指一種持續出現的不合規行為，顯示研究人員缺乏遵守規範的意願或知識，且此行為可能對研究參與者的權益與福祉造成不良影響，或增加參與者遭受傷害的風險。

a pattern of non‐compliance that indicates an unwillingness to comply or a lack of knowledge that may lead to an adverse effect on the rights and welfare of participants or may place participants at an increased risk of harm.

中文釋義翻譯自英文釋義之資料來源。

1. University of British Columbia. (n.d.). Glossary of Terms –  UBC SOPs. Retrieved August 25, 2025, from https://researchethics.ubc.ca/sites/default/files/documents/Glossary%20of%20Terms%20-%20UBC%20SOPs.pdf

2. Office for Human Research Protections (OHRP). (2016). Guidance on reviewing and reporting unanticipated problems involving risks to subjects or others and adverse events. U.S. Department of Health and Human Services. https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html

3. U.S. Food & Drug Administration (FDA). (2010). Guidance for IRBs, clinical investigators, and sponsors: IRB continuing review after clinical investigation approval. Silver Spring, MD: FDA. https://www.fda.gov/media/75330/download

• 原則上「單字中英文釋義」欄位的內容皆採用原文引用（即未經改寫），僅少部分內容有經微幅文字編輯。若欲對釋義內容有更深入的瞭解，敬請參考「資料來源」欄位所提供之原始出處的完整內容。
• 資料來源無編號：代表釋義內容出自同一筆來源。
• 資料來源有項目符號：代表釋義內容是引用多筆來源合寫而成。
• 資料來源有編號：代表該來源是相同編號之釋義內容的原始出處。