Assessment of the understanding of informed consent including participants’ experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research [version 1; peer review: 3 approved]

Abstract

Background: Informed consent is a basic ethical requirement of clinical research, yet deficiencies have been documented in the comprehension of its components among trial participants. Pregnancy research is sparsely conducted. Assessment of understanding of the informed consent among pregnant women suffering from Gestational Diabetes Mellitus enrolled in a randomized controlled trial, and their experiences was planned. Methodology: A prospective observational cohort study was conducted among participants of EMERGE clinical trial at the University Hospital, Galway. Willing participants allowed observation of their consent encounters. They completed the standard QuIC questionnaire at follow up visits for assessment of objective and subjective understanding of informed consent, and reasons to participate and level of satisfaction. Data was entered and analysed using Microsoft Office Excel and Minitab version 18. Results: The most commonly asked questions asked in the twenty consent encounters observed were focused upon the safety of the study drug for the developing foetuses and women. The general attitude of the women was positive towards participation. The mean objective understanding score was 72.43 ± 7 and the subjective understanding score was 91.67 ± 8.68 (out of 100). Critical components of consent like voluntarism, randomisation, withdrawal, and benefit to others were well understood. The domains related to nonstandard nature of treatment, additional risks/discomforts and compensation were poorly understood. The women cited the desire to provide benefit to future patients as the most common reason to participate, and most were satisfied with the consent process. Conclusion: Comprehension of informed consent is good in most aspects, but the grasp of certain concepts is poor among the pregnant women. Efforts are needed to improve informed consent through engagement of investigators, research nurses and possibly, the use of a decision aid.