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.
Note: NHSR determinations cannot be made on FDA regulated research, including secondary data analysis on de-identified samples and/or data, also known as “coded data.”
*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.
You are required to retain the checklist for your records. A NHSR determination letter from the IRB will not be generated for self-determinations.
If a researcher requires a NHSR determination letter from the IRB, the researcher will need to submit an exempt human subjects application in iStar.
The following is required to be completed:
- The short study title should include “NHSR Determination Request.”
- Section 1.1 – check “Research Protocol or Study on Human Subjects.”
- Section 1.5 – check “USC – Social Behavioral IRB.”
- Section 5.1 – check “exempt review.”
- Fully complete the remainder of the application and submit the protocol provided on the Forms and Templates page.
- If the project is interview and/or survey based, a copy (or examples) of the questions to be asked is required.
- If the project is not an interview and/or survey based, a description of the data source is required.
If the analyst determines the project is NHSR, a NHSR determination letter will be issued. If the analyst determines the application qualifies for exemption and all relevant information pertaining to an exempt determination is included, an exemption determination letter will be issued.
If additional information is required, for example a fully developed protocol, survey and/or interview instruments to make the determination, the application will be returned with a request for changes.
If you have any questions, please contact the IRB office firstname.lastname@example.org