Consent Guidelines

Overview

All supporting documents, including consent forms, should be written with the intended audience in mind. The guidelines below describe the required content and provide typical wording for consent forms. Please do not copy verbatim, but edit the language for suitability.

All information required by invitees to make an informed decision about their participation should be included in the informed consent form.

The MCREB now requires that the MCREB# (YY-XXX) is included in the footer of all consent forms. Do not include other references to review and approval by the Research Ethics Board in consent or other supporting documents, as this statement may unduly influence invitees in making an informed, objective decision regarding their participation in the study.

Any changes to the consent form must be approved by the Research Ethics Board before the research begins or continues.

Writing style

  1. Avoid technical terms and jargon if a plain language explanation is available. Try to achieve a readability score at the grade 7 level. You can display the Flesch-Kincaid Grade Level Score in Word files. For instructions, see: https://support.office.com/en-us/article/Test-your-document-s-readability-85b4969e-e80a-4777-8dd3-f7fc3c8b3fd2.
  2. Use acronyms sparingly and write in full on each page of the document the first time they are used (followed by the acronym in brackets).
  3. The consent form should be written in the second person. Use “you” not “I” when referring to invitees.

Formatting

  1. Type size should be a minimum 12-point font. Use a 13- or 14-point size if the majority of readers are seniors.
  2. The use of headings, small paragraphs and ample white space between paragraphs will increase readability.
  3. Include page numbers in the footer of each page: e.g., 1 of 3, 2 of 3, 3 of 3, etc.
  4. Include a version date in the footer of each page. 

Insert departmental or institutional details (full title and mailing address) and the Mohawk College logo at the top of the first page if the Principal Investigator is affiliated with Mohawk College or if there is a Locally Responsible Investigator from Mohawk College.

Please see the MCREB Informed Consent Sample for further guidance.