Studies that include both research AND human subjects are considered to be Human Subjects Research. Only Human Subjects Research studies require IRB review or IRB exemption.

If you have questions about whether your work qualifies as Human Subjects Research, or you believe that your project does not require IRB review and you want official determination documentation from the IRB, please complete the HSR Determination Worksheet via DocuSign. The IRB shall make the final determination as to whether an activity meets the definition of human subjects research. 

*Western SARE applicants: Do not fill out the DocuSign version. Instead, submit this worksheet with your proposal materials to Western SARE. Download HSR Determination Worksheet.

 

1) Is your project Research?

The Common Rule definesresearch as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” Additionally, the Belmont Reportdefines research as “an activity designed to test a hypothesis and permit conclusions to be drawn” through a formal study plan with a set of procedures to reach an objective.

 

2) Does your project include Human Subjects?

The Common Rule defines a human subject as 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.

 

Activities that are not considered research:

  1. Journalism

  2. Biographies

  3. Literary criticism

  4. Legal research

  5. Oral histories and historical scholarship that focuses only on specific individuals about whom the information is collected

  6. Public health surveillance activities under the direction of a public health authority

  7. Collection and analysis of information, specimens, or records, by or for a criminal justice agency for certain criminal justice or investigative purposes

  8. Certain in-class only projects

  9. Internal quality improvement and quality assessment studies 

 

See more information on Program Evaluation.

Of note, some projects may involve both research and quality assessment.