International Journal of Technology Assessment in Health Care

GENERAL ESSAYS

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

Beth K. Pottera1, Denise Avarda2, Ian D. Grahama3, Vikki A. Entwistlea4, Timothy A. Caulfielda5, Pranesh Chakrabortya6, Christine Kennedya7, Marissa McGuirea8, Glenn G. Grienera9, Mark Montgomerya10, George A. Wellsa11 and Brenda J. Wilsona12

a1 University of Ottawa

a2 University of Montreal

a3 University of Ottawa and Canadian Institutes of Health Research

a4 University of Dundee

a5 University of Alberta

a6 University of Ottawa and Children's Hospital of Eastern Ontario

a7 University of Calgary

a8 University of Ottawa

a9 University of Alberta

a10 University of Calgary and Alberta Children's Hospital

a11 University of Ottawa and University of Ottawa Heart Institute

a12 University of Ottawa

Abstract

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.

Footnotes

This project was funded by the Canadian Institutes of Health Research (CIHR) through an operating grant (principal investigators, B.J.W. and D.A.) and a post-doctoral fellowship (B.K.P.). We gratefully acknowledge the assistance of Jennifer Brault in helping to compile some of the information for the report. We are grateful to individuals from several organizations who verified the accuracy of table entries for particular policy frameworks; the authors take full responsibility for any errors in the final manuscript. Finally, we thank Scott Grosse and Linda Bradley for their comments on an earlier draft of this paper.