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An empirical study on the preferred size of the participant information sheet in research
  1. Evangelia E Antoniou1,
  2. Heather Draper2,
  3. Keith Reed1,3,
  4. Amanda Burls4,
  5. Taunton R Southwood5,6,
  6. Maurice P Zeegers1,7
  1. 1Unit of Urologic and Genetic Epidemiology, Department of Public Health, Epidemiology and Biostatistics, University of Birmingham, Edgbaston, UK
  2. 2Centre for Biomedical Ethics, Primary Care Clinical Sciences, University of Birmingham, Edgbaston, UK
  3. 3The Twins and Multiple Births Association (TAMBA), Surrey, UK
  4. 4Department of Primary Health Care, University of Oxford, Oxford, UK
  5. 5Institute of Child Health, University of Birmingham, Edgbaston, UK
  6. 6Birmingham Children's Hospital NHS Foundation Trust, Birmingham, UK
  7. 7Section of Complex Genetics, Department of Genetics and Cell Biology, NUTRIM School for Nutrition, Toxicology and Metabolism, Maastricht University Medical Centre, Maastricht, The Netherlands
  1. Correspondence to Evangelia E Antoniou, Department of Public Health, Epidemiology and Biostatistics, University of Birmingham, Edgbaston B15 2TT, UK; exa660{at}


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.

  • Electronic participant information sheets
  • ethics committees
  • ethics committees/consultation
  • informed consent
  • research ethics
  • web-based clinical research

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  • Competing interests None declared.

  • Ethics approval This study was conducted with the approval of the Ethical Review Committee of the University of Birmingham.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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