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).

When Can I Start My Study?

Research projects that involve human subjects need to be submitted to an Institutional Review Board (IRB) and approved before they start.  IRBs review these projects to be sure they apply the ethical principles in the Belmont Report, as operationalized in federal regulations, specifically 45 CFR 46, which is called the Common Rule.  Graduate projects with research-like exercises also need to be submitted to the IRB and approved before they start, when the projects involve interactions with people or analyzing private data with which a person could be identified.

What Do I Include?

Our IRB can review submissions with a detailed plan for interacting with people or analyzing their personal, identifiable data.  The details in the plan will show us how you inform potential participants of your project and invite them to volunteer (with no penalty and no pressure if they choose to opt out).  You will submit recruitment materials, informed consent documents, any instruments or protocols you will use to collect data, and a form that explains exactly what you plan to do (and matches the other materials perfectly).  Once you submit all your materials to the IRB, We strive to process them efficiently. (Typical timelines are posted.) 

You may contact the IRB at IRB@gonzaga.edu.