We would like to thank you and your child for taking part in FIRST-ABC. FIRST-ABC is a research study to find out which of the two commonly used modes of non-invasive respiratory support (called High Flow Nasal Cannula and Continuous Positive Airway Pressure) should be used as the first treatment option in children’s critical care units for unwell children who need non-invasive respiratory support. FIRST-ABC is funded by the National Institute for Health Research – Health Technology Assessment Programme.
Who are we?
The Great Ormond Street Hospital for Children NHS Foundation Trust are the Sponsor for the study. The Intensive Care National Audit & Research Centre (ICNARC) are managing the study. Both are based in the UK and are the data controllers for the study, responsible for looking after yours and your child’s information and using it properly.
What personal data do we collect?
To help us manage, and meet the objectives of, the study - ICNARC collects and holds personal data about you and your child (and other participants). This information (such as your child’s name, date of birth, NHS number, health data and your name and contact details) was collected by the research team at the hospital where you became involved in the study. This information was securely submitted to ICNARC. The research team will also collect information on your child’s survival from their medical records until the end of the study.
What do we do with your information?
ICNARC will follow-up on your child’s well-being by requesting some important health information, including survival and hospital stay data, from a national database held by NHS Digital (an organisation that manages access to a database of NHS records). To obtain this important information, the FIRST-ABC study team will send your child’s name, date of birth, home postcode, NHS number and unique trial number (these pieces of identifiable information are required to ensure that your child is identified in the database correctly) to NHS Digital using a secure password protected online file exchange service. An authorised person from NHS Digital will then ‘link’ the identifiable information to the national NHS records. NHS Digital will then securely send the pseudonymised survival and hospital stay data to ICNARC for storage on the secure FIRST-ABC study database. ICNARC will then share some of the pseudonymised data with a member of our team at the London School of Hygiene and Tropical Medicine, who will help with some of the analysis of the trial.
All of the information is held in a secure password protected database, with access only by authorised research team members as described above. The Great Ormond Street Hospital for Children NHS Foundation Trust will not receive any new identifiable information about you or your child that has arisen from this study.
Six months after you became involved in the study, we will use your name and contact details to send you a questionnaire to find out how your child is doing. If you opted to receive the questionnaire by email, then we will send you a link to the questionnaire using SurveyMonkey. SurveyMonkey’s privacy policy can be found here: https://www.surveymonkey.com/mp/legal/privacy-policy/.
Information collected during FIRST-ABC is stored on ICNARC's secure servers which are owned by an authorised contractor called Exponential-e (https://www.exponential-e.com/). ICNARC takes steps to ensure this information is not lost and makes regular back-ups of the data. ICNARC also contract Babble Cloud who provide external desktop and network managed services, including end user and infrastructure support. Employees at Babble Cloud will not access the data, however, they do have remote access to ICNARC servers
How long do we keep your information for?
At the end of the study, ICNARC will keep identifiable information (personal data) about you and your child for no longer than one year after the study has finished. The information will be then anonymised so that you can no longer be identified (unless you have agreed otherwise). It will not be possible to identify any person who has taken part in the study in any reports or articles.
Your rights over your information
ICNARC process data for this study under the legitimate interest legal basis. This is because ICNARC is a registered charity and the data processing described here is to support scientific and statistical research. Your rights to access, change or move your information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate. If you withdraw from the study, we will keep the information about you that we have already obtained. To safeguard your rights, we will use the minimum personally-identifiable information possible. There is no automated decision making or profiling.
If, when you consented to take part, you indicated that you did not want us to either obtain the above information from NHS Digital or to send you questionnaires, we will not process your data for these purposes. If you agreed for us to keep your contact details on file after the study ends, we may contact you if we feel you or your data could contribute to other important health questions.
You can opt out if you no longer wish that we process your data in these way (contact details below).
More information about the FIRST-ABC study is available on this website. If you have any other questions or wish to opt out or withdraw, please contact:
Robert Darnell, Trial Coordinator
robert.darnell@icnarc.org 020 7269 9277
ICNARC's overall Privacy Policy, and details of our Data Protection Officer, is available here. Where your rights are different for individual research studies compared to the ICNARC privacy policy, the individual research study privacy policy takes priority.
Your right to complain
If you have a complaint about our use of your information, you can contact the Information Commissioner’s Office via their website at www.ico.org.uk/concerns or write to them at:
Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
FIRST-ABC Privacy Policy v6.0, 9 June 2022