Application Pathways
At St James’s Hospital (SJH), the R&I application type you select depends on the ethics approval required for your study.
Once the appropriate ethics approval has been identified, you will follow one of the two R&I approval pathways outlined below.
- Pathway 1: Joint Research Ethics Committee (JREC Ethics) + R&I Approval
- Pathway 2: External Ethics (NREC, CTIS, University) + R&I Approval
The pathway determines which application form you complete in Infonetica and which documents you need to prepare.
Pathway 1
Pathway 1 is for projects applying for both JREC approval AND R&I approval
Pathway 1 consists of two connected applications: JREC application + R&I application
First the applicant must create and complete their JREC application.
Then, the R&I Pathway 1 form is created as a sub-form of your JREC application, and auto populates duplicated questions using the information input on the JREC application
Examples of Pathway 1 Applications
- Retrospective Chart Review
- Observational research study
- Device trial with CE marked device
- Staff Study - where ethics is being obtained from JREC
- Case study (5 or more cases)
Why Pathway 1?
Because JREC and R&I forms are connected inside Infonetica — completing the JREC form automatically populates parts of the R&I form.
Pathway 2
Pathway 2 is for applications applying for R&I with external ethics, for a project where external ethics can be accepted. Pathway 2 is also used for Biobank Sub-Studies and Biobank Biomarkers. These include:
- Low risk studies where the R&I office can accept university or institutional ethics
- High risk studies where external ethics such as NREC and CTIS are required
- Pathway two allows applicants to bypass the JREC form and enables applicants to upload their letter of external ethical approval.
- Biobank Sub-studies where the Biobank Amendment letter issued by JREC is accepted as ethical approval
- Biobank Biomarkers where ethical approval is not required
Examples of Pathway 2 Applications
Low Risk (University ethics can be accepted)
- Staff Study - where ethics is being obtained from a University/ Institution
- SJH as a site of advertisement
- Multi-site ionising radiation trial – where the first site has ethical approval in place
- Case study (less than 5 cases) – ethics not required
High Risk (CTIS or NREC Required)
- Clinical Trial
- Medical Device trial with non-CE marked medical device
Biobank Sub-Studies and Biobank Biomarkers
- Pathway 2 is now used for registering Biobank Sub-Studies and Biobank Biomarkers. Please see the quick guides below for step-by-step instructions on how to complete this type of application.
Why Pathway 2?
Pathway 2 allows you to upload your external ethics approval letter directly into the R&I form in Infonetica when JREC approval is not required.
How to Register a Biobank Sub-Study With The R&I Office
How to Register a Biobank Biomarker With The R&I Office