Coronavirus / COVID-19 - key guidance

• Guidance for sponsors, sites and researchers
  • The Health Research Authority (HRA) website provides guidance about Research Ethics Committees (REC) and NHS/HSC arrangements and information about fast track review of COVID-19 research.
  • For guidance relating to clinical trials of investigational medicinal products (CTIMPs) and medical devices please refer to the Medicines and Healthcare products Regulatory Agency (MHRA) website.


• Health and social care research projects for educational purposes conducted by undergraduate and master’s students
  Health and social care research applications from students working at master’s or undergraduate level are no longer being accepted for Research Ethics Committee (REC) review; Health Research Authority and Health and Care Research Wales (HRA and HCRW) Approval; and/or R&D study-wide review in Scotland and Northern Ireland. Please refer to the guidance published on the Health Research Authority (HRA) website for further details.

21 December 2020: IRAS updated to v5.18. This version includes updates to questions and question specific guidance for studies involving medical devices. Please refer to the Updates page for more information.

04 November 2020: IRAS updated to v5.17.This version includes the withdrawal of the NIHR Clinical Research Network (CRN) Portfolio Application Form (PAF) from use, and some minor question and checklist item changes. Please refer to the Updates page for more information.

1 June 2020: IRAS updated to v5.15. This version implements changes to the way amendments are notified to Research Ethics Committees (RECs) and/or HRA and HCRW Approval / NHS/HSC R&D across the UK. Electronic authorisations have not been affected by this update. Please refer to the Updates page for more information.

• Is a single system for applying for the permissions and approvals for health and social care / community care research in the UK
• Enables you to enter the information about your project once instead of duplicating information in separate application forms
• Uses filters to ensure that the data collected and collated is appropriate to the type of study, and consequently the permissions and approvals required
• Helps you to meet regulatory and governance requirements

• Administration of Radioactive Substances Advisory Committee (ARSAC)
• Confidentiality Advisory Group (CAG)
• Gene Therapy Advisory Committee (GTAC)
• Health Research Authority (HRA) and Health and Care Research Wales (HCRW) for projects seeking HRA & HCRW Approval
• Medicines and Healthcare products Regulatory Agency (MHRA)
• NHS / HSC R&D offices
• NHS / HSC Research Ethics Committees
• Her Majesty's Prison and Probation Service (HMPPS)
  
• Social Care Research Ethics Committee