임상진료지침의 윤리성 프레임워크와 이에 기반한 국내 임상진료지침 평가

Abstract

Purpose: This study aimed to establish an ethical framework encompassing both procedural and substantive values in the development of clinical practice guidelines (CPGs) and to evaluate the extent to which current South Korean guidelines embody these values. Methods: Drawing upon major international standards formulated by leading national and global guideline authorities, this study identified key ethical principles and classified them into procedural (e.g., stakeholder engagement, conflict of interest management, transparency) and substantive (e.g., patient values, equity, feasibility) domains. Using this framework, 40 Korean CPGs were systematically analyzed to determine how effectively they incorporated and operationalized these ethical values. Results: Although many guidelines met procedural standards such as external review and conflict of interest disclosure, few demonstrated meaningful patient or stakeholder participation. Substantive values extending beyond scientific rigor—such as resource implications, equity, and acceptability—were addressed inconsistently. Only a minority of guidelines explicitly described how issues such as priority setting, feasibility, or the needs of vulnerable populations were taken into account. Conclusion: To strengthen the ethical integrity of CPGs, efforts must move beyond procedural compliance to actively integrate values such as patient involvement, equity, and practical applicability. The proposed framework offers a foundation for developing future methodological tools and institutional standards that promote ethically robust guideline development.