Assessment of the understanding of informed consent including participants' experiences, and generation of a supplemental consent decision aid for Gestational Diabetes Mellitus (GDM) research.

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

SUBMITTER: Atal S 

PROVIDER: S-EPMC6973531 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature