为新生儿随机对照试验获取知情同意——一种“繁琐的程序”？ - Suppr

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Obtaining informed consent for neonatal randomised controlled trials--an "elaborate ritual"?

作者信息

Mason S

机构信息

Yorkshire Clinical Trials and Research Unit, Cookridge, Leeds.

出版信息

Arch Dis Child Fetal Neonatal Ed. 1997 May;76(3):F143-5. doi: 10.1136/fn.76.3.f143.

DOI:10.1136/fn.76.3.f143

PMID:9175941

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1720656/

Abstract

摘要

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Informed consent in oncology: do we need it?

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Clinical trials and neonatal intensive care.

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New approach for recruitment into randomised controlled trials.

Lancet. 1993 Mar 27;341(8848):812-3. doi: 10.1016/0140-6736(93)90573-y.

A "ladyplan" for trial recruitment?--Everyone's business!

Lancet. 1993 Mar 27;341(8848):795-6. doi: 10.1016/0140-6736(93)90568-2.

The rights of patients in research.

BMJ. 1995 May 20;310(6990):1277-8. doi: 10.1136/bmj.310.6990.1277.

Local research ethics committees.

BMJ. 1995 Sep 9;311(7006):639-40. doi: 10.1136/bmj.311.7006.639.

Why do research ethics committees disagree with each other?

J R Coll Physicians Lond. 1995 Jul-Aug;29(4):315-8.

Auditing a research ethics committee.

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相似文献

Obtaining informed consent for neonatal randomised controlled trials--an "elaborate ritual"?

Arch Dis Child Fetal Neonatal Ed. 1997 May;76(3):F143-5. doi: 10.1136/fn.76.3.f143.

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Lancet. 1995 May 27;345(8961):1370.

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Lancet. 1996 Feb 17;347(8999):475. doi: 10.1016/s0140-6736(96)90054-9.

Obtaining informed consent to neonatal randomised controlled trials: interviews with parents and clinicians in the Euricon study.

Lancet. 2000 Dec 16;356(9247):2045-51. doi: 10.1016/s0140-6736(00)03401-2.

A note on Zelen randomization: attitudes of parents participating in a neonatal clinical trial.

Control Clin Trials. 1999 Dec;20(6):569-72. doi: 10.1016/s0197-2456(99)00036-7.

Ethics of consent for babies in randomised clinical trials. The Steering Committee of the Collaborative UK ECMO Trial.

Lancet. 1995 May 27;345(8961):1370.

Informed consent in neonatal randomised trials.

Lancet. 2001 May 5;357(9266):1445-6. doi: 10.1016/s0140-6736(00)04596-7.

Adaptive designs, informed consent, and the ethics of research.

Control Clin Trials. 2001 Jun;22(3):203-10. doi: 10.1016/s0197-2456(01)00122-2.

Should Zelen pre-randomised consent designs be used in some neonatal trials?

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引用本文的文献

Two speeds of increasing milk feeds for very preterm or very low-birthweight infants: the SIFT RCT.

Health Technol Assess. 2020 Apr;24(18):1-94. doi: 10.3310/hta24180.

Clinical trials in neonates: How to optimise informed consent and decision making? A European Delphi survey of parent representatives and clinicians.

PLoS One. 2018 Jun 13;13(6):e0198097. doi: 10.1371/journal.pone.0198097. eCollection 2018.

Informed consent in paediatric critical care research--a South African perspective.

BMC Med Ethics. 2015 Sep 9;16:62. doi: 10.1186/s12910-015-0052-6.

Parents' views of involvement in concurrent research with their neonates.

J Empir Res Hum Res Ethics. 2010 Jun;5(2):47-55. doi: 10.1525/jer.2010.5.2.47.

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Arch Dis Child Fetal Neonatal Ed. 2004 Jul;89(4):F321-3. doi: 10.1136/adc.2002.021931.

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Arch Dis Child Fetal Neonatal Ed. 2004 May;89(3):F208-11. doi: 10.1136/adc.2003.041392.

本文引用的文献

Informed consent in oncology: do we need it?

Clin Oncol (R Coll Radiol). 1996;8(1):3-6. doi: 10.1016/s0936-6555(05)80032-9.

Clinical trials and neonatal intensive care.

Arch Dis Child Fetal Neonatal Ed. 1994 May;70(3):F231-2. doi: 10.1136/fn.70.3.f231-a.

New approach for recruitment into randomised controlled trials.

Lancet. 1993 Mar 27;341(8848):812-3. doi: 10.1016/0140-6736(93)90573-y.

A "ladyplan" for trial recruitment?--Everyone's business!

Lancet. 1993 Mar 27;341(8848):795-6. doi: 10.1016/0140-6736(93)90568-2.

The rights of patients in research.

BMJ. 1995 May 20;310(6990):1277-8. doi: 10.1136/bmj.310.6990.1277.

Local research ethics committees.

BMJ. 1995 Sep 9;311(7006):639-40. doi: 10.1136/bmj.311.7006.639.

Why do research ethics committees disagree with each other?

J R Coll Physicians Lond. 1995 Jul-Aug;29(4):315-8.

Auditing a research ethics committee.

J R Coll Physicians Lond. 1992 Apr;26(2):181-3.