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Peer-reviewedCC BY-NC-ND 4.0BMC Medical Ethics

Quality of informed consent for research participation obtained during labor versus mid-pregnancy in Uganda

  • Raymond Bernard Kihumuro1
  • Cindy Zhang2,3
  • Mehreen Zaigham4,5,6,7
  • Jessica E. Haberer8,9,10
  • Anacret Byamukama11
  • Edna Tindimwebwa11
  • Stephen Asiimwe1,11
  • Bizu Gelaye12,13
  • Francis Bajunirwe1
  • Adeline A. Boatin4,7,9,10
  • Joseph Ngonzi1
  • Lisa M. Bebell8,9,10,13,14
14 affiliations
  1. 1Mbarara University of Science and Technology, Mbarara, Uganda
  2. 2Massachusetts General Hospital Medical Practice Evaluation Center, Boston, MA USA
  3. 3Tufts University, Boston, MA USA
  4. 4Program of Global Surgery and Social Change, Harvard Medical School, Boston, USA
  5. 5Obstetrics & Gynecology, Skåne University Hospital, Malmö, Sweden
  6. 6Institute of Clinical Sciences Lund, Lund University, Lund, Sweden
  7. 7Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, USA
  8. 8Department of Medicine, Massachusetts General Hospital, Boston, MA USA
  9. 9Massachusetts General Hospital Center for Global Health, Boston, MA USA
  10. 10Harvard Medical School, Boston, MA USA
  11. 11Kabwohe Clinical Research Centre, Kabwohe, Uganda
  12. 12Epidemiology Branch, Division of Population Health Research, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD USA
  13. 13Department of Epidemiology, Harvard T. Chan School of Public Health, Boston, MA USA
  14. 14Division of Infectious Diseases Medical Practice Evaluation Center, Massachusetts General Hospital, Boston, MA USA
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Abstract

Background: Obtaining high-quality informed consent for research is an ethical imperative and crucial for protecting participants’ rights. For vulnerable populations, including pregnant women, this concern becomes even more paramount. We evaluated the quality of informed consent for research participation obtained at different times during pregnancy in Uganda.

Methods: This study was a nested prospective observational birth cohort study within the Placentas, Antibodies, and Child Outcomes (PACO) birth cohort. A total of 216 pregnant women were enrolled either during the second trimester (gestational weeks 16–24) or during labor at Mbarara Regional Referral Hospital and Kabwohe Clinical Research Centre in Uganda. The primary outcomes were objective (Quality of Informed Consent [QuIC]-A) and subjective (QuIC-B) informed consent scores. At the time of consent, we also assessed anxiety (Spielberger State-Trait Anxiety Inventory), pain (Wong-Baker Faces scale), and trust in medical researchers (Medical Researcher Trust scale, see Appendices for tools). We performed multivariable linear regression analyses to examine the association between consent timing and objective and subjective quality of informed consent for research participation.

Results: Of 216 participants, 134 (62%) were enrolled during mid-pregnancy and 82 (38%) during early active labor. Consent obtained during labor was associated with significantly lower objective (mean difference − 12.9; 95% CI -18.3 to -7.4; p < 0.001) and subjective (mean difference − 10.1; 95% CI -18.3 to -2.0; p = 0.02) informed consent scores compared to consent obtained mid-pregnancy. Higher anxiety score was significantly associated with lower objective (p = 0.009) and subjective (p = 0.001) consent scores. Both pain and trust in medical researchers were not associated with subjective or objective consent quality.

Conclusions: The quality of informed consent obtained during labor was significantly lower than consent obtained during mid-pregnancy, highlighting the need for strategies to optimize informed consent timing and processes.

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s12910-026-01549-6.

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Cite

BibTeXRIS
BibTeX
@article{kihumuro2026quality,
  title = {{Quality of informed consent for research participation obtained during labor versus mid-pregnancy in Uganda}},
  author = {Raymond Bernard Kihumuro and Cindy Zhang and Mehreen Zaigham and Jessica E. Haberer and Anacret Byamukama and Edna Tindimwebwa and Stephen Asiimwe and Bizu Gelaye and Francis Bajunirwe and Adeline A. Boatin and Joseph Ngonzi and Lisa M. Bebell},
  journal = {BMC Medical Ethics},
  year = {2026},
  month = jul,
  doi = {10.1186/s12910-026-01549-6},
  url = {https://doi.org/10.1186/s12910-026-01549-6},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Quality of informed consent for research participation obtained during labor versus mid-pregnancy in Uganda
AU  - Raymond Bernard Kihumuro
AU  - Cindy Zhang
AU  - Mehreen Zaigham
AU  - Jessica E. Haberer
AU  - Anacret Byamukama
AU  - Edna Tindimwebwa
AU  - Stephen Asiimwe
AU  - Bizu Gelaye
AU  - Francis Bajunirwe
AU  - Adeline A. Boatin
AU  - Joseph Ngonzi
AU  - Lisa M. Bebell
PY  - 2026
DA  - 2026/07/23
JO  - BMC Medical Ethics
DO  - 10.1186/s12910-026-01549-6
UR  - https://doi.org/10.1186/s12910-026-01549-6
AB  - Background: Obtaining high-quality informed consent for research is an ethical imperative and crucial for protecting participants’ rights. For vulnerable populations, including pregnant women, this concern becomes even more paramount. We evaluated the quality of informed consent for research participation obtained at different times during pregnancy in Uganda.  Methods: This study was a nested prospective observational birth cohort study within the Placentas, Antibodies, and Child Outcomes (PACO) birth cohort. A total of 216 pregnant women were enrolled either during the second trimester (gestational weeks 16–24) or during labor at Mbarara Regional Referral Hospital and Kabwohe Clinical Research Centre in Uganda. The primary outcomes were objective (Quality of Informed Consent [QuIC]-A) and subjective (QuIC-B) informed consent scores. At the time of consent, we also assessed anxiety (Spielberger State-Trait Anxiety Inventory), pain (Wong-Baker Faces scale), and trust in medical researchers (Medical Researcher Trust scale, see Appendices for tools). We performed multivariable linear regression analyses to examine the association between consent timing and objective and subjective quality of informed consent for research participation.  Results: Of 216 participants, 134 (62%) were enrolled during mid-pregnancy and 82 (38%) during early active labor. Consent obtained during labor was associated with significantly lower objective (mean difference − 12.9; 95% CI -18.3 to -7.4; p < 0.001) and subjective (mean difference − 10.1; 95% CI -18.3 to -2.0; p = 0.02) informed consent scores compared to consent obtained mid-pregnancy. Higher anxiety score was significantly associated with lower objective (p = 0.009) and subjective (p = 0.001) consent scores. Both pain and trust in medical researchers were not associated with subjective or objective consent quality.  Conclusions: The quality of informed consent obtained during labor was significantly lower than consent obtained during mid-pregnancy, highlighting the need for strategies to optimize informed consent timing and processes.  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s12910-026-01549-6.
SN  - 1472-6939
ER  -