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.

You can use these charts to determine if your project requires IRB approval, and what type of approval is required.
Charts to Help Determine whether a project requires IRB Approval

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 the principles outlined in the Belmont Report. These guidelines extend 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

New Submission Information

Completed applications need to be submitted via IRBNet by the Faculty 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. Meeting Dates and Submission Deadlines can be found to the right.

Submissions MUST be made by a Brenau Faculty Member.

Please note that the application will NOT be accepted if ALL signatures are not includedAlso, partially completed IRB applications will NOT be accepted.

You can download the Protocol Application Form (as a Word document) here:  Protocol Application Form (Updated 05/30/2017)

You can confirm the type of IRB review your project requires (Full Board, Expedited or Exempt) using these charts.

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

  • 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).
  • Be sure that ALL sections on the application are filled out.
    • 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 and uploaded as separate documents.
    • All consent forms should be on Brenau University letterhead and must include the contact information for both the Institutional Review Board AND the Faculty Principal Investigator.
    • NO student researcher contact information should be included on the Consent Form.
    • Please write all consent form(s) and additional documentation between a 5th and 8th grade level. 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/).
  • Each researcher/investigator on the project must have or create an IRBNet account linked to Brenau University and upload their CITI Certification under Training and Credentials in their User Profile
    • Choose “Other” as the Document Type and Enter CITI Training Certification as the Description. Make sure you enter the Effective and Expiration Dates. Don’t forget to hit “Submit”
    • CITI Registration and Certification can be completed at http://www.citiprogram.org.
  • 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.

Brenau’s IRB Committee has put together a Submission Checklist that you can use to help avoid common submission errors.

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

Submission Review Process

Completed applications will be reviewed by Brenau’s IRB Committee Members prior to the Board Meeting Date. Upon submission Brenau’s IRB Administrator will do a quick review of the submission to make sure all required documentation has been uploaded and is complete using the following checklist.

Submission Checklist: https://intranet.brenau.edu/download/irb-submission-checklist/

If anything appears to be missing the project will be unlocked and the researchers will be informed of the missing items. They will then have up to 48 hours from the submission deadline to correct the noted items and inform the Administrator that the corrections have been made, in order to have their research application reviewed by the Committee on the next meeting date. If the corrections are not made within 48 hours of the submission deadline then the submission will be reviewed as is (if the missing items were minor) at the next meeting or the submission will be tabled until the next meeting if large items or whole supporting documents are missing.

The reviewers’ comments, concerns and recommendations will be discussed by the Board and, as a whole, the Board will designate the submission as:

  • Approved
  • Approved with Conditions
  • Modifications Required
  • Not Approved

A notification will be sent out to your registered email via IRBNet with the Board’s decision. You can access the official decision letter under the “Board Documents” section of your project by clicking on the “Reviews” button to to the left of the screen. This is where you will find the Decision Letters. This includes the Modifications Required letters, which will list the modifications requested by the Board.

Please give the Board 24 hours from the Committee Meeting date to complete and post all decision letters.

Re-Submissions

Most new submissions will require at least some minor modifications prior to being approved. Please make sure to give yourself enough time prior to the beginning of your study to allow for one or more revisions. Revisions do not have to wait until the next IRB Committee meeting to be reviewed, but please allow for up to 2 weeks for a re-submission to be reviewed once it is submitted.

Upon receipt of a Modifications Required notification researchers should:

  1. Log on to IRBNet.org, open the current project and review the Modifications Required Letter which will list all of the modifications requested by the IRB Committee before the submission can be approved.
  2. Create a new Package. Once reviewed the current package cannot be modified.
    1. Click on “Project History” to the left side of the screen.
    2. Click on “Create New Package” at the bottom of the Project History page. This will create a new package designated by a -2 (or -3, -4, -5 etc.).
  3. Make the requested Modifications to your documents.
    1. Click on “Designer” to the left side of the screen.
    2. You can download a copy of any of the the currently uploaded documents to revise from the new package “Designer” page or you can use the latest version saved on the researcher’s computer.
    3. Make the changes requested in the Modifications Required Letter to the appropriate documents.
      1. Use the “Track Changes” feature under the “Review” tab in Word to track all of the changes you make to the document so that the reviewers can easily identify the changes that have been made to the document.
      2. If a document is not available in Word format, highlight any changes that are made to the document, scan it in color and upload the revised document with the highlights.  Protocol applications and Consent Letters will ONLY be accepted as Word documents with the revisions tracked using “Track Changes”.
    4. Upload ONLY the updated versions of those documents which required revisions, as separate documents, to the new package on the Designer page.
  4. Sign the new package.
    1. Once all revised documents have been uploaded, all researchers on the project MUST electronically sign the new package.
    2. Click on “Sign this Package” to the left side of the screen.
  5. Submit the completed package.
    1. Click on “Submit this Package” to the left side of the screen.
    2. The new package must be submitted by the Principal Investigator.
    3. The new package cannot be viewed by the IRB Administrator or Committee Members for review until the package is submitted

Submitted revisions will be reviewed by Brenau’s IRB Chair and Co-Chair who will determine whether the new submission is Approved or if it required further modifications. Decision notification will be sent out to the researcher’s registered email via IRBNet. You can access the official decision letter under the “Board Documents” section of your project by clicking on the “Reviews” button to to the left of the screen.

IRBNet

Brenau has adopted IRBNet as our IRB Submission Management software. All submissions must be submitted through IRBNet. Faculty Advisors will still be the Principal 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

Examples

To help you complete your application, here are some examples of previously approved submissions that you can review. These submissions used the old Protocol Application. These can also be found in Brenau’s IRBNet library.

Example of an Exempt submission
Example of an Expedited Submission
Example of a Full Submission which Required a Minor Revision
2nd Example of an Approved full Submission which Required a Minor Revision

 

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 Protocol Application

August 3, 2017

IRB Submission Checklist

September 20, 2017

IRBNet Training Energizer - New User Registration

May 11, 2016

IRBNet Training Energizer 1 for Researchers

May 11, 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
    Tuesday, September 5, 2017
    Tuesday, October 10, 2017
    Tuesday, November 14, 2017
    Tuesday, January 9, 2018
    Tuesday, February 6, 2018
    Tuesday, March 6, 2018
     Tuesday, March 27, 2018
    Thursday, April 26, 2018
    Tuesday, September 19, 2017
    Tuesday, October 24, 2017
    Tuesday, November 28, 2017
     Tuesday, January 23, 2018
    Tuesday, February 20, 2018
    Tuesday, March 20, 2018
     Tuesday, April 10, 2018
    Thursday, May 10, 2018

    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. Tamara Mills

    Helpful Links