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How do I write an Investigator Protocol?

Write your protocol using the appropriate protocol templates from the IRB’s Protocol Templates & Forms webpage . Use the “TEMPLATE: Biomedical Protocol Template (HRP-593)” for Biomedical research or “TEMPLATE: Social Behavioral Protocol Template (HRP-583)” for Social Behavioral research as a starting point for drafting a new Investigator Protocol. Use the “TEMPLATE: Data and Specimen Analysis Protocol (HRP-1704)” for a study focused on analyzing data or specimens. Please see the “GUIDANCE: Registry (Subject Pool) Best Practices (HRP-1103)” for creating a list or database of participants that multiple investigators will use for recruitment in the future. Please note that a registry requires IRB approval as an independent project. Reference the instructions and guidance in the template for the information the IRB looks for when reviewing research.

If you received an Investigator Protocol from your study sponsor or lead study investigator for multi-site research, use the “TEMPLATE: Local Protocol Addendum Template (HRP-508)” to document relevant local information not included in the sponsor or multi-site protocol. Upload both the received multi-site protocol and the local protocol addendum in eIRB+. The use of the Local Protocol Addendum applies to both Biomedical and Social Behavioral research.

Here are some key points to remember when developing an Investigator Protocol:

  • You are required to use one of the template protocols listed above for new Human Research, where the local protocol addendum alone will not suffice to describe all of your research activities.
  • There are questions and statements about what to consider in the protocol templates that guide investigators when developing an Investigator Protocol for submission to the IRB. You should delete all of the guidance comments before submitting the protocol to the IRB.
  • When writing an Investigator Protocol, always keep an electronic copy. You will need to modify this copy using the tracked changes function in Word when making changes to the Investigator Protocol. The eIRB+ system stores electronic copies.
  • Note that not everything that is in the protocol template will be relevant to every research study. Therefore, do not delete any primary sections if they do not apply; instead, indicate “N/A” (not applicable).
  • You may not involve any individuals of the following populations as participants in your research without specifically including them in your inclusion criteria and providing study-specific justification for their inclusion. This is because the inclusion of participants in these populations has regulatory implications.
    • Adults unable to provide legally effective consent
    • Individuals who are not yet adults (persons who have not attained the legal age for consent to treatments or procedures involved in the research under the applicable law of the jurisdiction where the research will be conducted)
    • Prisoners