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The following guidance has been produced to bring clarity to the issues surrounding consent under the Human Tissue Act 2004 for research relating to transplantation where donors are deceased. It applies in England, Wales and Northern Ireland, and is not affected by the Human Transplantation (...
Schedule 1 of the Human Tissue Act 2004 (the Act) sets out ‘performance assessment’ as a ‘scheduled purpose’.
An HTA licence is required if the human cellular material (‘relevant material’) to be stored for performance assessment has been removed from the deceased.
The Human Tissue Authority (HTA), the regulator for human tissue, cells and organs, has today published compliance reports for establishments licensed in the Anatomy and
The HTA has issued new General Directions for the anatomy, public display, research and post mortem (storage only) sectors, along with a
Establishments that conduct human tissue research under recognised research ethics committee approvals are exempt from being licensed for the storage of relevant material for research under the HT Act 2004.
A practical guide to implementing the Human Tissue Act (2004)'s requirements around research
This policy sets out the legal requirements of the HT Act with regard to consent for post-mortem examination, tissue retention and storage of tissue from the deceased.
The Human Tissue Act 2004 requires that the removal of tissue from the deceased for research within the scope of the Act must always be licensed, on specified premises, and that specific minimum requirements are met.