The U.K. Department of Health has approved the Health Research Authority (HRA) funding plans for HRA Assessment and Approval. This funding means the HRA will be able to reduce duplication and bureaucracy by incorporating assessments by NHS staff alongside the independent Research Ethics Committee opinion, which will result in one application, one assessment and one approval for research in the NHS in England.
These proposals will build on recent improvements in timelines for approvals, will radically simplify the regulation of research and will remove complexity for researchers and industry.
The HRA now will streamline this complex process, with the HRA’s Approval addressing practical, legal and ethical aspects of the study. This will allow local research teams to work with their NHS trust to set up and deliver the study.
The HRA will be able to recruit a team to develop and implement the plans with key partners, particularly the NIHR Clinical Research Network. It also will work closely with the devolved administrations to maintain U.K. compatibility.
Janet Wisely, chief executive of the HRA, said, “We are delighted that the Department of Health has approved our business plan. The research community will start to see further gains over the next few months. When fully implemented, this will streamline research in the U.K.: a real win for patients, for researchers, for funders and for industry, making the best value of everyone’s contributions.”
Earl Howe, Parliamentary Under Secretary of State for Quality, said, “I am pleased to announce the government will provide an additional investment of over $7.5 million in 2014-2015 to enable the HRA to take forward this important work.”
Jonathan Sheffield, chief executive of the National Institute for Health Research Clinical Research Network, said, “Clinical research is a vital component in improving treatments for NHS patients, so it is important that we do everything we can to streamline the process of setting up a study. That way, researchers can 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. We look forward to working with the Health Research Authority as they develop their plans to implement the single approval system, building on the great work that we, and others, have already done to speed-up the process of setting up a clinical research study in the NHS.”