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Safety reports for all other research

You should refer to the document below for an overview of the safety reporting process


The following guidance applies to research studies other than Clinical Trials of Investigational Medicinal Products (CTIMPs).


If your research is a CTIMP, you should refer to the safety reporting for CTIMPs page.  


Reporting SAEs

If a research participant experiences a SAE you should report this to the Research Ethics Committee that gave a favourable opinion of the study (the ‘main REC’) where in the opinion of the chief investigator the event was:

Serious Adverse Events

A serious adverse event (SAE) is defined as an untoward occurrence that:  

 

(a) results in death,
(b) is life-threatening,

(c) requires hospitalisation or prolongation of existing hospitalisation,

(d) results in persistent or significant disability or incapacity,

(e) consists of a congenital anomaly or birth defect, or

(f) is otherwise considered medically significant by the investigator.

  • ‘related’: that is, it resulted from administration of any of the research procedures; and

  • ‘unexpected’: that is, the type of event is not listed in the protocol as an expected occurrence.

 

Reports of related and unexpected SAEs should be submitted within 15 days of the chief investigator becoming aware of the event, using the form below. The form should be completed in typescript and signed by the chief investigator.

 


Reports of SAEs in double-blind trials should be unblinded.
 
The Coordinator of the main REC will acknowledge receipt of safety reports within 30 days.    


Multi-site studies

You should only send safety reports to the main REC. Other local RECs acting as assessors for individual non-NHS trial sites have no responsibilities for monitoring safety issues. 


Annual progress reports

There are separate requirements for the submission of annual progress reports to NHS RECs.