Research that falls under one of the categories below is exempt from the full IRB review. The IRB Committee and the LECOM Office of Research will review the application and determine whether the study falls under the exemption. Research conducted with prisoners does not qualify for an exemption and must go to the convened IRB for review. Please fill out the Non-medical or Medical IRB submission form. The list below will help you determine which exemption your study may fall under and the correct application that you will need to complete.

Exempt Research Categories

Exempt Category 1 Application

Federal Definition: Research conducted in established or commonly accepted educational settings, involving normal or educational practices.

• Children: If Children are the subjects, parental consent and child assent must be obtained.
• Cannot be subject to FDA regulation
• Cannot involve prisoners

Examples:

• Comparison of a new and standard math curriculum Assessment of classroom management strategies used in Special Ed classrooms.
• Study of a new reading technique on delayed readers in 3rd grade.

Click here to download an Exempt Category 1 Application

Exempt Category 2 Application

Federal Definition: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior.

• Children: This section is not applicable to survey or interview research involving children. However, this category may apply to research with children when the investigator observes public behavior but does not participate in that behavior or activity.
• Note: Surveys or interviews that are very sensitive or personal may not qualify for an exemption.
• Cannot be subject to FDA regulation
• Cannot involve prisoners

Examples:

• A survey of college students on their use of the Internet.
• A survey of local business owners and how they have been affected by corporate business growth.
• Interviews with Hispanics on their college experience.
• Observing adult and child interactions at a soccer game.

Click here to download an Exempt Category 2 Application

Exempt Category 3 Application

Federal Definition: Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observational of public behavior and the human subjects are elected or appointed public officials or candidate for public office.

• Cannot be subject to FDA regulation
• Cannot involve prisoners

Examples:

• Interview or survey of public officials on local issues.
• Comparing personality assessments scores of appointed judges in the state of Florida.

Click here to download an Exempt Category 3 Application

Exempt Category 4 Application

Federal Definition: Research involving the collection or study of existing data, documents, records pathological specimens or diagnostic specimens. If these sources are publicly available or if the information is recorded by the PI in such a way that the subject cannot be identified, directly or through identifiers linked to the subject.

• Note: data, specimens etc. must exist at the time of the application.
• Cannot be subject to FDA regulation
• Cannot involve prisoners

Examples:

• Analyzing de-identified data or tissue samples.
• Collecting de-identified data from patient charts that underwent hip replacement from 1995 to 2005.

Click here to download an Exempt Category 4 Application

Exempt Category 5 No Application

Federal Definition: 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 other examine; public benefit or service programs.

Category 5 research is reserved for Federal Government Research – not available for local IRB review, and is therefore not available at LECOM.

Exempt Category 6 Application

Federal Definition: Taste and Food quality evaluation and consumer acceptance studies.

• Note: Children may participate but you must obtain parental consent and child assent.
• Cannot involve prisoners

Examples:

• Taste testing of new calcium enriched soda.
• Tasting of a several yogurts to determine which texture is more pleasing.

Click here to download an Exempt Category 6 Application