The research question and methodology must be presented in sufficient detail to permit evaluation of the scientific merit of the project. The protocol should include:

  • Study purpose and rationale
  • Description of the population to be studied, inclusion and exclusion criteria
  • Sample size (and how sample size was determined)
  • Design and detailed description of methodology
  • Definition of end-point(s)
  • Measurements and measurement instruments
  • Data analysis plan
  • How subjects will be recruited, including advertisements/publicity
  • References
  • Include a version date and page numbering in the footer, Page 1 of x, 2 of x, etc.

A Collaboration of

Disclaimer: The Hamilton Integrated Research Ethics Board (HiREB) represents the institutions of Hamilton Health Sciences, St. Joseph’s Healthcare Hamilton, Research St. Joseph's-Hamilton, and the Faculty of Health Sciences at McMaster University and operates in compliance with and is constituted in accordance with the requirements of: The Tri-Council Policy Statement on Ethical Conduct of Research Involving Humans; The International Conference on Harmonization of Good Clinical Practices; Part C Division 5 of the Food and Drug Regulations of Health Canada,  and the provisions of the Ontario Personal Health Information Protection Act 2004 and its applicable Regulations; For studies conducted at St. Joseph's Healthcare Hamilton, HiREB complies with the Health Ethics Guide of the Catholic Alliance of Canada