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Rethinking Ethics Assessment in Health Technology Assessment: a Nonlinear Approach Aimee Zellers

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Rethinking Ethics Assessment in Health Technology Assessment: a Nonlinear Approach Aimee Zellers Duquesne University Duquesne Scholarship Collection Electronic Theses and Dissertations Spring 2015 Rethinking Ethics Assessment in Health Technology Assessment: A Nonlinear Approach Aimee Zellers Follow this and additional works at: https://dsc.duq.edu/etd Recommended Citation Zellers, A. (2015). Rethinking Ethics Assessment in Health Technology Assessment: A Nonlinear Approach (Doctoral dissertation, Duquesne University). Retrieved from https://dsc.duq.edu/etd/1405 This Immediate Access is brought to you for free and open access by Duquesne Scholarship Collection. It has been accepted for inclusion in Electronic Theses and Dissertations by an authorized administrator of Duquesne Scholarship Collection. For more information, please contact [email protected]. RETHINKING ETHICS ASSESSMENT IN HEALTH TECHNOLOGY ASSESSMENT: A NONLINEAR APPROACH A Dissertation Submitted to the McAnulty College and Graduate School of Liberal Arts Duquesne University In partial fulfillment of the requirements for the degree of Doctor of Philosophy By Aimee D. Zellers May 2015 Copyright by Aimee D. Zellers 2015 RETHINKING ETHICS ASSESSMENT IN HEALTH TECHNOLOGY ASSESSMENT: A NONLINEAR APPROACH By Aimee D. Zellers Approved April 30, 2015 ________________________________ ________________________________ Henk ten Have, MD, PhD Gerard Magill, PhD Director, Center for Healthcare Ethics Vernon F. Gallagher Chair for Integration Professor of Healthcare Ethics of Science, Theology, Philosophy and (Committee Chair) Law Professor of Healthcare Ethics (Committee Member) ________________________________ ________________________________ James Swindal, PhD Henk ten Have, MD, PhD Dean, McAnulty College and Graduate Director, Center for Healthcare Ethics School of Liberal Arts Professor of Healthcare Ethics Professor and Dean of McAnulty College (Center Director) (Committee Member) ________________________________ James Swindal, PhD Dean, McAnulty College and Graduate School of Liberal Arts Professor and Dean of McAnulty College (Dean) iii ABSTRACT RETHINKING ETHICS ASSESSMENT IN HEALTH TECHNOLOGY ASSESSMENT: A NONLINEAR APPROACH By Aimee D. Zellers May 2015 Dissertation supervised by Henk ten Have, PhD, MD The primary question this dissertation aims to answer is how ethics can be meaningfully integrated into health technology assessment (HTA). The contribution of this dissertation is two-fold. The first is to provide an honest and critical evaluation of current HTA practices, including those that involve ethics assessments and that do not. This evaluation will identify gaps and deficiencies in current HTA practices. The second contribution of this dissertation is to propose an approach for meaningful ethics assessment. The nonlinear approach contains five methodologically sound phases aimed to support both ethics assessment and scientific progress. The approach will be applied to emerging genetic health technologies, with a specific hypothetical application to expanded genomes. iv These contributions will be systematically addressed in the following chapters. The first chapter will provide a general introduction to the connection and relationship between technology and values. It will examine value statements and normative statements that are made about technology, including whether technology is value- neutral, value-free, or value-laden. This chapter will ultimately argue that technology is value-laden, and the relationship between society and technology is but two sides of the same coin. Chapter two will address current HTA practices in both the USA and Europe. A distinction between technology assessment (TA) and HTA will be reviewed, as well as a number of basic procedural aspects in HTA. Chapter three will critically assess the current methods of ethics assessment in HTA, including the role ethics plays, identify their shortcomings, and provide a justification for rethinking ethics in HTA. In chapter four, the foundations, methodology, benefits and limitations of the nonlinear approach are delineated. The nonlinear approach consists of five phases with methodologies grounded in multiple disciplines. A detailed description of the function and projected benefits of the nonlinear approach will be given in Chapter five. Chapter five will apply the nonlinear approach to an emerging genetic health technology. Chapter six will consist of a brief summary of the arguments, address the strengths, weakness and feasibility of nonlinear approach, as well as concluding remarks regarding the future genetic health technologies and the role of ethics assessment. v DEDICATION To my mother, Denise Zellers, and father, Kent Zellers, for their unconditional love and unwavering support. To my husband Todd, and our dogs Madison and Ace, for their understanding, encouragement, and love. To my family, immediate and extended, whose support will always be remembered and cherished. vi TABLE OF CONTENTS Page Abstract .............................................................................................................................. iv Dedication .......................................................................................................................... vi Chapter One: Society, technology and values .....................................................................1 1.1 Introduction ....................................................................................................................1 1.2 Technology ....................................................................................................................4 1.2.1 Description of technology ...........................................................................................5 1.2.2 Norms and technology ................................................................................................7 1.2.2.1 Technology as value-free or value-neutral ..............................................................8 1.2.2.2 Technology as value laden .......................................................................................9 1.2.2.3 Analysis..................................................................................................................13 1.3 The relationship between technology and society .......................................................14 1.3.1 Technological determinism .......................................................................................14 1.3.2 Social construction of technology (SCOT) ...............................................................16 1.3.3 Actor network theory (ANT) ....................................................................................20 1.3.4 Systems theory ..........................................................................................................23 1.3.5 Structuration theory ..................................................................................................24 1.3.6 Collective critical analysis of the relationship between society and technology ......27 1.4 Technology as value laden and its relationship to society ...........................................30 1.5 Conclusion ...................................................................................................................31 Chapter Two: Health Technology Assessment (HTA) ......................................................38 2.1 Introduction ..................................................................................................................38 vii 2.1.1 Connecting value and assessment .............................................................................38 2.2 Health Technology Assessment (HTA) .......................................................................39 2.2.1 Defining and explaining HTA ..................................................................................39 2.2.2 TA and HTA .............................................................................................................41 2.2.2.1 Difference in Scope ................................................................................................45 2.2.2.2 Understanding risk .................................................................................................46 2.2.2.3 Understanding uncertainty .....................................................................................48 2.2.2.4 The acceptability of risk .........................................................................................49 2.2.3 A brief history of HTA .............................................................................................53 2.2.4 Agencies responsible for HTA ..................................................................................54 2.2.4.1 USA and Canada ....................................................................................................54 2.2.4.2 Europe ....................................................................................................................59 2.2.4.3 The wider global HTA community ........................................................................63 2.3 Methods in HTA ..........................................................................................................64 2.3.1 Dominant frameworks/approaches ...........................................................................65 2.3.1.1 Technology-oriented ..............................................................................................65 2.3.1.2 Problem-oriented....................................................................................................65
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