Types of Reviews

All research involving human subjects must be submitted to the IRB for review. Research is defined as “any systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CRF 46.102d).

There are several types of review submissions:

1. Quality Improvement Project	Quality Improvement (QI) projects involve systematic, data- guided initiatives designed to improve processes or instruction. QI projects are not human subjects research and do not need to be reviewed by the IRB. Refer to the QI project determination checklist for guidance.
2. Exempt	Exempt reviews involve studies considered less than “minimal risk”. Studies should fit into one or more of the exemption categories defined from the Common Rule, 45 CFR 46. Refer to the Exempt self-determination form for guidance.
3. Expedited	Expedited reviews involve studies with no more than “minimal risk” or encounters normally experienced in daily life. Any studies that use audio/video recording should be submitted as Expedited.
4. Full Board	Full board reviews involve studies considered more than “minimal risk” and/or interventions that may involve physical or emotional discomfort or sensitive data.

The HHS Decision Charts can assist you in determining what level of IRB review your research requires.

The IRB reserves the right to change the level of review as needed. Principal investigators (PIs) will be notified if a change is needed.

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 (PI) and are asked to submit all reviews. However, all researchers involved in a submission should register with IRBnet in order to upload their CITI certificates, sign submissions, and receive review updates. You can access the IRBnet site at www.irbnet.org.

Step-by-step instructions and videos for how to use IRBnet may be located here: http://www.irbnetresources.org/tresources/training.html.

User Name: brenau
Password: training

R1: New Project Submission
Walks researchers through the steps of submitting a new project for review.

R2: Post-Submission Advanced Topics
Demonstrates the IRBnet messaging structure, how to successfully update project documents and submit a subsequent package (e.g., Modifications Required) for review and other advanced topics.

CITI Training

Brenau University is a Collaborative Institutional Training Initiative (CITI) affiliated participating organization. All Brenau University Institutional Review Board (IRB) Members, faculty conducting and/or supervising research, and students conducting human subjects’ research must complete designated CITI modules in order to supervise or conduct human subjects’ research at Brenau University.   

Review the CITI Policy for information on training requirements and instructions for getting started.

New Submission Review Process

All New Submissions

1. On Tuesdays and Thursdays, the IRB 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 the Principal Investigator (PI) will be notified about the missing items. The study will not be reviewed until the missing items are addressed and revisions are marked as completed.
2. The IRB Chair and Administrator will review submitted protocols to determine if the study requires Exempt, Expedited or a Full Board Review and the protocol will be assigned to the appropriate committee members for review.

New Submissions for Exempt Submissions

1. Exempt submissions will be assigned for review by the IRB Administrator and Chair to the designated Exempt review on the committee.
2. The committee member will review the submission to make sure the study meets exemption requirements. The committee member will either approve the Exempt study or request that it be resubmitted as an Expedited study. 
3. The IRB Administrator will create an IRB review decision letter approximately one week from when the submission was assigned to the committee member.

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 2 weeks of being assigned the protocol for review.
3. The IRB Administrator will create an IRB review decision letter based on the feedback from committee members.

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 PI will be informed that their study requires a Full Board Review and that it will be discussed at the upcoming IRB Committee meeting. The PI will be invited to attend the 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 three 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.
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

Resubmissions

Most new Expedited 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. 

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 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.
   5. Researchers are encouraged to upload a document that summarizes the changes that have been made to the submission in response to the Modifications Requested letter, in order to assist the committee members in their review of the re-submission.
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:

1. The IRB Administrator will check IRBNet every Tuesday and Thursday 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/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 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 and Administrator will review each committee member’s feedback and create an IRB review decision letter that will be sent to the Principle Investigator.

Study Continuation

If you are unable to complete your research project by the study’s expiration date, a Continuation Request form should be submitted to the IRB to continue your research. To submit a Continuation Request form, follow these steps:

1. Log on to IRBNet.org and open the current project.
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. Complete the Study Continuation Form. Click on “Designer” to the left side of the screen. Upload your Study Continuation Form.
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.

Completion of Study

Upon completion of your research project, submit a Completion of Study Report to the IRB. To submit a Completion of Study Report, follow these steps:

1. Log on to IRBNet.org and open the current project.
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. Complete the Completion of Study Report. Click on “Designer” to the left side of the screen. Upload your Completion of Study Report.
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.

Helpful Links

• Basic Elements of Informed Consent
• HIPAA Identifiers
• Guidelines for Responsible Data Management in Scientific Research