人體生物資料庫之知情同意與參與者保護：現在與未來

Informed consent and participant protection in human biodatabases: present and future

近年來，由於精準醫療發展的需求，帶動生物醫學研究蓬勃發展，以人口群或疾病罹患者群體為基礎的人體生物資料庫（biobank）因為同時蒐集生物檢體、基因資訊與醫療資料，可大量節省研究者於研究過程招募受試者的時間成本，而可方便於串連不同來源的生物或醫療資訊，因而越來受到重視。就生物資料庫的參與者自主權保障而言，取得參與者的知情同意（informed consent），與其他人體研究略有不同。其不同之處在於，生物資料庫所取得的是參與者概括式同意(broad consent)因此，應告知事項更著重於生物資料庫本身運作機制、未來風險的告知、基因資訊對自己與家屬的影響等，也因此參與者同意書法定說明項目較其他人體研究更多，以我國的人體生物資料庫管理條例第7條規定應說明事項即有17項，超過人體研究法定應告知事項9項。其次，就參與者而言，參與生物資料庫面對的生理風險較小，但其他的風險又過於抽象遙遠，容易因此輕忽。整體而言，如何取得參與者有效的同意，完整的知情、充分的理解，應由參與者角度，檢視同意書提供的資訊是否適於理解，說明與取得同意過程，如何發展適合評估方式以參與者確認理解。現行知情同意的過程多較為單向，同意書的說明、資訊的告知較少由參與者角度思考參與生物資料庫的意義。當生物資料庫連結越來越多項目的醫療、非醫療個人資料資訊後，參與者參與將更為重要，亦即，如何確認參與者的真正理解。畢竟，知情同意作為保護參與者自主權，其要件之一即是充分理解，有必要與時俱進引入不同的作法。

In recent years, due to the demand for the development of precision medicine, biomedical research has been booming. Human biological databases (biobanks) based on population groups or disease patient groups can simultaneously collect biological specimens, genetic information and medical data. It saves researchers the time and cost of recruiting subjects during the research process, and can facilitate the connection of biological or medical information from different sources, so it has attracted more and more attention. In terms of ensuring the autonomy of participants in biological databases, obtaining informed consent from participants is slightly different from other human studies. The difference is that the biodatabase obtains broad consent from the participants. Therefore, the matters that should be notified focus more on the operation mechanism of the biodatabase itself, notification of future risks, and the impact of genetic information on yourself and your family members. etc. Therefore, there are more statutory explanation items in the participant consent form than in other human studies. According to Article 7 of China’s Human Biological Database Management Regulations, there are 17 items that should be explained, exceeding the 9 items that are legally required to be notified in human research. Secondly, as far as the participants are concerned, the physiological risks faced by participating in the biological database are relatively small, but other risks are too abstract and distant, so it is easy to ignore them. Overall, how to obtain effective consent, complete knowledge, and full understanding from participants should be done from the perspective of the participant, including whether the information provided in the consent form is suitable for understanding, explaining and obtaining the consent process, and how to develop appropriate evaluation methods for participation. The person confirms understanding. The current informed consent process is mostly one-way, and the explanation of the consent form and the notification of information rarely reflect the meaning of participating in the biodatabase from the perspective of the participant. As biodatabases link more and more items of medical and non-medical personal information, participant participation will become even more important, that is, how to confirm participants’ true understanding. After all, one of the requirements for informed consent, as a means of protecting participant autonomy, is a full understanding of the need to keep pace with the times and introduce different practices.