Challenges in informed consent decision-making in Korean clinical research: A participant perspective

OBJECTIVES: This study investigated how the essential elements of informed consent are realised during the consent process and examined the challenges in obtaining genuine informed consent in Korea. METHODS: Through purposive sampling, we recruited 21 subjects from those participating in anticancer drug research since 2013. We undertook 1:1 in-depth interviews and analysed the data by framework analysis. RESULTS: Themes raised throughout the interviews were categorised into ‘disclosure’ and ‘understanding’ of clinical information and ‘decision’. Provider-centred information, both verbal and written, was delivered to each participant. There were few tools that the research staff might evaluate study participants’ level of understanding of the provided information during the clinical trial. Although participants did not understand basic clinical trial concepts as much as desired, they may not seek to solve difficulties through communication with trial researchers. Doubts were raised about whether participants had sufficient capacity and free will to provide informed consent. CONCLUSION: There is a concern that informed consent can fall short of genuine in Korea. To ensure informed consent meets the international standard, greater efforts should be made to establish an explicit standard operational protocol for obtaining informed consent.