Current and future clinical trials for Alzheimer's disease: evolving ethical concerns.

1. An increase in the cases of Alzheimer's disease, primarily consequent to the rapid growth of the elderly population necessitates the enhanced pace of anti-dementia drug development and an increase in clinical trials. Clinical trials with persons with dementia, however, present with a number of ethical concerns that need to be anticipated and analyzed. 2. The present review first discusses some of the on-going and possible future experimental approaches to anti-dementia drug development. 3. Some of the ethical concerns raised by anti-dementia drug research with human subjects are then examined. A few preliminary recommendations for future directions are proposed. It is important to anticipate issues of ethical and social concern and establish forums for appropriate bioethical analysis.

Informed proxy consent: communication between pediatric surgeons and surrogates about surgery.

OBJECTIVE: Informed consent for surgical procedures requires that the procedures are explained and that the patient understands the procedures and risks and agrees to undergo them. Proxy consent occurs when an individual is provided with the legal right to make decisions on behalf of another. This study was conducted to determine how surgeons communicate information to obtain an informed proxy consent, and to investigate how that information is received and processed by surrogates responsible for providing such consent. STUDY DESIGN: Twenty English-speaking parents or legal guardians and 5 surgeons in an urban pediatric hospital were interviewed before, and 2 to 4 weeks after, the surgical procedure. In addition, the interview between the surgeon and surrogate, when consent was obtained, was audiotaped and subsequently analyzed. Semistructured interviews were used to elicit the motivations and influences on the surrogates to consent to the procedure. The same methodology was used to elicit the corresponding impressions of the surgeons. The data were analyzed using descriptive statistics and crosstabulations. RESULTS: Demographic data did not influence the results. Although there was concordance between the surrogate's understanding of the procedure and the surgeon's impression of this understanding, only 3 of 17 surrogates could recall any specifics of the explained procedure. Contrary to the stated belief of surgeons, surrogates consulted with a variety of others, including medical and paramedical professionals, family members, and spiritual leaders. CONCLUSIONS: Communication plays an important role within the surrogate-surgeon dyad. Psychologic variables such as expectations, and the perception of both the surrogates and the surgeons, influence the amount of information that is proffered and the manner in which it is received. Improved communication may be achieved by use of visual aids, discussion of anesthesia and the postoperative course, recognition of the circumstances around the discussion, such as timing and location of the discussion, and personalization of the discussion.

Apolipoprotein E genotyping for pharmacogenetic purposes in Alzheimer's disease: emerging ethical issues.

OBJECTIVE: To present some of the ethical concerns pertaining to the anticipated use of apolipoprotein E genotyping in selecting therapy in Alzheimer's disease. METHOD: We review studies that support the utility of apolipoprotein E (APO E) genotyping for predicting drug responsiveness along with the published consensus statements and position papers related to APO E genotyping. Ethical issues pertaining to the use of APO E genotyping for pharmacogenetic purposes have not yet been fully explored, and these are discussed. RESULTS: This paper explores the bioethics surrounding the use of APO E genotyping for pharmacogenetic purposes. The rapidly increasing pace of clinical trials in Alzheimer's disease necessitates a critical examination of the evolving ethical issues. A framework for establishing guidelines is suggested. CONCLUSIONS: Clinical research trials for Alzheimer's disease with a genotyping component will increasingly be influenced by and benefit from a serious analysis of the ethics emerging alongside the scientific and clinical advances.

The attitude of Canadian nurses towards advance directives.

This article seeks to shed light on the beliefs that influence nurses' intention of respecting or not respecting an advance directive document, namely a living will or a durable power of attorney. Nurses' beliefs were measured using a 44-statement questionnaire. The sample was made up of 306 nurses working either in a long-term care centre or in a hospital centre offering general and specialized care in the province of Québec. The results indicate that nurses have a strong intention of complying with advance directives written by patients. The analysis also shows that four variables determine the strength of this intention: respect for autonomy; the location of the workplace; justice; and the dimension of relationships and emotions. Although these documents favour the expression of patients' wishes, nurses should be aware that they do not systematically guarantee respect of a patient's autonomy, nor do they replace a relationship based on trust between patients and health care professionals.

Comparison of patients' and health care professionals' attitudes towards advance directives.

OBJECTIVES: This study was designed to identify and compare the attitudes of patients and health care professionals towards advance directives. Advance directives promote recognition of the patient's autonomy, letting the individual exercise a certain measure of control over life-sustaining care and treatment in the eventuality of becoming incompetent. DESIGN: Attitudes to advance directives were evaluated using a 44-item self-reported questionnaire. It yields an overall score as well as five factor scores: autonomy, beneficence, justice, external norms, and the affective dimension. SETTING: Health care institutions in the province of Québec, Canada. SURVEY SAMPLE: The sampling consisted of 921 subjects: 123 patients, 167 physicians, 340 nurses and 291 administrators of health care institutions. RESULTS: Although the general attitude of each population was favourable to the expression of autonomy, multivariate analysis of variance (MANOVA) indicated that physicians attached less importance to this subscale than did other populations (p < .001). Above all, they favoured legal external norms and beneficence. Physicians and administrators also attached less importance to the affective dimension than did patients and nurses. Specifically, physicians' attitudes towards advance directives were shown to be less positive than patients' attitudes. CONCLUSION: More attention should be given to the importance of adequately informing patients about advance directives because they may not represent an adequate means for patients to assert their autonomy.

Consent to treatment--the principles, the provincial statutes and the Charter of Rights and Freedoms.

The author summarizes current law and trends affecting the right of psychiatric patients to refuse or consent to treatment. The discussion addresses the key principles involved: autonomy and inviolability of the person. Relevant provincial mental health legislation in effect at the time of writing is briefly reviewed. Finally, the possible impact of the new Canadian Charter of Rights and Freedoms is discussed.

Doing ethics and reforming health law--a Canadian experience.

KIE: A brief description of the Law Reform Commission of Canada and its health law project is followed by a general discussion of the challenges facing a national commission concerned with the reform of health policy and law. Drawing on his experience as coordinator of the Law Commission's Protection of Life Project, the author considers basic questions about the nature, composition, responsibilities, and mode of operation of such a commission.^ieng