Date of Award

May 2017

Degree Type

Dissertation

Degree Name

Doctor of Philosophy

Department

Nursing

First Advisor

Rachel Schiffman

Committee Members

Aaron Buseh, Hayeon Song, Carol Klingbeil

Keywords

Clinical Trials, Informed Consent, Understanding

Abstract

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.

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.

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