Korean Journal of Medical Ethics

The Korean Society for Medical Ethics

Korean J Med Ethics 2018; 21(4):344-359

pISSN: 2005-8284, eISSN: 2234-3598

DOI: https://doi.org/10.35301/ksme.2018.21.4.344

Article

만성신장질환자의 임상시험 설명문 및 동의서 이해도와 관련 요인*

여원경¹, 양숙자²^,^*

How Patients in Clinical Trials Understand Informed Consent*

Won-Kyeong YEO¹, Sook-Ja YANG²^,^*

¹이화여자대학교 간호대학 석사과정

²이화여자대학교 간호대학 교수

¹Master’s Course, College of Nursing, Ewha Womans University, College of Nursing, Ewha Womans University

²Professor, College of Nursing, Ewha Womans University, College of Nursing, Ewha Womans University

^*교신저자: 양숙자. 이화여자대학교 간호대학. Tel: 02-3277-2871. Fax: 02-3277-2850. e-mail: yangsj@ewha.ac.kr

ⓒ Copyright 2018 The Korean Society for Medical Ethics. This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Received: Nov 15, 2018; Revised: Nov 19, 2018; Accepted: Dec 13, 2018

Published Online: Dec 31, 2018

요약

본 연구에서는 임상시험에 참여한 만성신장질환자를 대상으로 임상시험 설명문 및 동의서 이해도와 관련 요인을 파악하기 위한 서술적 조사 연구이다. 자료수집은 임상시험에 참여하는 만성신장질환자 85명을 대상으로 2017년 7월 1일부터 2018년 4월 30일까지 설문조사를 통해 실시하였다. 본 연구의 결과로 설명문 및 동의서 객관적 이해도의 평균은 100점 만점에 69.56점, 주관적 이해도의 평균은 5 점 만점에 3.28점으로 나타났다. 임상시험 설명문 및 동의서 객관적 이해도의 관련요인으로는 참여 동기(F=13.603, p<.001), 동의서 보유 유무(F=-4.833, p<.001), 건강문해력(F=27.709, p<.001)으로 나타났다. 주관적 이해도의 관련요인으로는 참여 동기(F=5.542, p<.002), 추가정보(F=-3.095, p<.003), 질문(F=-3.399, p<.001), 동의서 보유 유무(F=-5.712, p<.001), 건강문해력(F=5.941, p<.001)으로 나타났다. 결론적으로 만성질환자의 임상시험 이해도는 국외의 연구에 비해 이해도가 낮은 수준이며, 설명문 및 동의서의 내용을 일방적으로 전달하기보다는 이해도와 관련된 요인을 고려하여 동의과정에서 대상자의 충분한 이해를 도울 수 있도록 노력이 필요할 것으로 생각된다.

ABSTRACT

The purpose of this study was to identify how patients with chronic kidney disease understand informed consent and related factors for clinical trials. Data from a paper-based survey was collected from July 1, 2017 to April 30, 2018. The subjects for this study were 85 adult patients with chronic kidney disease who were participating in clinical trials. Surveys were conducted by a tool modified from QuIC as designated by Joffe in 2001. The QuIC consists of two parts: objective and subjective cognition. These tools were modi- fied for this study. The average score for the objective understanding (OU) of informed consent for clinical trials was 69.56; the average score for the subjective understanding (SU) of informed consent for clinical trials was 3.28. It was found that health literacy predicted OU (F=27.709, p<.001) while SU was predict- ed by additional information (F=-3.095, p<.003), question (F=13.603, p<.001), and informed consent (F=-4.833, p<.001). In conclusion, the results of this study indicate that the understanding of informed consent for clinical trials among patients with chronic kidney disease is relatively low. Accordingly, alterna-tive methods that consider each patient’s health literacy levels and related factors need to be considered in order to improve their understanding of informed consents during the clinical trial process.

Keywords: 임상시험; 설명문 및 동의서; 이해도

Keywords: clinical trial; informed consent; comprehension