实用临床试验中同意书的豁免与变更：尊重尊重人的原则 - Suppr

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Waivers and Alterations to Consent in Pragmatic Clinical Trials: Respecting the Principle of Respect for Persons.

作者信息

Kim Scott Y H, Miller Franklin G

出版信息

IRB. 2016 Jan-Feb;38(1):1-5.

PMID:26964403

Abstract

摘要

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Hope and persuasion by physicians during informed consent.医生在知情同意过程中的希望与劝导。

J Clin Oncol. 2014 Oct 10;32(29):3229-35. doi: 10.1200/JCO.2014.55.2588. Epub 2014 Sep 8.

Regoaling: a conceptual model of how parents of children with serious illness change medical care goals.再调整：重病患儿父母如何改变医疗照护目标的概念模型。

BMC Palliat Care. 2014 Mar 13;13(1):9. doi: 10.1186/1472-684X-13-9.

Expectations and experiences of investigators and parents involved in a clinical trial for Duchenne/Becker muscular dystrophy.参与杜氏/贝克氏肌肉萎缩症临床试验的研究人员和家长的期望与经历。

Clin Trials. 2014 Feb;11(1):77-85. doi: 10.1177/1740774513512726. Epub 2013 Dec 4.

Understanding of informed consent by parents of children enrolled in a genetic biobank.遗传生物库入组儿童家长对知情同意的理解。

Genet Med. 2014 Feb;16(2):141-8. doi: 10.1038/gim.2013.86. Epub 2013 Jun 27.

Factors that influence parental decisions to participate in clinical research: consenters vs nonconsenters.影响父母参与临床研究决策的因素：同意者与不同意者。

JAMA Pediatr. 2013 Jun;167(6):561-6. doi: 10.1001/jamapediatrics.2013.1050.

Adolescent perspectives on phase I cancer research.青少年对癌症 I 期研究的看法。

Pediatr Blood Cancer. 2013 May;60(5):873-8. doi: 10.1002/pbc.24326. Epub 2012 Oct 3.

Parental permission and perceived research benefits in adolescent STI research.青少年性传播感染研究中的家长许可与感知到的研究益处

J Empir Res Hum Res Ethics. 2010 Jun;5(2):57-64. doi: 10.1525/jer.2010.5.2.57.

The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials.信仰和希望的文化：参与早期肿瘤试验的患者对预期治疗获益的高度评价的理由。

Cancer. 2010 Aug 1;116(15):3702-11. doi: 10.1002/cncr.25201.

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Pediatrics. 2010 Apr;125(4):e876-83. doi: 10.1542/peds.2008-3429. Epub 2010 Mar 29.

Decision-making by adolescents and parents of children with cancer regarding health research participation.青少年和癌症患儿家长在健康研究参与方面的决策。

Pediatrics. 2009 Sep;124(3):959-65. doi: 10.1542/peds.2008-2878. Epub 2009 Aug 10.

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