USC policy allows researchers to make a NHSR determination themselves if a project does not meet the regulatory definition of human subjects and/or research.
Some publishers and funders will require an official NHSR determination notice by the IRB. Please follow the guidelines below to request a NHSR determination prior to starting any activities. Determination notices will not be provided retroactively.
If you have submitted an iStar application that qualifies as NHSR you will be given a NHSR determination notice and be asked to withdraw the study from the system.
*From 45 CFR 46.102, The Federal Regulations on Human Subjects Research
Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information.
Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Please refer to policy chapters 6.1 and 6.5 for more information.
The NHSR Worksheet provides assistance for individuals who wish to determine whether an activity is human subjects research. If it is not human subjects research, IRB review and approval are not required.
To request a NHSR determination for a proposed project, please submit an email request to Julie Slayton at firstname.lastname@example.org.
In the subject line of the email enter “NHSR Determination Request.” In the email, please include the following:
- A summary of the study purpose.
- A description of what the researcher expects to do as a result of the activities conducted as part of the project.
- If the project is interview and/or survey based, either a copy of the questions asked or examples of the questions asked.
- If the project is not interview and/or survey based, a description of the data source should be included.
- A copy of the grant application and budget detail, if funded.
Emails that do not adhere to the guidelines described above will be asked to resubmit.
If you have any questions, please contact the IRB office at (323) 442-0114.