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700-13-Not Human Subject Research

Title: Not Human Subject Research
Owner: IRB
Last Update/Revised: 05/01/2024

Policy: The determination of whether a submission meets the definition of research involving human subjects lies exclusively with the IRB. No other individual has the authority to make this determination. This includes (but is not limited to): the investigator, chair of a doctoral committee/project, program director, or any other faculty or administrator.

Not all work that may colloquially be called research is considered research under the Common Rule (The Federal Policy for the Protection of Human Subjects).

To determine if a proposed activity is research with human subjects, two questions are asked:

1. Does the activity meet the regulatory definition of research? The Common Rule defines research as: “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(d)). Thus, two factors are assessed:

  • whether the activity involves a systematic investigation, and 
  • whether the activity is designed to develop or contribute to generalizable knowledge (there is no regulatory guidance on the meaning of generalizability).
    • Because systematic investigation and generalizable knowledge are not easily operationally defined, USU’s IRB Review Form begins with a screening checklist (Part 1) that will assist the IRB in determining whether the proposed activity is research and if it is, if it is research with human participants. 

If (and only if) the activity is deemed research, then a second question is asked.

    2. Does the research involve human subjects? A human subject is defined as “a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information” (45 CFR 46.102(f)(1),(2)).

    • When determining if the activity involves human subjects, an understanding of private information is needed. Regulations define private information as information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). To constitute research involving a human subject, private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

    Purpose: This policy provides the definitions that pertain to determining whether an activity meets the definition of research or human subject research, which requires a formal determination rather than approval.

    Procedures:

    1. All investigators complete Part 1 (Screening to determine if the activity is human subjects research) of the IRB Review Form.
      1. The investigator follows the directions for scoring the checklist. If the resulting score suggests the activity is not human subjects research, the investigator does not complete Part 2. If the score suggests the activity is human subjects research, the investigator completes Part 2.
      2. IRB submissions are sent directly from the investigator to the IRB via a Google Form, unless the investigator is a doctoral student, in which case the chair makes the submission.
      3. All information submitted by the investigator is reviewed using the appropriate IRB checklist. Determinations of not human subject research are made by IRB Chair or designee. Additional information may be requested via email.
      4. If a determination of not human subject research is made, the investigator (and chair of a doctoral student) is notified via a formal letter emailed from IRB@usuniversity.edu. This determination is recorded in the appropriate document in the IRB Google Drive (by the IRB Chair or designee).
        1. If the IRB staff member determines that the project meets the regulatory definition of human subject research, the investigator (and chair of a doctoral student) is instructed to complete Part 2 of the IRB Review Form and resubmit for review.

    Scope: This policy applies to activities conducted at USU that could potentially be considered not research with human subjects.

    Documents and Forms: 

    IRB Review Forms: DBA Program, DNP Program, EdD Program, Faculty & Staff (available in Policy 700-41)