IRB

I-IRB Application Protocol

Bellevue University’s (BU) Internal Institutional Review Board (I-IRB) requires researchers to submit an application for approval of data collection prior to conducting new research with human subjects, for an overview
1. First review the video to the right.
2. To proceed with the application process: Follow Steps 1-4 below.

*This certification must be completed before an IRB application will be reviewed.*

Prior to submitting an I-IRB application, researchers must come to this I-IRB website and complete BU’s I-IRB training.

To complete this training, proceed with the following:

1. Read the Belmont Report

** To access the report, select: Belmont Report.

2. Complete the I-IRB Research Ethics Quiz

** To take the quiz, Select: I-IRB Research Ethics Quiz

* Note: Upon passing the quiz, an automated notification email is sent to the Bellevue University IRB email and stored in the university’s I-IRB folder. If researchers would like their own certificate copy, be sure to provide an email address when participating in the quiz.

Next, researchers must complete and submit their I-IRB application form.

The following documents must be attached to all complete I-IRB applications for review:

• Consent form(s): For all BU I-IRB approved research with human subjects in which researchers collect new data, participants must give informed consent (obtained either as a physical document or online agreement). The researchers must maintain records of consent. If the study comprises trials requiring more than one session using the same participants, there should be records of consent for each session. A consent form template can be found in FORMS section of the BU I-IRB website.

• Debriefing form(s): All BU I-IRB approved research must provide a debriefing. Debriefings are an opportunity for participants to discontinue a study or have their data removed from the study. Debriefings also provide an opportunity to educate the participants on the research study topic, which supports the I-IRB’s mission of educating the BU community about research. A debriefing form template can be found in FORMS section of the BU I-IRB website.

• All questionnaires and measurements to be used in the study

*It is strongly recommended that researchers fill out the application in a Word document and then copy their answers to the online form because the form does not auto-save your progress.*

* To access the I-IRB application form, Select RESEARCH APPROVAL REQUEST FORM under FORMS:

After the I-IRB application has been submitted, the I-IRB chairman will review the I-IRB application and determine whether the application requires an “Expedited” or “Full Board” review:

• Expedited: Assigned to single I-IRB member who will either approve, deny, or ask for revisions via email

• Full Board: I-IRB members will evaluate during monthly I-IRB meeting, either approving, denying, asking for revisions, or determining application needs to be reviewed by external experts. Any decision will be communicated to the researcher via email.

After the application is approved, a PDF of their approval letter will be sent to the email(s) provided in their application from an I-IRB representative.

Step 1: Complete the BU I-IRB Ethics Training Certification

Step 2: Submit a complete I-IRB application

Step 3: Receive feedback on application from an I-IRB Reviewer

Step 4: Receive I-IRB approval to conduct research with human subjects