| 1. | The right of research subjects to safeguard their integrity must always be respected 受试验者保护其本人身心健全与完整性的权利必须加以尊重。 |
| 2. | Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects 医学之进步奠基于科学研究,而此研究终究必须有部份仰赖以人为受试验者。 |
| 3. | It is the duty of the physician in medical research to protect the life , health , privacy , and dignity of the human subject 医学研究中,医师之职责是在于保障受试验者之生命、健康、个人隐私及尊严。 |
| 4. | In medical research on human subjects , considerations related to the well - being of the human subject should take precedence over the interests of science and society 在进行有关人体试验之医学研究时,应将受试验者之利益置于科学及社会利益之上。 |
| 5. | No national ethical , legal or regulatory requirement should be allowed to reduce or eliminate any of the protections for human subjects set forth in this declaration 任何国家之伦理、法律、条例之制定,皆不应减损或忽视本宣言对受试验者所宣示之保障。 |
| 6. | When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship with the physician or may consent under duress 医师在取得受试同意书时,应特别注意受试验者是否对医师有依赖关系,或受试验者是否在胁迫下行使同意。 |
| 7. | Every medical research project involving human subjects should be preceded by careful assessment of predictable risks and burdens in comparison with foreseeable benefits to the subject or to others 任何有关人体试验的医疗研究计划,事前须审慎评估可能的风险、责任、以及对受试验者或其他人的可能益处。 |
| 8. | The specific reasons for involving research subjects with a condition that renders them unable to give informed consent should be stated in the xperimental protocol for consideration and approval of the review committee 对于此种在无法签署受试同意书之受试验者上的研究,研究人员应于试验计画书中,陈述其研究之具体原因,以供审查委员会之考量而核准。 |
| 9. | Every precaution should be taken to respect the privacy of the subject , the confidentiality of the patient ' s information and to minimize the impact of the study on the subject ' s physical and mental integrity and on the personality of the subject 研究人员应采取一切之预防措施,尊重受试验者之个人隐私,维护其个人资料的私密,并将此研究对其身心健全及人格造成之伤害降到最低。 |
| 10. | When a subject deemed legally incompetent , such as a minor child , is able to give assent to decisions about participation in research , the investigator must obtain that assent in addition to the consent of the legally authorized representative 当一个被视为无法律行为能力之受试验者,例如未成年之孩童,对参与研究的决定有表达同意之能力时,研究人员除了应取得该受试验者之同意外,亦必须取得其法定代理人之同意。 |