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No, in some research tissue banks the human tissue is taken out by multiple users almost immediately because of the nature of their work (e.g. fresh tissue is required). There are other research tissue banks which are accessible only to the staff of the company.
Yes. The research tissue bank should make this clear to the donor and should also provide information about how it charges, and to whom they will supply the human tissue samples.
The research application should be submitted to the REC which approved the research tissue bank application.
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.