Guidance for Applicants

To all our research ethics customers:

Please telephone the ORECNI staff if you have any questions or queries about the process of ethical review, our experienced staff are here to help.

For information on the research ethics application process, submitting an application for ethical review and access to forms required following ethical approval such as substantial amendment forms, annual progress report forms, end of study declarations, please use the link below:

Health Research Authority

This will redirect you to the Health Research Authority (HRA) website. Ethics applications to an HSC REC require use of the HRA forms and processes.

This site also contains guidance documents, and FAQ and Glossary which may be useful. A mechanism for providing feedback is also available.

Specific Guidance for Northern Ireland Based Studies involving Adults lacking Capacity to Consent (Non-Clinical Trials of Investigational Medicinal Products)

Further information and resources can be found in this guidance document which consists of:

  • Briefing note on current position
  • Case study of emergency research scenario
  • Case study of non-emergency research scenario
  • Flowchart A illustrating emergency research consent pathway
  • Flowchart B  illustrating non-emergency research consent pathway
  • Template Close Relative or Close Friend Information Form Northern Ireland (non-emergency)
  • Template Multidisciplinary Team (MDT) Form (non-emergency)
  • Template Close Relative or Close Friend Information Form (emergency)
  • Template Multidisciplinary Team Form (emergency)
  • Template Registered Medical Practitioner (RMP) Form (emergency)