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Compliance with the regulations | Amendment reporting

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Amendment reporting

In the past any change to a research project had to be notified to the NHS Research Ethics Committee which approved it. However, there is a new system which sets out different processes according to whether the amendment is ‘substantial’ or ‘minor’.

Full details of the amendment process can be found on the NRES website - CLICK HERE. Below is a summary of the contents.

 Substantial amendments

A substantial amendment is defined as an amendment that is likely to affect to a significant degree any of the following:

  • the safety or physical or mental integrity of the subjects of the trial
  • the scientific value of the trial
  • the conduct or management of the trial, or the quality or safety of any investigational medicinal product used in the trial.

This would include:

  • A change of sponsor(s)
  • Appointment of a new Chief Investigator
  • Inclusion of a new research site in a study requiring a site specific assessment consideration of local issues in a multi-centre study
  • Appointment of a new Principal Investigator at a research site
  • Change of inclusion or exclusion criteria
  • Changes to the recruitment process

 Who decides whether an amendment is substantial?

For a clinical trial of a medicinal product it is the sponsor of the trial who has the legal duty to decide. If the Trust or Queen Mary University of London (QMUL) is your sponsor then you should contact the JRMO on 020 7882 7272.

It has been drawn to our attention that in some cases companies and local research staff may disagree on how to classify an amendment. In this case, please call the JRMO.

For all other research it is the Main REC which makes the decision. If you are in doubt whether to submit an amendement as minor or substantial you should seek advice in the Joint Research Office or from the main REC. Contact details of East London and the City Research Ethics Committee>>

 Who do I need to notify if the amendment is substantial?

 
Clinical trials under the EU Directive

Approval for the amendment should come from the MHRA. Some amendments require an ethical opinion also, others should be sent to the main REC, which originally approved the project, for information only (for example an amendment relating to the quality of the medicinal product).

The Chief Investigator or sponsor needs to complete the EU notification of amendment form (download below) and send this to the MHRA and the main REC. The CI should also submit the original and amended versions of any documents. If the documents are lengthy then extracts may be submitted. NRES also recommend sending data monitoring committee reports, safety analyses etc, where these are relevant and available. If the protocol has been changed, the REC requires 4 hard copies of the new version.

If the amendment does not need an ethical opinion, this needs to be made clear in a covering letter from the sponsor or a letter approved by the sponsor from the Chief Investigator. In this case it is not necessary to include the supporting documentation provided to the MHRA.

Download EU notification of amendment form on NRES website - CLICK HERE.

Researchers must not implement the substantial amendments until they receive MHRA/REC approval unless this would compromise patient safety.

 
Non-EU Directive research

For other types of research, the NRES amendment form should be used and one hard copy, signed by the Chief Investigator, sent to the REC which originally approved the project. If there is a change of CI, you should include the CV of the new CI. 

The NRES Substantial Amendment Form can be downloaded at the NRES website - CLICK HERE.

 Minor amendments

Minor amendments cover a relatively small group of changes such as:

  • Correction of typographical errors in the protocol or other study documentation
  • Appointment of new support staff 
  • Changes in the documentation used for recording study data
  • Changes in the logistical arrangements for storing or transporting samples

 Who decides if a change is minor?

The same principles apply for minor and substantial amendments.

 Who do I need to notify of a minor amendment?

Minor amendments should be agreed by the sponsor and reported the JRMO. Changes to details such as contact information for the research team, minor changes to the consent or patient information sheet, should also be notified to the REC for information only. It needs to be made clear in a covering letter from the sponsor or a letter approved by the sponsor from the Chief Investigator that the amendment submitted is minor and is for information only.

It is advisable not to implement minor changes until the REC have acknowledged your amendment in case they decide

  • it is regarded as substantial and needs an ethical opinion
  • it affects the original decision to grant a favourable opinion.

 All amendments should be notified to the Joint Research Office.

When you report any amendments to the ethics committee it is essential that you also report them to us in the Joint Research Management Office. If you do not keep us informed of any changes to your research project you will be audited against out of date information. More information on audits>>

Please send a copy of the EU/NRES amendment form with a copy of any new versions of the protocol or supporting documentation to Research Ethics Facilitator. You will receive an email confirmation of receipt of these documents to keep in your main study file.