Brief descriptions of the different application requirements and their typical estimated review timelines appear below.  Merely submitting the required materials for review does not guarantee approval.  Applications that lack clarity or detail, or that come at certain times of the academic year such as during the final exam period or winter break, may take longer to review.  

It should also be noted that because GSW’s IRB may not contain any members on 12-month employment contracts with the university, the availability of any type of IRB review during the summer months cannot be assured.  Potential investigators are strongly encouraged to submit any proposals before the end of the spring semester.

Exemption applications are typically evaluated by the IRB chairperson, although the chairperson may solicit review from other IRB committee members in cases of potential conflicts of interest and/or lack of research expertise. To apply for Exemption from IRB review, the investigator must complete and submit the following materials:

There are no deadlines for submission of Exemption applications; however, investigators should allow at least one month for the application to be processed and approved.

Expedited Review applications are typically evaluated by the IRB chairperson and two IRB committee members. To apply for Expedited Review, the investigator must complete and submit the following materials:

There are no deadlines for submission of Expedited Review applications; however, investigators should allow at least one month for the application to be processed.

Full Review applications are evaluated by the entire IRB committee.  Therefore, all materials must be submitted to the IRB chairperson at least two weeks prior to the regularly scheduled IRB meeting.  Investigators are encouraged to attend these meetings to answer any questions about their application, but are not required to do so.  To apply for Full Review, the investigator must complete and submit the following materials:

Advertisements

Advertisements that incorporate the GSW name or logo must be approved by the Office of University Relations as well as the IRB. Investigators should contact University Relations at 229-931-2028 for more information about these guidelines. Advertisements should be limited to the following information:

• The name and address of the investigator
• The purpose of the research and a summary of the eligibility criteria
• A description of the benefits
• The location of the research
• The person to contact for further information

Duration of IRB Approval

A project’s IRB approval lasts for one year, unless otherwise specified, commencing with the approval date. High-risk projects may receive a shorter approval period.  

Renewal Instructions

Projects approved by full review and lasting longer than one year require annual renewal.  This is true for projects that are still recruiting subjects as well as projects that are still treating or monitoring subjects. However, renewal is not required for projects that have progressed to the point that they only require data analysis or assessment of follow-up clinical data obtained from clinical care procedures.  For IRB approval renewal, the principal investigator must submit to the IRB Chairperson the following materials:

• The completed Investigator's Progress Report
• The most recently approved consent form, minus the IRB approval stamp
• The complete protocol, including any modifications previously approved
• Any progress reports sent to the sponsoring/funding agency, if applicable

The IRB Chairperson should issue renewal notices to investigators of active studies prior to the protocol approval expiration date. However, the investigator is responsible for monitoring approval and expiration dates and ensuring that necessary renewal forms are submitted on time. Renewal of previously approved applications is not guaranteed.

2018 regulations have removed the requirement that projects receiving Exemptions or Expedited Review automatically require renewal if they last longer than one year.  However, these regulations do give the IRB the ability to request a renewal of these projects if deemed necessary.

Amendments or Changes to the Protocol and/or the Consent Form

The investigator must report to the IRB, in writing, any modifications in the consent form, study methodology, and/or protocol. The proposed changes and their effects must be reported and reviewed by the IRB before they are implemented.  IRB approval may be rescinded if the modifications to the protocol or consent form are considered to render the study unethical.

Adverse Effects or Unanticipated Problems

The investigator must report promptly to the IRB, in writing, any research-related injuries to human subjects or any unanticipated risks to subjects or others at participating sites. Any research project that results in unexpected serious physical, psychological, or emotional harm to the subjects must be terminated immediately. If the research involves an Investigational New Drug or Device, the investigator must also report such incidents to the sponsoring agency and/or the Food and Drug Administration.

Final Report Instructions

When the project is completed, researchers should submit the Investigator's Progress Report to the IRB, checking the box on the form indicating that the final report is being submitted.