Introduction

Good researchers show respect for participants' needs, rights, well-being and safety. In part, they do this by giving (potential) research participants clear and accurate written information. In this chapter we provide guidance on producing consent forms and information leaflets that are easy to read and understand. This will help researchers who prepare written information and research ethics committee (REC) members who review it. Researchers will need other sources of practical advice and we provide some references. For information on broader issues, you could contact Consumers for Ethics in Research (http://www.ceres.org.uk) or Consumers in NHS Research (http://www.hfht.org/ConsumersinNHSResearch/).

Information for potential participants should inform, educate and explain (Scotland, 1985). It must not coerce or unreasonably induce participation in research. Potential participants (patients, carers, users or volunteers) will usually have little medical knowledge and will possess a range of reading ages, education and intelligence. Participants with good reading and comprehension skills will not be insulted by simple and direct language.

Concern for participant welfare will guide study design and should be apparent in your writing. This chapter contains specific guidance on:

• content that is accurate, unambiguous and comprehensible

• style that is clear and direct (Anon, 2000)

• layout and presentation that indicates competence (Secker & Pollard, 1995).

Content of written information

Detailed guidance on what to write in consent forms and information leaflets can be obtained elsewhere, for example:

• your local REC

• the Central Office for Research Ethics Committees (COREC) (http://www.corec.org.uk)

• the US National Library of Medicine (http://www.clinicaltrials.gov)

• the International Conference on Harmonisation (http://www.ich.org)