1. Determine the type of review that best fits your project.
The IRB reserves the right to redirect your application to another approval route depending on the degree of risk proposed by the project, determined by the reviewer(s). To determine what type of review (Full Board, Expedited, or Exempt) is appropriate for your project, please see Types of Review.
2. Check your choice
Human Subjects Decision Charts produced by the U.S. Department of Heath and Human Services
Frequently asked questions about using the decision chart:
- GS is covered by an OHRP Assurance created under 45 CFR 46.103
- Private information includes all activities that an individual could reasonably expect to remain private: including solicitation of opinions.
- Existing data: data not originally collected for this research project. To use exemption, the data must be publicly available or recorded by the investigator in such a manner that subjects can not be identified directly or linked to the data through identifiers.
- Publicly available means accessible through open websites or other portals that do not require passwords, subscription or special permissions.
- Prohibited exemptions include research with vulnerable populations. E.g., prisoners, deception involved, children (except for instructional technique comparison or observation of behavior where the researcher does not participate in the activity)
- Exemption Determination: Researchers may apply to the IRB for approval of exemption status if they feel that their research fits one of the exemption categories. But…
- Exemption does not remove any of the researcher’s requirements to perform the research ethically and with full informed consent of participants.
- Surveys on sensitive or personal topics which may cause stress to study participants are not exempt from IRB review.
- Surveys where participants are identified and subject matter may be embarrassing or create consequence for participants are not exempt from IRB review.
- Educational data collected from school or institutional sources may not qualify for exempt status without inclusion of informed consent or documentation of parental permission for data release as required by the Family Educational Rights and Privacy Act (FERPA). Educational data collected from public sources (websites) do not require parental permission.
- In October 2008 the Department of Health and Human Service and the Office for Human Research Protections (OHRP) revised and updated specific guidance regarding whether the use of coded private information or specimens is or is not considered research involving human research subjects (45 CFR part 46).
Examples of studies and how they are classified.
If there is any question regarding what process to utilize, contact the Compliance Coordinator.
3. Complete Mandatory On-line Training.
All applicants, including exempt, must complete training and provide the certificate of completion with their application. There is no cost, but you must register. You may complete the training in one session or return at a later time. You will receive a certificate of completion. The certificate is applicable for 3 years from the date of completion.
- CITI– Collaborative Institutional Training Initiative, which is a consortium of Universities and institutions to distribute federally funded training content to meet regulatory compliance.
4. Select the appropriate forms your project will require.
5. Things to include in your application.
- A copy of the Compliance Cover Page with signatures.
- A narrative description or Exempt Questionnaire for your project. Include description of the subjects, what they will be asked to do, and how potential risks will be controlled.
- Certificate of Investigator Responsibilities
- Describe how consent will be obtained and include written informed consent documents.
- Any written instruments, sample questions, and/or other data collection tools.
- Emails, flyers, or other recruitment documents.
- Letter of Cooperation from collaborating institutions, if applicable.
- Copy of human subjects training certificate.
- Copy of CITI Health Information and Privacy Security (HIPS) training, if medical data is being collected.
- Any other necessary documents that will present the most complete case for research to be conducted.
6. Submit application materials.
If email not available, mail to:
Office of Research and Sponsored Programs
Georgia Southern University
PO Box 8005
Statesboro, GA 30460
Signatures are required on all applications before review will begin.
- Student researchers must include an original signature and a faculty adviser’s original signature on all applications. (In signing the student research cover page, faculty assume responsibility for scientific merit of the study and student conduct in the research.)
- Faculty researchers must submit an original signature or typewritten electronic signature, if the application is submitted from the faculty members University email account. (Note: If you have had a name change not reflected in your GS email account you must include your account name. e.g., email@example.com applying as Jane Smith Jones. Note in the application email the name change.)
7. Check for compliance with related regulations or guidelines.
- 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 by specific agreement and should be accompanied by brief description of the works used. Waivers should become part of the permanent research record for any work published or distributed. (Example)
- 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 in any Federal, State, or local civil, criminal, administrative, legislative,or other proceedings to identify such individuals. Researchers must apply through the NIH.
Last updated: 1/23/2017