Practical approaches for supporting informed consent in neonatal clinical trials-Reference-Cited by-同舟云学术

Practical approaches for supporting informed consent in neonatal clinical trials

Published:2024-02-22 Issue:5 Volume:113 Page:923-930
ISSN:0803-5253
Container-title:Acta Paediatrica
language:en
Short-container-title:Acta Paediatrica

Author:

Wootton Susan H.¹²³^ORCID,Rysavy Matthew²³⁴,Davis Peter⁵⁶⁷,Thio Marta⁵⁶⁷⁸,Romero‐Lopez Mar²³⁴,Holzapfel Lindsay F.³⁴,Thrasher Tamara³⁹,Wade Jaleesa D.⁴,Owen Louise S.⁵⁶⁷

Affiliation:

1. Division of Infectious Diseases, Department of Pediatrics McGovern Medical School at UTHealth Houston Houston Texas USA

2. Institute for Clinical Research and Learning Health Care McGovern Medical School at UTHealth Houston Houston Texas USA

3. Children's Memorial Hermann Hospital Houston Texas USA

4. Division of Neonatology, Department of Pediatrics McGovern Medical School at UTHealth Houston Texas USA

5. Newborn Research, Neonatal Services Royal Women's Hospital Melbourne Australia

6. Department of Obstetrics, Gynaecology and Newborn Health University of Melbourne Melbourne Australia

7. Clinical Sciences Murdoch Children's Research Institute Melbourne Australia

8. Gandel Simulation Service Royal Women's Hospital Melbourne Australia

9. March of Dimes NICU Family Support Program Houston Texas USA

Abstract

AbstractThe survival and health of preterm and critically ill infants have markedly improved over the past 50 years, supported by well‐conducted neonatal research. However, newborn research is difficult to undertake for many reasons, and obtaining informed consent for research in this population presents several unique ethical and logistical challenges. In this article, we explore methods to facilitate the consent process, including the role of checklists to support meaningful informed consent for neonatal clinical trials.ConclusionThe authors provide practical guidance on the design and implementation of an effective consent checklist tailored for use in neonatal clinical research.

Funder

Eunice Kennedy Shriver National Institute of Child Health and Human Development

National Center for Advancing Translational Sciences

National Health and Medical Research Council

Publisher

Wiley

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/apa.17165

Reference30 articles.

2. Deferred Consent in Neonatal Clinical Research: Why, When, How?

3. Parental perspectives about information and deferred versus two-stage consent in studies of neonatal asphyxia

4. Ethics and Clinical Research

5. eCFR::21 CFR Part 50 Subpart B – Informed Consent of Human Subjects [Accessed 30 November 2023]

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