Does My Project Need IRB approval?

Human Subject Research (HSR) Determination

Institutional Review Board

The IRB has the sole authority to make a final determination of whether a proposed activity is  research involving human subjects in accordance with IRB Policy and regulatory definitions. Unless you are familiar enough with the regulations to be certain that the activity does not represent human research, the activity should be submitted for a determination.

The Form 129 has been redone as the HSR Determination Form, which can only be accessed in OneAegis. Submissions of the old Form 129 will no longer be accepted after January 31st, 2026. 

Not sure if your project needs IRB approval? 

To find out if your study needs IRB approval, fill out and submit the HSR Determination Form in OneAegis. If you do not have a OneAegis account, use the OneAegis Request for Login Form to request access. 

What happens next:

The HSR Determination is primarily based on multiple choice responses. Based on your responses, the form may be able to make an automatic determination as to whether the project is considered research involving human subjects according to IRB Policy and regulatory definitions. If an automatic determination is made, then you can choose to immediately receive a copy of your form with this determination, or you can opt for manual review and a formal letter, which will take a few days. 

If the form is unable to make an automatic determination, it will then move on the HRPP for administrative review. Once a determination is made, you will receive an email with a copy of your determination letter. 

Your project will be determined as one of the following:

  • NOT human subject research.
    • This means the project is not research involving human subjects according to our institution's policy and does not require IRB approval.
    • Some projects may still need other institutional approvals (i.e., case studies that include HIPAA data), and the submitter is responsible obtaining relevant approvals prior to starting the activity.
  • Human subject research.
    • This means a New Protocol Submission xform is required and must be approved before initiating the research.  
    • Get Started with the IRB review process.

  • Unclear, which will require a new protocol submission to make a final determination. 

Additional Information:

  • Research definition

    When considering what constitutes research with human participants, or using data/specimens from humans, ETSU uses the DHHS definition defined in the regulations. Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 

    A systematic Investigation is typically a predetermined method for studying a specific topic, testing a specific hypothesis(es), answering a specific question, or developing a theory. To develop or contribute to generalizable knowledge typically means that results or conclusions of the activity are intended to be extended beyond the group or program being studied.

  • Human Subject definition

    If an activity or project meets the definition of research, the IRB considers whether there are human subjects involved. ETSU uses the DHHS definition defined in the regulations. A Human Subject is a living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

    Interaction not only includes in-person but also includes virtual or remote interactions such as email correspondence, online surveys, and zoom interviews. Intervention includes physical procedures such as blood draws or MRI as well as manipulation of the subjects or their environment for research purposes such as educational presentations, simulations, or medical procedures.

  • Clinical research
    Some clinical or biomedical research may be subject to FDA regulations, which has its own definitions and rules to follow. Instead of research, the FDA uses the term Clinical Investigation. A Clinical Investigation is any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under Section 505(i), 507(d) or 520 (g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. A human subject defined by the FDA is an individual who is or becomes a participant in research, either as a recipient of the test article or control. FDA regulations also define subjects as an individual on whose specimen a device is used. Note that when medical device research involves in vitro diagnostics and unidentified tissue specimens, the FDA defines unidentified tissue specimens as human subjects.
  • Activities that may not be research

    ETSU IRB Policy 5: Research Activities includes definitions and information about activities such as case studies and classroom research projects. 

    Additionally, the IRB has published guidance about Quality Improvement projects versus Research.

  • When a project requires ETSU IRB approval

    All individuals engaged in research with human subjects that is sponsored by East Tennessee State University, conducted by or under the direction of any faculty, staff, or student or agent of ETSU in connection with his or her institutional responsibilities, or conducted by or under the direction of any employee or agent of ETSU using any property or facility of ETSU must obtain ETSU or ETSU/VA IRB approval before beginning any research activities.