Background

A Manual For Investigators

Information from several of the IRB web pages is conveniently compiled into this IRB Investigators' manual.  This document is accurate as of Spring 2018.

Is It Research?

When the goal of the student project is to contribute to generalizable knowledge, Gonzaga University requires that all research involving human subjects affiliated with the University be reviewed and approved by its Institutional Review Board (IRB). This review and approval must be completed prior to initiation of research, regardless of the source of funding and regardless of its federal status as an Exempt, Non-exempt, or Full Board Review project.

"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." -U.S. Department of Health and Human Services §46.102 Definitions (d).

Research reviewed by the IRB must include human subjects. Not all experiments with human subjects, human data and/or human anatomical substances constitute "human research." For example, off-label use of FDA-approved medication or using a cheek swab for a Polymerase Chain Reaction (PCR) experiment are not part of research as defined above.

"Human subject means 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) Identifiable private information." - U.S. Department of Health and Human Services §46.102 Definitions (f).