title: Guidance for considering ethical, legal, and social issues in health technology assessment: application to genetic screening.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Department of Epidemiology and Community Medicine, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, Canada. bpotter@uottawa.ca
authors.forename: Beth K
authors.initials: BK
authors.lastname: Potter
authors.forename: Denise
authors.initials: D
authors.lastname: Avard
authors.forename: Ian D
authors.initials: ID
authors.lastname: Graham
authors.forename: Vikki A
authors.initials: VA
authors.lastname: Entwistle
authors.forename: Timothy A
authors.initials: TA
authors.lastname: Caulfield
authors.forename: Pranesh
authors.initials: P
authors.lastname: Chakraborty
authors.forename: Christine
authors.initials: C
authors.lastname: Kennedy
authors.forename: Marissa
authors.initials: M
authors.lastname: McGuire
authors.forename: Glenn G
authors.initials: GG
authors.lastname: Griener
authors.forename: Mark
authors.initials: M
authors.lastname: Montgomery
authors.forename: George A
authors.initials: GA
authors.lastname: Wells
authors.forename: Brenda J
authors.initials: BJ
authors.lastname: Wilson
mesh_terms: D005820:Genetic Testing / Q000941:ethics* / Q000331:legislation & jurisprudence*; D006291:Health Policy; D006801:Humans; D008403:Mass Screening / Q000941:ethics / Q000331:legislation & jurisprudence; D012931:Social Environment; D013673:Technology Assessment, Biomedical / Q000941:ethics* / Q000331:legislation & jurisprudence*