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

Chhoa, Celine Y.; Sawyer, Alexandra; Ayers, Susan; Pushpa-Rajah, Angela; Duley, Lelia

Authors

Celine Y. Chhoa

Alexandra Sawyer

Susan Ayers Susan.Ayers.1@city.ac.uk

Angela Pushpa-Rajah

Lelia Duley



Abstract

Background

The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. Preterm birth can be rapid and unexpected, allowing little time for the usual consent process. Therefore, in addition to the usual procedure for written consent, a two-stage pathway for consent for use when birth was imminent was developed. The aims of this study were to explore clinicians’ views and experiences of offering two consent pathways for recruitment to a randomised trial of timing of cord clamping at very preterm birth.
Methods

This was a qualitative study using semi-structured interviews. Clinicians from eight hospitals in the UK who had been involved in offering consent to the Cord Pilot Trial were invited to take part in an interview. Clinicians were interviewed in person or by telephone. Interviews were analysed using inductive systematic thematic analysis.
Results

Seventeen clinicians who had either offered usual written consent only (n = 6) or both the two-stage pathway (with oral assent before the birth and written consent after the birth) and usual written consent (n = 11) were interviewed. Six themes were identified: (1) team approach to offering participation; (2) consent form as a record; (3) consent and participation as a continual process; (4) different consent pathways for different trials; (5) balance between time, information, and understanding; and (6) validity of consent. Overall, clinicians were supportive of the two-stage consent pathway. Some clinicians felt that in time-critical situations oral assent presented an advantage over the usual written consent as they provided information on a “need to know” basis. However, there was some concern about how much information should be given for oral assent, and how this is understood by women when birth is imminent.
Conclusions

The two-stage pathway for consent developed for use in the Cord Pilot Trial when birth was imminent was acceptable to clinicians for comparable low-risk studies, although some concerns were raised about the practicalities of obtaining oral assent.

Citation

Chhoa, C. Y., Sawyer, A., Ayers, S., Pushpa-Rajah, A., & Duley, L. (2017). Clinicans' views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study. Trials, 18(196), https://doi.org/10.1186/s13063-017-1940-5

Journal Article Type Article
Acceptance Date Apr 11, 2017
Publication Date Apr 26, 2017
Deposit Date Aug 23, 2017
Publicly Available Date Aug 23, 2017
Journal Trials
Electronic ISSN 1745-6215
Publisher Springer Verlag
Peer Reviewed Peer Reviewed
Volume 18
Issue 196
DOI https://doi.org/10.1186/s13063-017-1940-5
Keywords Clinical trials, ethics, consent, oral assent, preterm birth
Public URL http://eprints.nottingham.ac.uk/id/eprint/45110
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1940-5
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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