Tackling ethical issues in health technology assessment: a proposed framework.

OBJECTIVES: Values are intrinsic to the use of health technology assessments (HTAs) in health policy, but neglecting value assumptions in HTA makes their results appear more robust or normatively neutral than may be the case. Results of a 2003 survey by the International Network of Agencies for Health Technology Assessment (INAHTA) revealed the existence of disparate methods for making values and ethical issues explicit when conducting HTA. METHODS: An Ethics Working Group, with representation from sixteen agencies, was established to develop a framework for addressing ethical issues in HTA. Using an iterative approach, with email exchanges and face-to-face workshops, a report on Handling Ethical Issues was produced. RESULTS: This study describes the development process and the agreed upon framework for reflexive ethical analysis that aims to uncover and explore the ethical implications of technologies through an integrated, context-sensitive approach and situates the proposed framework within previous work in the development of ethics analysis in HTA. CONCLUSIONS: It is important that methodological approaches to address ethical reflection in HTA be integrative and context sensitive. The question-based approach described and recommended here is meant to elicit this type of reflection in a way that can be used by HTA agencies. The questions proposed are considered only as a starting point for handling ethics issues, but their use would represent a significant improvement over much of the existing practice.

Nicotine addiction through a neurogenomic prism: ethics, public health, and smoking.

Studies are under way to examine the neurogenetic factors contributing to smoking behaviors. The combined approaches of genomics, molecular biology, neuroscience, and pharmacology are expected to fuel developments in pharmacogenetics, to create new genetic tests, and ultimately to provide the basis for innovative strategies for smoking cessation and prevention. The emergence of a neurogenomic understanding of nicotine addiction is likely to induce fundamental changes in popular, clinical, and public health views of smoking, which could significantly shape existing practices and policies to reduce tobacco use. Still a nascent area of research, nicotine addiction provides an excellent case study through which to anticipate key ethical and policy issues in both behavioral genetics and the neurogenomics of addictive behaviors.

Environmental and genetic determinants of tobacco use: methodology for a multidisciplinary, longitudinal family-based investigation.

This article describes the ongoing collaborative effort of six research teams to operationalize and execute an integrative approach to the study of gene x environment interactions in the development of tobacco dependence. At the core of the project is a longitudinal investigation of social and behavioral risk factors for tobacco use in individuals who were, on average, 13 years of age at intake and for whom smoking outcomes extending from early adolescence to young adulthood have been characterized previously (current average age of the cohort is 29 years). The conceptual framework for the integrative approach and the longitudinal investigation on which the study is based is presented. A description is also provided of the methods used to: (a) recruit participants and families to provide DNA samples and information on tobacco use; (b) assess participants for relevant tobacco-related phenotypes including smoking history, current use of tobacco, and nicotine metabolism; (c) assess the quality of the DNA samples collected from participants for genome-wide scanning and candidate gene analysis; (d) examine several research questions concerning the role of genetic and environmental factors in the onset and maintenance of tobacco use; and (e) ensure adherence to local and federal guidelines for ethical and legal investigations of genotypic associations with tobacco-related phenotypes in families. This investigation is unique among ongoing studies of the genetics of tobacco dependence in the extent to which equal importance has been assigned to both phenotypic and genotypic measurements.