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Frequently Asked Questions

Is the proposed activity research?

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge.

Are human subjects involved?

Human subject means a living individual about whom an investigator conducting research obtains (a) data through intervention or interaction with the individual or (b) identifiable private information.

Is the research required to undergo IRB review?

Specific research activities NOT subject to IRB review are (a) samples from deceased individuals; (b) samples collected for diagnostic purposes only; (c) Samples or data that are available from commercial or public repositories or registries; (d) established cell lines that are publicly available to qualified scientific investigators; and (e)self-sustaining, cell-free derivative preparations including viral isolates, cloned DNA or RNA.

All research involving human subjects that is conducted under the auspices of Gannon University must have approval of the Gannon University Institutional Review IRB before it is initiated.

What Federal requirements apply?

Federal regulations allow for 6 categories of Exemptions from Standard Review; 9 categories of Expedited Reviews, and Standard Reviews. Specifics are available to Gannon University community members on the IRB application forms, in the IRB Policy Manual, and on links at the Gannon University web site.

How is an IRB Review initiated?

The researcher visits the Gannon University web site to obtain instructions and application forms. Upon completion the application forms are submitted to the IRB office 3030C Palumbo.