芬蘭 FinnGen 計畫與人體生物資料庫之規範初探 (音)|貝塔語測
芬蘭 FinnGen 計畫與人體生物資料庫之規範初探 (音)

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Script 閱讀文本
The FinnGen project in Finland is a precision medicine research initiative based on public-private collaboration. Established at the end of 2017 with a budget of nearly €100 million, it collaborates with both Finnish biobanks and 12 international pharmaceutical companies. The project aims to integrate the country’s health registries and genetic data to facilitate medical innovation and precision healthcare, striving to be a leader in precision medicine research and provide services to Finnish citizens. With the core focus on human biobanks, the project plans to analyze the genes and health data of 500,000 participants, hoping to discover new disease prevention and treatment methods while establishing a biomedical research foundation based on big data. 
In terms of governance, the FinnGen project consists of a steering committee and a scientific committee responsible for decision-making and research oversight. Funding sources include support from the Finnish Business Funding Agency and international pharmaceutical companies, allocated for tasks such as biobank sample collection, data processing, and analysis. International pharmaceutical companies invest in the project but do not own the biological samples; instead, they acquire research outcomes through investment. Participants can express their willingness to participate through various channels and have the right to withdraw from the program. 
The primary source of biological samples is the human biobanks of collaborating hospitals in Finland, and participants can express their willingness to participate through various channels. Its uniqueness lies in covering almost all human biobanks within Finland, including regional and national repositories. The biological sample processing workflow includes steps such as identity information and biobank storage, DNA extraction, genotype analysis, encrypted transmission, and linkage with registry data. FinnGen integrates information from multiple registry data files to establish detailed longitudinal data files, including health registries, vaccine records, cancer registries, etc. Additionally, other registry data such as birth records, parental causes of death, and infectious disease data are included. 
Data release and usage are strictly controlled by governance mechanisms. Data are encoded to protect personal privacy and stored in the information system of the University of Helsinki, accessible only to approved research institutions and pharmaceutical companies. Aggregate statistical data are published twice a year, but only academic research institutions and pharmaceutical companies within the FinnGen consortium can use research results, with a one-year analysis embargo to ensure security. 
While making significant progress in precision medicine research, the FinnGen project faces challenges related to default consent and data openness. These limitations may affect social trust and long-term support for the project, prompting Finnish academia to rethink the regulations and responses concerning human biobanks. How to establish and utilize human biobanks to gain social trust becomes a critical issue. As Finland revises the regulations on human biobank management, it can draw on the experience of the FinnGen project to provide reference and guidance.    
Translation 中文翻譯
芬蘭的 FinnGen 計畫是一個以公私協力為基礎的精準醫學研究計畫,成立於 2017 年底,預算近一億歐元,合作對象包括芬蘭境內的人體生物資料庫和 12 家國際大型藥廠。計畫旨在整合該國的健康登記和基因資料以促進醫學創新和精準醫療,並成為精準醫學研究的領航者,提供服務給芬蘭國民。計畫以人體生物資料庫為核心,預計分析 50 萬名參與者的基因和健康資料,並希望能找到新的疾病防治方法,同時建立生醫研究的大數據基礎。 
在治理機制方面,FinnGen 計畫由指導委員會和科學委員會核心組成,負責決策和監督研究。資金來源包括芬蘭商業投資局和國際藥廠的資助,用於生物檢體收集、資料處理和分析等項目。國際藥廠作為投資者,並不擁有生物檢體,而是藉由投資獲取研究成果。參與者通過多種管道表達參與意願,且有權退出計劃。 
生物檢體的來源主要是芬蘭各合作醫院的人體生物資料庫,參與者可透過多種管道表達參與意願。其獨特之處在於涵蓋了芬蘭境內幾乎所有人體生物資料庫,包括區域性和全國性庫。生物檢體處理流程包括身份資料與生物檢體儲存、DNA 提取、基因型分析、加密傳送、以及與登記資料串連等步驟。FinnGen 整合了來自多個登記資料檔案的資訊,包括健康登記、疫苗接種、癌症登記等,以建立詳細的縱向資料檔案。此外,還包括了其他登記資料,如出生登記、父母死因、傳染病資料等。 
資料釋出和使用受到嚴格的治理機制控制,資料經過編碼處理以保護個人隱私,並存儲在赫爾辛基大學的資訊系統中,僅經核准的研究機構和藥廠可以訪問。每年兩次公布匯總統計資料,但只有 FinnGen 合作聯盟的學術研究機構和藥廠可以使用研究結果,且分析有一年的封鎖期以確保安全性。 
FinnGen 計畫在精準醫學研究方面取得了重要進展,但面臨預設同意和資料開放的限制。這些限制可能影響計畫的社會信任和長期支持,挑戰促使芬蘭學界重新思考人體生物資料庫的規範和應對措施。如何建立和應用人體生物資料庫以獲得社會信任成為關鍵問題。在人體生物資料庫管理條例修訂之際,可以借鑒 FinnGen 計畫的經驗,提供參考和指引。
‘FinnGen integrates information from multiple registry data files to establish detailed longitudinal data files’ 
In this sentence you can see ‘to V’ used to describe purpose: ‘to establish’. Very often in Taiwan, people use ‘for Ving’ to describe purpose, but this is not correct. You must use ‘to V’ when you want to describe the purpose of an action.
「FinnGen 整合了來自多個登記資料檔案的資訊以建立詳細的縱向資料檔案」
在這句話中,你可以看到「to V」用於描述目的:「建立」。在台灣,人們常用「for Ving」來形容目的,但這是不正確的。當你想描述一個動作的目的時,你必須使用「to V」。
文章分類:跨學科聲動網   醫學