Ssali, A; Namugumya, R; Nalubega, P; Kyohere, M; Seeley, J; Le Doare, K
(2024)
Exploring the consent process among pregnant and breastfeeding women taking part in a maternal vaccine clinical trial in Kampala, Uganda: a qualitative study.
BMC MEDICAL ETHICS, 25 (1).
p. 57.
ISSN 1472-6939
https://doi.org/10.1186/s12910-024-01055-7
SGUL Authors: Le Doare, Kirsty
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Abstract
Background The involvement of pregnant women in vaccine clinical trials presents unique challenges for the informed consent process. We explored the expectations and experiences of the pregnant women, spouses/partners, health workers and stakeholders of the consent process during a Group B Streptococcus maternal vaccine trial. Methods We interviewed 56 participants including pregnant women taking part in the trial, women not in the trial, health workers handling the trial procedures, spouses, and community stakeholders. We conducted 13 in-depth interviews and focus group discussions with 23 women in the trial, in-depth interviews with 5 spouses, and 5 women not in the trial, key informant interviews with 5 health workers and 5 other stakeholders were undertaken. Results Decision-making by a pregnant woman to join a trial was done in consultation with spouse, parents, siblings, or trusted health workers. Written study information was appreciated by all but they suggested the use of audio and visual presentation to enhance understanding. Women stressed the need to ensure that their male partners received study information before their pregnant partners joined a clinical trial. Confidentiality in research was emphasised differently by individual participants; while some emphasised it for self, others were keen to protect their family members from being exposed, for allowing them to be involved in research. However, others wanted their community participation to be acknowledged. Conclusion We found that pregnant women make decisions to join a clinical trial after consulting with close family. Our findings suggest the need for an information strategy which informs not only the pregnant woman, but also her family about the research she is invited to engage in.
Item Type: | Article | ||||||||||||
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Additional Information: | © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | ||||||||||||
Keywords: | Consent, Pregnant women, Maternal, Vaccine, Clinical trials, 2201 Applied Ethics, Applied Ethics | ||||||||||||
SGUL Research Institute / Research Centre: | Academic Structure > Infection and Immunity Research Institute (INII) Academic Structure > REF 2021 user group |
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Journal or Publication Title: | BMC MEDICAL ETHICS | ||||||||||||
ISSN: | 1472-6939 | ||||||||||||
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Publisher License: | Creative Commons: Attribution 4.0 | ||||||||||||
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Web of Science ID: | WOS:001227178300001 | ||||||||||||
URI: | https://openaccess.sgul.ac.uk/id/eprint/116630 | ||||||||||||
Publisher's version: | https://doi.org/10.1186/s12910-024-01055-7 |
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