If I have already joined SHARE. Can I now provide consent for the study of my spare blood ?
Please register again, the web site should now offer you the spare blood option. Alternatively you can email the SHARE team at [email protected] or call us at 01382 383471 (due to COVID-19 our team are working from home, please leave a message and we will return your call).
What if I've given permission for my blood to be used for research?
Every time you give blood for a routine clinical test, a small amount is left in the tube. This leftover blood can be valuable for research but your permission is needed to keep and use any of your leftover blood. If you have given permission for your spare blood to be collected, no further action is required on your part. You do not need to come to the hospital, and no additional blood samples will be needed. Only spare blood that remains in the NHS laboratory after you have had a test requested by your doctor will be stored. These samples will be stored carefully and de-identified so they cannot be directly traced back to you as the donor. The samples will only be used in research studies that have been approved by the SHARE Biobank Access Committee, which consists of a panel of doctors and scientists who ensure that research projects are well planned and are of medical value.
What kind of research will be done on the samples that I give permission for?
Recent advances in early diagnosis and treatment of diseases have been in part due to understanding genes and how people’s genetic code can influence disease and their responses to medications. This is an important growing area of research as the discovery of genetic variations can be used to develop new, more effective diagnostic tests, and drug treatments that can be better tailored to patients. Many people in Scotland have already been involved in genetic studies. 10% of the Scottish population has already volunteered for genetic studies into diabetes, obesity, cancer, heart disease, asthma, COPD, eczema or heart disease.
SHARE is helping expand the valuable research being carried out in these and other disease areas. You are giving consent for samples to be used for genetic research; this may eventually involve the reading of your entire genome (all 3 billion letters of your genetic code). In this way, information may be discovered that could provide useful information for the development of new tests or treatments. You may be selected and invited for research studies based on your genetic information in the future.
Why do you want my blood for research?
Using your blood researchers can look at, for example, the role of genes in health and disease or to develop new tests to spot disease earlier. By joining SHARE you are giving permission for your surplus blood to be accessed and securely stored. You are also giving permission for this surplus blood to be used for approved research studies that may include genetic analysis.
When your information is used in this way, your privacy is protected and personal details which identify you are removed (the information is ‘de-identified’). For example, if researchers are looking for blood from asthma patients to study the genes involved in asthma then they will get samples (after approval) from these patients (with no identifiers) but with knowledge that the samples came from asthma patients.
Will you take blood from me ?
It is only blood left-over from samples you may give in the future for testing when you visit your doctor or hospital that will be used. You are simply giving permission for researchers to use any of the left-over blood following routine clinical testing. No more blood will be taken than is usual for standard medical tests. You will not have to give extra samples.
What will happen to my blood sample?
Who will look after my donated blood samples?
Blood samples that are collected by the SHARE Biobank will be looked after by special facilities within the Universities and NHS. All samples will be registered with the Scottish tissue biorepositories. There are four of these in Scotland and they all have been independently accredited to ensure that they follow best practice and relevant laws around the collection, storage and use of human tissue samples. SHARE biobank make sure that the blood samples are coded (de-identified), stored carefully and safely, and that they are only given to researchers for approved research studies. Approval is given by a panel of scientists and doctors who ensure all projects are valid, well planned and of medical value.
Who can take part in this part of the register?
Will blood I donate for transfusion be used for SHARE?
Are there any possible disadvantages and risks of taking part?
As you don't have to do anything beyond completing the registration form, there is no extra discomfort, risk or side-effects.
What will happen to me if I take part?
What are the benefits of taking part in SHARE?
SHARE is making it easier to carry out health research in Scotland. This research is essential to learn about people's health and find better ways to treat and prevent disease. The more people get involved in research the better the help research can be to improving the future health of the whole population. You can keep up to date with research taking place on the SHARE website and our e-newsletters.
Will my taking part in this project be kept confidential?
All information which is collected about you during the course of the research will be kept strictly confidential. Patient confidentiality is paramount within the NHS and SHARE. Your full medical record will never be seen.
What will happen to any samples I give?
A secure code number is used to ensure that your identity cannot be associated with the information obtained from the sample. The genetic data will be collected and stored in secure databases. We will store some of the sample indefinitely for future research, so that we do not have to ask you again. However, we may retain multiple samples when they are processed by the NHS laboratories. This will be used when the original sample runs out, but will also be used for the analysis of non-genetic biochemical markers that may change through time. For example researchers may seek to examine how molecules change throughout the course of disease, or during specific treatments. Samples may also be sent to other research groups, including those outside the UK. Some of these research groups may work with pharmaceutical companies. The sample will be anonymised so that you will not be identifiable from it. These transfers of samples will be strictly governed by Biorepositories, to ensure your privacy and that appropriate research is being performed.
How long will the research last?
This register doesn't have a defined end date. We would ask your permission to store your sample and data (in anonymised form) so that we can consider it for use in future research studies. You are free to terminate your involvement at any time.
What happens when new information is found from this research?
Medical researchers are at an early stage of understanding the importance of most of your genetic code and what differences in the code between people may mean. Researchers using your blood samples will produce reports and publications of what they find out, and that information could point to a better understanding of how diseases develop or new ways to treat illnesses. However, because researchers don’t know who’s blood they are using you won’t be identified in these reports and publications and they or SHARE will not provide information to you about your own individual results.
Nevertheless, as knowledge improves, including from research supported by SHARE, this could guide future tests and treatments offered by the NHS. Publications resulting from SHARE involvement will also be published on the SHARE website (www.registerforshare.org/publications). It is also possible that information about you that comes from research on your samples could be important and helpful to doctors treating you in the future. If that is the case, it may be appropriate at some point in the future for this information to be added to your medical records. For example, we know that people respond differently to some drugs given to prevent heart disease depending on their genetic code. However, SHARE is not set up to do this currently and a change to this policy will require further ethical review and your consent.
Do I need to declare this for Medical Insurance?
Your agreement is to be registered to SHARE and, if you have given permission, to have blood stored for research, and not for the purposes of your medical care. Therefore insurance companies do not need to be informed.
What happens if I decide to withdraw AFTER my sample has been taken?
If you wish to withdraw your sample from the biobank , you simply need contact us and we will request for your sample to be destroyed and data removed from the register. We will confirm this.
If your withdrawal is after a sample has been collected, we will request destruction of any unused samples. However it is possible that - samples may already have been issued to researchers and we may not be able to take further action. The samples are de-identified and samples or results from external research will not be possible to remove.
What will happen if I don't want to carry on with the register?
You can withdraw from the register at any time without having to give a reason. We will remove your details and data from the register, and your blood samples will be disposed of after the clinical test has been carried out. Please contact the SHARE team on 01382 383230 (due to COVID-19 our team are working from home, please leave a message and we will return your call) or [email protected] to do so.
Will I be paid for taking part?
Who has reviewed SHARE?
The South East of Scotland Research Ethics Committee (REC) 2 has examined the proposal and has raised no objections from the point of medical ethics. It is a requirement that your records in this research, together with any other relevant records ,be made available for scrutiny by monitors from the University of Dundee and NHS Tayside, whose role it is to check that research is being conducted properly and the interests of those taking part are adequately protected. This register has also been reviewed by members of the scientific review board of the Wellcome Trust.
You may contact the SHARE team directly by telephoning 01382 383230 for further information at any time.
Email : [email protected]
Alternatively, you may contact your GP for independent advice regarding this register.
If you believe you have been harmed in any way by taking part in this study you have the right to pursue a complaint and seek any resulting compensation through the University of Dundee, who are acting as research sponsor. Details of this are available from the research team. As a patient of the NHS, you have the right to pursue a complaint through the usual NHS process. To do so you can submit a written complaint to :
Complaints and Feedback Team Lead
Complaints and Advice Team
Freephone : 0800 027 5507
Email : [email protected]
Note that the NHS has no legal liability for non-negligent harm. However if you have been harmed, and this is due to someone’s negligence, you may have grounds for legal action against the NHS Tayside but you may have to pay your legal costs.