Ethical
approval
In the
past, lifestyle surveys were based on the Electoral Ward
population framework (not involving any NHS databases),
so were often not presented for ethical approval.
However, this is now unlikely to be unacceptable,
and all such surveys carried out through NHS
organisations or involving collection of health related
data should be presented to NHS Ethics Committees for
the relevant area. If a survey is multi-centre,
and covers more than one Strategic Health Authority
boundary, then the study should be presented to
multi-centre Research Ethics Committees organised on a
regional basis. Further information and the
contact details of all Research Ethics Committees in the
UK are available from the NHS Research Ethics Committee
- for details
click
here.
Some
Ethics Committees offer the opportunity to present your
proposal and be involved in the discussion. If this is
on offer it is wise to go along: be prepared for some
difficult questions asking you to justify the way you
want to ask a particular question or do something in a
particular way. You should also make sure that you
leave sufficient time for the Ethics Committee approval
- further guidance can be obtained from your local area.
What will the Research Ethics Committee Do?
The Local Research Ethics
Committee task is to look at whether projects are done
ethically. Their task is not to say whether the
project is worth doing, nor to say if it is good or bad
research. Their role is to review proposed research
projects to ensure that participants’ dignity, rights
and safety and well-being are preserved throughout the
conduct of the research project.
A Local Research Ethics
Committee (LREC) is required to ethically review any
research project that involves human participation from
staff or patients of the NHS. A research project
will only be reviewed once, and if it is likely a project might cross the
boundary into additional Strategic Health Authorities or
geographical areas that are the responsibility of an
additional LREC, the information will have to be
submitted to the additional Local Research Ethics
Committees as well to be reviewed for locality
issues. These are:
-
The
suitability of the researcher i.e. adequately
qualified to undertake the research project
-
The
appropriateness of the ‘local’ research environment
and facilities
-
Any
specific issues that may relate to the ‘local’
community
Ethics Committees decide
whether to:
-
Reject projects when harm clearly exceeds
benefit
-
Refer projects back when they could be
revised to achieve a reasonable harm / benefit balance
-
Approve projects which present a clear,
un-pressured and reasonable harm / benefit choice to
potential subjects.
To
make a valid application for ethical approval the
following information must be submitted.
-
A completed
official application form
-
Full
research protocol
-
Information sheets with version numbers
and date of production e.g. Version 1, dated 6th
May 2002
-
Consent forms with version numbers and
date of production
-
Final / draft questionnaires that will be
used as part of the study
-
Any relevant certificates i.e. for drug
related studies
-
All letters of introduction to patients
or professional present
-
If a study is sponsored by a commercial
company the application fee has been sent with the
application form.
|
