Abstract
Background: Perinatal research to address the paucity of evidence-based treatments in pregnant women and infants has been increasing. The views of all stakeholders in perinatal research are important to understand, to design trials which are efficient and improve clinical practice, while maintaining the trust of participants and society.
Methods: A systematic review of the literature was conducted, examining stakeholder attitudes towards participation in and consent processes for perinatal research. Inclusion criteria were any empirical research paper published between February 2014 and February 2024 which addressed the issue of consent or participation in a clinical trial in pregnant women or neonates/infants. A narrative review of included papers was conducted, focusing on key themes.
Results: A total of 60 papers were included. The views of pregnant women and parents of infants differed from clinicians and investigators in several areas. Participants prefer to be approached antenatally, as early as possible in the pregnancy, for peripartum or delivery room trials of urgent interventions, while clinicians do not want to cause distress to most women who would not become eligible. Participants also prefer short verbal consent when trial risk is low and time is limited, and want their treating clinician to introduce or discuss consent to research, which is at odds with clinician views and research regulations.
Conclusions: Participant and parent views regarding consent to perinatal trials are at odds with those of clinicians, investigators and regulators in several aspects. Clinical trial design and research regulations should better reflect the views of participants and parents.
Poster presentation.