What is the NIHR BioResource?
The NIHR BioResource is a federation of eight individual local BioResources established around Biomedical Research Centres and a Biomedical Research Unit and are based in London, Cambridge, Oxford, Leicester and Newcastle with its National Coordinating Centre (NCC) Headquarters based in Cambridge. Together these local NIHR BioResources are establishing a resource of thousands of patients and volunteers who are interested in supporting research. The NIHR BioResource is supporting research studies looking at how genes influence disease. By gaining more information on the genes involved in disease and by understanding the differences in their function it is hoped that we can begin to cure or reduce the effect of the disease. By looking more closely at how diseases develop, it may be possible to identify new diagnosis and better to help prevent them from happening in the future.
What will happen if I agree to join the NIHR BioResource?
If you agree to join, you will be asked to sign a consent form and provide a small sample of your blood or saliva. Some local BioResources may also collect additional samples (such as saliva, urine and hair) and carry out a brief health check, including body composition, blood pressure and pulse rate. If you decide to join a local BioResource with such additional samples, this will be made clear in their consent form. DNA and other blood components will be isolated from your sample and will be used to measure chemicals in your blood and to determine your genetic makeup. You will also be asked to provide your contact details and answer a short questionnaire about your health and lifestyle. By joining the NIHR BioResource, you are agreeing to be contacted and invited to participate in a range of medical research studies based on data gathered about you either from samples you have provided and/or information you have shared with the study team. You will be provided with full information regarding each of these studies and will be free to decide whether or not to participate.
Do I have to be healthy to take part?
No, volunteers with pre-diagnosed health conditions are able to participate. Different studies are interested in different participants so although you may be excluded from one study because you have a health condition you may be an ideal candidate for another study.
Do I have to take drugs to be involved in NIHR BioResource studies?
No, you do not have to take drugs to help our research. We work with many different researchers and support a wide variety of studies with ranging commitments on behalf of the participants. The most common types of study supported by the NIHR BioResource are those that require the participant to provide a single blood sample. Usually no more than 50 ml of blood is collected and this should not affect your donation regime. Other studies may have different requirements, such as undertaking cognitive tests or fasting. There is no obligation or expectancy on you to take part when you are invited to a study, so you are free to decline without giving any reason.
Can I have feedback about my genes?
Your samples are processed anonymously to make it impossible for anyone in the research team to link your genetic information to you. We therefore cannot offer you any feedback about your genes.
Do I get paid for taking part?
You do not receive any money for joining the National NIHR BioResource or a local NIHR BioResource but you may be offered some remuneration for participating in certain studies to cover your time and any inconvenience. If participation in a study is reimbursed the amount of payment is calculated based on the level of participant involvement in the study and what the study requires you to do. For some studies there will be no payment at all or the payment will be minimal (e.g. travel or parking costs). This reflects the fact that we are funded purely for medical research on a not-for-profit basis.
Will you pass on my genetic information to other organisations such as insurance companies, the NHS or the police?
No, we do not share your genetic information with any other organisations unless forced to do so by the courts of law.
Why do I have to give my NHS number?
You will be asked to provide your NHS number so that the NIHR BioResource can obtain further information about your health from your medical records in order to better tailor your involvement in research studies.
Who will have access to my personal data and genetic information?
We utilise a process called ‘pseudo-anonymisation’, which ensures that research staff who work on your samples cannot identify you. The database that holds the genotyping data is separate to the one that holds identifiable data. Access to both databases is restricted. The database that holds all personally identifiable information such as names, addresses and the answers provided in your questionnaire can only be accessed by the clinical team who may contact you in the future about your participation in research studies. The database that holds the genetic information is accessed by the research team and a limited number of the data services team only who do not have access to the database that holds personal information. We do not share any of your personal data with other organisations.
What happens if you find out something about my health when I participate?
When you join the NIHR BioResource we do not screen your enrolment sample or use it to investigate your health. The sample is used to ascertain whether you have the genes of interest for studies we are recruiting to. Most research studies that you may be invited to participate in, do not offer feedback on your health. However, if you are invited to take part in a study that does involve tests that could provide indicators of your health you will be informed of this prior to participating. We do not complete health screening on blood samples but if you provide a blood sample for a study and there is something clearly unusual about it we will contact you and suggest you visit your GP. There is therefore a small potential for you to find out information about your current health as a result of taking part but nothing that would not be highlighted by normal health screening. The studies will never give you a diagnosis or any information about your genotype so there is no possibility that you will be told anything that has implications for your current or future health as a result of your genetic makeup.
If I am invited to participate in a study does it mean I am at risk of developing a disease?
No, being invited to take part in a study does not indicate that there is any risk to your health. The diseases we are investigating involve many interacting genes in addition to possible lifestyle and environmental factors. It is therefore usually impossible for researchers to infer anything about your health based on these genotypes alone.
I don’t live close to one of the local NIHR BioResources, can I still get involved?
Yes, participants do not have to live close to one of their local NIHR BioResources (Cambridge, London, Leicester, Newcastle and Oxford). They can decide only to join the National NIHR BioResource and can donate a blood sample and participate in future studies if agreed by using their local facilities such as Clinical Research Facilities or participating in alternative ways (e.g. filling in online questionnaires, sending saliva/stool samples to the NIHR BioResource using pre-paid post).
Are there any age limits on participation in the NIHR BioResource?
There are no lower or upper age restrictions for participants joining the NIHR BioResource.
How often will I be contacted if I join the NIHR BioResource?
You may be invited to participate in a maximum of four studies a year. We will also contact you with any recent news and developments, such as through newsletters and bulletins.
What if I change my mind about being involved?
Participants are free to withdraw from the NIHR BioResource at any time without giving a reason. You can chose to withdraw from your local NIHR BioResource and still be enrolled in the National NIHR BioResource (for example if you move houses and the local BioResource is not relevant to you anymore) or you can choose to withdraw from both the NIHR National BioResource and your local NIHR BioResource. Please contact us on 0800 090 22 33 or email with ‘withdraw from NIHR BioResource‘ in the subject line, include your name, address and date of birth in the email, and we will initiate the withdrawal process.
I have changed my email address, what should I do?
You can contact the study team on 0800 090 2233 or email us on email@example.com to let us know and we will update our records so you will continue to receive study correspondence.
Who do I contact if I have any concerns?
If you have any concerns or complains about anything to do with the NIHR BioResource then you can call our Freephone number on: 0800 090 2233 Mon to Fri 9:00-17:00 or email us at firstname.lastname@example.org
Specific for INTERVAL participants
What will happen if I agree to join the NIHR BioResource?
If you agree to join, you will be asked to fill in an online registration form. The first section will ask you for your date of birth and gender. This information will be used by the INTERVAL team to check the link was sent to the correct person. You will then be asked to provide your contact details and complete a consent form. Following your registration you will be sent an NIHR BioResource ‘Welcome pack’ by email which will include a link to a health and lifestyle questionnaire. In the future you may be invited to provide a small sample of your blood (3-10 teaspoons), or further samples if the initial sample you provided was insufficient for certain types of testing. DNA and other blood components will be isolated from your sample and will be used to measure chemicals in your blood and to determine your genetic makeup.
By joining the NIHR BioResource, you are agreeing to be contacted and invited to participate in a range of medical research studies based on data gathered about you either from samples you have provided and/or information you have shared with the study team. You will be provided with full information regarding each of these studies and will be free to decide whether or not to participate.