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Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials.15分钟咨询：新生儿和儿科重症监护试验中未经事先同意（延迟同意）进行研究的循证方法。
Arch Dis Child Educ Pract Ed. 2016 Feb;101(1):49-53. doi: 10.1136/archdischild-2015-309245. Epub 2015 Oct 13.
2
How experience makes a difference: practitioners' views on the use of deferred consent in paediatric and neonatal emergency care trials.经验如何产生差异：从业者对在儿科和新生儿急救护理试验中使用延期同意的看法。
BMC Med Ethics. 2013 Nov 6;14:45. doi: 10.1186/1472-6939-14-45.
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Consent for neonatal research.新生儿研究的同意书。
Arch Dis Child Fetal Neonatal Ed. 2006 Sep;91(5):F374-6. doi: 10.1136/adc.2005.075036.
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There will be blood.
Nature. 2011 Jul 13;475(7355):139. doi: 10.1038/475139a.
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Informed consent in paediatric critical care research--a South African perspective.儿科重症监护研究中的知情同意——南非视角
BMC Med Ethics. 2015 Sep 9;16:62. doi: 10.1186/s12910-015-0052-6.
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Consent for observational studies in critical care: time to open Pandora's Box.重症监护中观察性研究的同意书：是时候打开潘多拉魔盒了。
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[Legal aspects of consent in children (Part 1)].[儿童同意的法律问题（第1部分）]
Arch Pediatr. 2015 Sep;22(9):983-8. doi: 10.1016/j.arcped.2015.06.013. Epub 2015 Jul 27.
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The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research.关于早产儿或患病新生儿临床试验同意书的伦理问题：一项分析性（理论/哲学）研究的系统综述（框架综合）
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HAP-FAST: a feasibility study incorporating qualitative, mechanistic and costing sub-studies alongside a randomised pilot trial comparing chest x-ray to low-dose CT scan and empirical antibiotics to antibiotics guided by the BIOFIRE® FILM ARRAY® pneumonia panel in adults with suspected non-ventilator-associated hospital-cquired pneumonia.HAP-FAST：一项可行性研究，其中包括定性、机制和成本核算子研究，以及一项随机试点试验，比较了胸部 X 光检查与低剂量 CT 扫描，以及在疑似非呼吸机相关性医院获得性肺炎的成人中，根据 BIOFIRE® FILM ARRAY® 肺炎面板指导使用经验性抗生素与抗生素治疗的效果。
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BMJ Open. 2024 Feb 10;14(2):e081874. doi: 10.1136/bmjopen-2023-081874.
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Emergency research without prior consent in the United States, Canada, European Union and United Kingdom: How regulatory differences affect study design and implementation in cardiac arrest trials.在美国、加拿大、欧盟和英国未经事先同意进行的紧急研究：监管差异如何影响心脏骤停试验的研究设计与实施。
Resusc Plus. 2024 Feb 1;17:100565. doi: 10.1016/j.resplu.2024.100565. eCollection 2024 Mar.
7
Stakeholders' perspectives on clinical trial acceptability and approach to consent within a limited timeframe: a mixed methods study.利益相关者对临床试验可接受性和在有限时间内达成同意的方法的看法：一项混合方法研究。
BMJ Open. 2024 Jan 2;14(1):e077023. doi: 10.1136/bmjopen-2023-077023.
8
Implementing early rehabilitation and mobilisation for children in UK paediatric intensive care units: the PERMIT feasibility study.在英国儿科重症监护病房实施儿童早期康复和活动：PERMIT 可行性研究。
Health Technol Assess. 2023 Nov;27(27):1-155. doi: 10.3310/HYRW5688.
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Applying clinical decision aids for the assessment and management of febrile infants presenting to emergency care in the UK and Ireland: Febrile Infant Diagnostic Assessment and Outcome (FIDO) Study protocol.在英国和爱尔兰，为了评估和管理因发热而到急诊就诊的婴儿，应用临床决策辅助工具：发热婴儿诊断评估和结局（FIDO）研究方案。
BMJ Open. 2023 Sep 20;13(9):e075823. doi: 10.1136/bmjopen-2023-075823.
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Complex and alternate consent pathways in clinical trials: methodological and ethical challenges encountered by underserved groups and a call to action.临床试验中的复杂和替代同意途径：服务不足群体遇到的方法学和伦理挑战及行动呼吁。
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本文引用的文献

1
Clinical Trial Decisions in Difficult Circumstances: Parental Consent Under Time Pressure.艰难情况下的临床试验决策：时间压力下的父母同意。
Pediatrics. 2015 Oct;136(4):e983-92. doi: 10.1542/peds.2014-3402.
2
How parents and practitioners experience research without prior consent (deferred consent) for emergency research involving children with life threatening conditions: a mixed method study.父母和从业者如何体验未经事先同意（延迟同意）对患有危及生命疾病的儿童进行紧急研究：一项混合方法研究。
BMJ Open. 2015 Sep 18;5(9):e008522. doi: 10.1136/bmjopen-2015-008522.
3
Mechanical versus manual chest compression for out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised controlled trial.机械与手动胸外按压在院外心脏骤停中的应用（PARAMEDIC）：一项实用的、整群随机对照试验。
Lancet. 2015 Mar 14;385(9972):947-55. doi: 10.1016/S0140-6736(14)61886-9. Epub 2014 Nov 16.
4
Death, bereavement and randomised controlled trials (BRACELET): a methodological study of policy and practice in neonatal and paediatric intensive care trials.死亡、丧亲之痛与随机对照试验（BRACELET）：新生儿及儿科重症监护试验政策与实践的方法学研究
Health Technol Assess. 2014 Jul;18(42):1-410. doi: 10.3310/hta18420.
5
Dilemmas in undertaking research in paediatric intensive care.儿科重症监护研究中的困境
Arch Dis Child. 2014 Nov;99(11):1043-9. doi: 10.1136/archdischild-2013-304871. Epub 2014 Jun 11.
6
Doing challenging research studies in a patient-centred way: a qualitative study to inform a randomised controlled trial in the paediatric emergency care setting.以患者为中心开展具有挑战性的研究：一项为儿科急诊护理环境中的随机对照试验提供信息的定性研究。
BMJ Open. 2014 May 15;4(5):e005045. doi: 10.1136/bmjopen-2014-005045.
7
How experience makes a difference: practitioners' views on the use of deferred consent in paediatric and neonatal emergency care trials.经验如何产生差异：从业者对在儿科和新生儿急救护理试验中使用延期同意的看法。
BMC Med Ethics. 2013 Nov 6;14:45. doi: 10.1186/1472-6939-14-45.
8
Waiver of informed consent in pediatric resuscitation research: a systematic review.免除知情同意在儿科复苏研究中的应用：系统评价。
Acad Emerg Med. 2013 Aug;20(8):822-34. doi: 10.1111/acem.12180.
9
'The words will pass with the blowing wind': staff and parent views of the deferred consent process, with prior assent, used in an emergency fluids trial in two African hospitals.“言语随风而逝”：在两家非洲医院进行的一项紧急补液试验中，使用事先同意的延迟同意过程的医护人员和家长观点。
PLoS One. 2013;8(2):e54894. doi: 10.1371/journal.pone.0054894. Epub 2013 Feb 11.
10
What parents of children who have received emergency care think about deferring consent in randomised trials of emergency treatments: postal survey.已接受急救的儿童的父母对于在急救治疗随机试验中推迟同意的看法：邮政调查。
PLoS One. 2012;7(5):e35982. doi: 10.1371/journal.pone.0035982. Epub 2012 May 7.

Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials.

作者信息

Woolfall Kerry, Frith Lucy, Dawson Angus, Gamble Carrol, Lyttle Mark D, Young Bridget

机构信息

Department of Psychological Sciences, University of Liverpool, Liverpool, UK.

Department of Health Service Research, University of Liverpool, Liverpool, UK.

出版信息

Arch Dis Child Educ Pract Ed. 2016 Feb;101(1):49-53. doi: 10.1136/archdischild-2015-309245. Epub 2015 Oct 13.

DOI:10.1136/archdischild-2015-309245
PMID:26464416
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4752644/
Abstract
摘要