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An empirical study on the preferred size of the participant information sheet in research

Antoniou, E. E. and Draper, H. and Reed, K. and Burls, A. and Southwood, T. R. and Zeegers, M. P. (2011) An empirical study on the preferred size of the participant information sheet in research. Journal of Medical Ethics, 37 (9). pp. 557-562. ISSN 0306-6800

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URL of Published Version: http://dx.doi.org/10.1136/jme.2010.041871

Identification Number/DOI: 10.1136/jme.2010.041871

Background: Informed consent is a requirement for all research. It is not, however, clear how much information is sufficient to make an informed decision about participation in research. Information on an online questionnaire about childhood development was provided through an unfolding electronic participant sheet in three levels of information.
Methods: 552 participants, who completed the web-based survey, accessed and spent time reading the participant information sheet (PIS) between July 2008 and November 2009. The information behaviour of the participants was investigated. The first level contained less information than might be found on a standard PIS, the second level corresponded to a standard PIS, and the third contained more information than on a standard PIS. The actual time spent on reading the information provided in three incremental levels and the participants' evaluation of the information were calculated.
Results: 77% of the participants chose to access the first level of information, whereas 12% accessed the first two levels, 6% accessed all three levels of information and 23% participated without accessing information. The most accessed levels of information were those that corresponded to the average reading times.
Conclusion: The brief information provided in the first level was sufficient for participants to make informed decisions, while a sizeable minority of the participants chose not to access any information at all. This study adds to the debate about how much information is required to make a decision about participation in research and the results may help inform the future development of information sheets by providing data on participants' actual needs when deciding about questionnaire surveys.

Type of Work:Article
Date:April 2011 (Publication)
School/Faculty:Colleges (2008 onwards) > College of Medical & Dental Sciences
Department:School of Health and Population Sciences, Primary Care Clinical Sciences, Public Health, Epidemiology and Biostatistics
Subjects:BJ Ethics
RA Public aspects of medicine
Institution:University of Birmingham
Copyright Holders:The Authors, British Medical Journal Group
ID Code:1136
Refereed:YES
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