Information by Design
Lifestyle Survey Toolkit

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.