Who needs to Submit?

Do I Need to Submit an Application to the Institutional Review Board (IRB) for the use of human participants in research?

If your activities meet  the definitions outlined in the Code of Federal Regulations of both “research” and “human participant” you will need to submit an application to the Office for Research Protections for review. 

But, how do I know if it's really research?

Research is defined as a "systematic investigation designed to develop or contribute to generalizable knowledge" (Title 45 CFR (Code of Federal Regulations) Part 46.102(d), Federal Register, 56, p.28013).

When is someone considered to be human participant?

A human participant is a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information. (Title 45 CFR, Part 46.102.f)

Who Needs to Submit to the IRB for Review?

If University faculty, staff, administrators, or students conduct research according to Penn State's definitions of research and human participants, an application must be submitted to the ORP for review and approval by the Institutional Review Board (IRB).

Policy RA14 is applicable to all Penn State colleges and locations. The ORP is responsible for University Park and all other campus locations except the College of Medicine at the Hershey Medical Center. The Human Subjects Protection Office (HSPO) is responsible for the College of Medicine. Penn State has an assurance with the Office for Human Research Protections in compliance with 45CFR46. The College of Medicine maintains a separate assurance.

Investigators should contact the ORP or the HSPO at the College of Medicine when collaborative projects will occur between the College of Medicine and other Penn State campuses or researchers.

Externally funded projects involving the use of human participants are to be approved by the IRB prior to acceptance of funding. (Some funding agencies require human participants review and approval by IRB prior to consideration of a proposal for funding.)

The ORP should be contacted for guidance whenever projects that have been approved by IRBs at other institutions involve University personnel or University resources.

Getting Started → Preparing a New eSubmission Application → The Review Process → Ongoing Actions Post Approval → Closing the Study