Setting up NHS / Health and Social Care research in the UK
Following from the previous communication a UK Local Information Pack will be introduced on the 5 June 2019 to support the set-up of NHS / Health and Social Care research in the UK. Researchers working with NHS / Health and Social Care organisations across England, Northern Ireland, Scotland and Wales will benefit from a consistent package to support study set-up and delivery across the UK.
The UK Local Information Pack is the set of documents that NHS / Health and Social Care organisations use to formally start preparing to deliver the study. More information is given in the Local Information Pack section of IRAS Help but there are some key features:
1. One new feature of the UK Local Information Pack is the Organisation Information Document, which will replace the current Statement of Activities used in England and Wales for non-commercial studies and the Site Specific Information Form, used in Northern Ireland and Scotland. After this date the Statement of Activities and NHS / Health and Social Care Site Specific Information Form will no longer be in use.
In outline format the Organisational Information Document will be a component of the IRAS Form submission and in a localised format will be required as part of the UK Local Information Pack for both commercial and non-commercial research. Organisation Information Document templates and associated guidance are available in IRAS Help.
For non-commercial, studies that are not clinical trials or clinical investigations, the Organisation Information Document should also be used as the agreement between sponsor and participating NHS / Health and Social Care organisation.
2. Another feature of the UK Local Information Pack is the inclusion of a delegation log template, which is intended to be used at participating NHS / Health and Social Care organisations. This will allow NHS/Health and Social Care organisations to locally record who will be working on the study.
3. For non-commercial studies an IRAS Schedule of Events or a SoECAT will be a part of the IRAS Form submission and is used in the UK Local Information Pack as a way of providing clarity to participating NHS / Health and Social Care organisations on the cost attributions associated with a study.
Guidance on the use of the UK Local Information Pack has now been published in the Site Specific page of IRAS Help to help applicants get ready for the change. If you are making an IRAS Form submission or planning to set up research in an NHS / Health and Social Care organisation from 5 June 2019 please read the transition guidance so that you prepare the correct materials.
To support researchers and NHS / Health and Social Care organisations make the transition to using UK Local Information Packs, change management activities will be scheduled throughout April and May, with continuing support following implementation in June. Webinars have been scheduled to support the change (if you have not previously used the new HRA Learning Management System please register for an account via the link).
Information for Commercial Sponsors and CRO can be found here.