You are being invited to take part in a research study. Before you decide to participate or not, it is important for you to understand why the research is being done and what it will involve. We will need a decision in a short period of time and one of our team will go through the information with you to make sure you understand. Ask us if there is anything that is not clear or if you would like more information or time.
What is the purpose of the study?
Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 infection is a new rapidly spreading infectious disease. The virus causes a spectrum of disease ranging from mild cold-like symptoms to severe lung failure requiring admission to an Intensive Care Unit, to receive respiratory support via ventilation. Guidance from Public Health England identifies several groups that are at risk of severe disease including the elderly and individuals with chronic lung disease. Guidance from Public Health England identifies several groups that are at risk of severe disease including those with secondary immune deficiencies who should be prioritised for SARS-CoV-2 vaccination. This research study has been designed to help us understand the impact of immune deficiency on the immune response to vaccination. We will testing immune responses in patients who have been asked to attend hospital for SARS-CoV-2 vaccination.
Why have I been invited?
You have been chosen for this study because you have history of an immune deficiency and you have received a SARS-CoV-2 vaccine OR your clinical team have arranged for you to come to hospital for a SARS-CoV-2 vaccine. In total 340 people are being recruited to this study.
Do I Have to Take Part?
No, it is up to you to decide if you would like to take part. Your participation is voluntary. If you decide to take part you will be given this information sheet to keep and be asked to sign a consent form. You do not have to give any reason for declining to participate in the study. If you decide to take part you are still free to withdraw at any time without giving a reason. A decision to withdraw at any time, or a decision to not take part, will not affect the standard of care you receive. If you decide to withdraw from the study, samples collected prior to withdrawing will be utilised as part of the study unless you specifically ask for this to be withdrawn.
What will happen to me if I take part?
You will be seen by a member of the research team who will answer any questions you have and will go through the consent form with you. We would like to take 60mls of blood (2 tablespoons) for research purposes as well as samples from inside your nasal passage. All samples collected from you during the course of the research will be kept strictly confidential. Information or samples leaving the hospital with your name and address on will be removed so that you cannot be recognised.
Additional Blood Samples
The blood we collect will be stored in a freezer. With your permission, we will analyse this blood for biomarkers (molecules), which have been measured in SARS-CoV-2 vaccine trials. As the biomarker analysis is very early in its development, we do not anticipate the results to be meaningful for you at this stage and you will not receive additional results related to the biomarker analysis. Additionally, with optional consent, your samples will also be used to obtain DNA (genetic material) and RNA to help us study genes and their impact on the lungs and circulation. Lastly, again with your consent, we would also like to use some of the blood sample for additional research analyses as yet not specified. The samples collected will be stored for a maximum of 15 years.
Additional, Airway Samples
The samples we take from your nasal passage will be stored in a freezer and will be analysed as part of this study. Again, these samples collected from you will be kept strictly confidential, with samples leaving the hospital with your name and address on will be removed so that you cannot be recognised. We anticipate that we can find out how your upper airway responds to SARS-CoV-2 vaccination.
Data Collected
We would like your permission to collect the clinical data from your hospital visit including medication history, past medical history, blood pressure readings and any additional relevant information that you have as part of routine clinical care.
Follow Up
We would like to take the blood and nasal samples before your first 2 vaccines (if you have not received this as yet) and then 1 month and 6 months after your second vaccine. We will try and co-ordinate as close as possible your last 2 study visits with your clinical follow-up. If that is not possible, additional study visits will be arranged as needed at 1 and 6 months after completion of SARS-CoV-2 vaccination.
What do I have to do?
This is a simple study involving the blood and nasal sampling and data collection only.
What is the procedure that is being tested?
There are no new procedures being tested. We are evaluating the blood and nasal samples in response to SARS-CoV-2 vaccination.
What are the possible disadvantages and risks of taking part?
There are no perceived risks of taking part in the study other than minor risk and discomfort from venous blood and nasal sampling.
What are the possible benefits of taking part?
You may not personally gain any benefit from taking part in this study. If analysis of your immune function shows a significant clinical risk, we will inform you and your GP directly. By taking part you may help us to decide the best strategy for individuals with viral infections in the future.
What if new information becomes available?
Sometimes during the course of a research project, new information becomes available about the blood test results that are being studied. However, if some, as yet unknown, significant new information came to light that had a bearing on the study and your participation, this would be considered by the committee of experts who will oversee the conduct of the study and you would be informed.
What happens when the research study stops?
When the study is completed you will not be required to continue with any study procedures. If you agree, we will store samples and data from this study for future ethically approved research projects. Again, these samples collected from you will be kept strictly confidential, with your name and address removed so that you cannot be recognised.
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. 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 (RGIT).
Will my taking part in this study be kept confidential?
All information and samples collected about or from you during the course of the research will be kept strictly confidential, with information or samples leaving the hospital with your name and address on will be removed so that you cannot be recognised.
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 10 years after the study has finished in relation to data subject consent forms and 10 after the study has completed in relation to primary research data.
We will need to use information from your medical records for this research project. This information will include your initials, NHS number, name and contact details. 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.
LEGAL BASIS
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
INTERNATIONAL TRANSFERS
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. If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.
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-about-patients/
- by asking one of the research team
- by sending an email to prosaic-19@imperial.ac.uk
- by ringing us on 02033158251.
COMPLAINT
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 dpo@imperial.ac.uk, 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?
When the study is completed and the information analysed the results will be presented at scientific conferences and published in scientific journals. Your identity will not be divulged in any presentation, publication or report. You will be able to request a copy of any publications of the results from this study.
Who is organising and funding the research?
Imperial College is the sponsor for the study and is responsible for ensuring all aspects are carried out to a high standard. The study is being funded in part by the Wellcome Trust. A Steering Committee of experts in lung, immunology, heart disease and research methodology will oversee the conduct of the study. No researchers are receiving any personal payment over and above normal salary, or any other benefits or incentives, for taking part in this research.
Will I get paid to take part in the study?
You will not get paid to take part in the study, but we will be able to reimburse reasonable travel expenses for extra study visits required as part of the study. Please contact the local study team (details below) if required.
Who has reviewed the study?
The South-Oxford A Research Ethics Committee has reviewed this proposal and has given ethical approval and your hospital’s Research and Development department have reviewed the study for locality issues and given approval for the study to take place at your hospital.
What if there is a problem?
If at any point you have a concern about any aspect of this study, please ask to speak to the researchers who will do their best to answer your questions. Alternatively contact your hospital patient advice and liaison service as details below:
Harefield PALS department – 01895 823737 Ext: 6572
Consent form
Click here to download the PROSAIC-19 study patient consent form.
Contact for Further Information
Thank you for taking time to read this patient information sheet. If you decide to take part, we will ask you to sign a consent form. You will be given a copy of the signed consent form and the patient information sheet.
Investigator Name: Dr Anna Reed
Research Nurse: Vicky Thwaites and Hayley Middleton
Contact Number: 01895 823737 Ext 83042, Bleep 6429
Thank you for taking the time to read this. Please ask any questions if you need to.