| Summary: | <p><strong>Background:</strong><br />
More effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. The trial used simplified opt-out consent with concise parent information and no consent form.</p><br />
<p><strong>Objective:</strong><br />
To explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials.</p><br />
<p><strong>Methods:</strong><br />
A qualitative, descriptive interview-based study nested within a randomised trial. Semistructured interview transcripts were analysed using inductive thematic analysis.</p><br />
<p><strong>Setting:</strong><br />
Eleven neonatal units in England.</p><br />
<p><strong>Participants:</strong><br />
Eleven parents and ten health professionals with experience of simplified consent.</p><br />
<p><strong>Results:</strong><br />
Five themes emerged: ‘opt-out consent operationalised as verbal opt-in consent’, ‘opt-out consent normalises participation while preserving parental choice’, ‘opt-out consent as an ongoing process of informed choice’, ‘consent without a consent form’ and ‘choosing to opt out of a comparative effectiveness trial’, with two subthemes: ‘wanting “normal care”’ and ‘a belief that feeding is better’.</p><br />
<p><strong>Conclusion:</strong><br />
Introducing a novel form of consent proved challenging in practice. The principle of a simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as ‘opt-out’ can help to normalise participation and emphasise that parents can withdraw consent.</p>
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