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How to consent

How to consent

Informed ethical consent is fundamental for any study using human tissue to help improve and develop patient care.

Our team will explain how ethically-approved research studies will use your samples and data, so that you can make an informed decision about whether you wish to donate.

Roxy Brunton-Sim is the research consent lead for the Norwich Research Park Biorepository. She oversees the process of obtaining informed, ethical consent from people donating samples.

What is consent?

“Informed ethical consent is fundamental for any study using human tissue to help improve and develop patient care.”

The process of obtaining informed, ethical consent is a vital first step before any research can take place using samples you donate. It ensures that you fully understand why we are taking a sample, what it will be used for, the processes involved, and any risks. It also shows that you have given your sample voluntarily. This protects your rights

The consent process

Roxy and her colleagues in the consenting team work under NHS governance and are independent of the research trials. They work closely with clinicians at the Norfolk and Norwich University Hospital to let patients know about research studies. This may be in the form of posters or leaflets placed in clinics, or in appointment letters.

If you are interested in donating tissue to help research, Roxy or her colleagues will meet with you during your visit to the clinic. This will give you the full information about donating to help clinical research. You will also have the opportunity to ask any questions you might have.

If after this you consent to donating your sample, you simply complete the consent form. A copy of this form is stored in your patient records, and another is stored securely in the Biorepository’s database. You can also have a copy of your consent form if you wish.

We give you a copy of the Participant Information Sheet. This contains full details of the study. It also has the contact details should you have any further questions. It will also explain how you can withdraw your consent.

If you do consent, we will store your samples and data your samples and data securely in the Biorepository using a unique identifier. This means that the researcher will receive tissue and data that’s anonymous, and they cannot identify you from it. However, if they find something during the research relevant to your health or treatment, they can alert the Biorepository team. The Biorepository team can then consult the secure database and inform your clinician. This system of linked anonymisation (or pseudo anonymisation) protects your identity, but still allows the best possible patient care.

Withdrawing consent

You can withdraw consent at any time. You don’t need to give a reason and this will not affect your clinical treatment. Details of how to withdraw consent are in the Participant Information Sheet or you can contact the Biorepository team.