Huang, Tianhua
Bedford, H. Melanie
Rashid, Shamim
Rasasakaram, Evasha
Priston, Megan
Mak-Tam, Ellen
Gibbons, Clare
Meschino, Wendy S.
Cuckle, Howard
Mei-Dan, Elad
Article History
Received: 4 May 2021
Accepted: 16 February 2022
First Online: 8 March 2022
Declarations
:
: The Research Ethics Board of North York General Hospital has approved the study on May 17, 2017. The Informed consent was waived by NYGH’s REB. The informed consent was waived because our study meets the requirements specified in Canada’s Tri-council policy statements C, Article 12.3 (ExternalRef removed) for following reasons:1) The study is retrospective in nature. It is impracticable to seek consent from each individual patient. At the time of the sample collection, we did not know if a pregnancy will have an adverse pregnancy outcome (therefore will be include in the study). As screening tests were ordered by thousands of physicians across the province of Ontario, Canada, we do not have direct contact with patients.2) This study cannot be carried out without using residual samples.3) Using residual serum samples without patient consent will not have an adverse effect on patients because all subjects in the study have been managed using current standard of care guidelines for detection, follow-up, confirmation and treatment.4). We have de-identified the study dataset and study samples to protect the privacy of individuals and safeguard residual blood samples. No patients will be contacted. Only aggregate data will be published.All methods were performed in accordance with the relevant guidelines and regulations (Declaration of Helsinki).
: Not applicable.
: The reagent kits used in the study were provided by PerkinElmer free of charge. Professor Howard Cuckle is a consultant of PerkinElmer. Dr. Elad Mei-Dan is an Editorial Board Member of BMC Pregnancy & Childbirth. The rest of the authors declare to have no competing interest.