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

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; 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.