Part 4: Documentation for experts

Detailed scientific/technical protocol

Part 4 of the human participants 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.
  • 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.
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