Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study

Furyk, Jeremy, McBain-Rigg, Kristin, Watt, Kerrianne, Emeto, Theophilus I., Franklin, Richard, Franklin, Donna, Schibler, Andreas, Dalziel, Stuart R., Babl, Franz E., Wilson, Catherine, Phillips, Natalie, and Ray, Robin (2017) Qualitative evaluation of a deferred consent process in paediatric emergency research: a PREDICT study. BMJ Open, 7 (11).

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Abstract

Background: A challenge of conducting research in critically ill children is that the therapeutic window for the intervention may be too short to seek informed consent prior to enrolment. In specific circumstances, most international ethical guidelines allow for children to be enrolled in research with informed consent obtained later, termed deferred consent (DC) or retrospective consent. There is a paucity of data on the attitudes of parents to this method of enrolment in paediatric emergency research.

Objectives: To explore the attitudes of parents to the concept of DC and to expand the knowledge of the limitations to informed consent and DC in these situations.

Method: Children presenting with uncomplicated febrile seizures or bronchiolitis were identified from three separate hospital emergency department databases. Parents were invited to participate in a semistructured telephone interview exploring themes of limitations of prospective informed consent, acceptability of the DC process and the most appropriate time to seek DC. Transcripts underwent inductive thematic analysis with intercoder agreement, using Nvivo 11 software.

Results: A total of 39 interviews were conducted. Participants comprehended the limitations of informed consent under emergency circumstances and were generally supportive of DC. However, they frequently confused concepts of clinical care and research, and support for participation was commonly linked to their belief of personal benefit.

Conclusion: Participants acknowledged the requirement for alternatives to prospective informed consent in emergency research, and were supportive of the concept of DC. Our results suggest that current research practice seems to align with community expectations.

Item ID: 51580
Item Type: Article (Research - C1)
ISSN: 2044-6055
Additional Information:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Funders: Townsville Hospital, Emergency Medicine Foundation (EMF)
Projects and Grants: EMF EMRS-51R25-2016
Date Deposited: 19 Nov 2017 22:50
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1103 Clinical Sciences > 110305 Emergency Medicine @ 70%
11 MEDICAL AND HEALTH SCIENCES > 1117 Public Health and Health Services > 111704 Community Child Health @ 30%
SEO Codes: 92 HEALTH > 9299 Other Health > 929999 Health not elsewhere classified @ 50%
92 HEALTH > 9202 Health and Support Services > 920204 Evaluation of Health Outcomes @ 50%
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