Abstract

IntroductionIn the last several decades, South Korea has rapidly adopted Western customs and practices. Yet, cultural differences between South Korea and the United States exist. The purpose of this study was to identify and characterize potential cultural differences in the Korean and US institutional review board (IRB) approach to certain topics.MethodsA qualitative analysis of a 9-item survey, describing 4 research study case scenarios, sent to IRB members from the United States and South Korea. The case scenarios involved the following issues: (1) the need for consent for retrospective chart review when research subjects receive their care after the study is conceived; (2) child assent; (3) individual versus population benefit; and (4) exception from informed consent in emergency resuscitation research. The free-text responses were analyzed and abstracted for recurrent themes.ResultsTwenty-three of the 45 survey recipients completed the survey, for an overall response rate of 51%. The themes that emerged were as follows: (1) the importance of parental authority among Korean participants versus the importance of child autonomy and child assent among US participants; (2) the recognition of the rights of a proxy or surrogate who can represent an individual's values by all participants; and (3) the importance of the community, expressed by the Korean respondents, versus individualism, expressed by US respondents.ConclusionWhereas US participants appear to emphasize the importance of the individual and the autonomy of a child, the Korean respondents stressed the importance of parental authority and benefiting the community, above and beyond that of the individual person. However, there was substantial overlap in the themes expressed by respondents from both countries.

Highlights

  • In the last several decades, South Korea has rapidly adopted Western customs and practices

  • Whereas US participants appear to emphasize the importance of the individual and the autonomy of a child, the Korean respondents stressed the importance of parental authority and benefiting the community, above and beyond that of the individual person

  • In 1995, the Korean Good Clinical Practice Committee (KGCP) mandated that all institutional review board (IRB) review and monitor clinical trials, and in 2001, the KGCP encouraged the IRBs to adhere to international ethics guidelines

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Summary

Introduction

In the last several decades, South Korea has rapidly adopted Western customs and practices. The purpose of this study was to identify and characterize potential cultural differences in the Korean and US institutional review board (IRB) approach to certain topics. IRB Cross-Cultural Differences minimizing harm to research subjects while maximizing research benefit; justice in ensuring that research procedures are reasonable, fair, and equitable; and nonmaleficence in doing no harm. To this day, the Belmont Report provides the moral framework upon which an IRB ensures that human research projects meet ethical regulations. Comprised of IRB members from major hospitals, biomedical researchers, medical directors of pharmaceutical companies, and officers from health authorities, KAIRB aimed to help Korean IRBs conform to international medical ethics standards.[5]

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