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What Level of Review Does Your Study Need?

February 23, 2022

Many research professionals do not realize that there are several different types of institutional review board (IRB) review. A study’s specific design and the risks involved for participants determine the type of IRB review that meets regulatory requirements.

While some research requires review by the fully convened IRB, some studies may only require review by one IRB member. This is called expedited review. Some studies may even meet the definition in the regulations as “exempt” from the requirement for IRB review and research informed consent. Additionally, some projects may not even require IRB review because they do not meet the definition of a clinical investigation or research involving human subjects.

Based on the process used by Advarra IRB members, this infographic outlines a four-step evaluation process research professionals can use as they determine the necessary level of review for a given study.

Infographic of What Level of Review Does Your Study Need? (See full text below)

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What Level of Review Does Your Study Need?

When it comes to IRB review, all research is not equal. A specific study’s design and risk level determines if it’s reviewed by a fully convened IRB or a designated IRB member, whether it qualifies for exemption, or if it doesn’t meet the definition of human subjects research.

Within human subjects research, there are three levels of review:

The IRB is the ultimate arbiter as to which level of review is applied to the research. That said, it may be useful for investigators to know which level of review likely applies to their study. Follow this step-by-step process to determine your project’s review level.

Step 1: Does the Activity Involve Research?

Projects subject to the Common Rule: To be considered “research,” there should be systematic investigation throughout research development, testing, and evaluation. This may include:

Projects regulated by FDA: To be considered a “clinical investigation,” the experiment must involve a test article and one or more human subjects. It must also adhere to one of the following:

Does this activity involve research?

Step 2: Does the Activity Involve Human Subjects?

Projects subject to the Common Rule: A human subject is defined as a living individual about whom an investigator is conducting research. With human subjects (also known as participants), investigators:

Projects regulated by FDA: A human subject is an individual who is or becomes a participant in research.

If an activity does not meet the human subjects research definition, an IRB does not need to review.

Does this activity involve human subjects?

Step 3: Is the Activity Exempt?

When we refer to an activity as “exempt,” we’re saying the research is exempt from 45 CFR 46 regulations. Exemptions only apply to research involving no more than minimal risk to participants: i.e., the level of risk doesn’t outweigh the normal, everyday risk a participant may encounter, or in routine medical, dental, or psychological exams. There are eight possible exemption categories set out in the regulations:

Does this research qualify as exempt?

Step 4: Does the Research Qualify for Expedited Review?

Expedited review may occur when there’s no more than minimal risk to participants. Expedited isn’t synonymous with “faster review”; it simply means a designated IRB member may review the project rather than the fully convened IRB. The designated IRB member applies the same review criteria, but IRBs cannot disapprove research undergoing expedited review. There are seven possible categories for expedited review of a new study:

Does this research qualify for expedited review?

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