The guidance which follows applies primarily to multicentre pharmaceutical studies and encompasses the ICH Good Clinical Practice guidelines. However, the principles and much of the content will be of use to researchers writing information sheets in their particular fields, for trials involving patients, patient volunteers and healthy volunteers. You will find it helpful to refer also to other guidelines produced for writing patient information sheets.

Potential recruits to your research study must be given sufficient information to allow them to decide whether or not they want to take part. An Information Sheet should contain information under the headings given below where appropriate, and in the order specified. It should be written in simple, non-technical terms and be easily understood by a lay person. Use short words, sentences and paragraphs. ‘The readability’ of any text can be roughly estimated by the application of standard formulae. Checkson readability are provided in most word processing packages.

Consumers for Ethics in Research (CERES) publish a leaflet entitled ‘Medical Research and You’. This leaflet gives more information about medical research and looks at some questions potential recruits may want to ask. You may obtain copies from CERES, PO Box 1365, London N160 BW.

Use headed paper of the hospital/institution where the research is being carried out. Patient Information Sheets submitted to an MERC should be headed simply ‘Hospital/Institution/GP Practice headed paper’. If you are a local researcher for an MREC approved study, the Patient Information Sheet should be printed on local hospital/surgery paper with local contact names and telephone numbers before it is submitted to the LREC. Unheaded paper is not acceptable.