Who are we?
The Intensive Care National Audit & Research Centre (ICNARC), is the UK sponsor and data controller for the study.
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 other participants). This information (such as your name, date of birth, NHS number, health data and contact details) was collected by the research team at the hospital where you became involved in the study. The research team will also collect information on your survival from your medical records until the end of the study.
What do we do with your information?
ICNARC will follow-up on your well-being by requesting some important health information, including survival and hospital stay data, from national databases held by NHS Digital and NHS Wales Informatics Service (NWIS) - organisations that manage access to a database of NHS records in England and Wales, respectively. To obtain this important information, the TEAM Trial team will send your name, date of birth, home postcode, NHS number and unique trial number (required to ensure you can be identified in the database correctly) to NHS Digital/NWIS using a secure password protected online file exchange service. An authorised person from NHS Digital/NWIS will then link the identifiers to the national records and securely send back the relevant data for storage on the secure password protected database held at ICNARC, with access restricted to authorised research team members within ICNARC.
Once this information has been received, members of the trial team at ICNARC will combine it with information provided by yourself and from hospital records to calculate the information needed for the study’s primary outcome – the number of days alive and free from hospital at 180 days following enrolment into the study. At the end of this process ICNARC will produce a single number (e.g. 80 days alive and free from hospital), that will be transferred to the Australian and New Zealand Intensive Care Society-Research Centre to be combined with other international study data. The data transferred will be anonymised (using your study ID), meaning that the people who receive and analyse the data will not be able to identify you and will not be able to find out your name, NHS number or contact details.
In addition to the above, ICNARC will also use the identifiable data to contact you about the study to complete follow-up questionnaires regarding your health and well-being 180 days after you were entered onto the study.
Identifiable information collected during the TEAM Trial is stored on secure servers at ICNARC (office in London) or servers owned by an authorised contractor Red Technology (http://www.redtechnology.com/). ICNARC takes steps to ensure this information is not lost and makes regular back-ups of the data using authorised contractors (Disaster Recovery Service: http://securemediastorage.co.uk/ and GCI Network Solutions Limited: https://www.gcicom.net/).
How long do we keep your information for?
At the end of the study, ICNARC will keep identifiable information about you for five years 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 Section 6(1)(f) and Article 9(2)(j) (legitimate interest) legal basis from the General Data Protection Regulation. 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.
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 this purpose. 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. As you were very unwell at the time, a relative, close friend or an independent consultee may have provided their opinion, on your behalf. In either situation, you can opt out if you no longer wish that we process your data in these way (contact details below).
More information about the TEAM Trial is available on this website. If you have any other questions or wish to opt out, please contact:
Doug Gould Senior Researcher Doug.Gould@icnarc.org 020 7269 9277
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