Kējì Fǎxué Pínglùn (Jun 2013)

醫學研究與個人資料保護―以日本疫學研究為中心 Medical Research and Personal-data Protection ― Take Japanese Epidemiology Research as the Basis

  • 范姜真媺 Chen-Mei Fan Chiang

DOI
https://doi.org/10.3966/181130952013061001002
Journal volume & issue
Vol. 10, no. 1
pp. 61 – 113

Abstract

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我國現行個人資料保護法，對醫學研究部分，僅於第6 條第一項第四款規定，公務機關或學術研究機構基於醫療、衛生或犯罪預防之目的，為統計或學術研究而有必要，且經一定程序所為蒐集、處理或利用者，得蒐集、處理或利用有關個人之醫療、基因、健康檢查之資料。此規定是否能合理規範疫學研究上有關研究對象資料之蒐集或利用？雖我國所劃分規範醫學研究領域與日本不同，無法完全對應出相同部分作比較，但醫學研究上應遵守保護個人資料自主權與尊重當事人之基本倫理原則並無二致，故本文詳細介紹與分析日本訂定「疫學研究倫理指針」之原則、定位，個人資料之取得、利用及公開及安全管理等規範，並對我國個資法及醫療法等相關法律作說明，最後提出值得省思之處。 Medical progress is based on research that ultimately must include studies involving human subjects. For medical research using identifiable human material or data, it is the duty of physicians who participate in medical research to protect life, health, right to self-determination, privacy, and confidentiality of personal information of research subjects. This article provides an overview of ethical principles for epidemiology research which enacted by Japan in 2008. The ethical principles set forth three important subjects, the first how to get the informed consent from potential research subject, the second is the construct, function and duty of research ethical Committee, and the third protect personal information of research subjects. In Accordance with this ethical principles, the individual research subject should be provided appropriate access to participation in research, can constitute an adequate regulatory framework for protection in epidemiology research. On the other hand, Taiwan have, in the past enacted Human Research Act, Human Biobank Management Act, Medical Care Act, in order to regulate medical research and protect research subjects. Yet the scope of the existing regulations are restricted and there is considerable confusion about how the rules would be applied, they are insufficient to personal-data protection. Therefore to study ethical principles for epidemiology about Japan, we believe that can get some available reference to engage in constructive debate on the issue about personal information protection of research subjects.

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