Internal and External IRBs


Institutional Review Boards Charter 

IRB Compliance Statement

IRBs Available to Investigators:

  • IRB A (Biomedical) reviews all biomedical, non-cancer-related protocols.
  • IRB B (Social/Behavioral) reviews all social/behavioral and education protocols that do not have a biomedical component.
  • IRB C (Biomedical II) reviews biomedical and all cancer, pre-cancer, and post-cancer protocols.
  • Commercially Sponsored protocols may use an approved external IRB. Currently this is limited to Chesapeake Research Review, Inc. (CRRI) and Western Institutional Review Board (WIRB).
  • Cooperative Oncology Program protocols may use the National Cancer Institute (NCI) Central IRB (CIRB).

In special situations, NIH IRBs and the University of Georgia IRB can also serve as the IRB of record; these are discussed on a case-by-case basis with the IRB Director.

All new protocol submissions require department approval. Additionally, protocols to be reviewed by the IRB C must provide documentation of the Cancer Center Protocol Review and Monitoring Committee (PRMC) approval in the IRB application.

INTERNAL IRBS (AUGUSTA UNIVERSITY FWA# 00019721) 

IRB A- BIOMEDICAL I (IRB REGISTRATION #00000150)

  • IRB A serves as the Biomedical IRB for Augusta University, AU Medical Center, Children's Hospital of Georgia, Georgia War Veterans' Nursing Home, and the Charlie Norwood VA Medical Centers (Uptown and Downtown).
  • The IRB A meets once a month.  Each convened meeting agenda includes:

    • A New Study applications,
    • Amendment applications, and
    • Continuing Review applications.

    Agendas are assigned based on date of expiration (for Continuing Review applications), expertise available on the IRB, number of attending board members, or based on the order in which completed applications are correctly submitted to the IRB. Please note that we are unable to guarantee that your submission will be reviewed at a particular meeting.

  • How does the IRB Staff determine if a study is ready for FULL board review?

    After the IRB Staff completes an administrative analysis of the application, they will verify that all of the following items have been completed before they assign the study for review:

      1. All pre-board revisions are completed; and
      2. All applicable documents are attached; and
      3. The application is fully complete and correct; and
      4. Ancillary approvals (AUMC, IBC, ITSS, Radiation Safety, etc.) have been received or are in process.

    The study will not be assigned to a meeting until these items are complete. Submitting a study does not mean that it will be assigned to a meeting. Please note, it may take up to 5-10 business days for the administrative analysis and assignment to an agenda, based upon the completeness of the submission and number of new protocols submitted.

IRB B-SOCIAL/BEHAVIORAL (IRB REGISTRATION #00009620)

  • IRB B is responsible for the review social/behavioral, educational, and epidemiological human research studies.

    The Human Research Protection Program (HRPP) of Georgia Regents University is accredited by the Association for the Accreditation of Human Research Protections Program (AAHRPP).  AAHRPP accreditation indicates that our organization “follows rigorous standards for ethics, quality, and protections for human research”- http://aahrpp.org/
  • The IRB B meets once a month.

    Each convened meeting agenda includes:

    • A New Study applications,
    • Amendment applications, and
    • Continuing Review applications.

    Agendas are assigned based on date of expiration (for Continuing Review applications), expertise available on the IRB, number of attending board members, or based on the order in which completed applications are correctly submitted to the IRB. Please note that we are unable to guarantee that your submission will be reviewed at a particular meeting.

  • How does the IRB Staff determine if a study is ready for FULL board review?

    After the IRB Staff completes an administrative analysis of the application, they will verify that all of the following items have been completed before they assign the study for review:

      1. All pre-board revisions are completed; and
      2. All applicable documents are attached; and
      3. The application is fully complete and correct.

    The study will not be assigned to a meeting until these items are complete. Submitting a study does not mean that it will be assigned to a meeting. Please note, it may take up to 5-10 business days for the administrative analysis and assignment to an agenda, based upon the completeness of the submission and number of new protocols submitted.

IRB C-BIOMEDICAL II (IRB REGISTRATION #00009025)

  • IRB C (Biomedical II) was established in September 2012. IRB C is the primary Institutional Review Board designed to review biomedical and oncology protocols and to address the research growth in research involving human subjects at Augusta University. This includes, but is not limited to:

    • Humans
    • Records
    • Surveys
    • Tissues or other human derived materials

    This applies to all research conducted at Augusta University, GR Medical Center, PPG sites and Charlie Norwood VA Medical Center or by faculty, staff or students of those institutions.

    The IRB C also reviews off-campus research conducted by faculty, staff or students of those entities and non-Augusta University researchers using Augusta University facilities.

  • The IRB C meets once a month.

    Each convened meeting agenda includes:

    • A New Study applications,
    • Amendment applications, and
    • Continuing Review applications.

    Agendas are assigned based on date of expiration (for Continuing Review applications), expertise available on the IRB, number of attending board members, or based on the order in which completed applications are correctly submitted to the IRB. Please note that we are unable to guarantee that your submission will be reviewed at a particular meeting.

  • How does the IRB Staff determine if a study is ready for FULL board review?

    After the IRB Staff completes an administrative analysis of the application, they will verify that all of the following items have been completed before they assign the study for review:

      1. All pre-board revisions are completed; and
      2. All applicable documents are attached; and
      3. The application is fully complete and correct; and
      4. Ancillary approvals (AUMC, IBC, ITSS, Radiation Safety, etc.) have been received or are in process.

    The study will not be assigned to a meeting until these items are complete. Submitting a study does not mean that it will be assigned to a meeting. Please note, it may take up to 5-10 business days for the administrative analysis and assignment to an agenda, based upon the completeness of the submission and number of new protocols submitted.

IRB POTENTIAL MEMBERS

Thank you for visiting the website for the Augusta University IRB.  This page contains basic information about the IRB. 

The purpose of the Augusta University IRB is to perform ethical review of proposals for human subject research, and to provide leadership in the development of and education on policies and procedures for the responsible and ethical conduct of human subject research.  The primary concern of the Augusta University IRB is the protection of the rights and welfare of human subjects involved in research conducted at or by researchers affiliated with Augusta University.  The Augusta University IRB shall be responsible for reviewing, taking action on, and monitoring all proposed research activities conducted by the students, faculty, staff, or other agents/affiliates of Augusta University based on current federal, state, institutional or other regulations regarding research and/or investigational activities in human subjects.

Membership reflects federal regulations for IRB membership as further stated in 45 CFR 46.107 – IRB Membership. The IRB Chair is responsible for making recommendations to the Sr. VP for Research and Institutional Official for faculty and community members of the Board. Members are appointed to the IRB for a one (1) year renewable appointment. Near the end of the appointed year, each member is evaluated regarding their service to the IRB. 

Members of the Board are expected to attend all meetings.  These meetings are scheduled once a month and are held in person. The average meeting time is about 2-3 hours depending on the amount of items for review.

The IRB Office offers a comprehensive new IRB member orientation and training program upon IRB member appointment to ensure all new IRB members are aware of their responsibilities and are able to complete their reviews in the electronic system, IRBNet.

Thank you for your interest and please feel free to contact the IRB Office for additional information. 



Collaborative Research and External IRB Options
 

smartirb

When Augusta University is involved in a collaborative or multi-site research study, there are a few options for IRB review:
1) Each site's IRB can review the research for its site activities, or
2) All participating sites can cede IRB review to one single IRB. 

For each site that cedes IRB review to a single IRB, a fully-executed reliance agreement must be in place with the single IRB.

Please click on the frequently-asked questions below for information about reliance agreements and the single IRB process.

WHAT IS COLLABORATIVE RESEARCH?

Collaborative research is conducted in cooperation with an institution or facility that is not affiliated with Augusta University.  When two or more institutions are engaged in research, multiple IRBs are responsible for providing oversight.  As such, separate applications may be necessary; however, to avoid duplicate review, an IRB Reliance Agreement may be arranged to establish one IRB as the designated IRB of Record. 

Augusta University IRB has the discretion to decide whether to pursue a reliance agreement or not. 

A reliance agreement is NOT required unless both institutions are "engaged" in human subjects research. For example, if one site is only analyzing coded, deidentified data, and no one at that site can ever access the key linking codes to identifiers, then that site may not be "engaged" in human subjects research. There would be no need for an IRB reliance agreement in that case.  

However, if an individual from one site is obtaining identifiable private information, intervening or interacting with subjects, for the purpose of research, they may be considered “engaged" in human subjects research and a reliance agreement may be needed.   

Additional DHHS Engagement guidance may be located at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html.  

DEFINITIONS 

a.  Reliance Agreement- A formal, written agreement that provides a mechanism by which one institution or individual engaged in research delegate IRB oversight to an independent IRB, or an IRB of another institution. Institutions may use different terms for this kind of agreement, e.g. reliance agreement, IRB authorization agreement (IAA), individual investigator agreement (IIA), or memorandum of understanding (MOU). 

b.  Individual Investigator Agreement (IIA)- is utilized when an external individual wishes to collaborate on an AU human subject’s research project and they are affiliated with a non- FederalWide Assurance (FWA) holding entity or institution. This individual is considered an external team member as they are not considered affiliated with AU nor are they acting as an employee or agent of the institution. After the employee is determined to be engaged in human subjects research, the IIA will be used as a formal binding agreement that will clearly define the responsibilities of the external team member and their respective IRBs, if applicable.  

c.  Umbrella/Master Agreement - This covers multiple studies at once and can especially be useful when AU is participating in a group of studies or a network which requires the use of one single IRB.  The agreement can specifically list each protocol which is covered or it can allow AU IRB to cede review and oversight for every study within a certain network. 

d. Memorandum of Understanding (MOU) - This document is drafted between two institutions and defines the institutions’ relationship long-term. It’s generally broader than an umbrella agreement and may list a number of different scenarios under which either institution’s IRB would review the research.  

e. Reviewing IRB: The “IRB of record” or “Lead IRB” (including an IRB Organization) to which authority for IRB review and oversight has been ceded by another Participating Institution for an instance of Research under the Reliance Agreement. 

f. Relying Organization: A Participating Institution that cedes IRB review to a Reviewing IRB for an instance of Research under the Reliance Agreement.

 g. Ceded Review: An instance of IRB review in which one or more Participating Institutions invoke this Agreement to transfer IRB review and oversight authority for an instance of Research and rely on another Participating Institution’s IRB that accepts responsibility for IRB review and oversight of such Research.

h. FederalWide Assurance (FWA): The FederalWide Assurance in which a research institution commits to the Department of Health and Human Service (DHHS) that it will comply with DHHS rules and regulations with respect to Human Subjects Research. 

HOW DO I REQUEST A RELIANCE AGREEMENT?

Please ensure that you do not communicate to the other institution that the Augusta University IRB is willing to enter into a reliance agreement prior to receiving confirmation from the Augusta University IRB.  

Reliance Request notifications should be submitted via an email to IRBReliance@augusta.edu. The email should contain the completed AU Reliance Request Form. Please be sure the form is completed in its entirety and any applicable documents uploaded as an attachment. There will be questions about the other institution you might not know offhand. You MUST reach out to your counterparts at the other institution to get that information. If you submit a Request Form that is not completed in full, your Request will not be considered. If there are other sites that that may be added at a later time, please do not include them on the request form. They may be added later via an amendment.

Requests to enter into a reliance agreement are handled by the AU IRB Office Reliance Team which consists of the IRB Director, IRB Compliance Manager, IRB Operations Manager and IRB Coordinator; in accordance with decisions from the Institutional Official (I.O.) and Legal Counsel, as needed. The Reliance Team meets on a weekly basis to review requests. Following the Reliance Team meeting, communication will be sent to the AU PI regarding determination of reliance or if any additional information may be needed. Please allow 10business days to receive communication once a reliance request is submitted to our office as we need time to assess the request and follow up with the collaborating IRB as needed. 

If reliance is determined to be appropriate, the IRB Coordinator will reach out to the other institution's IRB to negotiate the agreement and have the agreement signed by the institutional officials for both institutions. Please note agreement will not be negotiated until there is confirmation from the Local PI, external PI and the other IRB confirming agreement to the reliance.

We prefer to work right from the start with the Augusta University study team instead of receiving requests from the other institution's IRB or PI. In this way, we are sure that the Augusta University study team agrees with the request.  

WHAT IF MY ONGOING STUDY NOW NEEDS AN EXTERNAL SITE OR STUDY TEAM MEMBERS FROM ANOTHER INSTITUTION ADDED?

 If you have an already approved study that now needs an external site or study team members from another institution added, an amendment will be needed to the already approved study. However, before initiating this amendment, you will need confirmation from the AU IRB regarding if a Reliance Agreement or an Individual Investigator Agreement is required. 

WHEN IS AN INDIVIDUAL INVESTIGATOR AGREEMENT (IIA) NEEDED INSTEAD OF A TRADITIONAL RELIANCE AGREEMENT?

An Individual Investigator Agreement (IIA) is utilized when an external individual wishes to collaborate on an Augusta University human subject’s research project. This individual is considered an external team member as they are not considered affiliated with Augusta University nor are they acting as an employee or agent of an institution. After the employee is determined to be engaged in human subject’s research, the IIA will be used as a formal binding agreement that will clearly define the responsibilities of the external team member and their respective IRBs, if applicable.

An IIA is used instead of a Reliance Agreement when the external investigator involved in AU’s research is associated with a non-AU IRB that does not hold an active Federal wide Assurance (FWA) or is not regularly involved in research involving human subjects.  

For additional information, see AU’s policy on Individual Investigator Agreement (IIA).

WHAT IF MY RESEARCH QUALIFIES FOR EXEMPT REVIEW?

Augusta University will not routinely enter into a Reliance Agreement nor an Individual Investigator Agreement where AU or the Reviewing IRB has determined the protocol is Exempt. The PI will be required to submit the study to AU IRB for review.

WHAT HAPPENS AFTER A RELIANCE AGREEMENT IS FINALIZED?

If Augusta University is the Reviewing IRB, the following might be necessary: 

If Augusta University is the Relying IRBthe following might be necessary: 

*You may observe that IRB reliance agreements do not eliminate work for any of the sites; but they do avoid the need to submit ongoing amendments and continuing reviews to the relying sites' IRBs. 

WHAT HAPPENS WHEN A REPORTABLE EVENT OCCURS AT AUGUSTA UNIVERSITY BU AN EXTERNAL IRB IS THE REVIEWING IRB OF THE STUDY?

Augusta University researchers submit reportable events to the Reviewing IRB using the Reviewing IRB's policies.  Please follow guidance of the Reliance Agreement with reporting to AU when AU is not the Reviewing IRB as there may be specific requirements outlined on the agreement.  

 ***PLEASE NOTE: REGARDLESS OF REVIEWING IRB, STUDY RELATED SUBJECT DEATHS ARE TO BE REPORTED TO AUGUSTA UNIVERSITY IRB VIA THE IRBNET REPORTABLE EVENTS SMART FORM***

WHERE DO I SUBMIT AN AMENDMENT IF THE STUDY DETAILS CHANGE WHEN AN EXTERNAL IRB IS REVIEWING THE STUDY?

If an External IRB is the reviewing IRB, amendments are not submitted to Augusta University IRB unless there is a change in PI: (IRBNet: Checklist for Submitting an Amendment for a Change in PI for an External Study)

Or study closure of an external IRB study: (IRBNet: Checklist for Submitting a Closure for an External Study)

If AU is the Reviewing IRB: (IRBNET: Checklist for Submitting an Amendment

WHAT IF I'M APPLYING FOR NIH FUNDING?

NIH SINGLE-IRB POLICY 

For most multisite NIH grant proposals due on or after January 25, 2018, NIH policy requires the use a single IRB of record.  THIS POLICY APPLIES ONLY TO NIH-FUNDED RESEARCH.  OTHER RESEARCH DOES NOT REQUIRE A SINGLE IRB UNLESS THE SPONSOR SPECIFICALLY STATES THE REQUIREMENT. 

Per the NIH: "This policy applies to the domestic sites of NIH-funded multi-site studies where each site will conduct the same protocol involving non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.  It does not apply to career development, research training or fellowship awards.

AU IRB may be able to serve as the single IRB of Record for multisite studies, on a case by case basis. Please contact the AU IRB Office per the Reliance request instructions for further information regarding this.  

IF YOU'RE APPLYING FOR NIH FUNDING, WHAT DOES THIS MEAN FOR YOU?

For multisite NIH grant proposals due on or after January 25, 2018, NIH policy will require the use a single IRB of record. If this policy applies to your proposal, please reach out to the AU IRB Office for next steps before communicating AU IRB will be the IRB of Record for the NIH funded study.

AU IRB may be able to serve as the single IRB of Record for multisite studies, on a case by case basis. Please contact the AU IRB Office per the Reliance request instructions for further information regarding this.

WHAT IS SMART IRB MASTER AGREEMENT?

SMART IRB is NOT an IRB nor other type of Human Research Protection Program (HRPP).  SMART IRB is the name of a model reliance agreement which is designed to streamline the reliance process and is once potential option.  It has all of the provisions which would normally be negotiated into a reliance agreement already written.  Institutions which have signed up as "Participating Institutions" with SMART IRB may use the model agreement for any given study instead of drafting a brand new agreement for each new protocol. 

Augusta University is currently a "Participating Institution" with SMART IRB. 

When Augusta University has been asked to serve as the IRB of Record for another institution, Augusta University IRB prefers to use the SMART IRB Agreement when the relying site is a "Participating Institution" with SMART IRB.  If the relying site agrees to use SMART IRB with Augusta University, the institutional official must sign the SMART IRB Letter of Acknowledgment. The relying site must also work with Augusta University on a SMART IRB Communication PlanAll other parts of the process when Augusta University is serving as the Reviewing IRB will be the same as described in the main section. 

Some SMART IRB Participating Institutions use online platforms for their SMART IRB reliance processes when serving as Reviewing IRB.  Augusta University IRB staff will help you navigate those on a case-by-case basis when Augusta University is asked to be relying site. 

OTHER PARTICIPATING COMMERCIAL EXTERNAL IRBS AT AUGUSTA UNIVERSITY

What is the NCI CIRB?

NCI CIRB will be the IRB of record for all NCI CIRB (National Cancer Institute) eligible studies.  

What is Western IRB (WIRB)

WIRB is the preferred commercial IRB for industry sponsored studies and may be used for specific investigator initiated studies.

*Please contact the IRB Reliance mailbox at IRBReliance@augusta.edu if the AU PI wishes to use another commercial IRB that is not listed above.  

WHAT UMBRELLA AGREEMENTS AND MOUs ARE IN PLACE?

Please contact the IRB Office for a list of current Umbrella Agreements and MOUs as we are regularly pursuing new agreements.

WHAT DO I DO IF HAVE MORE QUESTIONS?

What do I do if I have more questions? 

Send general questions regarding IRB Reliance to the IRB Reliance mailbox at IRBReliance@augusta.edu. Please allow 10 business days to receive a response.

Send general questions regarding participating Commercial External IRB’s to the External IRB mailbox at External_IRB@augusta.edu. Please allow 10 business days to receive a response.