UCL Discovery
UCL home » Library Services » Electronic resources » UCL Discovery

Research ethics committee decision-making in relation to an efficient neonatal trial

Gale, C; Hyde, MJ; Modi, N; WHEAT trial development group; (2016) Research ethics committee decision-making in relation to an efficient neonatal trial. Archives of Disease in Childhood - Fetal and Neonatal Edition , 102 (4) F291-F298. 10.1136/archdischild-2016-310935. Green open access

[thumbnail of F291.full.pdf]
Preview
Text
F291.full.pdf - Published Version

Download (384kB) | Preview

Abstract

OBJECTIVE: Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs). DESIGN: We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. SETTING: RECs in the UK. MAIN OUTCOME: Number of REC granting favourable opinions. RESULTS: The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid. CONCLUSIONS: A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials.

Type: Article
Title: Research ethics committee decision-making in relation to an efficient neonatal trial
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1136/archdischild-2016-310935
Publisher version: https://doi.org/10.1136/archdischild-2016-310935
Language: English
Additional information: This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Keywords: Electronic Health Records, Ethics Committees, Research, Ethics, Research, Informed Consent, Intensive Care, Neonatal, Blood Specimen Collection, Comparative Effectiveness Research, Erythrocyte Transfusion, Humans, Infant, Newborn, Infant, Newborn, Diseases, Neonatology, Randomized Controlled Trials as Topic, Risk Assessment, Risk Factors, Therapeutic Human Experimentation, United Kingdom
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health > Behavioural Science and Health
URI: https://discovery.ucl.ac.uk/id/eprint/10058260
Downloads since deposit
85Downloads
Download activity - last month
Download activity - last 12 months
Downloads by country - last 12 months

Archive Staff Only

View Item View Item