Literature DB >> 10461596

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

P Allmark1.   

Abstract

My aim is to suggest that there is a case for using a randomised consent design in some neonatal trials. As an example I use the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. In some trials the process of obtaining consent has the potential to harm the subject, for example, by disappointing those who end in the control group and by creating additional anxiety at times of acute illness. An example of such were the trials of extracorporeal membrane oxygenation (ECMO) in neonates suffering pulmonary hypertension. Pre-randomised consent could avoid or lessen these harms. However, a number of ethical objections are made to these research designs. They involve denial of information, using people, denial of choice, and "overselling" of allocated treatment. Furthermore, they are the wrong response; better communication might be the answer, for example. I argue that these objections are not completely persuasive. However, they are enough to suggest caution in the use of such designs.

Entities:  

Keywords:  Biomedical and Behavioral Research

Mesh:

Year:  1999        PMID: 10461596      PMCID: PMC479242          DOI: 10.1136/jme.25.4.325

Source DB:  PubMed          Journal:  J Med Ethics        ISSN: 0306-6800            Impact factor:   2.903


  13 in total

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Journal:  Clin Res       Date:  1992-10

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Authors:  J G Meran
Journal:  Lancet       Date:  1995-05-27       Impact factor: 79.321

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Authors:  N Modi
Journal:  BMJ       Date:  1993-12-04

6.  Informed consent in clinical trials. Should be comprehensive...

Authors:  M Emberton; C Wood; P Meredith
Journal:  BMJ       Date:  1993-12-04

Review 7.  Randomised consent designs in cancer clinical trials.

Authors:  D G Altman; J Whitehead; M K Parmar; S P Stenning; P M Fayers; D Machin
Journal:  Eur J Cancer       Date:  1995-11       Impact factor: 9.162

8.  Informed consent. Reactionary approach inhibits progress.

Authors:  M Baum
Journal:  BMJ       Date:  1994-01-22

9.  Randomized consent designs for clinical trials: an update.

Authors:  M Zelen
Journal:  Stat Med       Date:  1990-06       Impact factor: 2.373

10.  Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study.

Authors:  R H Bartlett; D W Roloff; R G Cornell; A F Andrews; P W Dillon; J B Zwischenberger
Journal:  Pediatrics       Date:  1985-10       Impact factor: 7.124

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  6 in total

1.  Research into emergency treatments--could the offer of 'advance directives' help?

Authors:  R Gillon
Journal:  J Med Ethics       Date:  1999-08       Impact factor: 2.903

2.  Presumed consent in emergency neonatal research.

Authors:  D J Manning
Journal:  J Med Ethics       Date:  2000-08       Impact factor: 2.903

3.  Ethical challenges in conducting clinical research in lung cancer.

Authors:  Peter Allmark; Angela M Tod
Journal:  Transl Lung Cancer Res       Date:  2016-06

4.  Parental preferences for neonatal resuscitation research consent: a pilot study.

Authors:  A Culbert; D J Davis
Journal:  J Med Ethics       Date:  2005-12       Impact factor: 2.903

Review 5.  Is it better to consent to an RCT or to care? Muetadeltaepsilonnu alphagammaalphanu ("nothing in excess").

Authors:  Didier Dreyfuss
Journal:  Intensive Care Med       Date:  2004-12-17       Impact factor: 17.440

Review 6.  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.

Authors:  Christopher Megone; Eleanor Wilman; Sandy Oliver; Lelia Duley; Gill Gyte; Judy Wright
Journal:  Trials       Date:  2016-09-09       Impact factor: 2.279

  6 in total

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