Today we have launched our updated Codes of Practice and Standards, which are available on our website here. These provide practical guidance on human tissue legislation for professionals.
We will also shortly be publishing lay guides to the Codes for the public, so they can be clear what to expect from establishments who work with human bodies, organs, and other tissue.
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 our interpretation of the governing legislation.
Our new Codes of Practice and Standards ensure that:
- the Codes and Standards reflect our current interpretation of the law and regulatory practice;
- the Standards are fit for purpose; and
- the Codes and Standards make our regulatory requirements clear, while minimising regulatory burden where possible.
Today’s launch marks the culmination of work that began in 2014, to produce a new streamlined set of Codes, which are underpinned by a set of principles drawn from the Human Tissue Act 2004.
In 2015, we carried out a wide-reaching public consultation on the proposed changes to the Codes. The consultation provided an opportunity for all those with an interest in the HTA’s regulatory activities, both professionals and members of the public, to inform the development of the revised Codes and Standards.
In December 2016, the revised Codes and Standards received Ministerial and Parliamentary approval and from today, the HTA will begin inspecting against them.
- The new Codes now seek to provide a clearer flow of information, and there are now fewer documents that establishments need to refer to.
- There is no longer a separate code on Disposal, nor on Import and Export. We have instead, included guidance on these topics in the individual codes, where it is relevant, so that the advice is tailored more to the needs of each sector.
- Code A on Consent, is the first of the suite of Codes, and is the overarching Code that all establishments must follow.
- The restructure means that establishments will need only to follow Code A, plus their relevant sector Code(s) and Standards.
Allan Marriot-Smith, Chief Executive of the HTA said: “The Codes of Practice and Standards are fundamental to our work, and are the primary source of advice and guidance we offer on the Human Tissue Act. Since 2009, when our Codes were last reviewed, we have seen many changes take place within the areas that we regulate, and to the way we licence and inspect organisations.
Our new Codes ensure that we provide further clarity and guidance to those whom we licence. By providing professionals with a clear, streamlined, and user-friendly set of documents to support their work, we can ensure that the way we regulate is straightforward and efficient.
We are committed to making sure that both the public and professionals continue to have confidence in the safe and ethical use of human tissue and organs, and we very much look forward to continuing to work with our licensed establishments in the months and years ahead.”
Notes on the Human Tissue Authority (HTA)
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.
Notes on the 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.
- The Codes of Practice and Standards provide professionals and 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. They 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 all the information establishments require is in Code A – ‘Guiding principles and the fundamental principle of Consent’ plus their relevant sector Code(s) and Standards, which are as follows: