Institutional Review Board
Protection of Human Subjects

Our Purpose

The purpose of the Brenau Univesity Institutional Review Board (IRB) is to insure the protection of any human subjects involved in research projects conducted under the auspices of the university in any capacity.

*Any research activity that involves human subjects, whether conducted on a large or a small scale, whether preliminary or fully designed research study, whether conducted by students or faculty, whether funded or not, and whether it involves minimal risk or more than minimal risk, is subject to the IRB Guidelines.

Guideline Information

Brenau University’s Institutional Review Board (IRB) strives to comply with guidelines as defined by the Department of Health and Human Services, Office for Human Research Protection, and to put into practice principles outlined in the Belmont Report. These guidelines are also extended to include review and oversight of any activity that involves Human Subjects or participants. The policy also applies to visitors of the university, and/or use of non-public records associated with the university to identify, contact, or recruit human subjects.

Department of Health and Human Services, Office of Human Research Protection(OHRP)
The Belmont Report

HHS.gov FAQ

Submission Information

Completed applications need to be submitted via IRBNet by the Research Advisor / Principal Investigator, with electronic signatures completed by ALL involved researchers , at least two (2) weeks prior to the upcoming committee meeting in order to be considered for review.  Make note that the application will NOT be accepted if all signatures are not included.  Also, partially completed IRB applications will NOT be accepted.

You can download the Protocol Application form (as a Word document) from the Tools section at the bottom of this page, or from the Brenau Library on IRBNet.

Please make sure that the submitted application meets the following criteria:

  • Be sure that ALL sections on the application are filled out.  And remember, there is always room for small risk.  With this in mind, please pay special attention to section 6.
  • Your consent form(s) and letter(s) of authorization MUST be turned in with your application.
  • Please write all consent form(s) and additional documentation at an 5th grade level (national average). If the target subjects can be reasonably assumed to have a higher literacy level then the consent and documentation can be written at the assumed literacy level. A free site that will check the readability of a document and make suggestions can be found at the following link (https://readable.io/text/).
  • SIGNATURES REQUIRED.  Please be sure that all applicants (research advisor/primary investigator, and when applicable, co-investigators) have electronically signed the application package before submitting your application for review.
  • Each document should be uploaded separately into the IRBNet Application package in its original file format (i.e. the Protocol Application should be uploaded as a Word document and a scanned file should be uploaded as a PDF).
  • Each researcher/investigator on the project must have or create an IRBNet account linked to Brenau University and upload their CITI Certification under Training Documents in their Account Profile (don’t forget to hit “Submit”) CITI Registration and Certification can be completed at http://www.citiprogram.org.
  • All consent forms should be on Brenau University letterhead and must include the Institutional Review Boards contact information, as well as, faculty adviser’s contact information. No student researcher contact information should be included on the Consent Form.

A Submission Checklist to help avoid common submission errors and Examples of approved submissions can be found in Brenau’s IRBNet library or in the Tools section below.

IRBNet

Brenau has adopted IRBNet as our new IRB Submission Management software. All submissions must be submitted through IRBNet. Faculty Advisors will still be the Principle Investigators and are asked to submit the Protocol Application, but we are requesting that all researchers involved in a submission register with IRBNet to upload their CITI forms, sign their submissions and receive updates.

You can access the IRBNet site to register and submit applications at www.irbnet.org.

Step by step videos and instructions for using IRBNet can be accessed using the links below with the following login information.

User Name: brenau
Password: training

R1: New Project Submission

Walks researchers and study coordinators through the five steps of submitting a new project.

R1: New Project Submission Instructional Video link http://irbnetresources.org/tresources/vd/r1.html

R1: New Project Submission Energizer (PDF) link http://irbnetresources.org/tresources/resources/IRBNet_Training_Energizer-Researcher_1.pdf

R2: Post-Submission Advanced Topics

Demonstrates the IRBNet messaging structure, how to successfully update project documents and submit a subsequent (ex. Modifications Required) package to a committee and other advanced topics.

R2: Post-Submission Advanced Topics Instructional Video link http://irbnetresources.org/tresources/vd/r2.html

R2: Post-Submission Advanced Topics Energizer (PDF) link http://irbnetresources.org/tresources/resources/IRBNet_Training_Energizer-Researcher_2.pdf

Please contact Kelly Peters (Phone 678-707-5029 Email irb@brenau.edu) if you have any questions about the registration or submission process.

Policy Statement

Any research activity that involves human subjects, whether conducted on a large or a small scale, whether preliminary or fully designed research study, whether conducted by students or faculty, whether funded or not, and whether it involves minimal risk or more than minimal risk, is subject to the IRB Guidelines.

Tools

2nd Example of an Approved full Submission which Required a Minor Revision

May 11, 2016

Brenau IRB Letterhead

February 16, 2016

Charts to Help Determine if Your Project Requires IRB Approval and What Type of Approval is Required

March 22, 2016

CITI Policy

February 4, 2015

Example of an Approved full Submission which Required a Minor Revision

May 11, 2016

Example of an Exempt Submission

May 11, 2016

Example of an Expedited Submission

May 11, 2016

Institutional Review Board Guidelines

February 4, 2015

Institutional Review Board Procedures

February 4, 2015

INSTRUCTOR DIRECTED ACTIVITIES

January 28, 2016

IRB Completion of Study Form

April 29, 2016

IRB Submission Checklist

February 16, 2016

IRBNet Training Energizer - New User Registration

May 11, 2016

IRBNet Training Energizer 1 for Researchers

May 11, 2016

IRBNet Training Energizer 2 for Researchers

May 11, 2016

NEW IRB Protocol Application

June 23, 2016

The Brenau IRB: Embrace the Urge for Research

October 17, 2016

    IRB Deadline and Meeting Dates

    NOTE: Additional dates will be added for review at a later date.  Please check back for further details.

    Deadline Date
    Committee Review Meeting Date
    Friday, October 14, 2016
    Thursday, October 27, 2016
    Thursday, November 3, 2016
    Thursday, November 17, 2016
    Thursday, January 12, 2017
    Thursday, January 26, 2017
    Thursday, February 2, 2017
    Thursday, February 16, 2017
    Thursday, March 2, 2017
    Thursday, March 16, 2017
     Thursday, April 6, 2017
    Monday, April 17, 2017
    Thursday, May 25, 2017
    Friday, August 4, 2017
    Thursday, April 20, 2017
    Monday, May 1, 2017
    Thursday, June 8, 2017
    August Date TBD

    Contact Information

    Brenau University
    Institutional Review Board
    c/o College of Health Sciences
    Brenau East Campus
    Address: 1001 Chestnut Street SE, Gainesville, GA 30501
    Phone: 678-707-5029
    Fax: 770-538-4666 (ATTN: Kelly Peters, Institutional Review Board)
    email: irb@brenau.edu

    Chair, Dr. Kristen Green

    Helpful Links