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Clinical Trial
. 2017 Sep 9;18(1):422.
doi: 10.1186/s13063-017-2149-3.

Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

Alexandra Sawyer  1 , Celine Chhoa  2 , Susan Ayers  2 , Angela Pushpa-Rajah  3 , Lelia Duley  4
Affiliations
Clinical Trial

Women's views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study

Alexandra Sawyer et al. Trials. .

Abstract

Background: The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The aim of this study was to explore women's views and experiences of two alternative consent pathways to participate in the Cord Pilot Trial.

Methods: We conducted a qualitative study using semi-structured interviews. A total of 179 participants in the Cord Pilot Trial were sent a postal invitation to take part in interviews. Women who agreed were interviewed in person or by telephone to explore their experiences of two consent pathways for a preterm intrapartum trial. Data were analysed using inductive systematic thematic analysis.

Results: Twenty-three women who gave either written consent (n = 18) or oral assent followed by written consent (n = 5) to participate in the trial were interviewed. Five themes were identified: (1) understanding of the implications of randomisation, (2) importance of staff offering participation, (3) information about the trial and time to consider participation, (4) trial secondary in women's minds and (5) reasons for agreeing to take part in the trial. Experiences were similar for the two consent pathways. Women recruited by the oral assent pathway reported being given less information about the trial but felt it was sufficient to make a decision regarding participation. There were gaps in women's understanding of the trial and intervention, regardless of the consent pathway.

Conclusions: Overall, women were positive about their experiences of being invited to participate in the trial. The oral assent pathway seems an acceptable option for women if the intervention is low-risk and time is limited.

Trial registration: ISRCTN Registry, ISRCTN21456601 . Registered on 28 February 2013.

Keywords: Clinical trials; Consent; Ethics; Oral assent; Preterm birth.

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Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Nottingham 2 Research Ethics Committee (NRES reference 12/EM/0283). Participants completed a consent form before being interviewed.

Consent for publication

Participants were asked for permission for the interview to be taped and for quotes to be used (anonymously).

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Participant flow with consent pathway
See this image and copyright information in PMC

References

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