The HTA ran a consultation on the proposed changes to its Codes of Practice and Standards documentation. The consultation, which was open until 5pm on 30 October 2015, provided an opportunity for all those with an interest in the HTA’s regulatory activities to inform the development of the revised Codes and Standards which will be published, subject to approval by Parliament, in 2016.
The HTA produces Codes of Practice and Standards to give professionals practical guidance on human tissue legislation. Since the last major review of the Codes of Practice in 2009, there have been a number of changes within the sectors we regulate, and to the HTA’s interpretation of its governing legislation.
The HTA sought comments and feedback on the revised Codes and Standards from professionals working in HTA licensed organisations, partner organisations, and anyone else who may have an interest in these documents. The feedback received from the consultation was used to inform the further development of the Codes and Standards, to ensure that they provide licensed establishments with a clear, streamlined, and user-friendly set of documents to support their work.
The HTA held workshops across the UK throughout September and October, to enable those working in sectors licensed by the HTA, interested stakeholders and members of the public, to engage with the review.
The consultation questions, along with the revised Codes and Standards can be found here.
The Human Tissue Authority
The Human Tissue Authority regulates the use of human tissue and organs in England, Wales and Northern Ireland. The interests of the public and those we regulate are central to our work and our aim is to ensure the safe and ethical use of human tissue and organs, with proper consent.
HTA Codes of Practice and Standards
The HTA produces Codes of Practice for professionals across the sectors we regulate, to give them advice and guidance on how to meet our Standards. The Codes also give guidance on the regulatory requirements for organ and bone marrow donations from living people.
Relevance to the public
The Codes of Practice and Standards provide the public with information about how HTA-licensed organisations and HTA-licensed activities should operate. The Codes also provide advice and guidance for professionals on informing the public and their families about their options and seeking consent for the use of organs, tissue and cells. The Codes also give guidance relating to organ and bone marrow donations from living people.
The Codes and Standards have been revised and re-structured to provide a clearer flow of information, and to reduce the volume of documentation that establishments need to refer to.
The restructure means that establishments will need only to follow Code A – ‘Guiding principles and the fundamental principle of Consent’ plus their relevant sector Code(s) and Standards as follows:
Code B – Post-mortem examinations
Code C – Anatomical examination
Code D – Public display of body parts
Code E – Research
Code F – Donation of solid organs for transplantation
Code G – Donation of allogeneic bone marrow and Peripheral Blood and Stem Cells