Institutional Review Board - IRB

Gonzaga University Institutional Review Board (IRB)

Partnering with you to make scholarly inquiry a reality.

Contact Information:  IRB@gonzaga.edu

WHAT IS THE IRB?

Gonzaga University’s Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of Gonzaga University. 

The IRB at Gonzaga University is represented by interdisciplinary faculty and community members that have received training and certification to conduct and evaluate research. Additionally, they represent expertise in working with vulnerable categories of subjects and represent expertise in scientific and nonscientific areas.

The IRB has the authority to approve, require modifications in, or disapprove all research activities that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.

The IRB functions independently of, but in coordination with, other committees across the university and in the community. This jurisdiction is defined by and comes from the Office of Human Research Protection (OHRP), the federal agency within the Department of Health and Human Services that oversees Institutional Review Boards.  The IRB at Gonzaga University functions within the guidelines provided and reviews human research as defined by the OHRP.


IS MY STUDY CONSIDERED HUMAN RESEARCH?

Researchers whose projects meet any dimension of the OHRP definition of human research need to complete and submit an IRB Protocol for review and approval.  Find OHRP definitions and additional information HERE.  

"Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities."

"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."

"Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects."

OHRP definitions can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#46.102


WHAT DO I INCLUDE IN MY SUBMISSION?

1.  Cover Sheet.  (Be sure to obtain all signatures.)

2.  Exempt or Non Exempt, Expedited protocol form (Expedited doesn't mean faster!)

3.  Informed Consent form (ages 18+), Informed Assent (ages 5-11) or Informed Assent (ages 12-17) form

4.  Attach interview guides, observation scripts, surveys or other tools used in recruiting subjects and gathering data

5.  Attach letters of support if you are partnering with or gathering data at other institutions (i.e. schools, hospitals, prisons, other organizations)

6.  Electronically send your completed protocol submission to irb@gonzaga.edu