The Health Research Authority (HRA) launches today as a Special Health Authority (SpHA), completing one of the key commitments made by the Government in the Plan for Growth, published in March 2011, towards rationalising and improving health research regulation. The Health Research Authority Directions 2011 comes into force today.
The HRA has a vital role to play in the health research system. Its central purpose is to protect and promote the interests of patients and the public in health research. The HRA will co-operate with others to combine and streamline the current approval system and promote consistent, proportionate standards for compliance and inspection. In doing so it will reduce the regulatory burden on research-active businesses, universities and the NHS, and improve the efficiency and robustness of decisions about research projects.
In its initial form as a SpHA, the HRA has the National Research Ethics Service (NRES) as its core and has taken on the functions, which have been the responsibility of the National Patient Safety Agency. In due course, it will perform the Secretary of State’s function of approving the processing of patient information for medical research.
Preparatory work continues on establishing the HRA as a Non Departmental Public Body (NDPB), which will enable it to take on more functions. There will be a consultation on the future of the Human Fertilization and Embryology Authority to determine if its research-related functions should pass to the HRA. The timing of its set up as a NDPB will take place when parliamentary time allows. It is the intention to publish clauses on the Health Research Authority for pre-legislative scrutiny in the second session.
The Director of NRES, Janet Wisely, is the interim Chief Executive. The recruitment of the Chair and Chief Executive will begin in the New Year.
The Minister for Health, Earl Howe said:
“The HRA will protect the interests of patients and the public taking part in research and will benefit both the research community and the life sciences sector by simplifying and streamlining the regulatory processes associated with health and care research.”
Dame Sally Davies, the Chief Medical Officer said:
“The new Special Health Authority is good news all round. It will provide the continuity and stability of the national research ethics system but will simplify the way regulations governing research are used whilst ensuring the safety of patients and the public is paramount. More patients will be able to take part in research, gaining access to innovative technologies or treatments and thereby provide the evidence to improve NHS services and the health outcomes for us all.”
Janet Wisely, the Interim Chief Executive of the HRA said
“The establishment of the HRA has been keenly awaited by many and I am delighted to have been given the opportunity to lead the organisation in its early months. The ambitions for the HRA are vital and real, we will begin immediately and we have published today our plans for the coming few months. These will provide tangible improvements as we work with colleagues to unify approval processes for research and to establish a consistent national system of research governance.”
National Patient Safety Agency (Amendment No.3) Directions 2011 published on 1 December 2011.