告知說明義務系列：人體臨床試驗研究對受試者仍有告知說明義務【醫事法學教室】 試閱
The Series of the Obligation to Disclose: The Participant of the Clinical Research Is the Object of the Obligation to Disclose
按醫療機構實施手術時，應向病人或其法定代理人、配偶、親屬或關係人說明手術原因、手術成功率或可能發生之併發症及危險，並經其同意，簽具手術同意書及麻醉同意書始得為之；醫師診治病人時，應向病人或其家屬告知其病情、治療方針、處置、用藥、預後情形及可能之不良反應。人體臨床試驗研究應於術前即令受試者知悉並了解該計畫之內容，以協助其選擇最適合之手術或麻醉方式及決定是否加入該研究計畫，且須於術前簽署「臨床研究受試者說明及同意書」，取得研究對象之同意後方得進行人體研究，否則即屬違反知情同意法則及告知說明義務。
Before an operation, the medical institution must explain the cause of the operation, the success rate of the operation, and the possible complications including dangers to the patients, their legal representatives, spouses, relatives, and partners. After the patients together with their relations accept the explanations and sign the surgical consent form and the anesthesia consent form, the operation could begin. When diagnosing and treating the patient, the physician shall inform the patient or the patient’s family of the status of the disease, treatment principles, treatment, medication, prognosis and possible unfavorable reactions.
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