What is SHARE?
SHARE, The Scottish Health Research Register and Biobank, is a register of adults and children aged 11 years and over, who are willing to be invited to take part in medical research projects and have also consented to allow researchers to use any leftover blood following routine clinical testing, for approved research. Often people who want to be involved in medical research (whether they are unwell or healthy) don’t know where to start or who to ask. Researchers have a similar problem; they need people to take part in studies but sometimes find it difficult to find enough people to take part in them.
Getting involved in research studies can range from answering surveys, having your blood tested, testing new medical devices and phone apps, to sometimes participating in studies. SHARE is for both healthy people and those with medical conditions. With your help, researchers can improve their understanding of diseases, find new ways to prevent or treat illnesses, and improve future care.
When you register, you will also be invited to give permission for any spare blood leftover following routine clinical tests, to be stored and used by researchers. Your blood could be useful for looking at the role of genes in diseases, as an example. The blood is stored carefully and only used for research that has been approved. You will not be identified so researchers won’t know whose blood they are using.
What do you mean by "Research Register"?
A Research Register is a collection of information about individuals. Our register connects people interested in being research participants with health studies.
Why is SHARE needed?
In order to develop new tests, treatments or ways to improve care, volunteers are needed to take part in research. We want to make it easier for people (healthy and those who may have medical conditions), to become involved in research. SHARE aims to help people find research projects which are relevant to them but also helps researchers find the right people for studies. SHARE allows individuals to register their interest directly.
SHARE was set up in 2012, to play a key part in helping improve Scotland's future health. At the moment, it is difficult for academics and those running studies to identify those individuals whose health profiles could benefit ongoing studies. Those who register with SHARE, allow secure access to their health records under tightly controlled, secure conditions.
The key to success in research is to be able to study as many people as possible, and therefore we are asking everyone in Scotland over 11 years of age to take part. This is regardless of current disease diagnoses or drugs prescribed.
Why do you need my personal information?
When researchers want to carry out a healthcare or medical research study, they will approach the custodians of the Register to identify individuals who are suitable for their study; they will look for specific characteristics such as: age, sex, geographical location, diagnosis of a specific health condition, prescribed medication or possibly individuals who are entirely healthy. Searching the register can return useful information for researchers, for example: "currently 231,000 people in Scotland have diabetes, of which 201,000 are Type 2". SHARE can identify how many individuals with specific characteristics are registered and, only if it is appropriate to do so, identify who they are as they may be potential research participants. The SHARE Team will approach suitable registered participants to inform them of current opportunities to be involved in studies.
How do health trials work?
Each one is unique and can vary from academic desk research to long term participation such as studies of child development over many years. Not all involve drug or medical intervention and may instead be more interested in lifestyle and environmental factors.
Why do you want my blood for research?
Researchers can learn a lot from looking at your blood, for example, they can investigate the role of genes in health and disease, or develop new tests to spot disease earlier. When you join SHARE, you can give permission for your surplus blood (spare blood remaining after routine blood tests) to be used for approved research studies that may include genetic analysis.
We ensure your sample(s) is (are) securely stored. If you give permission for your blood to be stored and accessed for research, your privacy is protected and personal details which identify you are removed from your sample (the information is ‘de-identified’). For example, if researchers require blood samples from individuals with a diagnosis of asthma, they will only obtain de-identified samples (after approval); no identifiable information will be available to researchers (they will not be able to tell whose blood sample they are using).
What happens when I give 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 the leftover blood that remains in the NHS laboratory after you have had a routine test, 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; the committee consists of a panel of doctors and scientists who ensure that research projects are well planned and are of medical value.
What will happen to my blood sample?
- The sample will be labelled with a barcode so no one can see any identifiable information.
- This anonymised / de-identified sample is then stored in the freezer to be used when a project, approved by ethics, makes a request for it.
- No one knows who the blood is from.
- They only know the age, disease and gender of the participant.
SHARE works in partnership with researchers in other institutions, charities, and pharmaceutical companies. To carry out research, sometimes samples and some health data is required eg, age, sex, disease, medication. Strict controls are in place to ensure your health data is stored securely. Before researchers receive samples and/or data needed for a research project, the information is de-identified (i.e. your name and all other identifiable information is removed, and you cannot be identified).
Is SHARE part of NHS Scotland?
SHARE is part of NHS Research Scotland (NRS) and NHS Scotland, both of which promotes and supports excellence in health research so that patients can benefit from new and better treatments. NRS is a partnership involving Scottish NHS Boards and the Chief Scientist Office (CSO) of the Scottish Government. The overarching aim of NRS is to ensure that NHS Scotland provides the best environment to support clinical research through the application of best practice. The CSO provides funding to support this aim. SHARE has the total support of the Scottish Government.
Who is involved in SHARE?
SHARE is a partnership organisation which includes Scotland's Medical Schools, Scotland’s Universities with academic partners, and supportive charities, such as the British Heart Foundation, Diabetes UK, Chest Heart & Stroke Scotland and the Stroke Association. SHARE is also supported by the Chief Scientist Office of the Scottish Government.
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 register, together with any other relevant records, be made available for scrutiny by monitors from the University of Dundee and NHS Tayside. It is the responsibility of the University of Dundee and NHS Tayside, 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.
Who is organising and funding SHARE?
The Register is part of NHS Research Scotland (NRS) and is organised and sponsored by NHS Tayside, with funding from the Scottish Government Chief Scientist Office (CSO).
The Biobank, which is the collection, storage and approved access of spare blood, is organised and sponsored by the University of Dundee and NHS Tayside, in collaboration with the Universities of Aberdeen, Edinburgh and Glasgow. The Biobank is funded from various academic and commercial grants including the Wellcome Trust.
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. To improve the future health of the nation, we need more people now to get involved in research. You can keep up to date with research taking place on the SHARE website and our e-newsletters.
How does SHARE work?
How does SHARE work and how could I be invited to participate in studies?
Joining the register is easy; all you need to do is provide your name, date of birth, postcode and contact details. This is the only information required to link to your health records within the NHS. Your details will be kept secure within the NHS Systems at the Health Informatics Centre (HIC).
- First of all, you need to complete the short SHARE registration form. This takes less than 1 minute to do.
- Researchers will approach SHARE with a prospective project. HIC will complete a coded data search to find anyone in the register who is eligible to participate. A list of names will be sent to the SHARE Team.
- Only HIC and the SHARE Team will be able to see your name and contact details. SHARE will contact you to explain what the research is about, and to answer any questions you may have.
- If you are interested, and only with your agreement, the SHARE Team will pass your contact details to the researcher; they will get in touch with you to discuss it further.
- You can decide if you want to take part in the study. It is your choice and you can say no at any time. There is no obligation to take part in any project. Financial incentives may be available for some studies and others will cover expenses.
- SHARE won't be involved directly in any study you participate in. We will keep track of your participation in a study and when the study completes, we may contact you about further studies.
What sort of research would SHARE invite me to take part in?
You might be asked to take part in some studies as a 'healthy volunteer', possibly because of your age or your sex, or simply because you are located near the site of the study. In other cases, you could be invited to take part in research studies because of a specific medical condition or because you are prescribed a specific medication. For example, if you suffer from chronic pain, you might be asked to take part in a study exploring a new drug for pain management.
Scotland has a first-class record of medical research and this covers a huge range of ailments from what some might see as minor to debilitating and life-limiting diseases such as cancer, diabetes, multiple sclerosis and motor neurone disease.
If I give permission for my spare blood to be used in research, what kind of studies will be carried out using the sample(s)?
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, with 10% of the population having volunteered for genetic studies into diabetes, obesity, cancer, asthma, chronic obstructive pulmonary disease, eczema or heart disease. SHARE is helping expand the valuable research being carried out in these and other disease areas.
You can give your 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). You may be selected and invited for research studies based on your genetic information in the future.
Will you take blood from me?
No, we will not take blood from you. We will only use leftover blood from samples you may give during routine testing when you visit your doctor or hospital. You are simply giving permission for researchers to use any of the leftover blood. No more blood will be taken than is usual for standard medical tests.
Will blood that I donate to the Blood Transfusion Service, be used for research?
SHARE does not access any of the blood you donate to the Blood Transfusion Service. If you are a blood donor please continue to donate.
Are there any possible disadvantages or risks of giving permission to use my blood for research?
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 give permission for my spare blood to be used in research?
No further action is required on your part; you do not need to come to the hospital, and no special blood tests will be requested. We will only store blood that remains in the NHS laboratory after you have had a test requested by your doctor. All stored samples will be anonymised / de-identified so that they cannot be directly traced back to you as the donor. Your identity will be kept separate from your anonymised / de-identified samples. Any medical information and samples used in research will have all personal information removed so that it cannot be identified as you.
What currently happens with medical data?
Every day, NHS computers throughout the country routinely talk to each other, swapping and updating information about the health of the Scottish population. The information held on these computers deals with such things as hospital admissions, waiting times, GP visits and outpatient appointments. There are also several computer-based registers which hold details on people with specific illnesses: for example, cancer or diabetes. Usually, this information is used anonymously at the national or regional level to plan, deliver and monitor the health service.
Your GP practice routinely stores your records on computer, coded to provide a shorthand summary of your state of health. NHS emergency workers can, with your permission, look at the Emergency Care Summary to get information about prescribed medicines and allergies. This is copied from your GP computer system and stored electronically. Your health records are managed to the highest level of security. Many searches can be done automatically by computer using the codes, so no person needs to look at individual records.
How will my information be used?
When you register for SHARE, you are giving permission for NHS Tayside Health Informatics Centre (HIC) to search your NHS health information to see if your characteristics match those needed by researchers for their studies. This may include your genetic profile if you have given permission for your blood to be stored. For example, a search might be conducted to find people on the register who are over the age of 40 years and have a diagnosis of diabetes. A list of people sharing these characteristics will be generated by HIC and shared with the SHARE Team. The SHARE Team will contact the individuals identified on the list, to ask if they are interested in speaking to the researchers who are carrying out a particular study and asking if they would like to be involved.
Researchers will not be able to identify or contact you, until you have given permission to the SHARE Team for this to happen.
Your full medical or genetic record will never be seen by SHARE or the Research Team (only information relevant to the study will be looked at).
Your privacy is paramount to the NHS and SHARE; your health information will only be used by SHARE in the way that you have given permission for when registering and in accordance with UK Data Protection Law and General Data Protection Regulations.
How are my donated blood samples used and stored?
Blood samples that are collected by the SHARE Biobank will be looked after by special facilities within the Scottish Universities and NHS; the samples are registered with the Scottish Tissue Biorepositories. There are four Tissue Biorepositories 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.
The SHARE Biobank ensures that 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.
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/these samples 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 out with the UK. Some of these research groups may work with pharmaceutical companies. The sample will be anonymised so that you will not be identified as the donor. These transfers of samples will be strictly governed by Biorepositories, to ensure your confidentiality and that appropriate research is being performed.
How long will the research last?
This register does not 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 withdraw at any time.
What happens when new information is found from research using my blood?
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. Information could point to a better understanding of how diseases develop or new ways to treat illnesses. However, because researchers don’t know whose blood they are using, you will not be identified in these reports and publications; researchers or SHARE, will not provide information to you about your own results.
The increase in knowledge from studies carried out (including those supported by SHARE), could guide future tests and treatments offered by the NHS. It is also possible that information that comes from research using your samples, could be important and helpful to doctors treating you in the future. If that is the case, it may be appropriate 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 currently not set up to add new information to health records and a change to this policy will require further ethical review and your consent.
Publications resulting from SHARE involvement will also be published on the SHARE website (www.registerforshare.org/publications).
Will I be paid for taking part?
You will not be paid for joining the Register, or for allowing your spare blood to be used in research studies. However, some studies may offer travel and subsistence costs if you participate. The real benefit of the SHARE register however lies in each individual helping to find better ways to relieve or cure a wide range of medical ailments.
How do I join?
How do I join the SHARE register?
Volunteers can sign up using the SHARE App or through our website www.registerforshare.org. The process should take about one minute. The only information we require is your name, date of birth and postcode; this is all we need to accurately identify you within the existing NHS system of records. Register here!
If I have already joined SHARE, how can I now provide consent for the study of my spare blood?
Please register again through our website. Alternatively you can email the SHARE team at [email protected] or call us at 01382 383471.
What happens to me after I join?
What will happen if I join?
If you decide to join SHARE you are agreeing to allow us to use the coded data in your various computer records to check whether you might be suitable for research projects, for example, we might seek individuals who have increased blood pressure, but who are not being treated by drugs.
We will contact you by letter, email or phone to let you know about any relevant studies that are suitable for you to take part in. It is entirely up to you, whether you participate.
You can tell us how often you would like to hear from us. We usually get in touch 2 – 3 times a year. Remember, joining the Register does not mean that you have to take part in research; it means that you are willing to be approached by us, about studies that might be suitable for you. If you are interested in participating in a study, a researcher will contact you (and you can still say no to them).
Do I have to take part in a study when invited?
No. It is your choice whether to take part in any study. Signing up to the Register involves no commitment to take part in studies. Should your health profile be found to match that of a research project in the future, SHARE may contact you to tell you about it and invite you to take part. However, it is up to you to decide at that time if you wish to take part.
Could there be any risk to my health in taking part in a clinical trial?
Trials are highly regulated. Most studies investigate the effect or usefulness of a new or revised treatment. Some are explicitly set up as safety studies. In all cases, safety is paramount. Participants are continuously monitored and studies would be modified or stopped if any risk was identified. Most studies use existing procedures and medicines and pose virtually no risk. If a treatment is novel and risk was less clear it would be clearly discussed with you before anything happened. You could of course choose not to proceed at any point.
Will I be bombarded by information from SHARE?
No. You can set limits on how often you want to be contacted about appropriate opportunities. Opportunities are very unlikely to arise more than 2 or 3 times per year at most. You can request we contact you once per year if you wish.
How can I find out more about the studies conducted through SHARE?
Please check our studies page on our website (click here) at any time to see the latest research updates from within the SHARE community.
Do I need to declare my involvement for Medical Insurance purposes?
Your agreement is to be registered with 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.
I'm worried about confidentiality
Your medical records will be held securely at all times. When a researcher wishes to contact people for a study, NHS staff will carry out a search through NHS electronic records to identify individuals that may meet the conditions that the researchers needs to complete their study (e.g. they may be interested in people who have high blood pressure or possibly healthy people who have never been in hospital). SHARE Register staff will then approach identified individuals to tell them about the study opportunity. If you are contacted and interested in participating in a study, then with your permission, we will let the researchers know. If not, you are completely free to decline.
Will my taking part in a study be kept confidential?
Yes. The General Data Protection Regulations (GDPR) and the NHS policies on Confidentiality and Records Management safeguard your privacy, as they do already. Your participation in the Register is also confidential.
Who will have access to my records?
No one will see to your health records when you register with SHARE. If you are on the SHARE Register, secure NHS computers are used to perform coded searches on your records by NHS staff. An example of a search for study participants could be to identify individuals who have a diagnosis of a specific disorder or individuals who are prescribed a particular medication.
What safeguards do I have that my personal health records will remain confidential?
The NHS adheres to strict governance policies and guidelines including Codes of Practice on Patient Confidentiality. All searches for patient identifiable information must be approved. In addition, much of the basic analysis and selection is completed anonymously; your name and address are only made available when we need to contact you. Even the act of addressing envelopes and posting letters is carried out according to the strictest possible rules and regulations.
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.
How do I manage my membership?
How long will I be registered for?
This register does not have a defined end date. We will keep you on the SHARE Register indefinitely and if you have given permission for use of your leftover blood, this may be kept indefinitely. However, you are free to withdraw at any time.
What if my contact details change?
If you change your phone number, mobile number or email address, please get in touch with your new contact details: [email protected].
What if I change my mind after registration? How do I withdraw if I want to?
You are free to withdraw from the SHARE Register and Biobank at any time. This will not affect your normal health care.
You registered to be contacted for medical research projects and this may have been at your medical appointment at your GP or at your local Hospital. You have total control and can decline to respond to any invitation to take part in a health study at any time, without having to give any explanation. You can also be withdrawn from the SHARE register. However, we need to know if you wish to:
- Unsubscribe from newsletters.
I no longer wish to receive newsletters.
- Withdraw from contact.
I no longer wish to receive invitations to take part in research studies but you may continue to collect and use samples for anonymous research.
- Withdraw from the Biobank.
I wish to withdraw from spare blood collection but you may continue to use my anonymised stored blood samples for research. No further blood samples will be collected. Please note it is possible that samples may already have been issued to researchers and we may not be able to take further action.
Please note if you would like to make any further clarifications to these options, please contact a member of our team.
Please can you email us ([email protected]) or call us (01382 383471 / 383230) to give us further information and we will act as per your request.
We will need your full name and postcode to identify your registration.
What happens if I decide to withdraw AFTER my sample has been taken?
If your withdrawal from the Register and Biobank is after a blood sample has been collected, we will store any previously collected samples for research but please be assured that all blood samples are de-identified (anonymised). If you would like us to make any further amendments please contact us. However, it is possible that samples may have been issued to researchers for their studies; in this case we may not be able to take further action. It will not be possible to remove any data obtained from external research findings (using your sample), should your sample be used in a study, prior to your withdrawal from the Register.
What if I have a complaint?
Please get in touch with the SHARE Team. 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
Level 9, Ninewells Hospital, Dundee, DD1 9SY
If you have any questions that cannot be answered from the above information, please get in touch with the SHARE Team: [email protected].