Step 1: Do you need to submit?

All Penn State employees and students conducting activities that meet the definition of both "research" and "human subject" must submit for Institutional Review Board (IRB) approval before beginning any research activity. IRB approval cannot be retroactive. 

If you are not doing Human Subjects Research but would like or need an official IRB determination, you can submit for a Non-Human/Non-Research Determination. See the Investigator Manual for details.  

Is it Research?

Research is;a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge"(45 CFR 46.102(d)).

Examples of Research

  • Federally funded research projects
  • Graduate theses and dissertations
  • Surveys, interviews, or observations (social sciences)
  • Studies that utilize test subjects for new devices, drugs, or materials (biomedical)

Nonexamples of Research

  • Activities or class projects intended ONLY to receive a grade in a course. However, if the results are intended to be used beyond the classroom, IRB review and approval/determination is required.
  • Program improvement evaluations
  • Projects for which the results are not intended to contribute to generalizeable knowledge

Is it a Human Subject?

A human subject is “a living individual about whom an investigator (whether professional or student) conducting research:

(i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens” (45 CFR 46.102(e)).

This means that people are human subjects. Existing data or specimens with identifiable, private information are also human subjects. This includes data that was not collected by the researcher herself or specfically for the study in question, but that can be traced back or identified with the individuals from whom it was collected.

If your activity falls under FDA regulations, note that the FDA definition of human Subjects research includes the use of test articles(i.e., drugs or devices)on humans or human specimens, whether identifiable or not (CFR Title 21).

 

What If I’m Not Sure? 

Not sure if you need to submit?  Contact us!  You can also refer to Penn State Policy RP03: The Use Of Human Participants In Research for further information. 

What's Next?  

If you do need to submit, move on to Step 2 for more details on training and getting started in CATS IRB.