If you do not already have a protocol that addresses the relevant elements included in the protocol templates, use the appropriate protocol templates as a starting point. Each of these templates includes instructional text that describes information to include in the protocol. The IRB looks for this information when reviewing research. Here are some key points to remember when developing a protocol:

  • Use instructional text as guidance when writing your study-specific protocol document, but delete these instructions prior to submission.
  • When writing a protocol, always keep your own electronic copy. You will need to modify this copy when making changes to the protocol.
  • Note that, depending on the nature of your research, certain sections of the template may not be applicable to your study. Indicate this as appropriate. Retain the section heading and add “not applicable”, rather than deleting the section.
  • Upload the protocol to the IRB application in Word format, as this allows for reviewer edits and comments to be easily placed in the document.
  • If you plan to involve any individuals who are members of the populations listed below as participants in your research, you must indicate this in your protocol and address the regulatory requirements that need to be met for including these populations. You are encouraged to consult the checklists referenced below to assist you in addressing these regulatory requirements.