Changes in research study set up

From 1 April 2016, there will be key changes that will affect the way research studies are set up across England. One is that all studies taking place in the NHS in England will use the Health Research Authority (HRA) approval process, which includes the REC opinion. The new process confirms that the responsiblity for the study lies with the sponsor.

As a consequence, the NIHR Coordinated System for Gaining NHS Permission (CSP) will cease to exist and the site specific information (SSI) form will no longer be required in England as another format for providing sites with local information is used. The aim of these changes is to improve the quality of study submissions and provide transparency, while reducing duplication.

These changes impact all teams conducting research and unless teams are prepared, initiation of new studies could be delayed.

For more information, or to express interest in a training event, please contact LCA Research Manager, Dr Michelle Chen (Michelle.Chen@nhs.net).

 

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