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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....
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.
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.
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.
No. A separate application should be made for each licensed research tissue bank, even if the DI is the same on both licences.
The management arrangements should ensure that each research application is subject to scientific critique, is appropriately designed in relation to its objectives and is likely to add something useful to existing knowledge.
The HTA has issued a code of practice on Public display which provides guidance to professionals.
Skin graft recipient tests positive for hepatitis B six months after the skin grafting procedure.reportable as a suspected SAR (communicable disease which may be linked to the tissue product).
Stem cell recipient exhibits fever post infusion, haemoculture matches bacterium discovered in...