The permissions or approvals required will depend on the type of research you are undertaking.
Permissions may include:
- NHS R&D approval
- NHS Research Ethics Committee
- NIHR Portfolio Adoption
- Medicines and Healthcare Products Regulatory Authority (MHRA)
For general information on all of the above permissions see: http://www.nres.nhs.uk/applications/approval-requirement
Integrated Research System (IRAS)
Most applications can be made via the (IRAS) http://www.myresearchproject.org.uk.
IRAS was developed to bring all the research regulatory application forms together in one place. By completing a checklist of questions, the system will generate the forms you need to complete based upon your responses including the:.
- Portfolio Adoption Form (PAF)
- Research & Development (R & D) Form
- Site Specific Information (SSI) Form
An IRAS training module is available (approx 60 minutes) that will lead you through the system and show you how all of the forms are generated. It also explains how certain information is pre-populated throughout the form to save having to repeat certain text.
NIHR Portfolio Adoption
All researchers with funded research projects should be encouraged to apply for NIHR portfolio adoption. This is important in order to bring additional funding into the Trust to support the delivery of research.
On the first page of their IRAS application you can choose to have your project assessed for NIHR Clinical Research Network (CRN) support and inclusion in the NIHR Clinical Research Network (CRN) Portfolio.
Research studies funded by NIHR and NIHR partners are eligible to be adopted on to the NIHR Portfolio. Other criteria for adoption include who is funding the research, if funding is awarded in open competition, if the study has received a peer review and if the research is of value to the NHS and fits within the needs and realities of the NHS. A portfolio adoption form (PAF) should be completed and submitted via IRAS. One application is required for the entire research project from the lead site, where the Chief Investigator is based. For more information visit:http://www.crncc.nihr.ac.uk/about_us/processes/portfolio/p_how
If your research study meets the criteria for portfolio adoption, it is important to submit the PAF form at an early stage (prior to the R & D form & SSI form) in order to be processed via the ‘Coordinated System for gaining NHS Permission’ (CSP) system for R&D approval, and funding received from the NIHR.
During the sponsorship review NBT may recommend that your research is submitted for NIHR Portfolio adoption.