Women’s and midwives’ views on the optimum process for informed consent for research that involves procedures initiated in the intrapartum period

Abstract

This dissertation details the findings from an integrated qualitative study which evaluated the model of information provision and receiving of informed consent used in the ASSIST II study, to establish recommendations for research governance and practice in studies that involve an intrapartum intervention.
Qualitative methods and a purposive sampling strategy were used to include women with a range of birth experiences who chose to accept or decline ASSIST II study participation and research midwives who offered the recruitment consultation. Data from audio-recordings of 21 recruitment consultations between research midwives and women who accepted or declined participation, 25 in-depth interviews with women participants, and six in-depth interviews with the recruiting research midwives were coded and interpreted primarily using thematic analysis, with some quantification techniques from content analysis applied to recruitment data.
Findings indicated that information provision and consent was challenging, complex and could be complicated by factors that impact on understanding and decision making. The findings generated three themes: a woman centred recruitment process; optimising the recruitment consultation; and making a decision for two. Women and research midwives agreed on what was important. Information should be freely available in pregnancy ideally first communicated through community midwives. The recruitment consultation should take place when women are in the ‘right state of mind', with full capacity and after clinical needs had been met. Finally, enough time should be given to women to research and discuss information before making a decision.
The findings challenge current RCOG advice for research initiated in the intrapartum period and present suggestions for research practice that promote a more woman centred approach. The proposals include widening participation in research by providing freely available engaging information that promotes understanding; a recognition that women are most vulnerable in labour; of midwifery gatekeeping practices and improved collaboration between the maternity research and community midwifery departments.

Date of Award	28 Sept 2021
Original language	English
Awarding Institution	University of Bristol
Supervisor	Jonathan C S Ives (Supervisor), Julia Wade (Supervisor), Emily Hotton (Supervisor) & Sam A Harding (Supervisor)