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