Consultation on the HTA's Code of Practice and Standards for the Research sector (Code E)

A Code of Practice sets out what licensed establishments and others working in this area must do to comply with the Human Tissue Act 2004, and gives practical advice on how to meet those requirements. The HTA is required to consult publicly before making changes to a Code.

The Research Code is the first Code to be updated as part of the HTA's wider Codes of Practice review programme. As the current Research Code was last subject to a major review around 10 years ago, this consultation gives stakeholders the opportunity to help ensure the Code and Standards remain clear, practical and fit for purpose.

This consultation is aimed at anyone with an interest in the regulation of human tissue for research purposes. This includes licensed establishments, Designated Individuals, researchers, research ethics committees, and patient and public groups, but we welcome responses from all interested individuals and organisations.

This consultation builds on earlier engagement with licensed establishments gathered through an initial survey and a dedicated engagement session.  The feedback received has helped shape the proposed changes to the Code and Licensing Standards set out in this consultation.

• improve clarity and usability
• provide greater practical support and examples
• strengthen research-specific guidance
• clarify regulatory expectations
• support a proportionate and risk-based approach to regulation.

Key changes

Research Code

• Updated introduction setting out the purpose, audience and geographical scope of the Code
• New "How to use this Code" section explaining the HTA's four guiding principles
• Improved structure and navigation to help users find information more easily
• Updated section providing clearer explanations of the research activities regulated by the HTA
• Research-specific guidance throughout the Code
• Improved clarity and consistency in the use of the term "relevant material" throughout the Code
• Greater clarity and consistency around legal duties, exemptions and key terminology
• Updated guidance on the release of diagnostic material for research
• Updated human application section to ensure the Code remains relevant in light of developments in regulation of Substances of Human Origin (SoHO)
• Additional worked examples and practical scenarios to support the application of requirements in practice
• Updated flowchart to support understanding of consent and licensing requirements
• New annex summarising key provisions of the Human Tissue Act 2004 and associated offences

Research Standards

• Updates to improve the clarity and consistency of the Standards
• Refinements to the way certain expectations are described and how compliance may be demonstrated
• Retention of existing requirements where these continue to be effective and fit for purpose

We are keen to understand whether the proposed changes:

• improve the clarity and usability of the Code and Standards
• provide sufficient practical support and examples
• clearly distinguish legal requirements from guidance
• support compliance in practice
• strike the right balance between clarity and proportionate regulation
• identify areas where further guidance, examples or supporting resources would be beneficial

The consultation is open from 28 August until 20 November 2026.

Please read the draft Code of Practice and Standards, then submit your response by 5pm on 20 November 2026.

Responses should be submitted via HTA Research Code E consultation survey.

Alternatively, you may request a copy of the consultation form to complete and return via policy@hta.gov.uk.

Where possible, please reference the relevant paragraph number when commenting on the Code, and the relevant standard ID when commenting on the Standards.

Responses to this consultation will be treated as anonymous. Please do not include any personal information about yourself or others within your responses unless it is necessary to do so. Any personal data inadvertently provided will be processed in accordance with HTA's Privacy Notice.

Consultation events

We are running virtual events during the consultation period to help stakeholders engage with the proposed changes and ask questions before submitting a response. Details to follow. 

Once the consultation closes, we will analyse the responses received and review the draft Code and Licensing Standards, taking your comments into account.

We will publish a summary of the consultation responses and explain how feedback has informed the final version of the Research Code of Practice and Standards.

Feedback received through the consultation may also help inform the development of guidance, resources and future engagement activities.

Contact us

If you have any questions or comments about the consultation process itself, please email: policy@hta.gov.uk