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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.
Not necessarily. If the diagnostic archive is based on premises already licensed by the HTA for storage (e.g.
If the archive functions as a resource for researchers (by inviting applications for the release of samples or advertising the archive as a research resource), it is functioning as a research tissue bank and needs to be covered by a HTA storage licence.
If a diagnostic archive releases tissue for research occasionally upon request, its status as a diagnostic archive remains clear and it doesn’t need to be covered by a HTA storage licence.
Samples used for diagnosis may be stored in an archive to benefit the person’s medical care. These samples can also be valuable resources for health research. Purely diagnostic archives do not need to be stored on HTA-licensed premises as no licensable activity would be taking place.
On completion of such research, the researcher must choose the most appropriate option:
Yes, but the samples must be stored on HTA-licensed premises unless a storage licensing exemption applies (e.g. the research will be carried out under project-specific REC approval).
Yes, unless the storage at each centre is only for up to seven days before transportation.
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.