Literature DB >> 25287456

When is waiver of consent appropriate in a neonatal clinical trial?

Mark S Schreiner1, Dalia Feltman2, Thomas Wiswell3, Susan Wootton4, Cody Arnold4, Jon Tyson4, John D Lantos5.   

Abstract

It is difficult to do scientifically rigorous research on treatments that must be administered urgently or emergently. Therefore, such treatments are often provided without a strong evidence base. Research would be facilitated if it were permissible to waive the requirement for parental consent. However, that raises a different set of concerns. Federal regulations allow waiver of the requirement for consent but only if studies meet certain conditions. Institutional review boards must decide whether those conditions are met. Sometimes, reasonable people disagree. We present and analyze a protocol for which investigators request a waiver of consent.
Copyright © 2014 by the American Academy of Pediatrics.

Entities:  

Keywords:  child; consent; equipoise; ethics; meconium aspiration; research

Mesh：

Year:  2014        PMID： 25287456      PMCID： PMC4533281          DOI： 10.1542/peds.2014-0207

Source DB:  PubMed          Journal:  Pediatrics        ISSN： 0031-4005            Impact factor:   7.124


  30 in total

1.  Improving the quality of consent to randomised controlled trials by using continuous consent and clinician training in the consent process.

Authors:  P Allmark; S Mason
Journal:  J Med Ethics       Date:  2006-08       Impact factor: 2.903

Review 2.  Unproven therapies in clinical research and practice: the necessity to change the regulatory paradigm.

Authors:  Susan H Wootton; Patricia W Evans; Jon E Tyson
Journal:  Pediatrics       Date:  2013-09-16       Impact factor: 7.124

3.  Meconium aspiration syndrome (MAS) - Where do we go? Research perspectives.

Authors:  Pekka O Kääpä
Journal:  Early Hum Dev       Date:  2009-10-12       Impact factor: 2.079

4.  What (not) to do at and after delivery? Prevention and management of meconium aspiration syndrome.

Authors:  Nestor E Vain; Edgardo G Szyld; Luis M Prudent; Adriana M Aguilar
Journal:  Early Hum Dev       Date:  2009-10-14       Impact factor: 2.079

5.  An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.

Authors:  Ruth R Faden; Nancy E Kass; Steven N Goodman; Peter Pronovost; Sean Tunis; Tom L Beauchamp
Journal:  Hastings Cent Rep       Date:  2013 Jan-Feb       Impact factor: 2.683

6.  The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight.

Authors:  Nancy E Kass; Ruth R Faden; Steven N Goodman; Peter Pronovost; Sean Tunis; Tom L Beauchamp
Journal:  Hastings Cent Rep       Date:  2013 Jan-Feb       Impact factor: 2.683

7.  Informed consent and SUPPORT.

Authors:  Jeffrey M Drazen; Caren G Solomon; Michael F Greene
Journal:  N Engl J Med       Date:  2013-04-17       Impact factor: 91.245

8.  Risk, consent, and SUPPORT.

Authors:  David Magnus; Arthur L Caplan
Journal:  N Engl J Med       Date:  2013-04-18       Impact factor: 91.245

Review 9.  The nocebo effect and its relevance for clinical practice.

Authors:  Luana Colloca; Franklin G Miller
Journal:  Psychosom Med       Date:  2011-08-23       Impact factor: 4.312

10.  Antenatal consent in the SUPPORT trial: challenges, costs, and representative enrollment.

Authors:  Wade D Rich; Kathy J Auten; Marie G Gantz; Ellen C Hale; Angelita M Hensman; Nancy S Newman; Neil N Finer
Journal:  Pediatrics       Date:  2010-06-29       Impact factor: 7.124
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  5 in total

1.  The challenges of research participation by children.

Authors:  Frank H Bloomfield
Journal:  Pediatr Res       Date:  2015-04-29       Impact factor: 3.756

Review 2.  Perinatal management: What has been learned through the network?

Authors:  Sanjay Chawla; Elizabeth E Foglia; Vishal Kapadia; Myra H Wyckoff
Journal:  Semin Perinatol       Date:  2016-08-01       Impact factor: 3.300

3.  Waiver of Consent in a Trial Intervention Occurring at Birth-How Do Parents Feel?

Authors:  Wade D Rich; Anup C Katheria
Journal:  Front Pediatr       Date:  2017-03-21       Impact factor: 3.418

Review 4.  Waived Consent in Perinatal/Neonatal Research-When Is It Appropriate?

Authors:  Wade D Rich; Anup C Katheria
Journal:  Front Pediatr       Date:  2019-11-26       Impact factor: 3.418

5.  Assessment and classification of protocol deviations.

Authors:  Ravindra Bhaskar Ghooi; Neelambari Bhosale; Reena Wadhwani; Pathik Divate; Uma Divate
Journal:  Perspect Clin Res       Date:  2016 Jul-Sep
  5 in total

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