Template documents

• Participant advertisement

  The participant advertisement (Word) or an alternative containing the same information must be used for projects where adverts will be used to recruit participants (displayed physically, or sent via post or email). Also consider the University's guidance on branding.

• Participant information sheet (PIS)

  The participant information sheet (PIS) (Word), or an alternative containing the same information, must be used for all research involving living human participants.

  The PIS:

  • provides key information about the project
  • helps to ensure consent is fully informed
  • helps to ensure consent is freely given
  • contains statements on use of participants’ data in compliance with data protection law.

  It is essential that participants are given:

  • a copy of the PIS that they can retain such as a hardcopy or downloadable PDF (if participants can read)
  • time to consider the participant information and decide whether to take part.

  There may be some instances where a PIS and consent form (in any format) are not appropriate, for example when accessing large external datasets via a 'gatekeeper'. If you feel this applies to you, discuss this with your School ethics committee and provide justification in Question 31 of the ethical review application form.

  Anonymous participants

  If you are conducting a study where the participants will be anonymous from the outset (such as an online questionnaire) you can use the  Participant information sheet (anonymous) (Word)

• Consent form

  The consent form (Word), or an equally robust consent process, must be used for all research projects involving living human participants.

  Written consent is considered the 'gold standard'. In limited circumstances an alternative such as oral consent may be appropriate but this must be justified in the ethics application - see the guidance on consent.

  Using the consent template ensures and evidences that participants have explicitly provided consent:

  • to participate in your project
  • in full knowledge of the nature of the project.

  It also ensures and provides evidence that participants have consented explicitly to audiovisual recordings or photographs, future contact from researchers, or other optional components. If possible, you should allow individuals to participate even if they decline optional components.

  The consent form contains sections on the use of participant data, ensuring compliance with data protection law.

  There may be some instances where a participant information sheet and consent form (in any format) are not appropriate, for example when accessing large external datasets via a 'gatekeeper'. If you feel this applies to you, discuss this with your School ethics committee and provide justification in Question 31 of the ethical review application form.

• Debrief

  The participant debrief (Word), or an equivalent debriefing process, must be used for projects that involve:

  • deception
  • withholding of information
  • where the participant is likely to experience distress.

  You must give the contact details of any support services or organisations that the participant may find helpful. The debrief should usually be in a format that participants can retain, such as a hardcopy or pdf but may be supplied in an alternative format if literacy or accessibility needs require.

  For other projects, the participant debrief (Word) is not mandatory but can be helpful to:

  • ensure participants know that their contribution is valued
  • remind participants of the aims of the research
  • remind participants of the contact details of the researcher
  • detail how participants can access the findings of the research when the project has completed.

• Participant information and consent for child participants

  When your research involves child participants, please use the age-appropriate versions of the participant information sheet (PIS) and consent forms as indicated below (PG indicates 'parent or guardian'). Consider the guidance above on 'normal' templates and alternative formats.

  Both parent (or guardian) and child should be given information about the study and provide consent (parent and older children) plus ongoing assent (children). Assent may be verbal for younger children. For very young or non-verbal children researchers must describe in their ethics application how they will ensure ongoing assent and identify any signs of discomfort or a child's wish to discontinue participation.

  These age groups are provided for guidance; however, researchers should consider which participant information and consent options are most appropriate for their participants (for example, due to literacy or comprehension levels). 

  Researchers working with child participants should seek guidance from the Child Panel representative, Barbara Dritschel (bd9@st-andrews.ac.uk).

  Child aged 0 to 8 years

  Participant information:

  • Parents or guardians should be given the PIS - PG (0-12y) (Word).
  • The child should be given information verbally.

  Consent:

  • Parents or guardians should be given the consent form - PG (0-12y) (Word).
  • The child’s ongoing assent should be ensured throughout the research activity.

  Child aged 8 to 12 years

  Participant information:

  • Parents or guardians should be given the PIS - PG (0-12y) (Word).
  • The child should be either given the information verbally, or using the PIS - child (12-16y) (Word), depending on their literacy and comprehension levels.

  Consent:

  • Parents or guardians should be given the consent form - PG (0-12y) (Word).
  • The child’s ongoing assent should be ensured throughout the research activity.

  Child aged 12 to 16 years

  Participant information:

  • Parents or guardians should be given the PIS - PG (12-16y) (Word).
  • The child should be given the PIS - child (12-16y) (Word).

  Consent:

  • Parents or guardians should be given the consent form - PG (12-16y) (Word).
  • The child should be given the consent form - child (12-16y) (Word) and their ongoing assent ensured throughout the research activity.

• Letter to school

  The template letters to schools must be used when planning research within a school, such as with pupils.

  There are two template letters to reflect the process of gaining approval:

  • The letter to school - agreement in principle (Word) is to establish with the school whether they agree, in principle, to participate. You will need this to apply for ethical and Local Education Authority (LEA) approval.
  • The letter to school - study commencing (Word) should be used, once you have obtained ethical and LEA approval, to confirm that the school is still willing to participate, and to arrange the practicalities of the research.

  Both letters include summary information about the project and what the participants, and the school, will be required to do.

• Letter to parent or guardian

  The letter to parent or guardian (Word), or an alternative format if needed due to accessibility or literacy requirements, must be used when planning research with participants under the age of 16 years.

  The letter includes summary information about the project and what the participant, and the parent if appropriate, will be required to do.

• Accessibility resources

  Researchers may find some of the following resources useful when considering accessibility and readability of participant documents. 

  Researchers should also consider the sections above on participant information sheets and consent forms for children. If researchers need to use a simplified version of the legal basis statement for the participant information sheet, they should use the version included in the template PIS - child (12-16y) (Word) as this was developed in collaboration with the University's Data Protection Officer to ensure it meets the University's obligations regarding GDPR. 

  University pages 

  Equality, diversity and inclusion

  Diversity online training

  Digital standards (this contains a variety of resources on accessibility, content standards and house style that are primarily aimed at University web pages and digital content but which can also be useful when thinking about participant information or where participants will be recruited via a web page).

  Tools to assess readability

  Hemingway Editor

  SMOG (simplified measure of gobbledygook) calculator

  Microsoft Word - get your document's readability and level statistics

  Readability Formulas

  Resources for suggested wording, styles and formatting

  The British Dyslexia Association style guide

  The Plain English Campaign

  Microsoft Word - make your Word documents accessible to people with disabilities

  Other tools and resources

  Microsoft Office 365 - accessibility checker

  We Are Colorblind - resources for colour blind friendly designs

  KnightLab at Northwestern University - blog on colour blind friendly graphics for reporting data