My project is Research – what approvals do I need?
My project is Research – what approvals do I need?
HRA Approval
All research projects taking place in the NHS in England require HRA approval as well as Trust confirmation of Capacity and Capability for the study. The Health Research Authority (HRA) promotes and protects the interests of participants in health research and streamlines the regulation of research.
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.
IRAS application
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.
Research Passports
The Research Passport is a system for issuing Honorary Research Contracts (HRCs) or Letters of Access (LoAs) to Higher Education Institutions (University) researchers who need to undertake their research within the NHS.
Clinical Trials Tool Kit
The Clinical Trials Tool Kit provides practical advice to researchers in designing and conducting publicly funded clinical trials in the UK.
MHRA Approval
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.
Data and Tissues Tool Kit
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.
RP - CAG Approval
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.
Prisons and Probation Service
HM Prison and Probation Service applications are required for projects that include Prisons or Probation Trusts.