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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.
For researchers working in NHS Scotland, it is expected that one of the four Healthcare Improvement Scotland-accredited Scottish Health Board research tissue banks will be used.
The HTA’s remit does not cover REC-approved research tissue banks in Scotland.
No, applications are voluntary but REC approval may facilitate programmes of research without a need for individual project-specific REC approval.
Not always but broad consent may avoid the need to seek further consent and this avoids a situation where a valuable tissue resource cannot be used for research in the future.
The types of research for which the tissue will be used should be explained, along with the circumstances under which the tissue will be disposed of.
If the tissue donated will be identifiable, the donor should be informed if they will be contacted by researchers, given feedback, or be...