Each centre obtained local research ethics committee approval following approval from the Multicentre Research Ethics Committee.
It was approved by each hospital's local research ethics committee, and, where required (Austria, Denmark, France, and Switzerland) by the competent authority responsible for medical devices.
Additionally, as associated research ideas develop, each of the local research ethics committees (RECs) will need to consider, presumably under the guidance of a multicentre REC, the research analyses to be conducted.
Ethics approval was obtained from the Medical Ethics Committee of the VU Vrije Universiteit Medical Center for the DCS, the Erasmus Medical Center for the Rotterdam Study, and for CARDS each centre obtained local research ethics committee approval after approval from the Multi-centre Research Ethics Committee.
In each hospital, a local research team (with the local medical investigator plus a medical or nursing coordinator) performed a prospective surveillance on severe maternal morbidity, daily reviewing all women admitted to hospital, considering the inclusion criteria: the presence of at least one WHO potentially life-threatening condition (PLTC) (Table 1 – [ 14]).
The study was implemented in each country by a local research team, with the exception of Niger where a JHSPH doctoral student took the lead on the research with support from local researchers.
25 Each social scientist convened a local research team for the focus groups within each country, composed of a note taker and an assistant.
The study has also been approved by the local research governance committees of each participating hospital.
Ethical approval was granted by the local research ethics committee in each of the participating centres.
The protocol was approved by the local research ethics committee of each participating institution.
