Institutional Review Board
Protection of Human Subjects

  1. Our Purpose
  2. Guideline Information
  3. New Submission Information
  4. Submission Review Process
  5. Re-Submissions
  6. IRBNet
  7. Tools

Our Purpose

The purpose of the Brenau University 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 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

The Department of Health and Human Services has created charts to help determine if your project requires IRB approval, and what type of approval is required.

HHS Charts

New Submission Information

Step 1: The Faculty Research Advisor / Principal Investigator submits the completed application via IRBNet, with electronic signatures completed by ALL involved researchers.

You can download the Protocol Application Form (as a Word document) here:  Protocol Application Form (Updated 09/05/2018)

Please Note:

  • Submissions must be submitted 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.
  • Applications will NOT be accepted if ALL investigators have not electronically signed the submission
  • Partially completed IRB applications will NOT be accepted.

Submitted applications must meet the following criteria:

  • Each item must be uploaded into the IRBNet Application package as a separate document in its original file format (i.e. the Protocol Application should be uploaded as a Word document).
  • ALL sections on the application must be filled out.
    • Remember, there is always room for small risk.  With this in mind, please pay special attention to section 6.
  • 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.
    • All consent form(s) and additional documentation being given to participants needs to be written at a 5th to 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.
    • Brenau’s CITI Policy and Requirements can be reviewed in the Brenau CITI Policy.
    • CITI Registration and Certification can be completed at http://www.citiprogram.org.
    • When uploading your CITI certification to your IRBNet 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”
  • SIGNATURES ARE REQUIRED.  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.

Step 3: Complete the IRB Committee’s Submission Checklist, designed to help you avoid common submission errors, and upload it to your IRBNet Submission Package.

Step 4:  Submit your project. The committee cannot see your submission until you Submit your project.

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

All New Submissions

  1. The day after the submission deadline the Administrator will review the submission according to the Preliminary Review Checklist. If something on the checklist is missing the submission will be unlocked in IRBNet and Principle Investigator will be notified about the missing items. The study will not be reviewed until the missing items are addressed.
  2. IRB Chair and Administrator will review the submitted protocols to determine if the study requires Exempt Review, Expedited Review, or a Full Board Review and the protocol will be assigned to the appropriate committee members for review.

New Submissions for Expedited or Exempt Research Studies

  1. Exempt or Expedited research studies will be assigned for review by the IRB Administrator and Chair to two IRB committee members on a rotating basis.
  2. Committee members will review the submission and provide feedback within one week of being assigned the protocol for review.
  3. The IRB Chair will review each committee member’s feedback, provide his/her feedback, and create an IRB review decision letter.

New Submissions for Full Board Review Research Studies

  1. Research studies that are determined to require a Full Board Review will be assigned for review by the IRB Administrator to all IRB committee members to be reviewed and discussed at the upcoming IRB Committee meeting.
  2.  The study’s principle investigator will be informed that their study requires a Full Board Review and that it will be reviewed at the upcoming IRB Committee meeting. The Principle Investigator will be invited to attend the following committee meeting to address any substantial modifications requested by the committee.
  3. An IRB review decision letter will be sent by 5:00 PM the day after the scheduled IRB Committee Meeting.

Review Decision Options

When reviewing submissions the Committee has 3 decision options, Approved, Minor Modifications Needed and Substantial Modifications Needed.

Approved: The submission has been approved and the researchers can begin their study.

Minor Modifications Needed: Minor modifications fall under the categories listed below and can be resubmitted as a new package for re-review by the committee members who reviewed the first submission. Re-submissions of studies requiring Minor Modifications may be resubmitted at any time and will be reviewed within 1 week from the Tuesday after they are submitted by IRBNet.

Minor Modification Categories

    • Simple Clarifications
    • Missing Minor Pieces of Information
    • Missing Information, or Needing Clarification on Data and Information Storage and/or Access
    • Date Disagreements

Substantial Modifications Needed:  Substantial Modifications fall under the categories listed below. If a study is found to need substantial modifications the decision letter will list the items that need to be addressed and the PI will be invited to attend the upcoming committee meeting to address them. To facilitate the submission review at the meeting, the PI is encouraged to work on addressing the listed items and submitting the changes on IRBNet prior to the committee meeting.

Substantial Modification Categories

    • Safety Concerns
    • Information or Participant Protection
    • Inappropriate or Unethical Recruitment Practices

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.

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 is locked and cannot be modified.
    1. Open the reviewed project.
    2. Click on “Create a New Package” under Project Administration to the left of the screen . 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. Please be aware that the new package cannot be seen by the IRB Administrator or Committee Members for review until the package has been submitted

Submitted revisions will be reviewed using the following process.

Modification Submissions for all Research Studies

  1. The IRB Administrator will check IRBNet every Tuesday morning.
  2. The IRB Administrator will review the Modification Submission to confirm that the changes have been made using the “Track Changes” feature in Word and that all new or changed information is highlighted in yellow.
    1. Modification Submissions that have not used the “Track Changes” feature in Word, highlighted all new or changed information in yellow, and/or have missing items will be unlocked on IRBNet and the Faculty Advisor or Principal Investigator will be notified so that the submission can be corrected and re-submitted for review.
      1. The Project/Package will not be assigned for review until the necessary changes have been made and/or any missing items have been submitted.
    2. For Exempt and Expedited research studies, the IRB Administrator will send the Modification Submission back to the two IRB committee members that reviewed the initial submission.
    3. For Full Board research studies, the IRB Administrator will send the Modification Submission back to two of the IRB committee members that reviewed the initial submission.
    4. Committee members will review the submission and provide feedback.
    5. The IRB Chair will review each committee members feedback, provide his/her feedback, and create an IRB review decision letter that will be sent to the Principle Investigator.

IRBNet

Brenau has adopted IRBNet as our IRB Submission Management software. All submissions must be submitted through IRBNet. Faculty Advisors are considered the Principal Investigators and are asked to submit the Protocol Application however, we are requesting that all researchers involved in a submission register with IRBNet in order 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 researchers using IRBNet can be accessed using the link below with the following login information.

http://www.irbnetresources.org/tresources/training.html

User Name: brenau
Password: training

R1: New Project Submission
Walks researchers and study coordinators through the five steps of submitting a new project.
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.

Tools

Brenau CITI Policy - Updated 09/13/18

November 19, 2018

Brenau IRB Letterhead

January 15, 2019

Brenau IRB Protocol Application

November 19, 2018

HHS Research Review Decision Charts (2016)

November 19, 2018

Instructor Directed Activity Form

January 15, 2019

IRB Preliminary Review Checklist

March 14, 2019

IRB Project Continuation Request Form (3-13-19)

March 13, 2019

    IRB Meeting Dates and Submission Deadlines

    NOTE: Posted submission deadlines are for those projects requiring full board review ONLY. Please use the Submission Type Formstack form to determine what type of review your project requires.

    Deadline Date
    Committee Review Meeting Date
    Tuesday, September 3, 2019
    Tuesday, October 8, 2019
    Tuesday, October 29, 2019
    Tuesday, January 7, 2020
    Tuesday, February 4, 2020
    Tuesday, March 3, 2020
    Tuesday, September 17, 2019 12:30 – 1:45
    Tuesday, October 22, 2019 12:30-1:45
    Tuesday, November 12, 2019 12:30-1:45
    Tuesday, January 21, 2020 12:30-1:45
     Tuesday, February 18, 2020 12:30-1:45
    Tuesday, March 17, 2020

    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. Brandi Worsham

    Helpful Links