What is a consent form?

A consent form is a document which provides prospective research participants with the information necessary to make an informed decision about whether to take part in research or not. It may or may not include a signature section. It will be referred to as the info/consent document.

What’s the difference between a consent form and an information letter?

  • Some researchers like to separate the information (found in an information letter) from the signature section (which they term the consent form) – this is your decision and is NOT required by the Research Ethics Board (REB), but DO NOT REPEAT the same information in both places.
  • You MUST provide the participant with a copy of the info/consent letter regardless of how you document consent.

General instructions

  • Write in a conversational tone.
  • Who is your audience? Speak directly to them. The language should be at grade 8-level.
  • Directly address the participant. ‘You’ are invited, not ‘the participant’ is invited. 
  • Avoid legalistic language (e.g. you hereby agree, you certify that, etc.)
  • Use bullet point lists to increase readability.
  • Use a readable font such as Arial, Courier, or Verdana. Use a minimum 12 point font.
  • The REB will NOT proof read for spelling and grammar.
  • The bodyshould provide a plain-language description of what the participant will experience. If you need to include more than a couple of sentences, add the description of the procedure as an appendix.

What are the biggest review problems I can avoid?

  • Inconsistency between the info/consent document, recruitment documents, and the REB application.
  • Unnecessary repetition of information between information letters and consent documents.
  • Missing required elements.
  • Cut and paste errors.
  • Misusing the terms CONFIDENTIALITY AND ANONYMITY
    • CONFIDENTIALITY – a person’s identity is kept confidential. The data you collect will be shared when you publish it.
    • ANONYMITY – data are anonymous ONLY when a person’s identity has never been associated with it.
    • Best practice is to avoid these terms altogether and just tell people what to expect. Some examples are:
      • We will use your name in the final report.
      • Your name will not be released with any of the data.
      • We will not collect any identifiers other than your signature on the consent form.

Readability

Give a draft to someone who is NOT in your academic discipline to proof read. Have them circle every word which is not entirely clear. Remove these words.

There is a feature in Word to test ‘Readability’. It is best used on individual paragraphs and is NOT fool-proof. But it will give you an idea.

  • In Word, go to “File”→”Options” → “Proofing”, then click ”Show Readability Statistics”. After Spell Check has been completed, Word displays readability information.
  • The Flesch Reading Ease scale has a maximum value of 100, with higher numbers representing greater reading ease (approximately 60-70 is a good target). 
  • The Flesch-Kindcaid Grade Level is an approximation of the grade-level of education necessary for someone to understand the document (e.g., a value of 8 means Grade 8). 
  • If you want to determine the readability for an individual paragraph, highlight the paragraph, run Spell Check and then click “No” when the message pops up “Word finished checking the selection. Do you want to continue checking the remainder of the document?”