Risk management in clinical research: Experience of an Institutional Review Board

Q3 Medicine

Ethics, Medicine and Public Health Pub Date : 2025-01-01 DOI:10.1016/j.jemep.2025.101095

P.A. Albarello , C. Ocampo-Benavides , C. Bello , M. Cañón , A. de la Torre

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引用次数: 0

Abstract

Background

Clinical trial complexity has grown, leading to global efforts to improve quality and safety through risk management (RM). However, clear guidelines for RM at Institutional Review Boards (IRBs) are lacking. This study describes the development and implementation of an RM process within an IRB, focusing on a quantitative risk assessment tool.

Methods

The RM process followed ISO 31000 guidelines. Risk assessment was performed using quantitative and qualitative strategies; for the quantitative strategy we developed an online tool (InRisk_Tool) with variables selected using the systematic team approach; analysis was conducted using the semi-quantitative method of risk indexes and the probability-impact matrix. Additionally, IRB members performed the qualitative analysis of each study. Risk treatment activities were implemented mainly according to the risk level established by the InRisk_Tool.

Results

The InRisk_Tool comprises 20 variables categorized into two dimensions: Probability and Impact. Categorical variables scored 0 for negative responses and 1 for positive ones. Quantitative variables also scored 0 or 1 based on the number of events. The scores for Probability and Impact ranged from 0 to 14 and 0 to 6, respectively. These scores were categorized into three levels: High, Intermediate, and Low. Combined scores formed a probability-impact matrix to determine overall risk levels.

Conclusions

The InRisk_Tool provides systematic, objective risk evaluation for clinical trials. Further refinements and artificial intelligence integration could enhance scoring, analysis, and decision-making, strengthening patient safety.

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临床研究中的风险管理：机构审查委员会的经验

临床试验的复杂性日益增加，导致全球努力通过风险管理（RM）来提高质量和安全性。然而，机构审查委员会（irb）缺乏明确的RM指导方针。本研究描述了在IRB中RM过程的开发和实现，重点是定量风险评估工具。方法RM流程遵循ISO 31000标准。采用定量和定性策略进行风险评估；对于定量策略，我们开发了一个在线工具（InRisk_Tool），其中使用系统团队方法选择变量；采用风险指标的半定量方法和概率-影响矩阵进行分析。此外，IRB成员对每项研究进行了定性分析。风险处理活动主要根据InRisk_Tool建立的风险等级来实施。结果InRisk_Tool包含20个变量，分为两个维度：概率和影响。在分类变量中，消极回答得分为0，积极回答得分为1。定量变量也根据事件的数量得分为0或1。概率（Probability）和影响（Impact）的得分分别为0 ~ 14分和0 ~ 6分。这些分数分为三个等级：高、中、低。综合得分形成一个概率-影响矩阵来确定总体风险水平。结论InRisk_Tool为临床试验提供了系统、客观的风险评价。进一步的改进和人工智能集成可以增强评分、分析和决策，加强患者安全。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Ethics, Medicine and Public Health Medicine-Health Policy

CiteScore

2.20

自引率

0.00%

发文量

107

审稿时长

42 days

期刊介绍： This review aims to compare approaches to medical ethics and bioethics in two forms, Anglo-Saxon (Ethics, Medicine and Public Health) and French (Ethique, Médecine et Politiques Publiques). Thus, in their native languages, the authors will present research on the legitimacy of the practice and appreciation of the consequences of acts towards patients as compared to the limits acceptable by the community, as illustrated by the democratic debate.