Documentation for experts

Detailed scientific / technical protocol

Part 4 of the human subjects ethics approval application should include:

• A formal protocol, if available, that has been prepared for reasons such as project planning or implementation, or to meet the requirements of regulatory agencies overseeing the project;
  
  
• Documents such as questionnaires to be administered to subjects, statistical justifications of numbers of subjects to be enrolled, or other detailed scientific or technical documents relative to the proposed project; and
  
  
• Technical details of products to be tested in the research, such as those that are required by regulatory authorities (e.g., Health Canada), or other documents relative to safety concerns.