The UK’s Health Research Authority (HRA), set up last December to unify and streamline the country’s research approvals process while protecting and promoting the interests of patients and the public, has secured Department of Health approval to test out a consolidated assessment procedure for all research in the National Health Service.
Work will begin immediately on the feasibility project, which will include a small pilot of new processes to gauge the effect of rationalising and combining aspects of current reviews by NHS Research and Development (R&D) Departments and Research Ethics Committees (RECs) review into a single HRA assessment.
The aim is not so much to centralise existing assessments as to filter out elements of the current review procedures in a way that might improve both study set-up times and the quality and consistency of ethical reviews.
“NHS organisations would be able to rely on the HRA assurance and devote their review to confirming their capacity and capability to host and deliver the research,” the agency explained. “RECs would be able to focus their expertise on projects raising ethical issues.”
Accordingly, the HRA would not be making decisions about research on behalf of NHS Trusts. “There will still be local decisions because individual providers of NHS services remain best placed to determine whether or not they can deliver a research project,” the Agency stressed.
Rather, it will examine the feasibility of a “quality-assured assessment provided by HRA that enables providers to make efficient local decisions on participation based on capacity and capability”. NHS Trusts could also benefit from more integrated working with the REC review system, the HRA noted.
The Agency’s proposal relates both to the research portfolio delivered by the National Institute for Health Research (NIHR) and to non-portfolio studies in England. According to the HRA, the devolved administrations support the initiative and will work with the Agency to provide a UK-wide approach.
As the feasibility project gets underway, collaborative workshops will consider specific areas of the proposal, leading to a pilot in Spring 2013. After that, a decision will be made on whether to move forward to full implementation.
Business plans published by the HRA in May 2012 included recommendations that the Agency should consider:
• The acceptability and benefits of the HRA providing an initial assessment of all shared documentation within the Integrated Research Application System (IRAS), as part of a co-ordinated validation and early-assessment mechanism within the unified approval process.
• The option of a single ‘legal review’ within a HRA-described framework to reduce duplication in reviewing research issues such as data protection, insurance and indemnity, and to consider the role of the NIHR Coordinated System for gaining NHS Permission within a unified approval process.
Early work on these recommendations resulted in the proposal for testing the feasibility of a consolidated assessment procedure.
It is envisaged that a single HRA assessment would “pro-actively identify and resolve issues that may otherwise delay the decision for a REC favourable opinion”, while reviewing study-wide issues of relevance to all NHS providers.
Part of the feasibility project will involve looking at which elements of current arrangements for reviewing research proposals could be undertaken by the HRA.
As the HRA points out, the majority of applications to Research Ethics Committees receive a provisional opinion.
A scoping project run by the Agency found that RECs often have to spend time “addressing minor issues of quality that do not require the full expertise of a committee, mainly in relation to changes to participant information sheets”.
The HRA’s proposal will investigate the potential of providing pro-active advice, support and expertise to research applicants, allowing ethics committee to devote their expertise to “the appropriate ethical issues”.
Portfolio of projects
This is one of a portfolio of projects being taken forward by the HRA under the umbrella of its UK-wide Collaboration and Development Steering Group.