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APPLICATION FOR EXEMPTION FROM FULL IRB REVIEW

APPLICATION FOR EXEMPTION FROM FULL IRB REVIEW 2025

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The document outlines the application process for exemption from full Institutional Review Board (IRB) review, detailing specific categories of research that qualify for such exemptions. It includes criteria related to educational research, surveys and interviews, existing data review, and evaluation projects of federal programs. Researchers must attach this application to their IRB proposal, and if deemed non-exempt, the proposal will undergo full board review.

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Which type of IRB review does not require approval?

Exempt human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

When can a study be considered exempt from IRB review?

Research can qualify for an exemption if it is no more than minimal risk and all of the research procedures fit within one or more of the exemption categories in the federal IRB regulations. Studies that qualify for exemption must be submitted to the IRB for review before starting the research.

What is an example of an exempt IRB review?

Examples of Commonly Exempted Research Research on educational practices or educational curriculums. Benign behavioral interventions with adult subjects. Anonymous surveys or interviews on non-sensitive topics. Passive observation of public behavior without collection of identifiers.

How to apply for an IRB exemption?

In order to establish an individual research project as exempt, an investigator must complete an IRB application. On the IRB application the investigator should indicate the number of the category under which an exemption is claimed. Final determination as to whether a project is exempt rests with the IRB.

What is an example of an exempt IRB?

Some examples of Exempt research are: surveys or interviews. benign behavioral interventions. passive observation of public behavior without collection of identifiers.

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When can an IRB be waived?

Waiver of All Consent In certain cases, federal regulations allow the IRB to waive the requirement to obtain any informed consent. Most complete waivers of consent involve studies in which there are minimal risks to subjects, but complete waivers are also possible in emergency care and other limited circumstances.

What projects are IRB exempt?

Exempt Categories: Education research. Surveys, interviews, educational tests, public observations (that do not involve children) Benign behavioral interventions. Analysis of previously-collected, identifiable info/specimens. Federal research/demonstration projects. Taste and food evaluation studies.

How much does it cost to get an exemption from the IRB?

The cost of an exemption review may be free or cost between roughly $500 and $1,000. A full review often costs between $1,000 and $5,000 for the initial review, with additional charges for changes and renewals. Which IRB should be contacted?

APPLICATION FOR EXEMPTION FROM FULL IRB REVIEW 2025

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Which type of IRB review does not require approval?

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