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Templates & Forms

Is my study human subject research?

If you are not certain whether your activity is Human Research or you would like for the IRB Office to make that determination for you and provide you with documentation of that determination, complete the Human Research Determination Form (HRP-503).

  • Human Research Determination Form (HRP-503) This document is intended for use for those studies that do not meet the definition of human subjects research.  Upload this document in the protocol section of the eIRB+ study application.

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 Guidance on the Use of Public Use Data)

Which protocol template do I use?

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

  • Social Behavioral Protocol Template (HRP-583): 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.
  • Biomedical Protocol Template (HRP-593): This document is intended for use primarily by those conducting biomedical research.
  • Local Protocol Addendum Template (HRP-508) This document contains local information 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. [Track Changes]
  • Data and Specimen Analysis Protocol (HRP-1704): This document is intended for use primarily by those involved in analysis of data and/or specimens.
  • 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.

Please consult this Protocol Conversion Guide 11-9-2014 for important information about using templates with new submissions or converting templates for previously approved research.  See also Recruitment Materials and Guidelines when developing the recruitment sections of your protocols.

Social Behavioral Studies

Consent Document Template

NOTE: If you are planning to obtain online or verbal consent, there are instructions at the end of the consent template (HRP-582) on how to alter the template for use with online or verbal consent.

Additional Consent Document Templates

Protocol Templates

Biomedical Studies

Consent Document Templates

Protocol Templates

Supporting Documents

HRP-216 – FORM Media Relations  

HRP-1201- FORM Compassionate Use Request for Investigational Devices

HRP-1202 – FORM Radiation Dosimetry

HRP-1203 – FORM Emergency Use of Investigational Drug, Device, or Biologic

Certificate of Translation Template For Non-English Documents

HIPAA Revocation Template Letter

Change in Contact Information Template Letter

IRB Authorization Agreement  – Please see the Reliance Agreements Webpage

Short-Form Consents

Arabic * Gujurati Lao * Serbian
Chinese Hindi Oromo * Somali *
Croatian * Hmong * Polish * Spanish *
English Khmer * Portuguese Tagalog
French * Korean Russian * Ukrainian
Vietnamese *

*Translation provided with permission from the University of Minnesota.

Certificates Of Translation:

For additional information, refer to OHRP’s guidance on obtaining and documenting informed consent of participants with limited English proficiency.

See alsoConsent Translation and Short Form Guidance.