S Andrew Spencer, Angus Dawson, Claire Rigby, Nicola Leighton, Janet Wakefield
Objectives To develop and evaluate an information sheet in order to e¡ectively increase background knowledge about medical research, including reasons for participation, risks and beneŽ ts and the processes of recruitment and consent.Design Recorded telephone questionnaire conducted at least 24 hours after receiving the information lea?flet.Setting Recruitment from antenatal/paediatric clinics and Newcastle-under-Lyme town centre.Participants Fifty recruits of whom 37 gave interviews.Main outcome measure Understanding of the lea?flet as judged by answers to the speciŽ c questions.Results In general the understanding of the leaflet was good and 90% of the participants indicated that they had understood most of it. It was thought to be generally informative. The question that caused greatest di¤culty related to the correct explanation of informed consent, with only 65% giving a correct response. Other areas of di¤culty related to questionsabout whether new treatments would be better or worse than standard treatments and details of consent in children. It was suggested that examples would be a helpful addition to the lea? et. Having read the leaflet, more than 70% of the participantswould be prepared in principle to participate in research. Less than 10% felt that they would be less likely to participate in research after reading the leaflet.Conclusion The idea of providing a general leaflet about research was supported by the results of the survey. A number of areas of improvement were identiŽfied. The lea? et has now beenmodiŽ ed to take account of these suggestions.
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