Consent and Participant Information Sheet
Preparation Guidance

Examples & Templates

This section of the site is a platform to share good practice. It provides practical examples and templates, which illustrate how to implement the guidance given in this site. You can also find examples of how to calculate readability scores for documents. It is a work in progress; as more topics are identified, new examples and templates will be developed and shared here.

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Participant Information Sheet and consent form templates

We have provided a framework to help you start to develop your Participant Information Sheet. We suggest that you use this framework in association with the guidance provided on this site.

The template gives you some suggested subheadings and highlights some of the issues you may need to cover.

It should not be considered a rigid template: you should try to design the most appropriate information sheet for your study and for your intended participants. Remember: one size does not fit all.

Other examples are available in the sections below.

Using different formats to aid understanding

The following real-life examples demonstrate how using different formats in consent documentation can aid understanding:

  • Example 1 - Interval
    We'd like to acknowledge Professors John Danesh and David Roberts, University of Cambridge for providing this example.
  • Example 2 - Newland Hill
    We'd like to acknowledge Dr Peter Knapp et al, for providing this example. (Note: This is only a portion of the complete PIS)
  • Example 3 - IBIS II
    We'd like to acknowledge Professor Jack Cuzick, Queen Mary University of London for providing this example.

Information provided in plain English

The following real-life example demonstrates a consent document that has been written in plain English:

  • Example 1 - TRAPEZE
    We’d like to acknowledge Professor Nicholas James, University of Warwick for providing this example.

Adults not able to consent for themselves (UK wide)

These templates should help you design consent documentation when recruiting adults who lack capacity to consent for themselves:

To record the advice given by consultees in non-CTIMP research in England and Wales:

To record consent given by Legal Representatives in non-CTIMP research in Scotland:

To record assent given by relative / close friend in non-CTIMP research in Northern Ireland:

Children and young people (UK wide)

The following guidance should help you develop consent documentation for children and young people:

Examples

The following real-life examples have been used in research involving children and young people:

Pragmatic trials

An example participant information sheet for use in pragmatic trials is provided below.  It may be suitable to adapt for use in other trials.  Note that it is provided here in a traditional text format, but another format may be better suited for your particular research.

Generic ionising radiation risk statements

This document has been produced by the Health Research Authority (HRA) to provide generic ionising radiation risk statements to be included in the IRAS application form and Participant Information Sheets but is not exhaustive.  It is recognised that there will be some studies that do not reflect the scenarios set out and in these instances bespoke statements will be required both in the IRAS form and in the Participant Information Sheet(s).  The statements contained within this document have been designed to meet the requirements of most studies and to ensure that information is provided to RECs and trial participants in a consistent manner.

The power of user testing and re-design

This example demonstrates how user testing has improved the study title and the format used to describe a complex clinical intervention. We have provided a portion of the real PIS before and after user testing to demonstrate how user input can improve information provision.

For more information on how user testing was conducted in this example, please see: P Knapp, D K Raynor, J Silcock, B Parkinson. Performance-based readability testing of participant information for Phase 3 IVF trial. Trials 2009, 10:79. doi:1186/1745-6215-10-79

Readability scores

This example shows how Flesch Reading Ease score or Fog score can be calculated. This helps improve readability of your Participant Information Sheet and Consent form.

  • Count the words and sentences.
  • Divide the number of words by the number of sentences.
  • Count the long words (more than two syllables).
  • Divide the long words by total words, and multiply by 100.
  • Add the two scores together and multiply by 0.4 to give the fog index.

To place Fog Scores in context, here are some examples:

  • A newspaper advertisement 4.
  • A popular novel 8.
  • A report on information technology 20.

Accessibility guidance is available from the Royal National Institute for the Blind (The Royal National Institute for the Blind: Advice for professionals). The Plain English Campaign offer guidance or assessment (www.plainenglish.co.uk). You can use the readability statistics function available in Microsoft Word to calculate a readability score. Other free readability calculators can be found at (www.readabilityformulas.com).