Step 1: Is It Human Subjects Research?

All Penn State employees (faculty/staff/administrators) and students conducting human subjects research, as defined by the Department of Health and Human Services (DHHS) and the Federal Drug Administration (FDA), need to submit required materials to the Office for Research Protections (ORP) for review before beginning any research activity.  

See Penn State Policy RP03: The Use Of Human Participants In Research for further information. 

Is It Research? 

Research is defined by DHHS as a "systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Research is defined differently by the FDA and has additional requirements.*  

Federally funded research projects, graduate theses, and dissertations can all be examples of research. Research can be in the social sciences (for example, surveys, interviews, or observations) or biomedical in nature (for example, taking tissue samples, testing drugs).   

Some activities, such as those carried out specifically to receive a grade in a course or for the purposes of program improvement (the results of which are not intended to be generalizable), often do not meet this definition of research and therefore would not require IRB review and approval/ determination. Student course projects intended ONLY to receive a grade in a course are not intended to contribute to generalizable knowledge and therefore do not require IRB review and approval or determination. If, in general, the results are intended to be used beyond the classroom, IRB review and approval/ determination is required. If you’re unsure whether your planned activities would be considered to be research, please contact us.   

Is It Human Subjects? 

A human subject as defined by DHHS is a living individual about whom an investigator conducting research either:

  • 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.

Human Subjects is defined differently by the FDA and the Department of Justice.*

This means that people are human subjects but so is data. If you’re unsure whether your planned activities would be considered to be human subjects research, please contact us. 

All activities that meet the definition of research and meet the definition of human subjects, regardless of subject area or where the research is taking place, need to be submitted to the IRB for review.   

What If I Need to Submit?  

The University Park IRB program is responsible for the oversight of human research conducted at or by investigators at the University Park campus and all other campus locations except the Penn State College of Medicine and College of Medicine University Park Regional Campus and the Milton S. Hershey Medical Center. The Human Subjects Protection Office (HSPO) has oversight of research occurring at or by investigators at these locations.  

All required materials, regardless of which office has oversight, are submitted via the CATS IRB system, which is further explained in Step 3

Studies that constitute Human Subjects Research will generally fall into one of three review categories, as defined by the Code of Federal Regulations: exempt, expedited, or committee review.  Exempt and expedited studies are not reviewed by the IRB committee but by a single experienced IRB member. The level of review is ultimately decided by the IRB/ORP. The Investigator Manual is the IRB’s primary resource for investigators; please see the Investigator Manual for more about review levels and related requirements.  

What If I’m Not Sure? 

Not sure if you need to submit?  Contact us!   

If you’re 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.  

*FDA defines human subjects research differently covering research use of test articles (i.e., drugs or devices) on humans or human specimens (CFR Title 21). The Department of Justice defines human subjects as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) information that is both private information and identifiable information," and this definition is used to determine whether DOJ-supported research requires IRB review. See the Investigator Manual for more details.