Donating your blood and urine samples
We would like to invite you to take part in our research studies by donating your blood and urine samples.
To help you decide on how you can best help us, we would like you to know more about:
- why we need your help with our research
- what happens to your samples that you provide
- what your involvement in our research would mean for you
- what happens with the results from our research.
Why we need your help with our research
This will help us research the causes, diagnosis, treatment and/or monitoring of joint problems (such as following injury or due to disease) and may also be used for a number of our related research studies. We are asking your permission to use your samples to study these joint problems.
Many different types of research rely on the use of human samples. They can be used to develop new tests or help diagnose injuries or diseases, or can be used to help develop new ways to treat or even cure joint problems. Some of the research may lead to new medical products, such as diagnostic tests and drugs, or new procedures.
We may want to carry out genetic research (for example the identification of genes or diseases that run in families) on your sample. On the consent form you will be given the option to exclude your tissue from this area of research.
Your samples may be retained at the end of this study for use in future research within the UK and abroad. At this stage we do not know what the research will involve but some of it could include genetic research (for example the identification of genes or diseases that run in families), animal research or use in the commercial sector. On the consent form you will be given the option to exclude your tissue from these areas of research.
All tissue will be supplied anonymously; recipients of the tissue will not be able to identify you from your tissue. Your tissue will not be sold.
You may withdraw your consent for the storage and future use of your samples at any point. If you do withdraw your consent your tissue will not be used in any subsequent studies and will be destroyed according to local practices. Any tissue already distributed for use in research prior to the withdrawal of consent will continue to be used in that study and any tissue remaining at the end of the study will be destroyed.
Access to your samples and any personal data that may be associated with your samples is strictly controlled and all members of staff undertaking future studies will bide by the Data Protection Act 1998 with any medical information related to you kept confidential.
The samples you donate may be given to other groups within Cardiff University as well as external research collaborators, for example, other Universities and Companies, in the UK and abroad, for approved medical research but the samples will not be sold for profit to you or the researchers.
Such researchers will only receive your donated samples and when appropriate, information about you (such as your sex, age and the reason for your clinical procedure) from your hospital record. The researcher will not receive your name, address, phone number or any other personal identifying information. This is done to protect your confidential information.
The tissue storage is organised and administered by the Arthritis Research UK Biomechanics and Bioengineering Centre at Cardiff University under the HTA licence. The Centre is funded by Arthritis Research UK and Cardiff University.
Some of the studies carried out in the centre are collaborations with industrial partners. We will provide you with additional information when this is the case.
This study has been reviewed by the Research Ethics Committee (REC) for Wales.
Cardiff University has a Human Tissue Authority (HTA) licence for the storage of human material for research purposes. This allows us under the Human Tissue Act to store human samples under strict and robust guidelines. We will be collecting and storing samples of blood and urine samples in the secure laboratories at Cardiff University. Some of these samples are stored in a special freezer or fridge; others are stored preserved in paraffin wax blocks.
The human sample storage facilities at Cardiff University are used to collect samples for research only.
Samples collected are usually kept at very cold temperatures, and can be stored this way for a very long time. Your samples will be stored indefinitely or until it is used up.
With your permission, we will ask a member of your clinical team or researchers who have been suitably trained to collect blood and/or urine samples during your routine clinic visits. In some circumstances, we may ask you to provide blood and/or urine samples at other times. The collection of blood and urine would involve up to half an hour of your time.
On the consent form we ask you if we can contact you at other times, if you are willing to provide these samples. We will pay any reasonable travel expenses you incur if you are asked to provide these extra samples.
For our studies we would like to collect information from your medical record, such as your weight, and record details of your condition, such as diagnosis and the results of various tests. We would also like to follow your progress after your procedure by looking at information that your doctor has collected from you during your routine follow-up visits. You will not have to make a special trip or appointment for this. Your doctor may record such information such as the medications you are taking and whether your level of pain has changed.
We would also like to ask your permission to send you ethically approved surveys or questionnaires to complete. This enables us to collect standardised information about large numbers of tissue donors. They ask questions about lifestyle choices such as smoking or exercise. No personal information will be collected without your permission.
In order to do research with your samples, researchers may need to know some things about you such as your age, sex, race, medical history, diagnosis, treatments and possibly some medical history. This information will be collected from your health record by the study staff. They may also look at your medical record in the future in order to update your personal health information. Neither your name nor any other identifying information will be shared with researchers.
Sometimes a note may be placed in your record that says you took part in this research study. This is so we can be informed if you are visiting clinic or having any future procedures. No research results will be placed in your medical record. Research results will not be shared with your doctor, you or your family members or used for your medical care.
If you agree to give up to a 40ml (eight teaspoons) sample of blood, where possible we will perform this at the same time as one or more of your routine clinical samples. If this is not possible, you may experience some minor discomfort from having the extra blood sample(s) taken. If you agree to provide a urine sample, there would be the minor inconvenience of you collecting this. There are no other obvious disadvantages to taking part in the study.
Genetic testing will be for research not diagnostic purposes and it may be many years before the results of any such tests could have clinical implications. In the consent form you can opt to have your GP informed of any findings that may be clinically relevant to you or your family, however you will not be notified personally of any clinically relevant results.
If you are harmed by taking part in this research project, there are no special compensation arrangements. If you are harmed due to someone's negligence, then you may have grounds for legal action but you may have to pay for it.
Regardless of this, if you wish to complain, or have grounds for concerns about any aspect of the way your have been approached or treated during the course of this study the normal National Health complaints procedure is available to you. The Complaints Officer can be contacted on +44 (0)29 2074 6296.
All information that is collected about you during the course of the research will be kept strictly confidential. No information about you will leave the hospital with your name and address on it so you cannot be recognised.
You can decide to withdraw from the study at any point. If you want to withdraw you can contact the research team and make that request and the samples and information we have obtained can be withdrawn and destroyed. However, any research data already obtained from your sample would remain in the study.
The results of our research
The results from these studies will be submitted for presentation at scientific conferences and publication in scientific journals. You will not be identified in any presentation or publication.
There will be no direct benefit to you because your sample will not be used for your immediate medical care. However, it is hoped that the results of the research on your samples and samples from other patients will provide information that will help patients with similar joint problems.
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