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Randomized Controlled Trial
. 2013 Oct 3;8(10):e76435.
doi: 10.1371/journal.pone.0076435. eCollection 2013.

Informing potential participants about research: observational study with an embedded randomized controlled trial

Helen M Kirkby  1 , Melanie Calvert, Richard J McManus, Heather Draper
Affiliations
Randomized Controlled Trial

Informing potential participants about research: observational study with an embedded randomized controlled trial

Helen M Kirkby et al. PLoS One. .

Abstract

Objectives: To assess: 1) the feasibility of electronic information provision; 2) gather evidence on the topics and level of detail of information potential research participant's accessed; 3) to assess satisfaction and understanding.

Design: Observational study with an embedded randomised controlled trial.

Setting: Low risk intervention study based in primary care.

Participants: White British & Irish, South Asian and African-Caribbean subjects aged between 40-74 years eligible for a blood pressure monitoring study.

Interventions: PDF copy of the standard paper participant information sheet (PDF-PIS) and an electronic Interactive Information Sheet (IIS) where participants could choose both the type and level of detail accessed.

Main outcome measures: 1) Proportion of participants providing an email address and accessing electronic information 2) Willingness to participate in a recruitment clinic. 3) Type and depth of information accessed on the IIS. 4) Participant satisfaction and understanding.

Results: 1160 participants were eligible for the study. Of these, 276 (24%) provided an active email address, of whom 84 did not respond to the email. 106 responded to the email but chose not to access any electronic information and were therefore ineligible for randomisation. 42 were randomised to receive the PDF-PIS and 44 to receive the IIS (with consent rates of 48% and 36%, respectively; odds ratio 0.6, 95% confidence interval 0.25 to 1.4). Electronic observation of information accessed by potential participants showed 41% chose to access no information and only 9% accessed the detail presented on the Research Ethics Committee approved participant information sheet before booking to attend a recruitment clinic for the intervention study. 63 of the 106 participants (59%) who chose not to access any electronic information also booked an appointment.

Conclusions: Current written information about research may not be read, emphasising the importance of the consent interview and consideration of new ways of presenting complex information.

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Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. Flow chart of participant recruitment (prepared and submitted as an individual file).
See this image and copyright information in PMC

References

    1. National Patient Safety Agency (2009) National Research Ethics Service. Information Sheets and Consent Forms Guidance For Researchers and Reviewers.
    1. Sugarman J, McCrory DC, Powell D, Krasny A, Adams B et al. (1999) Empirical research on informed consent. An annotated bibliography. Hastings Center Rep; 29(1): S1-42. doi: 10.2307/3528546. - DOI - PubMed
    1. Kirkby H, Calvert M, Darper H, Keeley T, Wilson S (2012) What research participants want to know about research: a systematic review. BMJ Open. - PMC - PubMed
    1. World Health Organization (1995) Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. p. 850.
    1. European Medicines Agency (2002) ICH Topic E6 (R1) Guideline for Good Clinical Practice. CPMP/ICH/135/95

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