Exempt Level of Review

Levels of IRB Review

Institutional Review Board

Exempt Submissions

Exempt research involving human subjects is a sub-set of minimal-to-no risk research that does not require comprehensive IRB review and approval. Only the ETSU IRB has the authority to grant an IRB exemption, which requires submission of the protocol for review by the IRB Chair, or designated IRB reviewer. To receive an exempt determination, the project must fall into one or more of the specific exemption categories defined by the Common Rule.

Exempt projects must be submitted in OneAegis (formerly IRBManager) on a New Protocol Submission xform
An exempt determination does not lessen the investigator's ethical obligations, including completion of human subjects protections training (CITI)
Exempt projects are not subject to continuing review
Amendments must be submitted for review to ensure that changes do not alter the exempt status previously determined

What is an exempt review process?

An exempt review procedure consists of a review by the IRB Chair. Studies that are determined to meet exempt status are not exempt from human subject protections and ethical principles but are exempt from some regulatory and institutional criteria.
What qualifies for exempt review?
Only studies that meet the specific categories of exempt activities as delineated by HHS Regulations are eligible to be given exempt status. See the specific exemption categories below.

Studies can NOT be exempt if either of the following is true:
1. the research includes prisoners except for research aimed at involving a broader subject population that only incidentally includes prisoners.
2. the research is regulated by the FDA (categories 1-5 and 7-8).
How do I submit a request for exempt review?

The principal investigator may make an initial request for study exemption by submitting a New Protocol Submission xForm in OneAegis (formerly IRBManager). The IRB Chair (or designee) will make the final determination for exempt status.

Exempt Categories

ETSU is not allowing exemptions under categories 7 and 8 at the current time.

Category 1: Educational Exemption
Educational Exemption

Research conducted in established or commonly accepted educational settings that specifically involves normal educational practices, so long as the research is not likely to adversely impact (a) students' opportunity to learn required educational content or (b) the assessment of educators who provide instruction.

An "established education setting" is any place where educational activities regularly occur such as schools, colleges, after school programs, daycares, libraries, museums, work places, training centers, etc.

"Normal educational practices" are activities that typically occur in a classroom or other educational setting. These are generally best practices that benefit students and support the required curriculum. Examples:
- Assessment of attitudes about learning
- Evaluation of classroom or school activities
- Innovative instruction methods or techniques
- Test development
- Comparison of classroom management methods
- Evaluation of educational tools such as online learning, computer software, or smart phones
In order to qualify for exempt category #1, the research must not:
1. Take time or attention away from normal instruction in a way that might negatively impact student achievement; or
2. Impact teachers/instructors in a way that could adversely affect assessments of their performance.
The exemption at Category 1 may be applied to research with children (research subject to subpart D) if the conditions of the exemption are met.

Examples of research studies that are not exempt under category #1:
- Research that collects information about personal characteristics beyond basic demographics of students, families, or teachers (such as mental health, personal beliefs or opinions beyond those associated with learning or curricula).
- Implementation of an untested curriculum or learning aid that is not consistent with the current required curriculum or local standard practice in the educational setting being studied.
Research in schools, especially with children, may require additional protections, regulations, or approvals.
- Research using educational records of students in most K-12 schools and colleges are subject to FERPA regulations.
- Research with children generally requires that researchers obtain written permission from the parent/legal guardian before asking the children for their affirmative assent to participate in research.
- Researchers should refrain from recruiting their own students for research to avoid potential undue influence/pressure on those participants.
- Researchers must obtain written permission from the educational setting/site(s) where the research is to occur and must provide that documentation to the IRB.
Find additional guidance and resources here.
Category 2: Surveys, Interviews, Educational tests, Observations
Exemption for Surveys, Interviews, Education Tests, and Observations of public behavior

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
1. The information obtained is recorded by the investigator in a way that participants' identity cannot readily be ascertained, directly or through identifiers linked to the subjects;
2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to ensure there appropriate safeguards to protect participants' privacy and confidentiality of the data.
Exemption #2 applies to studies that collect data using one of the following research methods ONLY:
- Surveys
- Interviews
- Focus groups
- Education tests (i.e., cognitive, diagnostic, aptitude, achievement)
- Observation of public behavior (i.e., behavior that occurs in a public place where there is no reasonable expectation of privacy and where no special permission is required to observe others)
Examples of studies that do not meet the criteria for Exemption #2:
- Projects that involve interventions or manipulations that are distinct from the data collection methods
- Observation of behavior in a public school, business, or hospital
- Collection of biospecimens in conjunction with the survey/interview procedures
- Linking information from anonymous surveys to other personally-identifiable data
Research with children:
Research including children may meet Exemption #2 for projects involving only educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed and the data is not recorded in an identifiable manner. Surveys, interviews, and focus groups including children as participants do not qualify for Exemption #2.
Category 3: Benign behavioral interventions
Benign Behavioral Interventions Exemption
1. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
  1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
  2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
  3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7).
2. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
3. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
Children cannot be included as participants for research to qualify for Exemption #3.

Benign behavioral interventions must be:
- Brief in duration
- Harmless
- Painless
- Not physically invasive
- Not likely to have a significant adverse lasting impact on the participants
- Not offensive or embarrassing
Examples include:
- Performing cognitive tasks
- Providing educational materials to participants with the intention of changing their behavior (i.e., smoking cessation, eating habits, diabetes management)
- Playing an online game
- Being exposed to stimuli such as color, light, or sound at safe levels
- Solving puzzles under various noise conditions
Allowable methods of data collection:
- Verbal or written responses from participants
- Observations
- Audiovisual recording
Data cannot be collected via physical procedures such as measuring height/weight, wearable sensors, activity trackers, blood pressure monitoring, blood draws, etc.

Other key points to qualify for Exemption #3:
- The investigator must describe the intervention and data collection procedures to potential participants and seek their prospective agreement to participate.
- If the investigator uses deception, or incomplete disclosure, potential participants must be told prior to participation that they will be unaware or misled about the nature or purpose of the research, and the participants must agree to participate.
Category 4: Secondary data
Exemption for use of Secondary Data for Research

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
1. The identifiable private information or identifiable biospecimens are publicly available;
2. When the information is recorded by the investigator in a nonidentifiable manner, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
3. The investigator's secondary use of the identifiable private information is regulated under HIPAA as "healthcare operations," "research," or "public health." (Note that HIPAA does not apply to biospecimens, so this provision applies only to the secondary use of identifiable private health information, which can include information obtained from biospecimens); or
4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, and the information is subject to federal privacy standards and other requirements specified in the exemption by OHRP.
"Secondary research" refers to research use of materials that are collected for either research studies distinct from the current secondary research proposal, or for materials that are collected for nonresearch purposes, such as materials that are left over from routine clinical diagnosis or treatments.

Private information and biospecimens do not have to be in existence prior to the start of the research so long as the current research proposal only includes data or materials that are originally collected for another purpose. This exemption does not allow any primary data collection.

If the proposal includes both primary and secondary data collection, where the researcher obtains consent from participants, the study cannot be eligible for Exemption #4.

Publicly available data:
“Publicly available” refers to data and/or biospecimens that are accessible to anyone in the general public, without the need for special qualifications, permissions, or privileges. Examples include data/biospecimens available for public purchase, searchable online, or available at a library. Most publicly available data sets are prepared for the intent of making them public and are not individually identifiable; therefore, analysis of of de-identified publicly available data do not constitute research involving human subjects. Data that are both publicly available and contain identifiable, private information require IRB review when being accessed and analyzed for research purposes. This may include public use datasets for which a researcher must request access, register, or sign an agreement to access.
Restricted Use Data:
Certain agencies and research organizations release files to researchers with specific restrictions regarding their use and storage. These restrictions are typically described in a data use or restricted use data agreement the organization requires be signed in order to receive the data. The records frequently contain identifiers or extensive variables that combined might enable identification, even if this is not the intent of the researcher. Research using these data sets are not eligible for Exemption #4. Note that the data use or restricted use data agreement must be reviewed by Office of Research and Sponsored Programs Administration for institutional approval.
Category 5: Public Benefit/Service Programs
Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
1. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
Federal Posting Requirement for this Exemption
Category 6: Taste & Food Quality Evaluation
45 CFR 46 and 21 CFR 56.104(d): Taste and food quality evaluation and consumer acceptance studies,
1. if wholesome foods without additives are consumed; or
2. 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 US Department of Agriculture.

Ethical Standards

If the IRB Chair, or designee, identifies ethical concerns in the research submitted for exemption, the study will not be exempted.

Studies submitted requesting exempt status will be reviewed by the IRB Chair, or designee, to determine whether the research fulfills the organization’s ethical standards. The standards are as follows:

The research holds out no more than minimal risk to the participants.
The selection of participants is equitable.
If the study includes recording of identifiable information, there are adequate provisions to maintain the confidentiality of the data.
*When appropriate, if the study includes interactions with participants, there is a consent process that discloses such information as:
1. that the activity involves research
2. a description of the procedures
3. that participation is voluntary
4. the name and contact information for the investigator
The research has adequate provisions to maintain the privacy interests of participants.

To find exempt information sheet examples, click here.

*The IRB Chair has the authority, in limited circumstances, to determine if this requirement is not appropriate. Consult the IRB Staff if you have questions about this requirement.

Exempt Policy & Procedure

IRB Policy 7: Exempt Review

IRB Procedure 7a: Exempt Review Procedures