Protocol Templates & Forms

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.

• Consult our Protocol Conversion Guide 11-9-2014 for important information about using templates with new submissions or converting templates for previously approved research.
• When developing the recruitment sections of your protocols please refer to our Recruitment Materials and Guidelines webpage.

Biomedical Research Templates

• Biomedical Protocol Template (HRP-593): (Rev. 11-10-2023) 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. 05-01-2023) 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. 11-01-2023) 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. 05-01-2023)
• Local Protocol Addendum Template (HRP-508): (Rev. 11-17-2022) 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. 05-01-2023) This document is intended for use primarily by those involved in analysis of data and/or specimens.

Supporting Documents

• Registry (Subject Pool) Best Practices (HRP-1103): A registry or subject pool is a list or database of participants that multiple investigators will use for recruitment in the future. A registry requires IRB approval as an independent project.
• FORM Emergency Use of Investigational Drug, Device, or Biologic (HRP-1203)
• FORM Compassionate Use Request for Investigational Devices (HRP-1201)
• FORM Radiation Dosimetry (HRP-1202)
• Debriefing Information Template (HRP-1726)
• Incident Assessment Tool (HRP-1207): This form can be used to assist the Principal Investigator in determining if an incident that occurs meets the IRB reporting criteria.

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