Literature DB >> 16923938

Consent for neonatal research.

L McKechnie1, A B Gill.   

Abstract

Inherent to all medical research is respect for the rights of the individual. Neonatal research is made more complex by the issue of proxy consent. Obtaining valid informed consent for entry of an infant into a research project needs to deal with this complexity. New evidence on the role and responsibilities of parents in giving consent has implications for all clinical staff that are considering embarking on and/or recruiting infants in research projects. This review explores the issues around informed consent for neonatal research and provides a framework by which consent could be improved. It is to be hoped that such improvements to the process will increase recruitment of infants to research studies while enhancing the validity of the consent process.

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Year:  2006        PMID： 16923938      PMCID： PMC2672847          DOI： 10.1136/adc.2005.075036

Source DB:  PubMed          Journal:  Arch Dis Child Fetal Neonatal Ed        ISSN： 1359-2998            Impact factor:   5.747


  19 in total

1.  Zelen randomization: attitudes of parents participating in a neonatal clinical trial.

Authors:  C Snowdon; D Elbourne; J Garcia
Journal:  Control Clin Trials       Date:  1999-04

2.  What do parents think about enrolling their premature babies in several research studies?

Authors:  C J Morley; R Lau; P G Davis; C Morse
Journal:  Arch Dis Child Fetal Neonatal Ed       Date:  2005-05       Impact factor: 5.747

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Authors:  S C Harth; R R Johnstone; Y H Thong
Journal:  J Med Ethics       Date:  1992-06       Impact factor: 2.903

Review 4.  The ethics of randomised controlled trials from the perspectives of patients, the public, and healthcare professionals.

Authors:  S J Edwards; R J Lilford; J Hewison
Journal:  BMJ       Date:  1998-10-31

5.  Consent to clinical research--adequately voluntary or substantially influenced?

Authors:  S Hewlett
Journal:  J Med Ethics       Date:  1996-08       Impact factor: 2.903

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

Authors:  S Mason
Journal:  Arch Dis Child Fetal Neonatal Ed       Date:  1997-05       Impact factor: 5.747

7.  Is informed consent in neonatal randomised controlled trials ritual?

Authors:  M Levene; I Wright; G Griffiths
Journal:  Lancet       Date:  1996-02-17       Impact factor: 79.321

8.  Determinants of parental authorization for involvement of newborn infants in clinical trials.

Authors:  J A Zupancic; P Gillie; D L Streiner; J L Watts; B Schmidt
Journal:  Pediatrics       Date:  1997-01       Impact factor: 7.124

Review 9.  Informed consent in the NICU setting: an ethically optimal model for research solicitation.

Authors:  Lisa Golec; Sharyn Gibbins; Michael S Dunn; Philip Hebert
Journal:  J Perinatol       Date:  2004-12       Impact factor: 2.521

10.  Resuscitation of asphyxiated newborn infants with room air or oxygen: an international controlled trial: the Resair 2 study.

Authors:  O D Saugstad; T Rootwelt; O Aalen
Journal:  Pediatrics       Date:  1998-07       Impact factor: 7.124
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  7 in total

1.  In vitro cytokine induction by TLR-activating vaccine adjuvants in human blood varies by age and adjuvant.

Authors:  Simon D van Haren; Lakshmi Ganapathi; Ilana Bergelson; David J Dowling; Michaela Banks; Ronald C Samuels; Steven G Reed; Jason D Marshall; Ofer Levy
Journal:  Cytokine       Date:  2016-04-12       Impact factor: 3.861

2.  Challenges and successes of recruitment in the "angiotensin-converting enzyme inhibition in infants with single ventricle trial" of the Pediatric Heart Network.

Authors:  Nancy A Pike; Victoria Pemberton; Kerstin Allen; Jeffrey P Jacobs; Daphne T Hsu; Alan B Lewis; Nancy Ghanayem; Linda Lambert; Kari Crawford; Teresa Atz; Rosalind Korsin; Mingfen Xu; Chitra Ravishankar; James Cnota; Gail D Pearson
Journal:  Cardiol Young       Date:  2012-07-05       Impact factor: 1.093

Review 3.  Key stakeholder perceptions about consent to participate in acute illness research: a rapid, systematic review to inform epi/pandemic research preparedness.

Authors:  Nina H Gobat; Micaela Gal; Nick A Francis; Kerenza Hood; Angela Watkins; Jill Turner; Ronald Moore; Steve A R Webb; Christopher C Butler; Alistair Nichol
Journal:  Trials       Date:  2015-12-29       Impact factor: 2.279

4.  Parental perspectives long term after neonatal clinical trial participation: a survey.

Authors:  Thomas Salaets; Emilie Lavrysen; Anne Smits; Sophie Vanhaesebrouck; Maissa Rayyan; Els Ortibus; Jaan Toelen; Laurence Claes; Karel Allegaert
Journal:  Trials       Date:  2020-11-02       Impact factor: 2.279

5.  The culture of research communication in neonatal intensive care units: key stakeholder perspectives.

Authors:  Jennifer Degl; Ronald Ariagno; Judy Aschner; Sandra Beauman; Wakako Eklund; Elissa Faro; Hiroko Iwami; Yamile Jackson; Carole Kenner; Ivone Kim; Agnes Klein; Mary Short; Keira Sorrells; Mark A Turner; Robert Ward; Scott Winiecki; Christina Bucci-Rechtweg
Journal:  J Perinatol       Date:  2021-10-18       Impact factor: 2.521

6.  A Delphi process to optimize quality and performance of drug evaluation in neonates.

Authors:  Frederic Legrand; Rym Boulkedid; Valery Elie; Stephanie Leroux; Elizabeth Valls; Adolfo Valls-i-Soler; Johannes N Van den Anker; Evelyne Jacqz-Aigrain
Journal:  PLoS One       Date:  2014-09-11       Impact factor: 3.240

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

Authors:  Virginia Neyro; Valéry Elie; Nicole Thiele; Evelyne Jacqz-Aigrain
Journal:  PLoS One       Date:  2018-06-13       Impact factor: 3.240
  7 in total

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