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Consent Forms

The OHREB reviews each Information Sheet and Consent Form to ensure that the information that is being presented to patients is clear and accurate.

General Guidelines

Specifically, Information Sheets and Consent Forms should meet the following criteria:

  • Use headings, and insert spaces between paragraphs
  • A ‘version date’ should appear on each page
  • Page numbers must be inserted using the following format:  1 of 4, 2 of 4, etc.
  • The use of medical jargon should be minimized. If technical wording is used, an explanation should also be presented
  • Ensure that the ‘Possible Side Effects and/or Risks’ section includes all major adverse events described in the Investigator’s Brochure
  • The document should be written at a Grade 8 reading level
  • All acronyms should be defined the first time they are used
  • The standard font size to be used is 12 point.  (This may be larger for studies recruiting research participants who may be visually impaired)
  • Use second person (“You”) throughout the Patient Information Sheet, and use first person (“I”) throughout the Consent Form
  • Be consistent with the “tense” used throughout
  • The use of tables is recommended to describe the procedures, particularly if they are to be repeated at several visits
  • Use standard clauses and formatting
  • Ensure that the document is checked for grammar and spelling before submitting to the OHREB
  • The document should not exceed 8 – 10 pages in length

A sample of an Information Sheet and Consent Form with standard clauses and recommended format is provided here.  Instructions are printed in ‘red’, with actual text in ‘black’.

The Information Sheet and Consent Form must be approved by the OHREB before it is given to potential research participants.

Once signed, the original Information Sheet and Consent Form must be kept on the study file, and a copy of the signed document provided to the study participant.

Withdrawal

If a research participant must submit their request to withdraw from the study in writing, a sample letter must be provided to them. A sample is provided here

Revisions

Any changes required to an approved document, must be approved by the OHREB before use, unless the changes are intended for the elimination of an apparent immediate hazard.

Research participants must sign the revised Information Sheet and Consent Form at their next study visit.  If the research participant has completed their participation in the study, the investigator must inform the research participant about any new information, unless there is no possible impact to them.

Witness

A ‘witness’ signature is not normally required.  Refer to Section 4.8.9 of the Good Clinical Practice Consolidated Guideline for further information which can be found at:  http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/goodclin_main_e.html

Genetic Research

For studies involving genetic research or tissue banking, a separate Consent Form is required (either as a separate section following the main form, or as a stand-alone form).

Research with Minors

If the research participant is a minor (between the ages of 7 and 15), they should sign an Assent Form, and the guardian should sign the Consent Form.