In April the Human Tissue Authority (HTA) published updated Codes of practice. This guest blog by Regulation Manager Fiona Maleady-Crowe explains what this means for Biobanks.
What are the Codes of Practice?
The HTA’s Codes of Practice provide practical guidance on the human tissue legislation and set out the HTA’s licensing standards. The Codes are important resources which help researchers and establishments comply with our regulatory framework.
Why are there new Codes of Practice?
The previous versions of the Codes were published in 2009. Since then, there have been a number of changes in the sectors regulated by the HTA. Our aim in reviewing the Codes was to make sure they better reflect current practice and guidance. We also wanted to improve the structure of the Codes and Standards and make them more accessible.
Has much changed?
The new Codes have been restructured so they provide a clearer flow of information. There are now seven Codes, rather than nine; there are no longer separate Codes on disposal or on import and export. Instead, guidance on these topics is in the individual codes, where it is relevant.
We’ve also introduced new guiding principles into Code A: Principles and Consent. This is the overarching Code and should be read alongside the sector specific Codes.
In terms of content, little has been removed. More than half of the research sector Code is new, with more examples to reflect current practices. The new information covers topics such as:
- cost recovery and charging;
- consent requirements for DNA analysis;
- licensable storage;
- Research Tissue Banks (RTBs) and diagnostic archives;
What implications are there for Biobanks?
The new research sector Code is as relevant for Biobanks as it is for any person or organisation involved in human tissue research. The Standards have been reviewed so they are clearer and more specific. This does set a higher benchmark. But, it is now easier to understand how to meet the Standards and what we expect from you.
What should tissue custodians do about these changes?
If you are a researcher working with human tissue, you should familiarise yourself with the new Codes and Standards. You can also access webinars on the Codes on our website to help understand the new Codes and Standards.
If you have any questions about the Codes and Standards, you always get in touch by emailing firstname.lastname@example.org.
Is it likely these will change again?
Yes but not for a few years. But, just because the Codes and Standards won’t change any time soon, that doesn’t mean our guidance will remain the same. We’ve published guidance on how to meet the Standards on our website. We intend to review this guidance on an on-going basis to reflect good practice and share learnings between organisations.
Is there anything else Biobanks should bear in mind?
You can keep up to date with all our news by signing up to the HTA’s professional newsletter. And if you ever have any questions, we’re always happy to help. Just give us a call on 020 7269 1900 or email us using email@example.com.