Ethics expertise for health technology assessment: a Canadian national survey.

OBJECTIVES: The aim of this study was to identify individuals with expertise in ethics analysis in Canada, who might contribute to health technology assessment (HTA); to gauge these individuals' familiarity with, and experience participating in, the production of HTA. METHODS: A contact list was developed using the Canadian Bioethics Society membership list and faculty listings of Canadian universities, bioethics centers, and health agencies. An eighteen-question email survey was distributed to potential respondents to collect data on demographic information, education and work experience in applied ethics, and involvement in HTA. RESULTS: The survey response rate was 52.8 percent (350/663). Respondents worked primarily in academic institutions (50.4 percent) or hospitals (15.4 percent). Many respondents (83.1 percent) had education, formal training, or work-related experience in practical ethics related to health care, with many having a doctorate (34.5 percent) or master's degree (19.0 percent). One quarter (24.5 percent; n = 87) of respondents indicated they had been involved in an analysis of ethical issues for HTA. Almost two-thirds (65.4 percent; n = 165) of those who had not previously participated in ethics analysis believed they might usefully contribute to an analysis of ethical issues in HTA. Experts who have conducted ethics analysis in HTA had more than twice the odds of having education and training in ethics and a PhD than those who might contribute to ethics analysis. CONCLUSION: Many people have contributed to ethics analysis in HTA in Canada, and more are willing to do so. Given the absence of a reliable credential for ethics expertise, HTA producers should exercise caution when enlisting ethics experts.

The ethics of dietary supplements and natural health products in pharmacy practice: a systematic documentary analysis.

OBJECTIVES: Many natural health products and dietary supplements are purchased in pharmacies and it has been argued that pharmacists are in the best position to provide patients with evidence-based information about them. This study was designed to identify how the pharmacist's role with respect to natural health products and dietary supplements is portrayed in the literature. METHOD: A systematic search was conducted in a variety of health databases to identify all literature that pertained to both pharmacy and natural health products and dietary supplements. Of the 786 articles identified, 665 were broad-coded and 259 were subjected to in-depth qualitative content analysis for emergent themes. KEY FINDINGS: Overwhelmingly, support for the sale of natural health products and dietary supplements in pharmacies is strong. Additionally, a role for pharmacist counselling is underscored. But another recurrent theme is that pharmacists are ill-equipped to counsel patients about these products that are available on their shelves. This situation has led some to question the ethics of pharmacists selling natural health products and dietary supplements and to highlight the existence of an ethical conflict stemming from the profit-motive associated with sales of natural health products and dietary supplements. CONCLUSIONS: This analysis raises concerns about the ethics of natural health products and dietary supplements being sold in pharmacies, and about pharmacists being expected to provide counselling about products of which they have little knowledge.

Guidance for considering ethical, legal, and social issues in health technology assessment: application to genetic screening.

OBJECTIVES AND METHODS: Many authors have argued that ethical, legal, and social issues ("ELSIs") should be explicitly integrated into health technology assessment (HTA), yet doing so poses challenges. This discussion may be particularly salient for technologies viewed as ethically complex, such as genetic screening. Here we provide a brief overview of contemporary discussions of the issues from the HTA literature. We then describe key existing policy evaluation frameworks in the fields of disease screening and public health genomics. Finally, we map the insights from the HTA literature to the policy evaluation frameworks, with discussion of the implications for HTA in genetic screening. RESULTS AND CONCLUSIONS: A critical discussion in the HTA literature considers the definition of ELSIs in HTA, highlighting the importance of thinking beyond ELSIs as impacts of technology. Existing HTA guidance on integrating ELSIs relates to three broad approaches: literature synthesis, involvement of experts, and consideration of stakeholder values. The thirteen key policy evaluation frameworks relating to disease screening and public health genomics identified a range of ELSIs relevant to genetic screening. Beyond straightforward impacts of screening, these ELSIs require consideration of factors such as the social and political context surrounding policy decisions. The three broad approaches to addressing ELSIs described above are apparent in the screening/genomics literatures. In integrating these findings we suggest that the method chosen for addressing ELSIs in HTA for genetic screening may determine which ELSIs are prioritized; and that an important challenge is the lack of guidance for evaluating such methods.

Exploring consumer and pharmacist views on the professional role of the pharmacist with respect to natural health products: a study of focus groups.

BACKGROUND: Natural health products (NHPs) such as herbs, vitamins and homeopathic medicines, are currently available for sale in most Canadian pharmacies. However, most pharmacists report that they have limited knowledge about these products which have been regulated in Canada as a specific sub-category of drugs. In this paper, consumers' and practicing pharmacists' perceptions of pharmacists' professional responsibilities with respect to NHPs are examined. METHODS: A total of 16 focus groups were conducted with consumers (n = 50) and pharmacists (n = 47) from four different cities across Canada (Vancouver, Edmonton, Toronto, and Halifax). RESULTS: In this paper, we illustrate the ways in which pharmacists' professional responsibilities are impacted by changing consumer needs. Many consumers in the study utilized a wide range of information resources that may or may not have included pharmacists. Nevertheless, the majority of consumers and pharmacists agreed that pharmacists should be knowledgeable about NHPs and felt that pharmacists should be able to manage drug-NHPs interactions as well as identify and evaluate the variety of information available to help consumers make informed decisions. CONCLUSION: This paper demonstrates that consumers' expectations and behaviour significantly impact pharmacists' perceptions of their professional responsibilities with respect to NHPs.

Stem cell research ethics: consensus statement on emerging issues.

This article is a consensus statement by an international interdisciplinary group of academic experts and Canadian policy-makers on emerging ethical, legal and social issues in human embryonic stem cells (hESC) research in Canada. The process of researching consensus included consultations with key stakeholders in hESC research (regulations, stem cell researchers, and research ethics experts), preparation and distribution of background papers, and an international workshop held in Montreal in February 2007 to discuss the papers and debate recommendations. The recommendations provided in the consensus statement focus on issues of immediate relevance to Canadian policy-makers, including informed consent to hESC research, the use of fresh embryos in research, management of conflicts of interest, and the relevance of public opinion research to policy-making.

Patient advocacy and professional associations: individual and collective responsibilities.

Professions have traditionally treated advocacy as a collective duty, best assigned to professional associations to perform. In North American nursing, advocacy for issues affecting identifiable patients is assigned instead to their nurses. We argue that nursing associations' withdrawal from advocacy for patient care issues is detrimental to nurses and patients alike. Most nurses work in large institutions whose internal policies they cannot influence. When these create obstacles to good care, the inability of nurses to affect change can result in avoidable distress for them and for their patients. We illustrate this point with a case study: the circumstances of the death of Michael Joseph LeBlanc, an inmate at Kingston Penitentiary Regional Hospital (Ontario). We conclude that patient and their nurses will suffer unnecessarily unless or until nursing associations cease to burden individual nurses with the responsibility for patient advocacy.

Conflict of interest in clinical research: direct payment to the investigators for finding human subjects and health information.

The recent death of teenager Jesse Gelsinger in a drug therapy trial has drawn attention to how financial conflicts of interest may compromise patient protection. While research institutions throughout the world have instituted a variety of conflict of interest guidelines, the potential conflicts associated with investigators receiving direct payment from private companies for both the recruitment of patients and the running of clinical trials in pharmaceutical research remains a relatively unexplored area. Clinical researchers undoubtedly deserve to be reasonably compensated for their participation. But these incentive mechanisms also have the potential to create conflicts of interest--both real and perceived.