Received: 4 March 2020
Accepted: 25 March 2020
First Online: 15 April 2020
Ethics approval and consent to participate
: NeoCLEAR received approval from the NHS Health Research Authority, South Central Hampshire B Research Ethics Committee on 12 June 2018 (ref: 18/SC/0222, ExternalRef removed). Trust Confirmation of Capacity and Capability will be obtained at each site. The Chief Investigator or delegate will submit an Annual Progress Report, End of Study Notification, and Final Report to REC, HRA, host organisation and Sponsor.Where necessary, approvals will be obtained from the above parties for all substantial amendments to the original approved documents, and disseminated by NPEU CTU to relevant parties.Parents of eligible infants would be provided with both verbal and written information in the form of a Parent Information Leaflet, by their clinical team. Parent(s) with legal parental responsibility of eligible infants would be approached to discuss the trial further, answer any questions they may have, and to request consent. Parent(s) will have as much time as they need to consider the information, and the opportunity to question the research team, or other independent parties to decide whether they will participate in the study. Informed consent for the study will be obtained by a suitably qualified member of the study team. A parent must personally sign and date the latest approved version of the Informed Consent form before any study specific procedures are performed. For parents completing the STAI-S, they will also be asked to sign and date the consent form to agree to participate themselves.
: Not applicable.
: MS, grant co-applicant and NeoCLEAR Investigator, is supported via salary awards from the BC Children’s Hospital Foundation, the Canadian Child Health Clinician Scientist Program and the Michael Smith Foundation for Health Research. MS has been an investigator on projects funded by Pfizer, Merck, VBI Vaccines, Seqirus, Sanofi-Pasteur and GlaxoSmithKline. All funds have been paid to his institute, and he has not received any personal payments.EJ was a member of the NIHR HTA General Board from 2016 to 2017 and the HTA funding committee (commissioning) from 2013 to 2016, but was not involved in reviewing the NeoCLEAR funding application. EJ and LL report receipt of funding from NIHR, outside the submitted work. There are no further conflicts of interest to declare.