Medical Care Act Article 78
This English translation was last updated on 2023-06-28, but the Chinese text was amended on 2026-09-23. Later amendments may not be reflected in the translation — please refer to the Chinese text.
For the purpose of improving the level of medical care or prevention of disease in the country, teaching hospitals may conduct human research after formulating a plan and obtaining approval from the central competent authority, or upon entrustment of the central competent authority. Notwithstanding the foregoing, the approval of the central competent authority is not required for human research with aim of evaluating the bioavailability and bioequivalence of generic drugs.Non-teaching hospitals may not conduct human research. However, the preceding paragraph may apply mutatis mutandis to medical care institutions with specific expertise and having obtained the approval of the central competent authority.The plan for human research by a medical care institution shall be first reviewed and approved jointly by a board consisting of medical technologists, legal experts and impartial citizens or representatives of civil groups; people of either gender shall constitute no less than one third of the board. Members of the review board shall abide by the principle of recusal due to conflicts of interest.Subsequent changes of the human research plan shall be implemented only after being examined and verified or approved according to the preceding three provisions.
中文原文 醫療法第78條
為提高國內醫療技術水準或預防疾病上之需要，教學醫院經擬定計畫，報請中央主管機關核准，或經中央主管機關委託者，得施行人體試驗。
但學名藥生體可用率、生體相等性之人體試驗研究得免經中央主管機關之核准。
非教學醫院不得施行人體試驗。
但醫療機構有特殊專長，經中央主管機關同意者，得準用前項規定。
醫療機構施行人體試驗應先將人體試驗計畫，提經醫療科技人員、法律專家及社會公正人士或民間團體代表，且任一性別不得低於三分之一之人員會同審查通過。
審查人員並應遵守利益迴避原則。
人體試驗計畫內容變更時，應依前三項規定經審查及核准或同意後，始得施行。
但學名藥生體可用率、生體相等性之人體試驗研究得免經中央主管機關之核准。
非教學醫院不得施行人體試驗。
但醫療機構有特殊專長，經中央主管機關同意者，得準用前項規定。
醫療機構施行人體試驗應先將人體試驗計畫，提經醫療科技人員、法律專家及社會公正人士或民間團體代表，且任一性別不得低於三分之一之人員會同審查通過。
審查人員並應遵守利益迴避原則。
人體試驗計畫內容變更時，應依前三項規定經審查及核准或同意後，始得施行。