Human Tissue Authority

The regulator for human tissue and organs

The Human Tissue Authority publishes compliance reports for the Anatomy and Research sectors

Issue date: 
03 August 2016

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 Research sectors.

In December 2015, all HTA-licensed establishments within these sectors were required to provide updates to their licensing information and to complete a self-assessment. These compliance updates have been collected every two years since the first round in 2011.

The collection of this information supports the HTA’s system of continuous licensing. Compliance updates help to maintain oversight of regulated sectors, guides HTA’s regulatory approach to each sector, and informs the scheduling of site-visit inspections.

The reports present a snapshot of selected findings from these compliance updates and provide a brief analysis of the trends and themes.

Allan Marriott-Smith, Chief Executive of the HTA said: “We are pleased to find a high level of compliance amongst establishments licensed in both the Anatomy and Research sectors.

For the HTA, the highlight within the Research report is the high level of compliance with consent standards. This finding affirms our experiences of regulating the sector and supports our view of the sector as ‘low risk’. Similarly, licensed establishments in the Anatomy sector demonstrated their commitment to upholding the dignity of the deceased.

Such findings support our core aim to ensure that human tissue and organs are used safely, ethically, and with proper consent. We look forward to continuing our work with licensed establishments to maintain public confidence in all the sectors we regulate.”

Notes

Research

We license organisations for the removal and storage of human tissue for research in England, Wales and Northern Ireland. This role is limited to licensing premises, such as tissue and brain banks, which store tissue from the living and deceased.

We do not license the use of tissue for research or approve individual research projects or clinical trials. Neither do we have a role in the ethical approval of research. We do, however, work in partnership with other organisations to ensure that the regulatory environment is easy for researchers to navigate and understand.

Anatomy sector

Human bodies are used to teach students and to train surgeons and other healthcare professionals. We license and inspect organisations, such as medical schools, that carry out these activities in England, Wales and Northern Ireland. We do this to provide assurance to the public that bodies or tissue from the deceased are given with proper consent, and are used appropriately.

About compliance updates

Every two years, we ask establishments to self-assess their compliance with HTA licensing standards. These self-assessments are used to inform our approach to regulation, including the scheduling of site-visit inspections. Where areas of non-compliance are found, we work with establishments to help them meet our standards. 

You can view the reports here:

Anatomy sector compliance updates review 2015/16

Research sector compliance updates review 2015/16

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