Karim Raza: Ethics

This doesn’t need ‘ethics approval’

... because it’s audit / service evaluation

Clinical audit

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?

NRES guidance

http://www.nres.npsa.nhs.uk

Sources of advice

• Clinical effectiveness department of host NHS Trust

• NHS Trust R&D department

• NRES helpline: [email protected]

The Human Tissue Actapplies to normal donors

The Human Tissue Actapplies to normal donors

A need to facilitate collection of blood from normal individuals:

Routine phlebotomy servicePool of normal donorsEach give up to 450mls of blood at intervalsBroad ranging ethical approval for use of this material

? Follow standards from blood transfusion service: concerns about ‘competition’ with the BTS

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.

Read the instructions and look at the

templates

.... they change frequently!

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

Facilitating the unanticipated