人體研究法

This provision states that the Act is enacted to protect the rights and interests of human research participants, and that matters concerning the conduct of human research are governed by this Act unless another law specially provides otherwise.

If research is carried out in two or more research institutions, the institutions may jointly agree on a review committee to handle review, supervision, and audit responsibilities.

審查會必須獨立審查；研究機構必須確保審查不受不當影響。

研究計畫原則上要依審查會核准的同意方式取得研究對象同意，但主管機關公告免同意的案件除外。

以屍體作為研究對象時，必須符合列出的同意或證明條件之一。

研究主持人在取得同意前，必須用對方能理解的方式，先告知研究與同意相關的九項事項；取得同意時，不得使用強制、利誘或其他不正當方式。

研究原住民族的人，除依第12條至第14條外，應先諮詢並取得各該原住民族同意；發表研究結果時也一樣。

研究機構在審查通過的研究計畫執行期間，必須進行必要監督；發現重大違失時，必須命令研究中止或終止。

審查會每年至少要查核一次已通過的研究計畫；若發現列舉情形，得要求停辦並限期改善或終止研究，且要通報研究機構及中央目的事業主管機關。研究計畫完成後，遇到列舉情形時，審查會還要調查並通報。

中央目的事業主管機關要定期查核審查會並公布結果；也可以委託民間專業機構或團體辦理查核。未經查核通過的審查會，不得審查研究計畫。

研究材料原則上在研究結束或保存期限屆滿後要立即銷毀；但經當事人同意或已去連結的，不在此限。

Human-subject research should respect participants’ autonomy and protect their rights.

主管機關在認為研究計畫可能侵害研究對象權益時，可以隨時查核或調閱資料；研究機構及相關人員不得妨礙、拒絕或規避。

研究主持人及研究有關人員不得洩露因業務知悉的秘密或與研究對象有關的資訊。

If a research institution’s research personnel commit any listed violation, the central competent authority may fine the institution NT$100,000 to NT$1,000,000; if the case is serious, the competent authority may order the research to stop and may publish the institution’s name.

研究機構審查會或獨立審查會違規時，中央目的事業主管機關可處罰鍰，並命限期改善；不改善時可命解散審查會，情節重大者可停止審查一個月到一年。

If a research institution, its principal investigator, or other members commit any of the listed violations, the central competent authority may fine the institution NT$50,000 to NT$500,000 and may order the research to stop or end.

研究機構受處罰時，研究主持人或所屬成員也會被併處同樣的罰鍰；情節重大且處分確定後一年內，受處分人不得申請政府研究經費補助。

This provision says the law takes effect on the day it is promulgated.

本條指定衛生福利部為本法主管機關，並規定研究機構相關的人體研究監督、查核、管理、處分及研究對象權益保障事項，由其中央目的事業主管機關管轄。

This article defines three terms: “human research,” “human specimens,” and “de-identification.”

研究主持人在研究開始前要先擬定計畫，並經倫理審查委員會審查通過；計畫變更時，也要先取得原審查會同意。

The research plan must include nine specified items, including the plan title, team and institution, summary, subjects and methods, schedule, rights protection and consent details, resources, funding sources, expected results, ownership/use of成果, and disclosure of conflicts of interest.

The review committee must have at least five members, including legal experts and other socially fair persons, with outsiders making up at least two-fifths and no gender below one-third.

Research plan review is divided by risk level into a general procedure and a simplified procedure; only research cases announced by the competent authority may use the simplified procedure.

Certain research plans may not start until they have been reviewed and approved by a review committee.

Chapter 1: General provisions.

This chapter concerns the protection of research subjects’ rights and interests.

This chapter concerns the management of research plans.

This chapter covers penalties.

Chapter Six: Supplementary Provisions.

This chapter concerns review of research plans.