a comprehensive and current review of the literature surrounding ethics education for medical students. Following this review, the authors summarize the deficits in the current literature and provide recommendations for future inquiries on medical ethics education. METHOD: In 2004, the authors searched MEDLINE and PubMed using the following search terms: ethics, ethics education, medical ethics education, curriculum, undergraduate medical education, virtue, role model, philosophy of medicine, and outcomes research. No limit was placed on dates for this literature search. Articles whose primary focus was professionalism were excluded because the professionalism literature tends to focus on competencies and postgraduate education, whereas the primary focus of this study was on undergraduate education. Literature on physicians as role models to medical students as a form of teaching medical ethical ethics was excluded as well because the current discussion examines the formal undergraduate medical ethics curricula. Also excluded were reports from foreign countries (unless there were no equivalent studies in the United States). The authors found almost no literature exploring students' backgrounds (cultural, religious, socioeconomic, etc.) and the teaching of medical ethics in medical schools. Otherwise, the authors reviewed everything they could find, regardless of imperfections in individual reports such as small sample size or poor research methodology. RESULTS: The review, which encompassed articles from 1978 to 2004, revealed that deep shortcomings exist in the literature on medical ethics education. Deficits exist in all areas of the literature: (1) theoretical work done on the overall goals of medical ethics education; (2) empirical studies that attempt to examine outcomes for students; (3) studies examining teaching methods in medical ethics education, and (4) studies evaluating the effectiveness of various teaching methods. CONCLUSIONS: There are substantial opportunities for contribution to the literature on medical ethics education in all of the areas where deficits exist. The literature suggests that two points of view exist regarding the purpose of teaching medical ethics: (1) that it is a means of creating virtuous physicians; and (2) that it is a means of providing physicians with a skill set for analyzing and resolving ethical dilemmas. This dichotomy made it difficult to arrive at a consensus regarding the goals of medical ethics education. The field would benefit from further theoretical work aimed at better delineating the core content, core processes, and core skills relevant to the ethical practice of medicine. The time has come to organize an effort to improve and validate medical ethics education. In the end, effective medical ethics education will further the goals of medicine in dramatic and tangible ways.
PURPOSE: Dental hygiene ethics is an essential component of the dental hygiene curriculum. The accreditation standards for dental hygiene education state that graduates must be competent in applying ethical concepts to the provision and/or support of oral health care services. Although the standards for entry into the profession of dental hygiene emphasize the importance of ethical reasoning, there is little published research specific to ethics instruction in dental hygiene programs. The purpose of this study was to assess how ethics is taught in the dental hygiene curriculum. METHODS: A 17-item survey was designed and distributed to 261 accredited dental hygiene programs in the United States for a response rate of 56% (N=147). The survey requested that participants provide information on teaching and evaluation methodologies, didactic and clinical hours of instruction, individuals responsible for providing instruction, and the degree of emphasis placed on ethics and integration of ethical reasoning within the dental hygiene curriculum. RESULTS: Results of the survey reflect that dental hygiene programs devote a mean of 20. hours to teaching dental hygiene ethics in the didactic component of the curriculum. With regard to the clinical component of the curriculum, 63% of respondents indicated that 10 or less hours are devoted to ethics instruction. These results show an increase in didactic hours of instruction from previous studies where the mean hours of instruction ranged from 7 to 11.7 hours. Results showed 64% of respondents offered a separate course in ethics; however, 82% of programs surveyed indicated that ethics was incorporated into one or more dental hygiene courses with 98% utilizing dental hygiene faculty to provide instruction. Most programs utilized a variety of instructional methods to teach ethics with the majority employing class discussion and lecture (99% and 97% respectively). The type of institution-technical college, community college, four-year university with a dental school, and four-year university without a dental school-had little influence on the degree of emphasis placed on teaching ethics. Although the number of hours devoted to ethics instruction has increased, 43% of respondents indicated that they would like to see more emphasis placed on ethics in the program with which they are affiliated. CONCLUSION: This study reveals that programs have taken measures to employ a variety of teaching strategies to ensure that students are competent in applying ethical concepts in the provision of oral health care. However, programs continue to rely primarily on traditional methods of instruction and evaluation such as lecture, discussion, quizzes, and written assignments. Inferential analysis focusing on the influence of the type of institution, showed that in general, the type of institution has little influence on the level of emphasis placed on teaching ethics in dental hygiene curricula. It is recommended that dental hygiene programs continue to implement and evaluate instructional methods that simulate real life experiences and emphasize ethical concepts that promote comprehensive oral health care. Future studies should investigate the effectiveness of ethics instruction within dental hygiene curricula.