Note: The Principal Investigator should not make the final determination as to whether a project constitutes human subject research or not; that determination may only be made by the IRB. In addition, many journals and/or national organizations require a formal determination from the IRB in order to submit a manuscript or abstract.

According to 45 CFR 46.102:

Human subject means 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.

Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes 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 which 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). 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) in order for obtaining the information to constitute research involving human subjects.

The IRB’s role is to oversee human subject research. Therefore, studies that do not involve human subjects or do not meet definition of research are considered Not Human Subjects Research (NHSR).

Submit an NHSR proposal in eIRB using the applicable forms for each common category listed below. (Supporting documents may be needed as described on the forms.)

Or, see more detailed guidance for common types of NHSR projects:

• Analysis of de-identified data/specimens
• Quality Assurance / Quality Improvement Projects
• Tufts not Engaged in research

If you have questions about the documents, information that need to be submitted, or whether your project qualifies for a Not Human Subject Research determination do not hesitate to call the IRB Office at (617) 636-7512.