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The HTA only has the power to make a decision on a case if the donor is a child not competent to consent, or an adult lacking capacity to consent. The HTA must therefore explore competence before confirming whether or not we can make a decision on the case. If a child appears to have competence...
When the HTA receives notification of an SAE or SAR, a member of the serious adverse events and reactions (SAEARs) team will review the information provided in the initial report and contact you if further information is required. Establishments are expected to submit a follow-up report once...
There are specific circumstances when you can carry out procurement under a third party agreement rather than a licence. In order to carry out procurement under a third party agreement you must:
The Human Tissue Authority (HTA) has been responsible for regulating living organ donation since 1 September 2006. This is when the Human Tissue Act 2004 came into force.
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.