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 (Cancer) reviews 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 (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-CANCER (IRB REGISTRATION #00009025)*

  • IRB C (Oncology-Focused) was established in September 2012. IRB C is the primary Institutional Review Board designed to review oncology protocols and to address the research growth in Oncology 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 COMMITTEE MEMBER RESOURCES*

IRBNet Resources

How to Review a Submission in IRBNet  (video) (pdf)

This video and pdf will assist you with the following:

  1. Manage your Submission Manager workspace
  2. Review project submission details, including documents, Training & Credentials, and COI Disclosures
  3. Communicate with committee administrators and members
  4. Add comments and reviewer documents to a submission
  5. Manage your review work queue

Locating Documents and Previously Logged Reviewer Comments in IRBNet (video) (pdf)

This video and pdf will assist you with the following:

  1. Locate IRB Approved Stamped Documents
  2. Locate documents within a specific project
  3. Locate the status of previously submitted packages in a project
  4. Locate previous Reviewer Comments on previous packages

*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 me for additional information.

Angela M. Toole, MS, CIM
IRB Operations Manager
Augusta University
Institutional Review Board (IRB) Office
p:  (706) 721-9346 | f: (706) 721-1393
Email: antoole@augusta.edu

 

 

 External IRB Options

  • National Cancer Institute Central IRB (CIRB) - National Cancer Institute's (NCI) Central Institutional Review Board (CIRB) using facilitated review. The NCI CIRB was designed to 1) improve access to NCI-sponsored Cooperative Group clinical trials for potential study participants and their physicians by enabling local IRBs to rapidly approve clinical trials through the use of a facilitated review process; 2) enhance the protection of study participants by providing consistent expert IRB review at the national level; and 3) reduce the administrative burden for local IRBs and research staff. Since this Institution has completed enrollment in the CIRB Initiative by submitting a completed CIRB Application, submitting two signed Authorization Agreements, and including the CIRB on the Institution's FWA, the local IRB and investigators may take advantage of the CIRB's reviews.
  • Western IRB (WIRB)
  • Consideration for use of other external IRBs can be requested by submitting an email to irb@augusta.edu