The National Research Ethics Service (NRES) was
launched on 1 April 2007. NRES comprises the Head Office function
(formerly COREC) and NHS Research Ethics Committees (RECs) in
England. NRES continues to work with colleagues in Scotland, Wales
and Northern Ireland to maintain the established UK-wide framework
for ethical review of research.
Changes to the Requirements for Ethical
Review: From 1st September changes to the
Governance Arrangements for Research Ethics Committees (GAFREC)
mean that it is no longer necessary to submit to the National
Research Ethics Service for review of studies where the requirement
is based solely on the use of NHS staff as participants or the use
of NHS premises. Other changes will mean some studies
involving only tissue or data may be exempt however a large number
of exceptions necessitate review of each study against the guidance. This change relates only to the
National Research Ethics Service (NRES), studies not requiring NRES
approval may still require NHS R&D Approval and/or University
Ethics Approval and should still be processed through IRAS.
NRES has produced an algorithm to help researchers to determine
whether their project requires ethical review by a REC.
Applications for ethical review:
Use of a standard NHS REC application has been mandatory since
March 2004. This form, together with guidance notes on completion,
can be found on the National Research Ethics Service (NRES)
website.
A copy of the NRES application process flowchart is
available.
Following re-organisation within NRES the following Research
Ethics Committees operate in the South West:
The procedure for booking applications locally has recently
changed and a Local Allocation System (LAS) is now in
place.
Applicants should telephone 01392 405757 to obtain a REC
reference number and slot on the agenda. Researchers should
only telephone for this number once their application is complete,
except for the reference number and signatures. Researchers should
contact LAS one month prior to the meeting date.
Dates for SW Committee meetings can be found on their
website.
Points to note/remember:
- Information sheets and consent forms must as far as possible
follow the standard format provided on the NRES website. There are certain clauses
which apply, regardless of whether it is a simple or complex
research study.
- Where Non-NHS indemnity/insurance applies, a copy of the
Insurance certificate must accompany the application.
- A copy of the CV template for research applicants
is available.
- For student research a copy of the student CV and supervisors
CV must be provided. It would be helpful for the supervisor
to attend the meeting with their student.
- Once a REC reference number has been allocated the LAS operator
will promptly send an email confirmation including details of where
to send the paperwork.