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COVID-19: Guidance for sponsors, sites and researchers

The HRA has produced new guidance for sponsors, sites and researchers about the COVID-19 pandemic.

 

1.  New studies relating to COVID-19

An expedited review process is available for studies relating to COVID-19 where there are public health grounds for rapid review. The full process for fast-track reviews is set out in the Standard Operating Procedures for Research Ethics Committees.

Researchers should contact the HRA Director of the Approvals Service (who will liaise with colleagues in Scotland, Wales or Northern Ireland if applicable), copying in their research sponsor, as early as possible to request expedited review.

Please also contact:

If an expedited review is agreed, the service can arrange for the application to be reviewed at a scheduled meeting, or for an existing Research Ethics Committee (REC) to hold an extraordinary meeting, or for a new REC to be formed to consider a particular application.

For studies taking place in the NHS (and/or HSC), the UK study-wide assessment will consider any arrangements to expedite study set-up across NHS organisations.

The Confidentiality Advisory Group provides an expedited review for studies that will involve use of confidential patient information without consent.

 

2.  Amendments to existing studies to address COVID-19 elements

There are a number of possible scenarios where there may be a need to rapidly amend an existing study.

  • All amendments requiring submission should be submitted by email through the usual email route, clearly marking them with the subject header: IRAS ref# Amendment - COVID-19, so that they can be expedited.

All amendments should be sent to participating sites in accordance with existing guidance. To support site implementation it is important that:

  • The changes and local implications are made clear
  • Any changes to documentation are provided in tracked changes
  • For multi-centre studies in Scotland or Northern Ireland, amendments should be provided to R&D offices through the national coordinating functions as usual.
  • In England and Wales All correspondence to sites should be copied to R&D/I department and the PI/ delivery teams
  • Where indicated below, the sponsor should include the category and confirm that no assessment is required.

To read more see the the HRA website at: www.hra.nhs.uk/coronavirus