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If the researcher wishes to use identifiable clinical information on the samples they have received, they must apply have project-specific REC approval. The research tissue bank’s consent form and participant information leaflet must meet the requirements of the General Data Protection...
Where samples have been donated with broad consent, the research tissue bank must be satisfied that the use of the samples complies with the terms of donor consent.
Samples and any associated clinical information must be non-identifiable to the researcher at the point of release.
No. A separate application should be made for each licensed research tissue bank, even if the DI is the same on both licences.
Yes. The application should include information about each collection, including policies for access to tissue in each collection and distribution to external researchers.
Alternatively, the applicant can submit a separate application for each research tissue bank.
Yes, an annual report must be provided to the REC. The annual report summarises the research work of the research tissue bank, publications, updated protocols, applications to the research tissue bank and traceability of tissue being distributed from the research tissue bank.
Approval is given for a period of five years, which may be renewed (for further periods of five years) following submission and review of a renewal application to the REC.
The ethical review applies to the management of the research tissue bank as a whole, including arrangements made with collaborators. There is no requirement for individual research sites involved in human tissue collection (‘Tissue Collection Centres’) or storage to apply for ethical approval....
An HTA licence, when required, can be applied for at the same time as applying for ethical review or afterwards. However, if relevant material is being stored in the research tissue bank, the bank will not be allowed to operate until the required HTA licence arrangements have been confirmed.
The application is made through the Integrated Research Application System (IRAS) by selecting the research tissue bank category. If the research tissue bank will be storing relevant material then the details of the Designated Individual (DI) are required, along with a copy of the licence...
RECs will normally only review research tissue bank applications from organisations within the UK. Applications from outside the UK are only accepted for review if the research tissue bank plans to collect biological samples relating to UK donors.