Institutional Review Board
Protection of Human Subjects

Given the impact of COVID-19 and Brenau University’s focus on social distancing, the Institutional Review Board recommends that all research should be conducted remotely if at all possible. A document with guidelines and suggestions is available in the TOOLS section at the bottom of the page

  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

Exempt Studies and Quality Improvement Projects

Many of the research studies performed at Brenau qualify as Exempt studies or Quality Improvement projects according to HHS Guidelines. Before you complete a full Protocol Application, take a moment to review the Quality Improvement Project Determination Check List and  Exempt Self Determination Form found in the Tools section at the bottom of this page.

For the Quality Improvement Project Determination Check List, answer the questions provided.  If all of the check marks are inside the shaded gray boxes, then the project is very likely Quality Improvement and not human subjects research. Projects that are not human subjects research do not need review by the IRB. If you have any questions about this, you can call the IRB Administrator at 678-707-5029.

If your project is not a Quality Improvement project, it may be an Exempt Study. The first 2 pages of the Exempt Self Determination Form provide a quick checklist to see if your study qualifies for Exempt Review. If so, you can complete the rest of the form and submit it, along with a short description of the project, on IRBNet for review and approval instead of the full Protocol application.

Exempt Submissions should include the following:

  • Exempt Self Determination Form
  • Exempt Study Participant Information Sheet (This serves as the Consent Form for an Exempt Study)
  • Description of Project (1-2 pages)
    • Includes:
      • Research Question
      • Recruitment Method
      • Study Procedures (What is being done)
  • Any Recruitment Materials
  • Any Measurement Tools (such as surveys)
  • CITI Training Certification for all researchers

 

Exempt submissions will be assigned to a committee member for review to make sure they meet the exemption requirements. The committee member will either approve the exempt study or request that it be re-submitted as an Expedited study using the full Protocol application. Turnaround time for Exempt submissions should be 1 week from when the submission is assigned to the committee member.

New Submission Information for Non-Exempt Studies

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 09/17/2020) A version of the Protocol Application with suggestions for completing the form can be found in the Tools section at the bottom of the page.

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.
    • The IRB Committee has provided templates for both Signed and Unsigned Consent Forms, which can be found in the Tools section at the bottom of this page. We highly encourage you to use these templates in order to make sure everything meets the IRB requirements.
      • 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.
  • 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 Expedited Review or a Full Board Review and the protocol will be assigned to the appropriate committee members for review.

New Submissions for Expedited Submissions

  1. 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. 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

Consent Template - Signed

September 17, 2020

Consent Template - Unsigned

September 17, 2020

Exempt Self Determination Form

September 3, 2020

Exempt Study Participant Information Sheet

September 17, 2020

Guidelines for Human Subjects Research During COVID-19

April 15, 2020

HHS Decision Charts - Updated June 2020

September 3, 2020

Instructor Directed Activity Form

January 15, 2019

IRB Completion of Study Form (Updated 9/17/20)

September 17, 2020

IRB Continuation Request Form (Updated 9/11/20)

September 17, 2020

IRB Preliminary Review Checklist

March 14, 2019

IRB Protocol Application (Updated 9/17/20)

September 17, 2020

IRB Protocol Application (Updated 9/17/20) with Suggestions for Completion

September 17, 2020

Quality Improvement Project Determination Check List

September 17, 2020

    IRB Meeting Dates and Submission Deadlines

     

    Submission Deadline Committee Meeting Date
    Tuesday, September 8, 2020
    Thursday, October 1, 2020
    Thursday, November 5, 2020
    Friday, December 4, 2020
    Thursday, January 7, 2021
    Thursday, February 4, 2021
    Thursday, March 4, 2021
    Tuesday, March 30, 2021
    Tuesday, April 20, 2021
    Thursday, September 17, 2020
    Thursday, October 15, 2020
    Thursday, November 19, 2020
    Thursday, December 10, 2020
    Thursday, January 21, 2021
    Thursday, February 18, 2021
    Thursday, March 18, 2021
    Tuesday, April 13, 2021
    Tuesday, May 4, 2021

    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