NHS, Invasive or Clinical Research

• Human Tissue Act 2004

• Human Tissue Authority Codes of Practice

• IRAS Guidance

• NHS Health Research Authority

• HRA Guidance on the General Data Protection Regulation

• Public Patient Involvement (PPI) Guidance (INVOLVE)

• Relevant material under the Human Tissue Act 2004

• Adults with Incapacity (Scotland) Act 2000

• BERA Ethical Guidelines for Educational Research

• British Psychological Society Ethics and Standards

• ESRC Framework for Research Ethics

• Mental Capacity Act 2005

• SERA Ethical Guidelines for Educational Research

• Royal College of Paediatrics and Child Health research resources

• UK Policy framework for health and social care (2018)

Request ethical approval from the NHS, Invasive or Clinical Research committee

Additional Approval

Staff and students carrying out the types of research described on this page always need approval from the University’s NICR committee, but may also need to seek NHS Research and Development and NHS Research Ethics Committee approval via the Integrated Research Application System (IRAS). If you have any questions about seeking ethical approval through IRAS, please contact us at nicr@stir.ac.uk.

You must discuss with the appropriate NHD R&D Office as to whether NHS R&D approval ONLY is required, or whether NHS R&D and NHS REC approval is required, and seek guidance from them as to the subsequent application process.

Approval through NICR should proceed as outlined below:

Staff

Staff should complete and submit an IRAS application form, then send a copy of the application (including reference number) to NICR along with their completed NICR approval coversheet.

Students

Students should complete an IRAS application form, but not submit it. Instead, they should save a copy of the IRAS PDF form and send it to us alongside their completed NICR approval coversheet for authorisation.

Staff and Students NHS Sponsorship Letters

As well as NHS REC approval through the IRAS system applicants are also required to confirm the sponsor for your project and provide proof of indemnity cover as part of your application. Letters confirming both sponsorship and indemnity will be provided by Research and Innovation Services.

The process for obtaining letters:

• Download the Sponsorship form
• Complete and sign the Sponsorship form - then gather all the additional signatures required (electronic signatures are acceptable): 
  
  • University of Stirling supervisor (if applicable)
  • Dean of Faculty
• Email the fully signed form, copying in all signatories as an audit trail, to the Research Integrity and Governance Manager ethics@stir.ac.uk.
• On IRAS add the Research Integrity and Governance Manager's details as sponsor representative (Qs A4 and A64)
• Once your IRAS form is complete and has been signed off by the Chief Investigator and supervisor (as applicable) request authorisation from the sponsor representative.
• The Research Integrity and Governance Manager will review the IRAS form and then issue you with a letter confirming sponsorship and a letter confirming indemnity cover.

Please allow time for this process as both letters will only be issued once the above process has been completed. In addition, indemnity letters may not be issued immediately as any high risk topics (e.g. pregnant women or small children) may require confirmation from the University insurer that the project will be covered.

Committee meetings

The NICR committee meets regularly throughout the year to consider ethical approval applications. See their schedule of upcoming meetings and submission deadlines below.