Details of our most recent substantial amendment SA-14 (England, Wales and Northern Ireland) and SA-11 (Scotland) are documented here.
Scotland A-REC - Favourable opinion letter
*Numbers were transposed on the modified amendment tool from the original amendment tool in error - Please use the above sponsor reference in England, Wales and NI, in line with the FO letter.
West Midlands Coventry and Warwickshire REC - Favourable Opinion Letter
The protocol will look different with a new and updated font, and we have clarified some sections. Please always refer to the protocol but for ease we have highlighted key changes below:
We have widened and clarified our inclusion criteria to include all patients whose primary reason for admission to ICU/HDU is due to ‘any infection’. (Primary admission is key for us - hospital acquired pneumonia and incidental covid positive tests are examples of infections that are not eligible). Infections are only eligible if they are the primary reason for admission to critical care.
New exclusion - please exclude any patient who has had a bone marrow transplant. This is the only exclusion condition for GenOMICC.
Full details are within the protocol and here - Entry
The case report form on REDCap has been adapted minimally, to incorporate the new inclusion criteria, along with some minor text changes. The updated REDCap guidance is available online - REDCap
All GenOMICC participants must be receiving or have received some form of continual monitoring. In addition to cardiovascular or respiratory support, this definition has now been expanded to include any organ support.
Our inclusion criteria have been extended to include babies born less than 32 weeks gestational age so that we can look for genetic factors affecting the development of Bronchopulmonary Dysplasia.
As with all GenOMICC patients, there is no timeline for recruitment and babies can be recruited at any point. We are hoping to set up recruitment in neonatal intensive care units across the UK and would be delighted to support any areas who have not already expressed an interest in setting up.
Dried Blood Spot (DBS) cards have been added as an additional sampling option available to the paediatric and neonatal units. Contact the GenOMICC team if you are interested in this method of sampling and we’ll supply the DBS cards and instructions.
In England, Wales and Northern Ireland, a deferred consent process is now available.
We’ll be sending some GenOMICC specific guidance on this to research teams shortly, but in summary, where appropriate, samples can be held at the recruiting sites for up to 7 days pending appropriate consent / advice. No samples will be transferred to the central laboratory for testing, or stored at site beyond 7 days, without consent having first been obtained.
Deferred consent should only be utilised if it is not reasonably practicable to seek advice from a personal consultee in the first instance.
We’ve added more details to the protocol around following up on with participants who did not consent directly the first time around.
Details have been added about reconsenting children for continued life course follow up on reaching 16.
We’ve introduced a sub-study called GenOMICC Acute. This sub study is a pilot phase and is not being rolled out across all sites at the moment, so for most areas there will be no impact. We’re already in discussion with the small number of sites who volunteered to help with the pilot phase.
The Acute study aims to extend GenOMICC by collecting more blood so we can look at other molecules to better understand the biological processes happening early in the disease process.
There is a new document set for Acute but again, this will only be in use in a small number of sites initially. Acute study docs
GenOMICC is designed to be compatible with all other studies, including interventional trials. It’s for this reason we’ve written into the protocol that no further paperwork is needed to co-enrol patients to GenOMICC. Checks only need to be made with the other study.
We have updated several sections to enhance clarity, including hazardous pathogens (falling into group 3 and 4), recruitment procedures, consent, what happens to data following withdrawal and updated the study sample size to 200,000.
All documents have now been updated to - version 5
Study documents v5: minor edits and enhancements have been made to improve clarity and flow. We have also listed what personal data is collected and clarified what happens to data following withdrawal. The role of the consultee has been defined in the telephone consent script.
We can help with localising documents for you - just let us know.
We have developed small cards that can be handed out with a QR code which links directly to our explanatory video. Please contact the study team if you would like us to send you a batch. This video is not a replacement for the consent process.
Hopefully, the changes will simplify the recruitment process to GenOMICC and as ever, we are extremely grateful for your support. Let us know if you have any questions and if preferred, we would be happy to set up a call with you and your team to go through these changes.
