Clinicans' views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study
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,...
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| Format: | Article |
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BioMed Central
2017
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| Online Access: | https://eprints.nottingham.ac.uk/45110/ |
| _version_ | 1848797071557001216 |
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| author | Chhoa, Celine Y. Sawyer, Alexandra Ayers, Susan Pushpa-Rajah, Angela Duley, Lelia |
| author_facet | Chhoa, Celine Y. Sawyer, Alexandra Ayers, Susan Pushpa-Rajah, Angela Duley, Lelia |
| author_sort | Chhoa, Celine Y. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | 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. |
| first_indexed | 2025-11-14T19:58:03Z |
| format | Article |
| id | nottingham-45110 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T19:58:03Z |
| publishDate | 2017 |
| publisher | BioMed Central |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-451102020-05-04T18:42:56Z https://eprints.nottingham.ac.uk/45110/ 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 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. BioMed Central 2017-04-26 Article PeerReviewed Chhoa, Celine Y., Sawyer, Alexandra, Ayers, Susan, Pushpa-Rajah, Angela and Duley, Lelia (2017) Clinicans' views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study. Trials, 18 (196). ISSN 1745-6215 Clinical trials ethics consent oral assent preterm birth https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-1940-5 doi:10.1186/s13063-017-1940-5 doi:10.1186/s13063-017-1940-5 |
| spellingShingle | Clinical trials ethics consent oral assent preterm birth Chhoa, Celine Y. Sawyer, Alexandra Ayers, Susan Pushpa-Rajah, Angela Duley, Lelia Clinicans' views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study |
| title | Clinicans' views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study |
| title_full | Clinicans' views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study |
| title_fullStr | Clinicans' views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study |
| title_full_unstemmed | Clinicans' views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study |
| title_short | Clinicans' views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study |
| title_sort | clinicans' views and experiences of two alternative consent pathways for participation in a preterm intrapartum trial: a qualitative study |
| topic | Clinical trials ethics consent oral assent preterm birth |
| url | https://eprints.nottingham.ac.uk/45110/ https://eprints.nottingham.ac.uk/45110/ https://eprints.nottingham.ac.uk/45110/ |