Informed Consent in Radiation Oncology: A Nationwide Survey of Institutions in Korea.

Abstract

Background: This study aimed to analyze the current radiotherapy (RT) consent forms in Korea and present inter-institutional variations in the content, format, and level of detail provided to patients across major cancer types.

Methods: Between June and October 2022, the Informatics Committee and Clinical Practice Guidelines Committee of the Korean Society for Radiation Oncology collected RT consent forms from board-certified radiation oncologists. The consent forms for six cancer types were analyzed, including the five most common cancers treated with RT in Korea (breast, lung, prostate, colorectal, and liver cancer) as well as head and neck cancers.

Results: Forty-nine institutions (49% of 101 institutions) submitted their consent forms, including all 13 Regional Cancer Centers. Of these, 46 provided complete site- or cancer-specific forms for analysis, whereas one provided partial information and two used free-text forms. Seventy percent of institutions (33/47) clearly documented the purpose for RT. Seventy percent of institutions (33/47) categorized side effects as acute and chronic, whereas 30% (14/47) did not make this distinction. In addition to variations in categorizing acute and chronic side effects, a wide range of variations was observed in reporting the side effects of each cancer type. Most forms did not specify the probability of having side effects.

Conclusion: This study uncovered notable inter-institutional variations in RT consent forms across Korea, especially in specifying side effects. These findings establish a basis for developing standardized consent forms, which could enhance patient-centered care, strengthen legal clarity, and promote ethical practices in radiation oncology.