Research Ethics Committees

Download Report

Transcript Research Ethics Committees

NRS R&D permissions process
Scottish sites only, multicentre
IRAS Integrated Research Application System
Submit IRAS
REC form
Submit IRAS MHRA form
(if applicable) and/or other
regulatory submissions
Complete IRAS R&D Form
(integrated data set), and SSI Forms
CDAs for commercial projects (if required)
Email research
application pack to NRS
Permissions CC
 IRAS R&D Form
 supporting global
project documentation
NRS
Submit SSI Forms to
local PIs for
authorisations, then
submission to local
R&D offices
Permissions CC checks submission, uploads into
SReDA, notifies R&D offices and confirms when
NRS ‘full document set’ available
Approvals granted
from MHRA / other
regulatory bodies
REC favourable
opinion granted
pending NHS
permission
Commercial projects: for
each participating Health
Board negotiate and agree
contract and costs
Generic Review
(lead R&D office)
- global governance checks
Local Reviews
(participating Health Boards)
- local governance checks
Certificate of Compliance
Local Management permission letter
(for each participating Health Board in Scotland)
(NHS permission)
Research can start at a site when permission letter
is received from that NHS organisation