:: IRB ::

IRB Review Categories:

There are three levels of IRB evaluation that a research study may undergo, depending on the level of risk to human subjects. These levels are: Full Board (convened) review, Exempt review and Expedited IRB review.

Note:

The level of evaluation can only be determined by the IRB, in accordance with Clinical Research guidelines. Even if an investigator believes a study is exempt, no research should begin until the IRB reviews the protocol and makes the final determination. All research studies require full (convened) Board review and approval.

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Full Board Review

Full Board review: Types of Research Requiring Full Board Review: A. therapeutic and non-therapeutic studies, in addition to research studies that involve greater than minimal risk for human subjects this includes: - Some research involving children or other vulnerable populations . - Research that involves experimental dru ..

Expedited Review

Expedited Review: Type of Research Qualifying for Expedited Review: In research studies qualifying for expedited review, human subjects incur no more than minimal risk. Special abbreviated consent form formats are available for tissue collections that meet criteria for expedited review. The decision to approve projects submitted for expedi ..

Exempt Review

Exempt Review: Certain research activities involving human subjects have been given exemptions from IRB full board review. If an investigator believes that the research activities being proposed fall into one of the exemption categories, the protocol should be submitted to the IRB for exemption review. The decision to approve a project submitted for exempti ..