More from the HTA on the plans to reorganise the regulation of health research

Posted on August 15, 2011 by


The Human Tissue Authority’s latest newsletter just popped into my inbox and it has a few interesting bits of info on the planned changes to research regulators – in particular that the consultations we have been expecting on the future of the Human Fertilisation and Embryology Authority (HFEA) and HTA are expected in October or November.

There’s also a clear statement of the HTA’s position on any reorganisation; they are keen to ensure that all their functions, including the regulation of all research involving human tissue, are kept together in one place as they are at the moment in the HTA. The original plan was for the HTA’s functions to be split up with the research regulating functions being moved into a single regulator of all health research.


In their review of Department of Health arm’s length bodies published last July, the government proposed to put the research regulation functions of the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) together into a single regulator of research.

The Academy of Medical Sciences review of the regulation of health research in the UK in January went on to recommend a single regulator of health research be established and in the Plan for Growthpublished alongside the 2011 budget, the government committed to setting this up as the Health Research Regulatory Authority (HRRA).

The government is planning to establish the HRRA as a special health authority shortly, introducing primary legislation in the next parliamentary session to make it an official independent body.

The government have undertaken to consult on the movement of the research regulation functions of the HFEA and HTA and not to move them before the HRRA has been set up in primary legislation.

The Public Bodies Bill has been introduced to give government the necessary powers to reorganise the HFEA and HTA without opening up the original legislation which established them. This has been debated by the Lords and is currently in the Commons.

Interesting bits on this from the HTA newsletter

The Government’s consultation on the HTA and Human Fertilisation and Embryology Authority’s (HFEA) functions is expected to start in October or November. In the meantime we are working increasingly closely with the CQC and the HFEA and on the shared services agenda.

To support this approach we have agreed with the CQC and the HFEA that we will adopt a strategic partnership agreement which will set out the principles of working together on a tripartite basis, to ensure the most efficient use of our combined resources, to ensure a joined up approach with the other bodies, and to reduce the burden on those we regulate.

The Authority’s ambition of keeping all our functions (including research) together appears to have general support. This is good news for public confidence in the safe and ethical use of human tissues and organs, and should give greater reassurance regarding the retention of expertise and for the future of the HTA.

What next?

The HTA have a page keeping track of the changes and their position

The public bodies bill which would give the government the power to reorganise the HTA’s functions is still being debated by parliament – a Commons committee will begin scrutinising it clause by clause on 8 September.

We are waiting for the consultations on the movement of the research regulation functions of the HFEA and HTA to be published.


Posted in: Policy