Step 1

Applicants shall use the following tools before completing their application:

• Is my study considered as research using the HRA decision tool
• Does my study require REC review using the HRA REC decision tool
• For student research, the Student Research Toolkit

Step 2

If your study is research, then complete your application and supporting documentation in Integrated Research Application System (IRAS).

Once submitted you can continue to prepare your Local Information Pack(s).

For specific support with commercial and non-commercial studies before submission:

• Feasibilities for commercial
  • As a single point of contact, the NHS Research Scotland Centralised Feasibility Service aims to assist in the identification of appropriate investigators and sites across Scotland for the delivery of clinical research studies. See the study pathway for further details
• Networks for non-commercial
  • Delivery of a range of high-quality studies across a spectrum of diseases is provided through the our Research Areas they support the development, set up and completion of clinical research studies across Scotland by providing advice on study design and feasibility, identifying potential sites, facilitating access to resources and monitoring recruitment in specialist disease areas

Step 3

The NHS Research Scotland Permissions Coordinating Centre (PCC) shall receive your application, allocate a Study Wide Reviewer and share with the relevant R&D offices in Scotland.

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

Step 4

The Study Wide Reviewer shall undertake the UK and Scotland specific aspects of the governance review (accepted across the UK) and shall provide this to the Permissions Coordinating Centre.

Any regulatory approvals (e.g., REC, MHRA) shall also be provided to the Permissions Coordinating Centre as required.

Step 5

Participating R&D offices in Scotland shall undertake local review of the application and issue NHS Permission (note HRA/HCRW permission is not required in Scotland).

NOTE: Full information on the overall UK amendments process is available on IRAS Help.

• Single Centre Studies
  • In Scotland, single centre study amendments shall be sent directly to the R&D office and research team at the participating organisation as per the information in the Amendment Tool
• Multicentre Studies
  • For multicentre studies, amendments shall be submitted online, although Sponsors shall also continue to send amendments directly to the R&D office and research team at the participating organisation

• Guidance document
• Access application

The Permissions Coordinating Centre team can be contacted at gram.nrspcc@nhs.scot or via Microsoft Teams using the contact details below.

For queries on the progress of single-centre studies, contact the local R&D office.

NHS Research Scotland's Permissions Coordinating Centre is based within NHS Grampian. You may contact the team with queries on the process, or to check the progress of a submission.