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Annual Progress Reports

 
NHS Research Ethics Committees (RECs) are required to monitor research that has received a favourable opinion.


Introduction

A progress report should be submitted to the REC which gave the favourable opinion (the ‘main REC’) 12 months after the date on which the favourable opinion was given. Annual progress reports should be submitted thereafter until the end of the study.


  • Study commencement date

  • Extension of the period of the study 

  • Multi-site studies 

  • Review by the main REC 

  • Waiving the requirement for progress reports 

  • Safety reports  

Study commencement date

The first annual progress report should state the commencement date for the study. This is normally assumed to be the date on which any of the procedures in the protocol are initiated.
 
If the study has not started within 12 months of the favourable opinion, you should give an explanation for the delay in the first progress report.  


Extension of the period of the study

If the chief investigator plans to extend the duration of the study beyond the period specified in the application form, you should notify the main REC in writing, giving reasons for the extra time needed to complete the research.  
 
Extension of the study period is not in itself a substantial amendment, except where it is related to other amendments that would be substantial. You do not need to obtain a favourable ethical opinion from the REC for extension of the study period.   

Overview of safety and progress reporting

Forms

There are separate forms for submitting progress reports, depending on the type of research:  

 

 

You should complete the forms in typescript and have them signed by the chief investigator. A paper copy should be sent to the REC within 30 days of the end of the reporting period.


Multi-site studies

In the case of multi-site studies, you only need to send progress reports to the main REC. You do not need to send copies to other local RECs. 

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Review by the main REC

The REC office will acknowledge receipt of all progress reports.
 
The REC chair and/or another REC member will normally review progress reports in correspondence. They will notify the full committee at its next meeting that the report has been received.
 
The chief investigator may be invited to attend a meeting of the main REC or a sub-committee to discuss the progress of the research.
 
The main REC does not need to re-confirm its favourable ethical opinion each time a progress report is received. It is generally assumed that the opinion applies for the duration of the research, although the REC may review its opinion at any time. 

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Waiving the requirement for progress reports

Following receipt of the first progress report, the chair of the main REC has the discretion to waive the requirement for further reports on receipt of a written request from the chief investigator. This might be appropriate where a study has completed recruitment and intervention but has a long period of follow-up with minimal participant involvement.  

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Safety reports

You should note that there are separate requirements for submitting safety reports.