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The use of electronic participant information sheets as a means of tailoring information to the needs of potential research participants

Investigator: Heather Draper has led various different funded projects, working with Professor Mel Calvert University of Birmingham, amongst others

InformationThe information provided to research participants is often long and complex, especially for clinical trials. There are concerns that the length of these information sheets may deter people from participating in research. It may even be a source of bias if those who feel overwhelmed come from similar backgrounds (those who are not confident or regular readers). Equally, researchers are obliged to ensure that participants are fully informed as part of the consent process and those who are sponsoring the research may be fearful that anything less than complete and full information may open them to legal action in the event of some adverse event occurring. We have been working on developing an information sheet that contains different levels of information and allows participants to read very simplified information as a way of accessing more complex information if they chose to do so.

Much of this work was funded through the MRC Midland Hub for Trial Methodology.

This research is now continuing in Kirstie Shearman's doctoral research.


Kirkby, H.M., Calvert M., McManus R.J., Draper H. (2013) Informing Potential Participants about Research: Observational Study with an Embedded Randomized Controlled Trial. PLoS ONE 8(10): e76435. doi:10.1371/journal.pone.0076435 (open access)

Kirkby, H., Calvert, M, Draper, H, Keeley, T, Wilson S What patients want to know about research: a systematic review. BMJOpen 2012;2:e000509 (open access)

Kirkby, H., Wilson, S., Calvert, M., Draper, H., (2011) Using email recruitment and an on-line questionnaire to establish sample size: a worked example. BMC Medical Research Methodology; 11:89

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

Ives J., Draper H., Damery S., Wilson S. (2009) Do family doctors have an obligation to facilitate research? Family Practice 26:543-548

Draper, H., Wilson, S., Flanagan, S., Ives, J. (2009) Offering payments, reimbursement and incentives to patients and family doctors to encourage participation in research. Family Practice 26(3):231-238

Wilson S., Draper H., Ives, J. (2008) ‘Should recruitment for research take place in the GP consultation?’ Family Practice 2008; 25: 456–461

Draper, H., Wilson, S. (2007) Editorial ‘Research ethics approval: comprehensive mechanisms are essential but not available. Family Practice 24(6): 527-8