Guidelines for researchers: patient information sheet and consent form.

The guidance, which follows, applies primarily to multi-centre 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 layperson. Use short words, sentences and paragraphs. ‘The readability’ of any text can be roughly estimated by the application of standard formulae. Checks on readability are provided in most word processing packages. Use headed paper of the hospital/institution where the research is being carried out. Patient Information Sheets submitted to an MREC should be headed simply ‘Hospital/Institution/GP Practice headed paper’.