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If you or someone within your organisation is carrying out procurement of tissues and / or cells for patient treatment, an HTA licence will normally be required. Procurement may be carried out by an unlicensed establishment under the terms of a third party agreement, provided:
Any serious adverse reaction in a living donor which may influence the quality and / or safety of tissues and cells should be reported to the HTA.
There are no time limits for which signed consent forms remain valid and there are no legal requirements for the format of consent forms. There is no need to ask for new forms to be signed if consent was written down by the donor several years before he or she died.
A serious adverse event (SAE) can occur at any stage from donation to transplantation. A suspected SAE should be reported to the HTA when one or more of the following applies:
The initial notification to the HTA should be made within 24 hours of the discovery or determination of the SAE or SAR by the licensed establishment. Third parties and end users should be instructed to report to the licensed establishment within 24 hours of their discovery of SAEs or SARs.
A follow-up report should be submitted using the online system within 24 hours following completion of the internal investigation.
New licence applications for processing of tissue or cells for human application must include a PPD to describe the process validation. Processing of the tissues and cells cannot commence until the processes proposed under a new licence have been authorised. We also require new or modified...
S45 and Schedule 4 of the HT Act set out the provisions regarding DNA. However, where relevant material is removed from a body or stored for the purpose of DNA analysis, the scheduled purposes in Schedule 1 of the HT Act may also apply.
Copies of relevant human tissue legislation are available via the government legislation website.
The HTA has issued a code of practice on Public display which provides guidance to professionals.