The strengthening of Institutional Review Board (IRB) and Human Research Protection Program (HRPP) for clinical research on advanced regenerative medicine reflecting the 3 Principles of the Belmont Report (Respect, Beneficence, Justice) is very important. The research institution IRB should naturally be in charge of managing the clinical research process. And it is crucial to reinforce HRPP for the protection of research subjects in institutions conducting advanced regeneration clinical research. So, it is needed to establish a Protection System for Advanced Regenerative Medical Research Subjects composed of clinical research management communication system for advanced regenerative medicine between KAIRB (Korean Association of IRB) of research institutes and National Management Agency for Advanced Regenerative Medical Research. In advanced regenerative medicine clinical research to verify safety and efficacy of the investigational drugs to the subjects with rare and incurable diseases rather than to treat the patients, it is hoped that a management system that guarantees the scientific characteristics of research and the rights of research subjects would be well organized and operated.

Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.

Purpose: This study aims to develop preliminary items for measuring the perceived service quality of clinical trials among participants and to verify content validity. Methods: This study was designed as a methodological study. A conceptual framework was established based on Brady and Cronin's hierarchical model, and preliminary items were prepared through translation-back-translation, a review of existing instruments, and in-depth interviews with clinical trial participants and clinical research coordinators. The final items were completed through content validity testing by experts and a review of items by clinical trial participants for the prepared preliminary items. Results: Through this study, a set of 58 items across four domains (quality of interaction with researchers, the physical environment, performance procedures, and performance results) and 9 components (information·education·communication, trust, respect for participant preferences, securing facilities and space, accessibility, comfortability, informed consent, coordination of care, subjective understanding of clinical trials) on the service quality of clinical trials were completed. The scale content validity index of all preliminary items was 0.96, meeting the recommended standards. The individual-item content validity index also meets the recommended criteria for most items, excluding four items. Conclusion: This study holds significance in developing items to measure the quality of clinical trial execution from the perspective of participants. By verifying the reliability and validity of these items through subsequent research, it is expected that they can be utilized as a valuable instrument to devise strategies for improving the quality of clinical trials.