The UK’s Department of Health (DH) has endorsed, and announced extra funding for, the Health Research Authority’s plans to implement a single application, assessment and approval process for National Health Service research proposals in England.
Earl Howe, Parliamentary Under Secretary of State for Quality, said the government would provide additional investment of more than £4.5 million in 2014-15 “to enable the HRA to take forward this important work”.
The Health Research Authority reported last October that it had presented a business case and options appraisal to the DH for HRA Assessment and Approval of research in the NHS.
The aim is to introduce a single approval for research in the National Health Service that will incorporate assessments from NHS staff employed by the HRA alongside an independent Research Ethics Committee opinion.
Excessive effort
As things stand, a typical clinical trial in the NHS may involve thousands of patients at more than 20 NHS sites, the HRA pointed out.
The research team will need to have the study reviewed by a Research Ethics Committee, while also seeking permission from each participating NHS organisation before it can begin recruiting participants at that site.
Researchers have complained that the existing process requires excessive effort and incurs unnecessary costs for all concerned, as well as causing delays to the overall research effort and hampering the benefits for patients and the public, the HRA noted.
Standardised expectations
Addressing practical, legal and ethical aspects of research studies, the HRA Assessment and Approval system will be based on standardised expectations for study documents and applications, providing “authoritative assurance to NHS organisations about the suitability, compliance and quality of research proposals”.
Decisions on participation at NHS sites can then be made “on local capacity and capability alone”, the agency said.
The process will also be coordinated with matching mechanisms in the devolved administrations and with other regulatory approvals, so that the approval process for research proposals will be unified across the UK.
HRA Assessment and Approval will be available for both National Institute for Health Research (NIHR) portfolio studies and for non-portfolio studies in England.
Builds on NIHR efforts
The agency will now recruit a team to develop and implement the plans with key partners – in particular the NIHR Clinical Research Network, which said the initiative built on its efforts to reduce the number of days it takes to obtain NHS permission for conducting a research study across all sites.
This metric has “improved five-fold in two years”, the Network added.
With a single approval process, researchers will be able to “get to the business of answering the research question more quickly, and we can offer patients the opportunity to take part in studies that could benefit them without delays”, commented Dr Jonathan Sheffield, chief executive of the NIHR Clinical Research Network.
The HRA will also work closely with the devolved administrations to maintain UK compatibility.
Health research falling under other specific legislation will still need to secure the relevant approvals from other regulators, the agency observed. These approvals will continue to be coordinated within an overall UK-wide framework for research.
The intention is to roll out the new system on an application-type basis.
Multiple benefits
Researchers will benefit from HRA Assessment and Approval through its elimination of duplicate application routes and paperwork, enabling them to “work on establishing research sites, recruiting participants and completing studies on time”, the HRA said
Patients will reap the benefit through earlier opportunities to participate in studies, as well as “efficient and effective” research leading to improved treatments and care, the agency added.
Industry will gain from “more joined-up access” to NHS sites for research, making the UK a more attractive location for health studies, the HRA noted.
“The research community will start to see further gains over the next few months,” commented Janet Wisely, chief executive of the Health Research Authority.
“When fully implemented, this will streamline research in the UK: a real win for patients, for researchers, for funders and for industry, making the best value of everyone’s contributions.”
More competitive
Government funding for a centralised HRA assessment and approval process was also welcomed by the Association of the British Pharmaceutical Industry (ABPI), which has previously called for a streamlined research-governance process to help sharpen UK competitiveness in attracting clinical studies.
“Improved NHS management of clinical trials is a key driver of UK competitiveness, ensuring that clinical research remains at the heart of innovation in the NHS,” commented ABPI clinical development manager Dr Rebecca Lumsde.
