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Protocol Templates & Forms

Is your study human research?

  • Human Research Determination Form (HRP-503):  (Rev. 11-01-2023) Researchers can self-determine whether their activities are human research. If you are unable to determine whether your activities meet the regulatory definition of “research” with “human subjects,” OR if you would like/need the IRB to evaluate your study to provide an official determination that your activity is not human subjects research, complete this form.
  • Guidance on the Use of Public Use Data: Researchers using specified “public use” data sets for secondary analysis may not need to submit to the IRB for review since publicly available data does not constitute research with human subjects (as defined under 45CFR46:102). See our Policies & Guidance webpage for more information.

If Northwestern University is the Primary Awardee of a federal grant where a subaward institution or organization will conduct non-exempt human subjects research then the human research determination form is NOT appropriate because 5 CFR 46.103(f) applies. A full IRB application should be submitted with full details outlining which portions of the work will be conducted at Northwestern and/or by other institutions and organizations. Please see our Guidance Regarding Federal Requirements for IRB Review of Grants and Single IRB Planning webpages for more information. 

Which protocol template should you use?

The IRB Office has developed protocol templates for use by the Northwestern University research community to describe research/human research activities. 

Biomedical Research Templates

  • Biomedical Protocol Template (HRP-593): (Rev. 12-01-2024) This document is intended for use primarily by those conducting biomedical research.
  • Local Protocol Addendum Template (HRP-508): (Rev. 11-01-2023) This document is intended for use when local information is not represented in the main protocol document received from a study sponsor or non-Northwestern University research collaborator. The Local Protocol Addendum should be uploaded along with the main protocol document in eIRB+ and modified as necessary throughout the duration of the study to account for local changes to the research. 
  • Data and Specimen Analysis Protocol (HRP-1704): (Rev. 12-01-2024) This document is intended for use primarily by those involved in analysis of data and/or specimens.

Social and Behavioral Research Templates

  • Social Behavioral Protocol Template (HRP-583): (Rev. 11-01-2024) This document is intended for use primarily by those conducting social, behavioral, or educational research. If your research involves physical procedures or devices, you may need to include sections that are contained in the biomedical template protocol.
  • Social Behavioral Protocol Template Appendix B (HRP-1724) (Rev. 11-20-2022) 
  • Local Protocol Addendum Template (HRP-508): (Rev. 11-01-2023) This document is intended for use when local information is not represented in the main protocol document received from a study sponsor or non-Northwestern University research collaborator. The Local Protocol Addendum should be uploaded along with the main protocol document in eIRB+ and modified as necessary throughout the duration of the study to account for local changes to the research. 
  • Data and Specimen Analysis Protocol (HRP-1704): (Rev. 12-01-2024) This document is intended for use primarily by those involved in analysis of data and/or specimens.

Supporting Documents