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R&D Permission in Scotland

The R&D permissions process in Scotland aims is to make the researcher experience of study set up simple and facilitative whilst maintaining compatible cross-border processes.

On 5 June 2019, the ‘UK Local Information Pack’ is fully implemented as the UK-wide mechanism for setting up participating NHS/HSC organisations. It provides a consistent package to support study set-up and delivery across the UK and should be used for all studies with participating NHS/HSC organisations from this date.

An exception is where a study is planned as a single centre study with an NHS Sponsor (i.e. there is a single participating NHS organisation and it is the same as the NHS Sponsor for the study). In this specific scenario, a UK Local Information Pack and Organisation Information Document is not required.

A key component of the UK Local Information Pack is the Organisation Information Document. This replaces the NHS Site Specific Information (SSI) Form that was used in Scotland. The Organisation Information Document is used for both commercial and non-commercially sponsored research in the NHS.

The Sponsor, or authorised delegate, is responsible for sharing the UK Local Information Pack with participating NHS organisations and controls when this occurs.

To share the Local Information Pack in Scotland, the Sponsor must email using the relevant template and listed documents to the NRS Permissions Coordinating Centre (NRS PCC) at nhsg.NRSPCC@nhs.net.

NRS PCC will make the Local Information Pack available to the participating NHS organisation(s) in Scotland including R&D, who share with the research team, and Network/Specialty Groups as relevant. The template email, and associated documents, for a number of participating NHS organisations in Scotland can be grouped and sent to NRS PCC in one email or individually as available: please see IRAS Help for more information.

For Scotland, there is no requirement to resend the documents submitted with the IRAS Form. The NRS Permissions CC will have made these available to the R&D offices of the participating NHS organisations.

For participating Scottish NHS organisations, the Local Information Pack can be shared after the IRAS Form submission is validated.

It remains the Sponsor responsibility to ensure the final approved documentation is available for the research teams to start the study.

Amendments

A new UK amendment process will be implemented across the 4 UK nations on 2 June 2020, this includes online submission of amendments and a new amendment tool. These new processes for handling amendments are part of our ongoing programme to improve services for applicants.

  • The amendment tool is designed to simplify the amendment process for applicants and
  • The ability to submit amendments online means that applicants can track the submission history of amendments.

To help with these changes, we have now published:

Research access in prisons

Research access in prisons - guidance document and access application.

Contact

  • The NRS Permissions CC team can be contacted at nhsg.NRSPCC@nhs.net
  • For general enquiries, call 01224 552690
  • For queries on the progress of single-centre studies contact the local R&D office.

NRS Permissions Co-ordinating Centre is based within NHS Grampian. You may contact the team with queries on the process, or to check the progress of a submission.

John McDonald
NRS PCC Change Manager

john.mcdonald@nrs.org.uk

Tel: 01224 551118

Pamela Shand
Senior Administrator

pshand@nhs.net

Tel: 01224 552361

Kalyar Lwin
Senior Administrator

kalyar.lwin@nhs.net

Tel: 01224 552360

Anne Brebner
Senior Administrator

anne.brebner@nhs.net

Tel: 01224 552126