Donating your clinical waste samples

We would like to invite you to take part in our research studies by donating your clinical waste 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

The aim of analysing samples obtained following Orthopaedic or Rheumatology clinical procedures will help us research into the causes, diagnosis and treatment of joint diseases, such as arthritis. Research with such samples can help us to find out more about what causes joint diseases, how to prevent and treat them.

Many different types of research rely on the use of human samples. They can be used to develop new tests or help diagnose diseases or can be used to help develop new ways to treat or even cure diseases. 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 tissue. On the consent form you will be given the option to exclude your tissue from this area of research.

Access to your samples and any personal data that may be associated with your tissue is strictly controlled.  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 sample you donate may be given to other groups within Cardiff University as well as external research collaborators including other Universities and Companies in the UK and abroad for approved medical research.  However samples will not be sold for profit to you or the researchers.

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.

Your samples

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.  Arthritis Research UK BBC will be collecting and storing samples of bone, other tissue from joints and synovial fluid in the secure laboratories at Cardiff University. Some of these samples are stored in a special freezer or fridge with others stored preserved in paraffin wax blocks.

The human sample storage facilities at Cardiff University are used to collect tissues for research only.

Samples collected are usually kept at very cold temperatures and can be stored this way for a very long time. The tissue that is stored in paraffin wax is stabilised before it is stored in the wax and can be stored at room temperature. Your samples will be stored indefinitely or until it is used up.

If you want to withdraw from the study you can request that your sample is removed and destroyed. However any research data already obtained from your sample would remain in the study.

Your involvement

With your permission we will ask your consultant to save the samples removed during your Orthopaedic or Rheumatology clinical procedure for us.

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.

Further information

For further information please contact us.

Arthritis Research UK Biomechanics and Bioengineering Centre