Scholarlink

Background <p>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.</p> Methods <p>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.</p> Results <p>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; <i>p</i> &lt; 0.001) and subjective (mean difference − 10.1; 95% CI -18.3 to -2.0; <i>p</i> = 0.02) informed consent scores compared to consent obtained mid-pregnancy. Higher anxiety score was significantly associated with lower objective (<i>p</i> = 0.009) and subjective (<i>p</i> = 0.001) consent scores. Both pain and trust in medical researchers were not associated with subjective or objective consent quality.</p> Conclusions <p>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.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月23日

查看全文
  • Raymond Bernard Kihumuro,
  • Cindy Zhang,
  • Mehreen Zaigham,
  • Jessica E. Haberer,
  • Anacret Byamukama,
  • Edna Tindimwebwa,
  • Stephen Asiimwe,
  • Bizu Gelaye,
  • Francis Bajunirwe,
  • Adeline A. Boatin,
  • Joseph Ngonzi,
  • Lisa M. Bebell

摘要

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.