Research Protocol

What to include in a Research Protocol?

The Research Protocol should provide enough detail for the REB to determine the soundness of the research. Therefore, the research 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)
  • Detailed description of how subjects will be recruited into the study, including recruitment sites, who will make initial contact, who obtains consent and any follow up contact
  • Design and detailed description of methodology including any risks that may be involved for research participants, research staff or investigators
  • Definition of end-point(s)
  • Demographics, surveys, measurements, interview guides, standardized questionnaires, review of patient or client files
  • Data analysis plan
  • References