1. This doesn’t need ‘ethics approval’
... because it’s audit / service
evaluation

2. Clinical audit

3. Service evaluation
• What proportion of my patients with RA
develop infections requiring antibiotics?
• How does this relate to which
immunosuppressive treatment they are on?
• Does measuring serum immunoglobulin levels at
baseline / following treatment predict which
patients will develop infections?

4. NRES guidance
http://www.nres.npsa.nhs.uk

5. Sources of advice
• Clinical effectiveness department of host NHS
Trust
• NHS Trust R&D department
• NRES helpline: queries@nres.npsa.nhs.uk

6. The Human Tissue Act
applies to normal donors

7. The Human Tissue Act
applies to normal donors
A need to facilitate collection of blood from normal individuals:
Routine phlebotomy service
Pool of normal donors
Each give up to 450mls of blood at intervals
Broad ranging ethical approval for use of this material
? Follow standards from blood transfusion service: concerns
about ‘competition’ with the BTS

8. Applications to NHS Research Ethics
Committees
• At least one-third of the members must be
‘lay’.
• When the form says “please put this in
language comprehensible to a lay person”, it’s
a good idea to do so.

9. Read the instructions
and look at the
templates
.... they change
frequently!

10. Once you’ve got approval,
... you can only do what you said you
were going to do
• It is the responsibility of the sponsor to
determine whether an amendment is
substantial
• Substantial amendments need to be approved
by the REC

11. Facilitating the unanticipated