The following questions will help you determine if your research project falls under one of the categories classified as exempt under Federal regulations and therefore not subject to IRB oversight. All of the activities that your study will employ must fall into one or more of the exempt categories in order for the project to be classified as exempt. Please contact the IRB at (678) 797-2268 or email@example.com if you are unsure or have additional questions.
1. Are you using existing data only and will have no contact with subjects?
2. Does this research involve the use of any drug, device or invasive procedure, place participants at risk for bodily injury or involve them in risky behavior?
3. Does your research target pregnant women or fetuses (and put the pregnancy or fetus at risk), prisoners, including individuals on probation or otherwise involved in the criminal justice system, or individuals with impaired decision-making capacity?
4. Is the research conducted in established or commonly accepted educational settings? “Accepted educational settings” includes but is not limited to schools and colleges and may include other sites where educational activities regularly occur.
4a. Does the research involve normal education practices only (such as research on regular or special education instructional strategies, research on effectiveness of or comparison among instructional techniques, curricula, or classroom management methods) and involve no extraordinary educational or non-educational activity?
Note: If your project involves surveys or interviews of minors under 18, it cannot be exempt.
Submit IRB Exemption Request under Category 1
5. Does your research involve only the administration of standard educational tests (e.g., cognitive, diagnostic, aptitude, achievement)?
Note: Research conducted in schools, even if exempted by the IRB under Category 1 or 2, must follow any guidelines/restrictions imposed by the school(s) or district(s). You should submit evidence of approval from any school in which the research will take place. The IRB may require parental consent even if the school does not.
6. Does the research involve observation of public behavior in which the investigator does not participate in the activity being observed?
7. Does your research involve the collection of data through surveys, questionnaires, interviews or focus groups, or observation of public behavior in which the investigator interacts with the subjects being observed?
7a. Are any of your subjects under the age of 18?
7b. Could the data collected reveal damaging or sensitive financial or personal information, or expose criminal activity about your subjects, or persons they know?
You must also answer YES to 7c, 7d, OR 7e to qualify for an exemption
7c. Are data collected anonymously so that no link ever exists between the research records and the participant’s identity?
7d. Are your subjects elected officials or candidates for public office?
7e. Does any Federal statute, without exception, require that the confidentiality of the personally identifiable data be maintained throughout the research and thereafter?
Note: If you did not answer “YES” to 7c, 7d, OR 7e, you must submit an IRB Approval Request.
8. Is the research conducted or approved by a Federal Department or agency head and involves only the study, evaluation, or examination of a public benefit or service program; e.g., Social Security, Medicaid, etc.?
Submit IRB Exemption Request under Category 5
9. Is this a study of food preference or quality assessment to determine consumer acceptance of wholesome foods containing either no additives or additives at levels found to be safe by the Food and Drug Administration or approved for consumption by the Environmental Protection Agency or the U.S. Department of Agriculture?
Submit IRB Exemption Request under Category 6
Questions 10a through 10c are for studies involving access to secondary data only with no direct interaction or involvement with human subjects.
10. Are the subjects who provided the data individually identifiable?
Your research does not meet the Federal definition of “research on human subjects” and therefore no IRB action is required.
10a. Will all data, documents, records, or specimens be in existence before your research project begins?
10b. Is the archive, database, or record collection publicly available?
10c. Will any identifying information that may link your project data to individuals in the database/archive be included in your research records; i.e., will you create a link list for follow-up purposes or to compare data from multiple sources?