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How Patients in Clinical Trials Understand Informed Consent

  • Korean Journal of Medical Ethics
  • Abbr : 의료윤리
  • 2018, 21(4), pp.48-63
  • DOI : 10.35301/ksme.2018.21.4.48
  • Publisher : The Korean Society For Medical Ethics
  • Research Area : Medicine and Pharmacy > General Medicine
  • Received : November 15, 2018
  • Accepted : December 13, 2018
  • Published : December 31, 2018

YEO Wonkyeong 1 Sook Ja Yang 2

1이화여자대학교 간호대학
2이화여자대학교

Accredited

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.

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