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: 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.

Biobank Sub-Study Quick Guide

Biobank Biomarker Quick Guide

How to Register a Biobank Sub-Study With The R&I Office

How to Register a Biobank Biomarker With The R&I Office