The Health Research Authority (HRA) was established in December 2011 to promote and protect the interests of patients in health research and to streamline the regulation of research. All studies taking place in the NHS in England require HRA approval as well as Trust confirmation of capacity and capabability for the study.
The HRA’s National Research Ethics Service (NRES) in England is responsible for Research Ethics Committees (RECs), which safeguard the rights, safety, dignity and well-being of people participating in research in the National Health Service.
The Integrated Research Application System (IRAS) is a single online system for applying for permissions and approvals for health and social care/community research in the UK.
The Research Passport is a system for issuing Honorary Research Contracts (HRCs) or Letters of Access to HEI researchers who need to undertake their research within the NHS.
The Clinical Trials Tool Kit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for ensuring that medicines and medical devices work, and are acceptably safe. All drug and device trials need to be registered and approved by the MHRA.
The Data and Tissues Tool Kit provides practical help with the legislative and good practice requirements relating to the use of personal information and human tissue samples in healthcare research in the UK.
The HRA Confidentiality Advisory Group provides independent expert advice to the Health Research Authority (for research applications) and the Secretary of State for Health (for non-research applications) on whether applications to access confidential patient information without consent should or should not be approved.
National Offender Management Service applications are required for projects that include Prisons or Probation Trusts.