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1
Fully informed consent is impossible in surgical clinical trials.在外科临床试验中，完全知情同意是不可能的。
Can J Surg. 2005 Aug;48(4):271-2.
2
Regarding "Consent for residents to perform surgery".关于“住院医师进行手术的同意书”。
J Vasc Surg. 2003 Apr;37(4):918; author reply 918-9. doi: 10.1067/mva.2003.193.
3
Improving subject recruitment by maintaining truly informed consent: a practical benefit of disclosing adverse clinical trial results.通过维持真正的知情同意来改善受试者招募：披露不良临床试验结果的实际益处。
Am J Bioeth. 2009 Aug;9(8):36-7. doi: 10.1080/15265160902940048.
4
Respecting participant autonomy and the disclosure of clinical trial results.尊重参与者的自主权及临床试验结果的披露。
Am J Bioeth. 2009 Aug;9(8):38. doi: 10.1080/15265160902979806.
5
What about Learners' Roles in the Operating Room Should Be Disclosed to Patients?手术室中学习者的角色应向患者披露哪些内容？
AMA J Ethics. 2018 Apr 1;20(4):336-341. doi: 10.1001/journalofethics.2018.20.4.ecas2-1804.
6
Disclosure of adverse clinical trial results--should legal immunity be granted to drug companies?临床试验不良结果的披露——制药公司是否应被给予法律豁免权？
Am J Bioeth. 2009 Aug;9(8):45-7. doi: 10.1080/15265160902939933.
7
Time to stop worrying about the therapeutic misconception.是时候停止担心治疗性误解了。
J Clin Ethics. 2012 Fall;23(3):272-87.
8
The duty to disclose (even more) adverse clinical trial results.披露（甚至更多）不良临床试验结果的义务。
Am J Bioeth. 2009 Aug;9(8):33-4. doi: 10.1080/15265160902893874.
9
Ethics in clinical research: need for assessing comprehension of informed consent form?临床研究中的伦理学：有必要评估知情同意书的理解情况吗？
Contemp Clin Trials. 2011 Mar;32(2):169-72. doi: 10.1016/j.cct.2010.12.002. Epub 2010 Dec 10.
10
The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 7: Informed consent and xenotransplantation clinical trials.国际异种移植协会关于开展1型糖尿病猪胰岛产品临床试验条件的共识声明——第7章：知情同意与异种移植临床试验
Xenotransplantation. 2009 Jul-Aug;16(4):255-62. doi: 10.1111/j.1399-3089.2009.00546.x.

引用本文的文献

1
Giving Consent to the Ineffable.对不可言喻之事表示同意。
Neuroethics. 2024;17(1):11. doi: 10.1007/s12152-024-09545-6. Epub 2024 Feb 15.
2
Obtaining informed consent from patients hospitalized in the surgical wards as a major legal challenge.在外科病房获取住院患者的知情同意是一项重大的法律挑战。
Ann Med Surg (Lond). 2021 Nov 17;72:103053. doi: 10.1016/j.amsu.2021.103053. eCollection 2021 Dec.
3
Patient Perspectives on the Participation of Neurosurgery Resident Physicians in Their Care.患者对神经外科住院医师参与其治疗的看法。
Cureus. 2020 Feb 4;12(2):e6880. doi: 10.7759/cureus.6880.
4
Neuro-oncology: Under-recognized mental incapacity in brain tumour patients.神经肿瘤学：脑瘤患者认知能力受损未被充分认识。
Nat Rev Neurol. 2014 Sep;10(9):487-8. doi: 10.1038/nrneurol.2014.143. Epub 2014 Aug 12.
5
Competing for patients: an ethical framework for recruiting patients with brain tumors into clinical trials.竞争患者：将脑瘤患者招募入临床试验的伦理框架
J Neurooncol. 2011 Sep;104(3):623-7. doi: 10.1007/s11060-011-0536-2. Epub 2011 Feb 12.
6
Patients' perception of the informed consent process for neurooncology clinical trials.患者对神经肿瘤学临床试验知情同意过程的认知
Neuro Oncol. 2008 Jun;10(3):348-54. doi: 10.1215/15228517-2008-007. Epub 2008 Apr 3.
7
Ethical guideposts to clinical trials in oncology.肿瘤学临床试验的伦理准则。
Curr Oncol. 2006 Apr;13(2):55-60. doi: 10.3390/curroncol13020004.

本文引用的文献

1
Therapeutic optimism in the consent forms of phase 1 gene transfer trials: an empirical analysis.1期基因转移试验知情同意书中的治疗乐观态度：一项实证分析。
J Med Ethics. 2005 Apr;31(4):209-14. doi: 10.1136/jme.2003.006247.
2
Interventions to improve osteoporosis treatment following hip fracture. A prospective, randomized trial.改善髋部骨折后骨质疏松症治疗的干预措施。一项前瞻性随机试验。
J Bone Joint Surg Am. 2005 Jan;87(1):3-7. doi: 10.2106/JBJS.D.02289.
3
Uncertain benefit: investigators' views and communications in early phase gene transfer trials.益处不明：早期基因转移试验中研究者的观点与交流
Mol Ther. 2004 Aug;10(2):225-31. doi: 10.1016/j.ymthe.2004.05.013.
4
A qualitative study of attitudes toward error in patients facing brain tumour surgery.一项关于脑肿瘤手术患者对错误态度的定性研究。
Can J Neurol Sci. 2004 May;31(2):208-12. doi: 10.1017/s0317167100053841.
5
Conflict of interest: it is ethical for an investigator to also be the primary care-giver in a clinical trial.利益冲突：在临床试验中，研究者同时担任主要护理人员是符合伦理道德的。
J Neurooncol. 2003 Jun;63(2):107-8. doi: 10.1023/a:1023959021758.
6
An entrustment model of consent for surgical treatment of life-threatening illness: perspective of patients requiring esophagectomy.
J Thorac Cardiovasc Surg. 2000 Aug;120(2):264-9. doi: 10.1067/mtc.2000.106525.
7
Informed consent in surgical trials.外科试验中的知情同意。
World J Surg. 1999 Dec;23(12):1215-9. doi: 10.1007/s002689900650.
8
Randomized study of brachytherapy in the initial management of patients with malignant astrocytoma.近距离放射治疗在恶性星形细胞瘤患者初始治疗中的随机研究。
Int J Radiat Oncol Biol Phys. 1998 Jul 15;41(5):1005-11. doi: 10.1016/s0360-3016(98)00159-x.
9
Intracranial arterial occlusion associated with high-activity iodine-125 brachytherapy for glioblastoma.与高活性碘-125近距离放射治疗胶质母细胞瘤相关的颅内动脉闭塞
J Neurooncol. 1993 Sep;17(3):253-60. doi: 10.1007/BF01049980.

Fully informed consent is impossible in surgical clinical trials.

作者信息

Bernstein Mark

出版信息

Can J Surg. 2005 Aug;48(4):271-2.

PMID:16149359
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3211530/
Abstract
摘要