This guidance is designed for use with RCOG Clinical Governance Advice No. 6: Obtaining Valid Consent.
This guidance is intended to provide a good practice framework for researchers regarding; the timing and detail of study information provision and the taking of consent for participation in research involving either mother or baby when valid consent is required while in labour or in the immediate postpartum period.
Typically, this may be in the intrapartum period where eligibility for a study is established, for example, preterm birth is anticipated or planned, or in the neonatal period where the baby has or develops a specific condition.
This document does not cover issues relating to undertaking medical research in women who are deemed to lack the mental capacity to consent.
This Clinical Governance Advice was developed prior to the emergence of the COVID-19 coronavirus.
This is the second edition of this guidance.
Please note that the Patient Safety Committee regularly assesses the need to update. Further information on this review is available on request.
Developer declaration of interests
Dr S Kenyon PhD MA RM, Birmingham: None declared.
Professor A Ewer MB ChB MD MRCP FRCPCH, Birmingham: None declared.