Did you know that you could donate blood to help develop treatments for, and the understanding of, the COVID-19 virus? We are interested in ALL patients attending hospital, not just those with respiratory symptoms, and healthcare workers.
We are asking you if we can take and store a blood sample to understand the inflammatory and immune responses within the population, during the COVID-19 pandemic. This will be done anonymously and all blood samples will be destroyed after processing is complete.
Please take time to read the following information carefully and discuss it with friends and relatives if you wish to. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether you wish to take part in our research or not. If you decide to take part, you may keep this Participant Information Sheet.
WHAT EXACTLY IS THE RESEARCH ABOUT?
The COVID-19 pandemic is a global health problem and potentially one of the biggest challenges the NHS has ever faced. One of the most difficult things to understand and potentially one of the most important things to understand is why some people who get COVID-19 become very sick and others do not.
We will measure chemical substances in your blood (such as cytokines) that indicate inflammation, and other molecules that fight infection. We will also look to see if your genes (the DNA building blocks for everything in your body) contribute to the risk of becoming become sick.
What does the study involve? We are inviting you to be involved in our study by providing us with a blood sample
What will happen if I agree? If you agree a blood sample (the equivalent of three tablespoons of blood) will be taken and transferred to the Nottingham Tissue Bank, where they will be processed in a laboratory that is licensed by the Human Tissue Authority (HTA), in a way that maintains the quality of the samples. If you are a patient, your blood will be taken in one visit by one of the doctors or nurses during your hospital visit in the ward where you are in.
Will I be told the results of individual research tests on my sample? No. Individual results of research on your samples will not be given to you or your doctors (including your GP) because this research is not
part of any routine medical treatment you might be having. The overall results of the research may be published as research papers in scientific and medical journals.
WHY ME?
We are looking for all patients and healthcare workers (male or female) of any age to donate blood to help develop our understanding of this pandemic. In the future people like you could benefit from this work.
If you are a healthcare worker we are inviting you to provide several blood samples a week apart.
HOW WILL MY BLOOD BE USED?
We need blood samples to l allow us to understand how many people have had the disease (by testing for antibodies), and to see if they have any substances in their blood that are related to the presence of COVID- 19 symptoms such as cough or fatigue
WHAT DO I HAVE TO DO TO DONATE MY BLOOD?
Giving your blood will not affect you in anyway and there is NO increased risk to your health. The blood you have donated will simply be transferred to our laboratories where the research will be performed. If you would like to donate your blood, you will be asked to sign a consent form. If you are a patient here, you will not undergo any additional tests than what you would normally.
HOW WILL MY DETAILS BE STORED AND USED?
All information on blood and tissue donors is stored in a secure unit within the Nottingham Tissue Bank (NTB), in accordance with the General Data Protection Regulation (GDPR). Only designated personnel will have access to such data (information). The scientists working on your donated blood tissue will not have access to any of your personal information. Personal data is not kept for longer than is necessary and all obsolete data is destroyed by fire. Personal data is not processed for any other purpose or passed onto third parties for any use.
Does the NTB benefit financially? The NTB is part of the University of Nottingham and NHS Trust, and is therefore non-profit making. We are able to recover the costs from researchers for work carried out on their behalf. The benefit to the University and Trust is that blood and tissues are made available for research purposes, which helps to improve medical knowledge and ultimately aims to improve patient care.
HOW EASY IS IT TO SAY ‘NO’?
It is very easy to say ‘NO’. There is no obligation or pressure on you to give a sample of blood. Some people will prefer, for personal reasons, not to give their blood. You are free to say ‘NO’ for whatever reason you may have, you do not need to share any reason and no further questions will be asked.
You may withdraw your consent to blood donation at any time by contacting the Nottingham Tissue Bank on 0115 8231117.
WHO WE ARE
The Nottingham Tissue Bank (NTB) is located in the Queen’s Medical Centre, within the University Department of Orthopaedics, Trauma and Sports Medicine and we store human tissue for transplant and research purposes (including blood). We are a Licenced Tissue Bank (no. 11035) in accordance with the Human Tissue Authority (HTA) regulatory system for Tissue Banks. The HTA regulate organisations, such as hospitals and Universities that remove and store human tissue (including blood) for research and medical treatment. They provide advice and guidance about the Human Tissue Act 2004. This law ensures that human tissue is used safely and ethically, with proper consent. For more information on licensing, regulations and inspections go to www.hta.gov.uk.
In relation o this research on COVID-19, a partnership between the University of Nottingham and Nottingham University Hospitals NHS Trust, a team of doctors and scientists are working together to improve the outcome for people like yourselves
FURTHER USEFUL INFORMATION
Will information about me be given to people outside of the Trust? All information about you will remain confidential and will be stored in accordance with the General Data Protection Regulation (GDPR). Under the GDPR you are entitled to see what is recorded about you. No information will ever be released to an insurance company. Your blood is given a unique identifying number which we store within a secure database. We need this information to keep accurate records on the blood collected, and for audit purposes, which is a requirement of the Human Tissue Authority.
Do I benefit in any way? We all may benefit at some point in the long term from your donation, but it is unlikely that there will be any direct benefit to you. You will not receive any personal reward for donating your blood.
What are the risks to me? There is NO increased risk to your health. You may have a small amount of bruising from where you’ll have your blood sample taken. This will disappear after a few days. You will only be allowing us to use blood samples (which may be collected anyway as part of your normal care) and there are no more risks of giving blood for research beyond that of your normal treatment.
What happens if I change my mind? You can change your mind at any time by contacting the NTB on 0115 8231117. You do not have to give a reason why. If you tell us you have changed your mind, this will not affect your care or treatment in any way, now or in the future and all blood samples in storage will be disposed of according to hospital policy. Similarly, the information we stored about you will be deleted. We will also contact any research groups using your blood and ensure that they destroy any unused samples and associated data (information). If you change your mind after a long period of time, the samples may already have been used. We cannot recall samples or information from researchers if this is the case.
What do I do if I need to make a complaint about the removal of my blood or the consent process? If you wish to make a complaint about the donation process, you may do so by contacting the Nottingham Tissue Bank on 0115 8231117.
CONTACT INFORMATION
If you require any further information or have any questions, please contact either:
- The Nottingham Tissue Bank (NTB): 0115 8231117
- Miss Jessica Nightingale. Orthopaedic Research Manager, Queens Medical Centre, Derby Road, Nottingham. NG7
Thank you for considering taking part in our study.
Feedback? We appreciate and encourage feedback If you need advice or are concerned about any aspect of care or treatment please speak to a member of staff or contact the Patient Advice and Liaison Service (PALS).