Who are we and why we are using your or your child’s personal data?
PICnIC is a study investigating whether it is feasible to conduct a multicentre trial in critically ill children comparing Selective Decontamination of the Digestive tract (SDD) with standard infection control procedures. Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge are the Sponsor of the study. The Intensive Care National Audit & Research Centre (ICNARC) is the data controller for the study. PICnIC is funded by the National Institute for Health Research (NIHR) – Health Technology Assessment Programme.
What personal data do we collect?
To effectively explore the aim of this study, ICNARC may collect anonymised data about your child. This information (i.e., age, weight, and health data) was collected by the research team at the PICU where your child was admitted and securely submitted to ICNARC. If given consent, you will be approached to complete a questionnaire or an online interview, where your thoughts regarding how PICnIC has been undertaken will be recorded (for example, how satisfied you are with the information provided to you about the study).
What do we do with your information?
ICNARC will be requesting more data from the Paediatric Intensive Care Audit Network (PICANet) including key health information, such as survival and hospital stay data (e.g., ventilation duration). To achieve this, your child will be assigned a PICANet ID number to retrieve the information, keeping their identity anonymous at all times. In addition, to understand representativeness of the wider PICU population, anonymous, aggregate level data from PICNAet will be obtained through HQIP.
All data is kept under a secure password protected database, owned by an authorised contractor called Exponential-e (https://www.exponential-e.com/). Only authorised members of ICNARC and the participating PICUs are able to access this. At ICNARC regular backups of your data are undertaken to avoid data loss.
Upon termination of the study, statisticians from ICNARC will assess the feasibility of the protocol. Data is kept anonymous at all times.
How long do we keep your information for?
ICNARC will keep the data for a minimum 15 years following the ICH GCP guidelines upon termination of the study. The site PI will be responsible for archiving all data documents. After 15 years arrangements will be made for confidential destruction of all data.
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 child’s information are limited, as we need to manage your information in specific ways in order for the research to be reliable and accurate.
Additionally, you have the right to have your and/or your child withdraw from any of the items you may have previously consented to, at any given time. Please note that your child’s anonymous data that has been obtained until the time of withdrawal will be kept and used for PICnIC’s research purposes.
More information about PICnIC is available on this website. If you have any other questions or wish to withdraw, please contact:
Alanna Brown Trial Manager Alanna.firstname.lastname@example.org
Gema Milla Research Assistant email@example.com
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
Version 1.0, 14 October 2021