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