Consent and Participant Information Guidance

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.

• Participant Information Sheet (PIS) Template
• Consent form template

Other examples are available in the sections below.

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.

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.

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 and Northern Ireland:

• Consultee Information Sheet
• Consultee Declaration form

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

• Welfare Guardian / Welfare Attorney / Nearest relative Participant Information Sheet and Consent form
• Recovered Capacity Participant Information Sheet and Consent form
  We’d like to acknowledge Dr Alex Bailey and Dr Lynn Morrice, South East Scotland Research Ethics Service for providing the Scotland templates.

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

• Medicines for Children Research Network (MCRN) Young Person's Advisory Group (YPAG) - Guidance for researchers designing Patient Information Leaflets
• Top tips... What we young people want to know

Examples

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

• Example 1 – OXBAV less than 6
• Example 2 – OXBAV 6-9
• Example 3 – OXBAV 10-15
  We'd like to acknowledge Dr Malenka M Bissell, University of Oxford for providing the OXBAV examples.
• Example 4 - Appendicitis 6-12
• Example 5 - Appendicitis 6-12 control group
• Example 6 – Appendicitis 13-15
• Example 7 – Appendicitis 13-15 control group
• Example 8 – Appendicitis Parent and carer
• Example 9 – Appendicitis Parent and carer control group
  We'd like to acknowledge the Research Team, Sheffield Children's NHS Foundation Trust for providing the Appendicitis examples.

The introduction of the General Data Protection Regulation (GDPR) brings with it stricter requirements around how organisations inform people of how their personal data is being used. The HRA has drafted recommended wording to help organisations meet this requirement.

• HRA’s recommended wording

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.

• Example PIS for pragmatic trials

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.

• HRA generic ionising radiation risk statements

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.

• Newland Hill – Before user testing
• Newland Hill – After user testing

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

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).