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The purpose of any IRB application is to provide sufficient information about the study’s purpose and methodology to allow the committee to effectively evaluate its ethicality. It cannot be assumed that reviewers will be experts in any particular research area. Investigators must therefore prepare their applications with the goal of providing as much relevant information as possible with as little jargon and as few omissions as possible. Neglecting to provide sufficient or clear information regarding the research goals and procedures may delay the approval and research process.

All IRB materials and correspondence should be submitted to the IRB Chair (irb@gsw.edu). Investigators who require more detailed contact information for the IRB Chair should request that information from the Office of Academic Affairs, Room 205, Administration Building, 229-928-1361.

Investigator and Committee Member Training

All investigators are required to complete National Institutes of Health (NIH) training or Collaborative Institutional Training Initiative (CITI) training. NIH and CITI certification for investigators is valid for three years. A copy of the NIH or CITI certificate must be submitted every time investigators submit an IRB application. Georgia Southwestern State University (GSW) does not offer CITI training; however, GSW accepts CITI training certificates obtained at other institutions.

IRB committee members are required to complete and submit proof of NIH or CITI certification to the IRB Chair at irb@gsw.edu. IRB committee member certification is good for two years.

Application Types and Projected Review Timelines

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 of the proposed research. 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: 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:

  • The Exemption Application
  • Any questionnaires, consent forms, and other relevant material such as advertisements
  • Any external funding agency’s protocol or application materials
  • Any special approvals, such as release forms from agencies providing specimens

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: 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:

  • The Expedited Review application
  • The consent form that will be used
  • Any questionnaires and other relevant materials, including advertisements
  • Any external funding agency’s protocol or application materials
  • Any special approvals, such as release forms from agencies providing specimens

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: 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:

  • The Full Review application
  • The consent form that will be used
  • Any questionnaires and other relevant materials, including advertisements
  • Any external funding agency’s protocol or application materials
  • Any special approvals, such as release forms from agencies providing specimens

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. Research activities should not continue past the one-year anniversary of the IRB approval date unless the IRB has approved a renewal.

Renewal Instructions

Projects 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. 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.

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 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 Final Progress Report to the IRB.

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