Consent Form Template

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Instructional Notes for Informed Consent Form Template – 2018-02-06
(These notes are instructional and should not be included in the informed consent form submitted to the REB or given to the prospective research participant.)

  • This informed consent form (ICF) template is intended for use by investigators, study coordinators, or informed consent form authors when drafting ICFs. It has been designed to meet current regulatory and ethical standards, while using language approved by the Nova Scotia Health Authority (NSHA) REB.

  • Please read these guidelines carefully before submitting your application to the research ethics office. The REB requests that all ICFs follow the prescribed structure and format as set out in this template to facilitate REB review.

  • All ICFs submitted to the REB must adhere to the requirements of the NSHA REB and the 2nd Edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2). All ICFs for clinical trials that have been submitted to Health Canada or the Food and Drug Administration (FDA), and Phase IV trials (i.e. post marketing), must also follow the International Conference on Harmonization (ICH) Guidance E6: Good Clinical Practice (GCP): Consolidated Guideline.

  • Sections may be omitted if they are not relevant to the specific protocol. Renumber sections accordingly. The section headings should also follow the order suggested in this template.

  • Instructions are in italics, << examples >> and << suggested text >> for use in the ICF are in red; therefore this template will serve you best if it is viewed electronically or printed in color. All red text should be edited appropriately for the specific protocol. After all edits have been completed, convert the text to black.

  • Before submitting the ICF to the REB for review, take the time to review carefully for spelling, grammar and formatting issues that may have arisen during editing of this template.

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