健康資料與生物資料庫研究之倫理議題

Ethical Issues in Health Databases and Biobanks Research

透過累積大量的健康資料與生物資料，資料庫研究將促進生醫、流行病學、公共衛生等領域進行有助於提昇群體健康福祉的各項研究。然而，健康資料與生物資料庫研究亦具有別於一般臨床研究之特，例如難以適用傳統之特定知情同意形式、隱私保障與資料保密管理、族群研究的社會風險、研究成之公益性等，為此領域研究帶來特殊之倫理議題。2016年世界醫師會通過「台北宣言：健康資料與生物資料庫之倫理考量宣言」，針對可辨識身份之人類資料與生物檢體，其龐集，儲存與使用提出倫理原則作為指引。本文探討資料庫研究之倫理議題，參照台北宣言與我國相關法規，闡述進行健康資料與生物資料庫研究之倫理考量。

Abstract: By accumulating large quantity of health data and biospecimen, database research could boost the advancement of biomedical, epidemiology and public health researches and promote health welfare of the society and specific groups. However, health databases and biobanks researches bear certain features which are generally different from clinical trials and medical research, and therefore the ethical consideration may be different. For example, the process of informed consent, privacy and confidentiality issues, possibility of group harm, and the purpose of promoting common good which all bring about new challenges of research ethics. In 2016, The WMA announced the Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks in Taipei which provides special ethical guidance for health database and biobank research. This paper explores the main ethical issues arising from health databases and biobanks research, refers to the Declaration of Taipei and local regulations in Taiwan, and aims to elaborate the ethical considerations for health database and biobank research.