Overview

Certain activities that may appear to involve human participants do not meet the federal definition of “human subjects research” and therefore do not require IRB review or oversight. This guidance helps investigators understand when a project qualifies for a Not Human Subjects Research (NHSR) determination and outlines how to request that determination.

Federal Definition of Human Subjects Research

Per 45 CFR 46.102(e), a human subject is:

A living individual about whom an investigator (whether professional or student) conducting research:

Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Interaction includes any form of communication or interpersonal contact between the researcher and participant.
Intervention includes physical procedures or manipulations of the subject or the subject's environment.*

If neither of these apply, the activity may be considered Not Human Subjects Research.

*Interaction includes communication or interpersonal contact between investigator and subject. Surveys do not count as an intervention.

When Is a Survey Study NHSR?

A project may qualify as Not Human Subjects Research if all of the following conditions are met:

The data collected is completely anonymous
- No names, email addresses, IP addresses, or other identifiable information are collected.
- There is no way for the research team to link responses to individuals.
There is no interaction or intervention with participants
- The survey or data collection is passive and self-administered.
- The research team does not directly contact or recruit participants.
The research team does not manage or have access to a recruitment list
- The research team must be blinded to the identities of potential participants throughout the recruitment process.
- Recruitment should occur through self-selection (e.g., public flyers, QR codes) or be facilitated by a third party (e.g., instructor, administrator) who does not share any identifying information with the study team.
- At no point should the research team possess or access a list of individuals who were contacted or invited to participate.

Example of a Fully Anonymous NHSR Survey Study

✅ A fully anonymous survey where the research team receives only non-identifiable data. Recruitment is completely anonymous (flyer posted in a public space containting a QR code for self recruitment or emails contianing links sent on behalf of the study team). No identifiable data is collected that could identify participants.

Examples that Likely Do Not Qualify as NHSR that Would Require IRB Oversite

❌ A survey that asks for email addresses for follow-up.
❌ A study where the researchers directly email or interview participants.
❌ A study using coded data where a key exists and could be re-linked to identifiers.
❌ Any interaction between the research team and participants, even through a recruitment process (e.g., face-to-face recruitment).
❌ Any study that involves a Benign Behavioral Intervention—such as a cause-and-effect experiment*

* Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.

Requesting an NHSR Determination

Investigators who believe their project qualifies as NHSR may request a formal determination letter from the IRB. This may be required for publication or course documentation.

To request a formal NHSR determination, submit the following to the IRB:

Submit a completed Form 1 to the IRB for review.
Indicate in Question 1 (study summary), that the study is a Fully Anonymous Survey not requiring IRB oversite.

Important Notes

Only the IRB is authorized to issue a formal NHSR determination on behalf of the institution.

If there is any uncertainty, or if documentation of the determination is needed (e.g., for publication or compliance), investigators are strongly encouraged to submit the project for review. A representative of the IRB or Research and Scholarship Administration will assess the scope of the activity and, if appropriate, issue an official NHSR determination.
If your project is determined to be NHSR, you may proceed without IRB oversight.
If your methods change (e.g., you begin collecting identifiers or contacting participants), you must re-consult with the IRB.

Questions, Appeals, and Discrepancies

If a principal investigator disagrees with a reviewer’s NHSR determination or has concerns about the decision, they may request a second review by another IRB reviewer. If discrepancies or conflicting assessments arise between the two reviewers, the IRB Chair will serve as the final authority in resolving the determination.

Investigators are always welcome to request clarification or schedule a consultation with the IRB Office to better understand the rationale behind a determination.