Please complete the first four steps before you submit your IRB application (step 5). Also, please have a look at the IRB FAQs before contacting the IRB with any questions. Many of the most common questions are being answered right there.
Please check HHS guidelines to decide what level of IRB review your research project requires (exempt, expedited, or full). Note: All research projects - including those considered "exempt" - require IRB oversight at the University of North Georgia. Also, given the complexity of federal, state, professional and institutional mandates, the IRB committee reserves the right to change the level of review as needed. Some projects, however, do not constitute research as stipulated in DHHS 45 CFR 46.102(d) and thus do not require IRB review. If in doubt, please check the FAQ section and/or contact the IRB chair (firstname.lastname@example.org).
All applicants, including exempt, must complete CITI* training and provide the certificate of completion with their application. Training may be completed in one session or you may return to complete it at a later time. You will receive a certificate of completion upon the end of your training. The certificate is applicable for 3 years from the date of completion. There is no cost for registration. The IRB's online application portal, IRB Manager, will automatically check for the appropriate CITI training completion for UNG users when applications are submitted. Please ensure that your CITI profile is associated with your UNG email (ex. FirstName.LastName@ung.edu) for the check to completed in IRB Manager. CITI completion certificates for non-UNG researchers can be uploaded to your IRB application in IRB Manager. To find the appropriate training course(s), visit the CITI Training and Certification or use the CITI Training Determination Tool in the IRB Application Portal in IRB Manager.
Unless instructed otherwise, please make sure you have the following items to include with your application:
- consent/assent form (IRB Form 3.1)
- any written instruments, sample questions, and/or other data collection tools (e.g. interview protocol/s or other verbal instructions, survey questionnaire/s, debriefing statement (instructions after study is completed) or other measures)
- emails, flyers, or other recruitment documents
- copy of appropriate CITI Training Certifications for non-UNG research personnel
- grant documentation if funded internally or externally (other information may be requested on a case by case basis)
- letter of cooperation from any collaborating institutions (e.g. schools, other universities).
- other forms (e.g. related to possible HIPAA requirements)
- Family Educational Rights and Privacy Act (FERPA) limits student data that can be released by the university without student permission (e.g., email addresses for research solicitation or use)
- Permission to use student works should be specified by agreement and should be accompanied by a brief description of the works used. Waivers should become part of the permanent research record for any work published or distributed
- Certificate of Confidentiality limits compelled disclosure of research information where the research subjects that may be engaged in illegal behavior. The certificate protects the privacy of the subjects in that the researcher may not be compelled to identify such individuals in any Federal, State, or local proceedings (civil, criminal, administrative, legislative, or other). Researchers must apply through the NIH.
All applications for IRB review should be submitted online through IRB Manager. Please click the link below to login using your UNG username and password. After you have logged in, you can begin a new application by clicking the link named "Click here to start the IRB Application Portal" in the left hand column of your IRB Manager dashboard. The application portal includes tools to help you determine which type of application to submit and what CITI training is required.
Researchers wishing to submit applications for continuing review or research modifications, or to submit notifications of adverse/unanticipated events or completion of research, may login to IRB Manager, and select your study from the "My Studies" menu in your IRB Manager dashboard. From there you will select "Start xForm" in the left hand column and select the "IRB Protocol Portal" to choose the appropriate online form.
For any questions regarding IRB Manager, please email Chris Jackson at email@example.com.
Final Note: Now sit back and relax. Your job is completed and ours has just began. Depending on the nature of the application, either the IRB chair, a subcommittee, or the full IRB committee will review your application. This process can take up to 35 days (though some reviews may be completed much more quickly). In the meantime, you may check the status of your application in IRB Manager. Also, once you have received the IRB notification/approval letter please make sure to carefully read it. The document details the responsibilities of the researcher/PI to the IRB after project "approval" has been granted (e.g. reporting adverse events, making changes to research protocols/designs, terminating/completing the project).