Abstract
Abstract
Background
Israel’s Patients’ Rights Act (IPRA, 1996) established a unique statutory model for ethics committees (ECs), with legally binding authority, differing from the advisory nature of ECs in most countries. Following the 2015 State Comptroller’s report highlighting widespread under-implementation, the Ministry of Health (MOH) issued a directive in 2018 aimed at standardizing EC structure, procedures, and training. However, the extent of subsequent implementation and operational activity has remained unclear.
Methods
This secondary analysis of the 2022‑2023 MOH national survey examined EC structure, governance, training, and activity in 52 institutions (response rate: 71%), including general, geriatric/rehabilitation, and psychiatric hospitals, MOH district bureaus, health maintenance organizations (HMOs), and the Israel Defense Forces (IDF). Institutional characteristics were merged from MOH administrative databases and compared with available 2015 baseline data. Logistic regression and Generalized Estimating Equation (GEE) models were used to identify factors associated with low EC activity. Low EC activity was defined as a committee that reported both one or fewer (≤ 1) meetings AND one or fewer (≤ 1) applications per year. Conversely, committees reporting more than one meeting or more than one application annually were classified as having high activity for the purpose of the analysis.
Results
The prevalence of statutory ECs was higher in 2022 (89.7%) than in 2015 (70.9%), and the proportion of committees maintaining written protocols was higher (91% vs. 67%), consistent with substantial structural consolidation. However, more than half of institutions were characterized by low EC activity, reporting one or fewer meetings as well as application per year. Low activity was associated with smaller hospital size, geriatric/rehabilitation hospital type, private ownership, lack of trained members, and absence of internal ethics advisors. In contrast, the presence of trained members and a designated contact person was associated with higher EC activity, while advertising alone was not.
Conclusions
Israel’s experience demonstrates that robust statutory mandates and top-down regulatory directives successfully drive formal structural consolidation, yet remain insufficient on their own to ensure active clinical utilization. Bridging the gap between structural existence and functional engagement requires institutional integration—specifically through accredited training, designated points of contact, internal ethics advisors, and an institutional culture of deliberation. For health systems internationally, these findings show that translating ethics governance into meaningful bedside practice depends on operational resourcing and clinical integration rather than legal mandate alone.