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. (See Submitting a Non-Human Subjects Research project in eIRB+ for step-by-step instructions)
Which protocol template do I use?
The IRB Office has developed three new protocol templates for use by the Northwestern University research community to describe research/human research activities:
- 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.
- 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 Template Protocol (HRP-593): This document is intended for use primarily by those conducting biomedical research.
Please consult this Protocol Conversion Guide 11-9-2014 for important information about using those templates with new submissions or converting to those 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 and Examples
- Example of Assent Consent
- Example of Assent Script
- Example of Online Consent
- Example of Verbal Consent
- Example of Parent Permission w/ Child Assent
- Example of Parent Consent and Permission w/ Child Assent
Consent Document Templates
These worksheets are used for initial review, continuing review, and review of modifications to previously approved Human Research. Investigators and their research teams are encouraged to use the worksheets to write their protocols in a way that addresses the criteria for approval (HRP-314).
The following are posted with permission from the University of Minnesota. See OHRP's Guidance on obtaining and documenting informed consent of subjects who do not speak English.