Tappin, David
Mackay, Daniel
Reynolds, Lucy
Fitzgerald, Niamh
Article History
Received: 14 June 2021
Accepted: 29 April 2022
First Online: 13 May 2022
Declarations
:
: Ethics approval was given by the local research ethics committee in 2010 which included a pilot study [CitationRef removed] followed by a main study. For the main study, the ethics committee approved passive consent where women were sent a generic Patient Information Sheet that did not pin-point the reason for the extra sample collection but indicated that it was for ‘research’ purposes to improve obstetric care and all studies would be anonymous, that is: researchers would not be able to identify participants or their offspring. Written consent was not required and women could opt-out if they wished at the time of routine blood sample collection at maternity booking. Amendment to the protocol, in 2018, allowed anonymous follow-up of the outcome for offspring using a Safe Haven to link and hold the data and the Safe Haven statistical platform to analyse the data, ensuring anonymity.
: The Ethics Committee and the Head of Midwifery have reviewed this manuscript and approved it for submission for publication. It was not applicable (or possible) for the researchers to ask individual participants for permission to publish.
: None of the authors have any competing interests in the manuscript.