NHS, Invasive or Clinical Research

Research requiring approval from the NICR panel includes, but is not restricted to:

• ALL research involving NHS patients, NHS staff or taking place in NHS sites which requires NHS R and D approval
• Research in health care settings in other countries
• Clinical trial of an investigational medicinal product
• Clinical investigation or other study of a medical device
• Combined trial of an investigational medicinal product and an investigational medical device
• Other clinical trial to study a health related intervention or randomised clinical trial to compare interventions in health and social care practice 
• Study limited to working with human tissue samples (or other human biological samples) and data (specific project only) or Research tissue bank
• Basic science study involving procedures with human participants: 
  • Imaging investigations (MRI, ultrasound etc.)
  • Physical examinations (blood pressure, Pulse, Respiratory rate etc., max strength tests
  • Physical tests. (EEG, ECG, EMG, BioPAC etc.) If using EEG, BioPAC, fNIRS and following the University of Stirling’s approved protocol you may be able to apply to GUEP.
  • Computer tests where there are potential health consequences e.g. dementia, sleep apnoea, depression tests
  • Filming or photography (as part of a health research study or in a health setting/context)
  • Sample-taking urine, blood, hair, muscle biopsy
  • Ingestion of substances, fluids or alcohol
  • Questionnaires, surveys or interviews/focus groups with sensitive questions with implications for health (e.g. depression, mental health etc)

• HRA Learning and Development

• IRAS Guidance

• NHS Health Research Authority

• HRA Guidance on the General Data Protection Regulation

• Public Patient Involvement (PPI) Guidance (INVOLVE)

• Human Tissue Authority Codes of Practice

• Relevant material under the Human Tissue Act 2004

• Adults with Incapacity (Scotland) Act 2000

• Mental Capacity Act 2005

• Royal College of Paediatrics and Child Health research resources

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

• HRA Amending an approval

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

Approval through NICR should proceed as outlined below:

Staff applying to IRAS

Staff applying through IRAS for ethical approval of their study should complete and submit an IRAS application form. Staff do not require NICR approval before they submit through IRAS.
Once submitted staff should also lodge details of their IRAS application through the Ethics Review Manager (ERM) where they will be asked to upload a PDF copy of their IRAS application.

Students applying to IRAS

Students should complete an IRAS application form, but not submit it. Instead, they should save a copy of the IRAS PDF form and submit it through ERM for review by the NICR Panel. Only once NICR have granted approval for submission through IRAS should the application be submitted.

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.

Staff and Students NHS Indemnity 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)
• The Research Integrity and Governance Manager will then issue you with a letter confirming sponsorship and a letter confirming indemnity cover.
• 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.

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.

Panel meetings

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