The statutory instrument we’ve been waiting for to start setting up the new Health Research Authority (HRA) has been tabled today. Department of health press release here. I haven’t had time for a proper look yet to see what it looks like… This is the first step in creating the HRA. Establishing it as a special health authority to give a home to the National Research Ethics Service, with a plan to establish the authority in primary legislation before moving further research regulation functions – possibly from the Human Tissue Authority and Human Fertilisation and Embryology Authority – into the regulator.
The Academy of Medical Sciences reviewed the regulation of health research in the UK and recommended how this could be improved. Their recommendations included establishing a single regulator of health research. In the Plan for Growth published by the government alongside the 2011 budget, the government committed to setting this up as the Health Research Authority (HRA).
They have said that they plan to set this up as a special health authority in the first instance, introducing primary legislation in the next parliamentary session to make it an official independent body.
The Academy’s report also recommended other measures to make the process of getting permission to do a research project easier, including streamlining the process of getting separate permissions from multiple NHS trusts.
We are waiting for the government to give us more detail on what the Health Research Authority is going to look like and their vision for how it will work. The Academy’s recommendations to improve the system are widely supported and we’re concerned that the new Health Research Authority can deliver these.
The statutory instrument published today will be able to establish the initial special health authority and should give us more of an idea of the government’s vision for how it will look.
The government has committed to consultations on whether the research regulatory functions of the HTA and HFEA will be moved into the regulator. These are expected later this year.
The statutory instrument is due to come into force on 1 December 2011. I think this is a negative statutory instrument so does not have to be debated by parliament. However, if parliamentarians choose to ‘pray’ against it – basically make a public objection to it being passed undebated – within the next 40 days, it will be debated by a committee (more on this procedure here).