Participant Information Sheet
Research study title: SCAMP COVID19 – the Sleep and Physical Activity (SPA) study
Dear SCAMP participant,
You are being invited to take part in the SCAMP COVID19 SPA Study. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read this information, it has everything you need to know about this study. If you have any questions regarding the SPA study, please contact by emailing email@example.com.
What is the purpose of the SPA Study?
Due to the COVID-19 pandemic, life has changed substantially for individuals at all levels of society. Under this circumstance, the SCAMP COVID19 study is conducting to evaluate impacts of COVID-19 pandemic and public measures on adolescent mental health and wellbeing. As a part of the SCAMP COVID19 study, the SPA Study is interested in understanding whether any changes to sleep or physical activity because of COVID-19 lockdown restrictions have had an impact on adolescent mental health.
Why have I been chosen?
You have been selected to participate in partly due to your important contribution to the personal monitoring study in SCAMP we carried out between 2016 and 2018, which monitored a representative sample of about 200 SCAMP participants. We measured your mobility/location by using the ExPom device, and your physical activity by using a smartphone-based activity diary throughout the three-day study period. This data will provide a baseline estimate for physical activity prior to COVID-19 lockdown restrictions, which can be used for comparison with the data we are collecting now. The SPA study size will consist of up to 200 dedicated participants (including you).
Do I have to take part?
It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason, but we will keep information about you that we already have.
What will happen to me if I take part?
A personal wearable wrist device called Garmin watch will be used to monitor and measure your sleep, physical activity and personal mobility, and the data will be stored on the Garmin Connect platform. The SCAMP Team will post a package containing the wearable device, a pre-paid return envelope, and a detailed instruction to your personal address making the process as hassle free as possible. You will need to download Garmin Connect APP on your phone to login and setup your profile. After the one-week duration of the study, the wearable device must be returned via the pre-paid return package and reply to us with the tracking number. You will also need to complete a sleep, physical activity and mobility diary online using the link we email to you every day, to help us better understand your physical lifestyle and sleeping habits.
What are the possible disadvantages and risks of taking part?
The wearable wrist device that will be given to you for the duration of the study period does not pose any health risk to you or anyone around you. The device has been CE certified and is safe to operate in the UK.
What are the possible benefits of taking part?
By taking part in this study, you will be contributing to better understanding of the link between sleep, physical activity, mobility and the mental health of adolescents. Upon the return of all equipment back to the team you will receive a £50 Amazon gift voucher for your efforts.
What happens when the research study stops?
All data will be stored long-term on a secure computer network at Imperial College. Your identifying information including name and address are stored separately from information about your health and behaviour to preserve confidentiality.
What if something goes wrong?
Imperial College London holds insurance policies which apply to this study. If you experience harm or injury as a result of taking part in this study, you will be eligible to claim compensation without having to prove that Imperial College is at fault. This does not affect your legal rights to seek compensation.
If you are harmed due to someone’s negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator (Professor Mireille B Toledano; firstname.lastname@example.org). The normal National Health Service mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial College, Research Governance and Integrity Team.
How we will use information about you?
Imperial College London is the sponsor for this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Imperial College London will keep your personal data for 25 years after the study has finished in relation to data subject consent forms. We will need to use information from you for this research project. This information will include your name, date of birth, and contact details, held by Imperial College London. People will use this information to do the research or to check your records to make sure that the research is being done properly. People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure. Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
As a university we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research. This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study.
Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research.
There may be a requirement to transfer information to countries outside the European Economic Area (for example, to a research partner). Where this information contains your personal data, Imperial College London will ensure that it is transferred in accordance with data protection legislation. If the data is transferred to a country which is not subject to a European Commission (EC) adequacy decision in respect of its data protection standards, Imperial College London will enter into a data sharing agreement with the recipient organisation that incorporates EC approved standard contractual clauses that safeguard how your personal data is processed.
Sharing your information with others
For the purposes referred to in this privacy notice and relying on the bases for processing as set out above, we will share your personal data with certain third parties: other College employees, agents, contractors and service providers (for example, suppliers of printing and mailing services, email communication services or web services, or suppliers who help us carry out any of the activities described above). Our third party service providers are required to enter into data processing agreements with us. We only permit them to process your personal data for specified purposes and in accordance with our policies.
What are your choices about how your information is used?
You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
Where can you find out more about how your information is used? You can find out more about how we use your information at www.hra.nhs.uk/information-aboutpatients/, by asking one of the research team by sending an email to email@example.com.
If you wish to raise a complaint on how we have handled your personal data, please contact Imperial College London’s Data Protection Officer via email at firstname.lastname@example.org, via telephone on 020 7594 3502 and/or via post at Imperial College London, Data Protection Officer, Faculty Building Level 4, London SW7 2AZ.
If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO). The ICO does recommend that you seek to resolve matters with the data controller (us) first before involving the regulator.
What will happen to the results of the research study?
Study findings will be published in scientific journals but no data individually identifying you’re your family or your school will ever be published. Key findings will be shared with you, your parents, and your school via newsletters, social media and the SCAMP study website. Feedback on individual participants will not be available.
Who is organising and funding the research?
The study is being organised by Imperial College London and funded by the Medical Research Council. Researchers will not be paid for including you in this study.
Who has reviewed the study?
This study was given a favourable ethical opinion for conduct by the North-West Haydock Research Ethics Committee.
SCAMP COVID19 SPA Study Participant Information Sheet, Version 1.0, Date 10.08.2021
IRAS number: 150360