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NHS REC amendments

If you need to make any change to a study that has already received approval from an NHS REC, you must seek approval from the original NHS REC that you submitted your application to. The process for applying for amendment is dependent upon the change required and whether this is a substantial or non-substantial amendment.

Substantial amendments normally require a favourable opinion from the main REC before they can be implemented.

The only exceptions to this are:

  • where urgent safety measures need to be taken;
The sponsor or investigator may take appropriate urgent safety measures in order to protect research participants against any immediate hazard to their health or safety.

You must notify the main REC immediately and in any event within three days that such measures have been taken and the reasons why.
  • in the case of substantial amendments to CTIMPs which require authorisation by the competent authority (the Medicines and Healthcare products Regulatory Agency (MHRA)) but do not require ethical review.

How long will approval of an amendment take?

The co-ordinator of the main NHS REC will write to you confirming whether or not the notice of amendment is valid for review, usually within five working days of receipt. Amendments are normally reviewed by a sub-committee of the NHS REC, either at a meeting or in correspondence. Exceptionally, amendments may be reviewed at a meeting of the full committee. The NHS REC will issue an ethical opinion on the amendment within a maximum of 35 days from the date of receipt of a valid notice of amendment.

Further information can be found at NHS HRA: UK Process for Management of Amendments.