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Improving Research Participants' Understanding of Informed Consent Debra Jean Gillespie University of Wisconsin-Milwaukee

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Improving Research Participants' Understanding of Informed Consent Debra Jean Gillespie University of Wisconsin-Milwaukee University of Wisconsin Milwaukee UWM Digital Commons Theses and Dissertations May 2017 Improving Research Participants' Understanding of Informed Consent Debra Jean Gillespie University of Wisconsin-Milwaukee Follow this and additional works at: https://dc.uwm.edu/etd Part of the Nursing Commons Recommended Citation Gillespie, Debra Jean, "Improving Research Participants' Understanding of Informed Consent" (2017). Theses and Dissertations. 1475. https://dc.uwm.edu/etd/1475 This Dissertation is brought to you for free and open access by UWM Digital Commons. It has been accepted for inclusion in Theses and Dissertations by an authorized administrator of UWM Digital Commons. For more information, please contact [email protected]. IMPROVING RESEARCH PARTICIPANTS’ UNDERSTANDING OF INFORMED CONSENT by Debra J. Gillespie A Dissertation Submitted in Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy in Nursing at The University of Wisconsin-Milwaukee May 2017 ABSTRACT IMPROVING RESEARCH PARTICIPANTS’ UNDERSTANDING OF INFORMED CONSENT by Debra J. Gillespie The University of Wisconsin-Milwaukee, 2017 Under the Supervision of Professor Rachel Schiffman Twenty-five to sixty percent of research participants are unable to understand important information during the research consenting process. This lack of comprehension may unintentionally expose research participants to potential harm. The purpose of this study was to test the teach back method of communication as an intervention to improve research participants’ understanding of informed consent. The Shannon Weaver Communication model was the theoretical framework supporting this study. The pre-intervention sample (control group) of 18 participants enrolled in a cardiology clinical trial at a large tertiary hospital in New England completed the Quality of Informed Consent (QuIC) survey. Two cardiology research coordinators were trained in teach back communication as the intervention. A post-intervention sample (experimental group) of 5 participants completed the QuIC survey. There was no significant difference in mean scores of objective understanding between the pre-intervention and post intervention groups. There was also no significant difference in the relationship between objective and subjective understanding in the pre-intervention group compared to the post intervention group. There was poor understanding of compensation for research-related injury where 50% of the pre-intervention group and 60% of the post intervention group were either unsure or answered questions related to this concept incorrectly. ii Another poorly understood concept was with a description of the procedures to be followed. Sixty-one percent in the pre-intervention and no one in the post intervention group understood this concept. A Chi-square test for independence indicated no significant association between highest educational level obtained and understanding of compensation for research- related injury or an understanding of procedures to follow. With the uncovering of a poor understanding of the two concepts of compensation for research-related injury and procedures to follow, not reported in the literature, more research specifically targeting these concepts and participants’ understanding are warranted. Inductive and deductive approaches may yield interesting results. Institutional and national policies need to be put into place assuring participant understanding of all regulatory requirements. However, the practical application of such policies cannot be mandated until there is comprehensive science available to support its practice. iii © Copyright by Debra J. Gillespie, 2017 All Rights Reserved iv TABLE OF CONTENTS List of Figures ................................................................................................................. viii List of Tables .................................................................................................................... ix List of Appendices ..............................................................................................................x Acknowledgements .......................................................................................................... xi CHAPTER 1.STATEMENT OF THE PROBLEM .............................................................1 Informed Consent for Research ....................................................................................1 Background ...................................................................................................................2 Problem Statement ........................................................................................................6 Theoretical Framework ...............................................................................................11 Purpose of the Study ...................................................................................................16 Research Question and Hypothesis .............................................................................16 Significance to Nursing...............................................................................................17 Chapter Summary .......................................................................................................20 Structure to Dissertation .............................................................................................21 CHAPTER 2.REVIEW OF THE LITERATURE Chapter Introduction ...................................................................................................22 Manuscript One: A Critique of the Shannon Weaver Theory of Communication Title Page ....................................................................................................................23 Abstract .......................................................................................................................24 Introduction .................................................................................................................25 The Origins of the Theory...........................................................................................25 The Meaning of the Theory ........................................................................................26 The Logical Adequacy of the Theory .........................................................................27 The Usefulness of the Theory .....................................................................................28 The Generalizability of the Theory .............................................................................30 The Testability of the Theory .....................................................................................31 Significance to Nursing...............................................................................................32 Conclusions .................................................................................................................33 References ............................................................................................................. 35-38 Manuscript Two: Interventions to Improve Research Participants’ Understanding of Informed Consent: A Systematic Review ......................................40 Title Page ....................................................................................................................41 Abstract .......................................................................................................................42 Introduction .................................................................................................................43 Methods.......................................................................................................................44 Results .........................................................................................................................45 PRISMA Literature Search Process ............................................................................45 Interventions ...............................................................................................................46 Modifications/Supplements to the Informed Consent Document ........................46 v Education .............................................................................................................52 Monetary Reward.................................................................................................53 Communication ....................................................................................................54 Multi-Media .........................................................................................................57 Discussion .....................................................................................................................61 Limitations ....................................................................................................................62 Conclusions ...................................................................................................................63 Evidence Table........................................................................................................ 64-67 References ............................................................................................................... 68-74 Chapter Summary .........................................................................................................75 CHAPTER 3.METHODS ..................................................................................................76
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