Kennesaw State UniversityKennesaw State University

Office of Research

IRB Oversight Decision Tree

The following questions will help you determine whether your research project is considered to be human subject research under the federal guidelines. Please contact the IRB Administrator at (678) 797-2268 or irb@kennesaw.edu if you are unsure or have additional questions.

1. Does this activity meet the regulatory definition of research, which is a systematic investigation designed to develop or contribute to generalizable knowledge? (An example of generalizable knowledge would be research conducted to evaluate whether a program had the desired effect on program participants and then using the collected data to inform other programs -- or research conducted with the intent to replicate an evaluated program.)

IRB review and approval is not required.

2. Does this activity involve interaction or intervention with, collection of information about, or collection of specimens from living individuals?

This research does not involve human subjects. IRB review is not required and nothing needs to be submitted to the IRB.

3. Does the research involve intervention or interaction with these living individuals?

IRB review is required. Please review the Exemption Screening Checklist on the IRB web site to determine which of the three types of IRB review is required for your project.

4. Does the research involve access to information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information.)

This research does not involve human subjects. IRB review is not required and nothing needs to be submitted to the IRB.

5. Does the research involve private information (i.e., about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or provided for specific purposes by an individual and which the individual can reasonably expect will not be made public, such as a medical or school record)?

This research does not involve human subjects. IRB review is not required and nothing needs to be submitted to the IRB.

IRB Exemption Screening Checklist

The following questions will help you determine which type of IRB review is required for your project. The three types of review include:

1. Exempt Review - research involves no more than minimal risk to participants. Exempt review consists of an initial IRB review, and following classification as exempt, the study is exempted from continuing annual IRB oversight. Please note that all future proposed revisions to an exempted study must be reviewed by the IRB prior to implementation to ensure the study remains exempt. A study is classified as exempt when it falls under one or more of the six categories of exempt research (see below).

2. Expedited Review - conducted when a project involves no more than minimal risk to participants but the project cannot be classified as exempt. Initial review consists of review by the IRB chair and one or more IRB members. The study is subject to continuing oversight by the IRB on an annual basis.

3. Full Board Review - conducted when a project involves more than minimal risk to participants, and initial review includes all members of the IRB. The study is subject to continuing oversight by the IRB on an annual basis. Investigators (and faculty advisors, if applicable) are required to attend the IRB meeting at which the study will be reviewed.

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 that would 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” include but are not limited to schools and colleges and may include other sites where educational activities regularly occur.

4a. Does the research involve normal educational 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 years of age, it cannot be classified as exempt.

Submit IRB Exemption Request under Category 1

5. Does your research involve the administration of standard educational tests (e.g., cognitive, diagnostic, aptitude, achievement) only?

Submit IRB Exemption Request under Category 2

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?

Submit IRB Exemption Request under Category 2

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?

Note: If your project involves surveys or interviews of minors under 18 years of age, it cannot be classified as exempt.

7b. Could the data collected reveal damaging or sensitive financial or personal information, or expose criminal activity about your subjects, or persons they know?

Submit IRB Exemption Request under Category 2

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?

Submit IRB Exemption Request under Category 2

7d. Are your subjects elected officials or candidates for public office?

Submit IRB Exemption Request under Category 3

7e. Does any federal statute, without exception, require that the confidentiality of the personally identifiable data be maintained throughout the research and thereafter?

Submit IRB Exemption Request under Category 3

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 at the time of IRB review and approval of the project?

10b. Is the archive, database, or record collection publicly available?

Submit IRB Exemption Request under Category 4

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 coded list for follow-up purposes or to compare data from multiple sources?

Submit IRB Exemption Request under Category 4

IRB Exemption Categories

Category 1: Educational Purposes Only

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. The research is not FDA regulated and does not involve prisoners as participants.

Category 2: Educational Tests, Surveys, Interviews, Public Observation

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. If the research involves children as participants, the procedures are limited to educational tests and observation of public behavior where the investigators do not participate in the activities being observed. Research is not FDA regulated and does not involve prisoners as participants.

Category 3: Elected or Public Officials

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under category (2), if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. Research is not FDA regulated and does not involve prisoners as participants.

Category 4: Research with Existing Data

Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Research is not FDA regulated and does not involve prisoners as participants.

Category 5: Public Benefit or Service Programs

Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Category 6: Taste Tests

Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. The research does not involve prisoners as participants.