Development of an evaluation indicator system for the quality of science and technology ethics review committees: a Chinese study based on the structure-process-outcome framework
摘要
Science and technology drive research progress but also introduce growing risks, value conflicts and ethical challenges. Science and technology ethics review committees (STERCs) serve as key institutional mechanisms to ensure that scientific activities comply with ethical principles and professional norms. However, the establishment of STERCs worldwide remains at an early developmental stage, and structured, systematic criteria for evaluating their quality are largely absent. This study aims to develop a structured evaluation indicator system for STERCs and to explore its preliminary applicability.
MethodsThis study conducted a literature review and qualitative interviews to develop a preliminary evaluation indicator system, which was organized using Donabedian’s three-dimensional framework of structure, process, and outcome. The final indicator system was established after two rounds of expert consultation. The preliminary self-assessment data were collected from 80 medical institutions and 19 companies across 14 cities in Hunan Province.
ResultsBoth rounds of the Delphi consultation achieved a 100% response rate. The mean authoritative coefficient (Cr) was 0.900, while familiarity (Cs) and judgment basis (Ca) scores were 0.867 and 0.933, respectively. Kendall’s coefficient of concordance (Kendall’s W) was 0.300 (p < 0.001) in round one and 0.213 (p < 0.001) in round two. The final evaluation indicator system consisted of three first-level indicators, nine second-level indicators and 52 third-level indicators.
ConclusionsThis study proposes a unified framework for science and technology ethics review, integrating activities involving humans, animals, and other potential technological risks into a single evaluation system. The indicator system supports institutional self-assessment, promotes standardization, and guides continuous improvement. Preliminary findings indicate its feasibility and internal consistency, but these results should be interpreted cautiously due to the limited sample scope and reliance on self-reported data.