Implementing amendments at NHS and HSC organisations
Making it easy to do high quality research is a key priority for the Health Research Authority. One of the best ways for us to do this is to remove any barriers that may exist for people wanting to do research. We are listening to your feedback. It is clear that there is a lack of clarity and detail in the current guidance about how to share amendments with participating NHS and HSC organisations. We have updated our guidance to address areas you were concerned about.
In the updated guidance we have:
- removed information which was not relevant to sharing amendments with participating NHS and HSC organisations
- added a new section about sponsors, applicants and participating organisations working together to resolve issues
We have also provided more information on:
- the role of categories
- how to add new sites
- sharing information with participating organisations across the UK
- how to implement amendments
- the 35 day “no objection” deadline
The updated guidance is available on IRAS now.
Further clarifications and changes to the amendments process will come in future based on your feedback.
NHS Digital merger with NHS England
On 1 February 2023, NHS Digital will merge with NHS England. NHS England will be responsible for all of NHS Digital’s activities. If you have Confidentiality Advisory Group (CAG) support or Research Ethics Committee (REC) opinion which involves working with NHS Digital, you may be wondering what this means for your application.
You can find out the answers to the following questions on our website:
- What do I need to do for my existing research that has HRA, REC or CAG approval?
- Do I need to submit an amendment request for an existing approval?
- What if I am about to submit an application for approval?
More background and information on the merger can be found on the NHS Digital website
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