Institutional Review Board - IRB

Gonzaga University Institutional Review Board (IRB)

Partnering with you to make scholarly inquiry a reality.

Contact Information:  IRB@gonzaga.edu

TIME FRAME: We're experiencing a higher volume of submissions than in the past.  Due to the volume of submissions, we cannot accommodate requests for urgent reviews. Please submit your materials at least a month before you plan to start your study.  Thank you.


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 here


WHAT DO I INCLUDE IN MY SUBMISSION?

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

2.  Exempt or Non-Exempt protocol form

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

4.  Research Tools: Include any interview questions, survey questions, recruitment email scripts, flyers, or any other tools used in your study.

5.  Letters or Emails of Support: Include a letter/email of support if your research involves an organization, group, or class. The letter/email should show an understanding of what you are planning to do, and give permission.  

     => For more information about letters/emails of support, see FAQs #9.

6.  Electronically send your completed protocol submission, with all supporting research documents, to the IRB at irb@gonzaga.edu.


HOW WILL MY PROTOCOL BE EVALUATED?

Reviews can be conducted when all research materials have been submitted with the necessary signatures and permissions, and when sufficient detail is present in the protocol descriptions.

In keeping with the criteria for IRB approval of research outlined in 45 CFR 46.111, Gonzaga IRB members evaluate protocols using this form.