精準醫學趨勢下醫療性基因檢測同意書重要條款【本期企劃】 試閱
Key Elements of the Consent Forms for Clinical Genetic Testing in the Precision Medicine Era
為縮小醫病資訊落差、維護民眾權利，本文參考國際學術界、產業界基因檢測同意書，列舉並討論重要條款如下：一、檢測項目範圍；二、檢測目的與利益；三、檢測方法、流程及限制；四、替代診斷方法；五、檢測報告內容、結果類別；六、臨床意義不明的基因變異；七、無預期資訊、偶然發現、未經請求的發現；八、風險；九、隱私與保密；十、是否告知家屬；十一、病歷保存；十二、檢體保存；十三、資料分享；十四、再接觸；十五、本人死亡後資料、檢體處理方式；十六、檢測志願性；十七、撤回同意／變更意願／不知情權。
Genetic testing is a vital tool in precision medicine. To address the information gap between healthcare institutions and patients while protecting patients’ rights, this article examines the design of genetic testing consent forms proposed by international experts, outlining and discussing key clauses as follows: 1. Scope; 2. Benefits; 3. Procedure and Limitations; 4. Alternative Diagnostic Methods; 5. What is Reported, Types of Results; 6. Variants of Uncertain Significance (VUS); 7. Unexpected Information/ Incidental Findings/Unsolicited Findings; 8. Risks; 9. Privacy and Confidentiality; 10. To inform relatives or not; 11. Health Records; 12. Sample Storage; 13. Data Sharing; 14. Recontact; 15. In Case of Death; 16. Voluntary; 17. Withdrawal/Change of Mind/Right not to Know.
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