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. 2017 Jul;102(4):F291-F298.
doi: 10.1136/archdischild-2016-310935. Epub 2016 Sep 14.

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

C Gale  1 , M J Hyde  1 , N Modi  1 ; WHEAT trial development group
Collaborators, Affiliations

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

C Gale et al. Arch Dis Child Fetal Neonatal Ed. 2017 Jul.

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.

Keywords: Electronic Health Records; Ethics Committees, Research; Ethics, Research; Informed Consent; Intensive Care, Neonatal.

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Conflict of interest statement

Competing interests: CG reports grants from Health Research Authority (HRA), grants from National Institute of Health Research (NIHR), grants from The Academy of Medical Sciences during the conduct of the study. CG has been awarded the British Association of Perinatal Medicine (BAPM) Travel Awards, which are supported by Chiesi Pharmaceuticals, to attend educational conferences outside the submitted work. MJH reports grants from HRA and grants from NIHR, he is also the vice-chair of the UK Research Ethics Committees. In the last 5 years, NM has received consultancy fees from Ferring Pharmaceuticals, speaker honorarium for an educational meeting funded by Nestle International in which they had no organisational involvement and grants from the NIHR, British Heart Foundation, Westminster Children’s Trust Fund, NHS England and Bliss. TPvS reports grants and personal fees from GSK, Sanofi and Roche, all outside the submitted work.

References

    1. Chalmers I, Glasziou P. Avoidable waste in the production and reporting of research evidence. Lancet 2009;374:86–9. 10.1016/S0140-6736(09)60329-9 - DOI - PubMed
    1. Al-Shahi Salman R, Beller E, Kagan J, et al. . Increasing value and reducing waste in biomedical research regulation and management. Lancet 2014;383:176–85. 10.1016/S0140-6736(13)62297-7 - DOI - PMC - PubMed
    1. Grossmann C, Sanders J, English RA. Large simple trials and knowledge generation in a learning healthcare system. In: Medicine Io, ed. Washington DC: The National Academies Press, 2013. - PubMed
    1. Lantos JD. The “inclusion benefit” in clinical trials. J Pediatr 1999;134:130–1. 10.1016/S0022-3476(99)70400-2 - DOI - PubMed
    1. Berry JG, Ryan P, Duszynski KM, et al. . Parent perspectives on consent for the linkage of data to evaluate vaccine safety: a randomised trial of opt-in and opt-out consent. Clin Trials 2013;10:483–94. 10.1177/1740774513480568 - DOI - PubMed

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