辛基宣言的倫理原則，並與 GCP 及相關法規要求一致。
2.1Clinical trials should be
conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).
2.2 在試驗開始前，應權衡對個 別之受試者和整體社會所造成 可預期的危險、不便與預期效 益。只有在預期效益超過風險
2.2 Before a trial is initiated, foreseeable risks and
inconveniences should be weighed against the anticipated
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時，才應開始並持續此試驗。 benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
2.3 受試者之權利、安全及福祉 是最重要之考量，並應優先於 科學及社會之效益。
2.3 The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.
2.4 目前已知有關試驗藥品之非 臨床及臨床資料，應能適當地 支持所提出的臨床試驗。
2.4 The available nonclinical and clinical information on an
investigational product should be adequate to support the proposed clinical trial.
2.5 臨床試驗應有科學根據，臨 床試驗計畫書應清楚及詳盡的 描述。
2.5 Clinical trials should be
scientifically sound, and described in a clear, detailed protocol.
2.6 試驗應依照經主管機關或人 體試驗委員會\獨立倫理委員會 核准\贊同意見之試驗計畫書執 行。
2.6 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC)
approval/favourable opinion.
2.7 給予受試者之醫療照顧及為 醫療決策為合格醫師或牙醫師 的責任。
2.7 The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified
physician or, when appropriate, of
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a qualified dentist.
2.8 每一位參與試驗執行之人 員，應有符合工作資格之教 育、訓練及經驗。
2.8 Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
2.9 受試者參與試驗前，應獲得 其自願給予之受試者同意書。
2.9
Freely given informed consent should be obtained from every subject prior to clinical trial participation.
2.10
所有臨床試驗資料應予記錄、
處理及貯存，以供確實報告、
呈現及確認。
附錄
此原則適用本指引中所指之紀 錄，不論其所使用之媒介為 何。
2.10
All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
ADDENDUM
This principle applies to all records referenced in this
guideline, irrespective of the type of media used.
2.11
應保護可辨認受試者身分之紀 錄的機密性，符合相關法規對 隱私及機密之規定。
2.11
The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
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2.12
試驗藥品的製造、處理及貯存 應符合 GMP。試驗藥品的使用 應遵照已核准之試驗計畫書。
2.12
Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.
2.13
試驗應採用所有能確保其品質 的規範及程序。
附錄
這些系統應著重於確保受試者 保護及試驗結果可信度之面 向。
2.13
Systems with procedures that assure the quality of every aspect of the trial should be
implemented.
ADDENDUM
Aspects of the trial that are
essential to ensure human subject protection and reliability of trial results should be the focus of such systems.
第 3 章、人體試驗委員會/獨立倫理委員會(INSTITUTIONAL