Activities not considered Human Subjects Research
The Revised Common Rule (2018) was implemented by the U.S. Department of Health and Human Services and other Federal Departments. The regulatory text includes a number of definitions (45 CFR Part 46.102) around what is and is not considered 'Human Subjects Research', as well as updated categories of review, and the role of the Institutional Review Board (IRB).
- 46.102 - (e)(1) Human Subject - means 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.
- 46.102 - (l) Research - means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Activities that are generally not considered Human Subjects Research
What tools can help me decide?
Decision charts, produced by the Office for Human Research Protections (OHRP), may help investigators and institutional officials follow whether activities should be considered Human Subjects Research, and whether they might meet certain categories which determine the type of review needed.
Presentation Slides (February 2022) - OHRP presentation material may also be useful on: 'What is Research and what it isn't? And Who is a Human Subject Anyway?'
Who can I ask for help and what should I do next?
For further information please contact CPHS at email@example.com.
If you are ready with a project idea and would like a determination from CPHS please submit a form for NHSR determination, available at the CPHS Forms Page. Submitting the form is an efficient way to explain the project and how data will be collected.
While you may be seeking a determination that the proposed project is not considered ‘Human Subjects Research’ it still likely touches on topics of handling data, understanding identifiers, and potential risks to participants and researchers. It is important to understand the definitions and what would become human subjects research should the project change. The CITI Program Human Subjects training is valid for three years and offers good insight, background, and research examples to help inform your research application.