Please complete the first five steps before you submit your IRB application (step 6). 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 (email@example.com).
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. Be sure to print the certificate and include it with your complete IRB application package. To find the appropriate training module, visit the CITI Training and Certification.
Unless instructed otherwise, please make sure you have the following things included with your application package:
- signed and fully complete form/s (IRB Form 1.1 or Forms 2.1 and 2.2)
- 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 Modules
- 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.
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 (coming soon). 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).