Regulations for Good Clinical Practice Article 22
The informed consent form and any other written information to be provided to subjects shall include explanations of the following:1.That the trial involves research.2.The purpose of the trial.3.The trial treatment(s) and the probability for random assignment to each treatment.4.The trial procedures to be followed, including all invasive procedures.5.The subject's responsibilities.6.Those aspects of the trial that are experimental.7.The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.8.The reasonably expected benefits.9.The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks.10.The compensation and/or treatment available to the subject in the event of trial-related injury.11.The anticipated prorated payment, if any, to the subject for participating in the trial.12.The anticipated expenses, if any, to the subject for participating in the trial.13.That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.14.That the monitor(s), the auditor(s), the Ethics Committee, and the Competent Authority will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject is authorizing such access.15.That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.16.That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the subject's willingness to continue participation in the trial.17.The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury.18.The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated.19.The expected duration of the subject's participation in the trial.20.The approximate number of subjects involved in the trial.
中文原文 藥品優良臨床試驗作業準則第22條
受試者同意書或提供受試者之其他書面資料應說明以下內容：
一、臨床試驗為一種研究。
二、試驗之目的。
三、試驗治療及每個治療之隨機分配機率。
四、治療程序，包含所有侵入性行為。
五、受試者之責任。
六、臨床試驗中尚在試驗之部分。
七、對受試者或對胚胎、嬰兒或哺乳中幼兒之可預期危險或不便處。
八、可合理預期之臨床利益。
九、其他治療方式或療程，及其可能之重要好處及風險。
十、試驗相關損害發生時，受試者可得到之補償或治療。
十一、如有可獲得之補助，應告知參與臨床試驗之受試者。
十二、如有應支付之費用，應告知參與臨床試驗之受試者。
十三、受試者為自願性參與試驗，可不同意參與試驗或隨時退出試驗，而不受到處罰或損及其應得之利益。
十四、經由簽署受試者同意書，受試者即同意其原始醫療紀錄可直接受監測者、稽核者、人體試驗委員會及主管機關檢閱，以確保臨床試驗過程與數據符合相關法律及法規要求，並承諾絕不違反受試者身分之機密性。
十五、辨認受試者身分之紀錄應保密，且在相關法律及法規要求下將不公開。
如果發表試驗結果，受試者之身分仍將保密。
十六、若新資訊可能影響受試者繼續參與臨床試驗之意願，受試者、法定代理人或有同意權之人會被立即告知。
十七、進一步獲知有關試驗之資訊和受試者權利之聯絡人，及與試驗相關之傷害發生時之聯絡人。
十八、受試者終止參與試驗之可預期情況及理由。
十九、受試者預計參與臨床試驗之時間。
二十、大約受試者人數。
一、臨床試驗為一種研究。
二、試驗之目的。
三、試驗治療及每個治療之隨機分配機率。
四、治療程序，包含所有侵入性行為。
五、受試者之責任。
六、臨床試驗中尚在試驗之部分。
七、對受試者或對胚胎、嬰兒或哺乳中幼兒之可預期危險或不便處。
八、可合理預期之臨床利益。
九、其他治療方式或療程，及其可能之重要好處及風險。
十、試驗相關損害發生時，受試者可得到之補償或治療。
十一、如有可獲得之補助，應告知參與臨床試驗之受試者。
十二、如有應支付之費用，應告知參與臨床試驗之受試者。
十三、受試者為自願性參與試驗，可不同意參與試驗或隨時退出試驗，而不受到處罰或損及其應得之利益。
十四、經由簽署受試者同意書，受試者即同意其原始醫療紀錄可直接受監測者、稽核者、人體試驗委員會及主管機關檢閱，以確保臨床試驗過程與數據符合相關法律及法規要求，並承諾絕不違反受試者身分之機密性。
十五、辨認受試者身分之紀錄應保密，且在相關法律及法規要求下將不公開。
如果發表試驗結果，受試者之身分仍將保密。
十六、若新資訊可能影響受試者繼續參與臨床試驗之意願，受試者、法定代理人或有同意權之人會被立即告知。
十七、進一步獲知有關試驗之資訊和受試者權利之聯絡人，及與試驗相關之傷害發生時之聯絡人。
十八、受試者終止參與試驗之可預期情況及理由。
十九、受試者預計參與臨床試驗之時間。
二十、大約受試者人數。