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Guidance on the Use of Expedited Review Procedures - hhs

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Regulatory Requirements Expedited review procedures are described in HHS regulations at 45 CFR 46. 110. Under an expedited review procedure the IRB Chairperson or one or more experienced reviewers designated by the Chairperson from among the members of the IRB reviews the research protocol* The IRB shall adopt a method for keeping all IRB members advised of research proposals that have been approved under the expedited review procedure. In conducting expedited review the IRB reviewers may ex ...

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When can a protocol be eligible for expedited review by IRB?

In some cases, a protocol needs IRB approval but the level of risk in the protocol is considered minimal and the review can be expedited. One of the key elements to defining an expedited protocol for the Social and Behavioral Sciences is determining if the protocols risk level is minimal (aka minimal risk).

What is an example of expedited review?

The following types of research are commonly processed under expedited review: Studies involving collection of hair or saliva samples. Studies of blood samples from healthy volunteers. Studies involving noninvasive and minimal risk FDA-approved medical devices (e.g., MRI, electrocardiography, ultrasound, etc.)

What determines whether an IRB should review a research proposal as an expedited review or a full review?

There are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt. The review path is determined by: Level of risk to subjects associated with the project. The type of research being conducted (e.g., an educational intervention, a survey, an ethnographic observation, etc.)

In what circumstances might your human participants protocol be considered for expedited review?

Federal regulations (45 CFR 46.110 ) authorize the use of an expedited review process for: Minimal risk human research that meets one or more of the OHRP Expedited Review Categories. Minor changes to research previously approved by the full board.

In what circumstances might your human participants protocol be considered for expedited review?

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Which of the following IRB determinations may not be used for an expedited review?

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate

What are the two characteristics of studies eligible for expedited review by the Institutional Review Board?

If the proposed research presents no more than minimal risk, does not involve any vulnerable populations (i.e., children, prisoners, individuals with impaired decision-making capacity, and/or economically or educationally disadvantaged persons), and involves any of the following, it may qualify for Expedited Review.

When can expedited review be used?

Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. The IRB regulations permit, but do not require, an IRB to review certain categories of research through an expedited procedure if the research involves no more than minimal risk.

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When can a protocol be eligible for expedited review by IRB?

What is an example of expedited review?

What determines whether an IRB should review a research proposal as an expedited review or a full review?

In what circumstances might your human participants protocol be considered for expedited review?

In what circumstances might your human participants protocol be considered for expedited review?

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Which of the following IRB determinations may not be used for an expedited review?

What are the two characteristics of studies eligible for expedited review by the Institutional Review Board?

When can expedited review be used?

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Get the up-to-date Guidance on the Use of Expedited Review Procedures - hhs 2024 now

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How to edit Guidance on the Use of Expedited Review Procedures - hhs in PDF format online

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Got questions?

When can a protocol be eligible for expedited review by IRB?

What is an example of expedited review?

What determines whether an IRB should review a research proposal as an expedited review or a full review?

In what circumstances might your human participants protocol be considered for expedited review?

In what circumstances might your human participants protocol be considered for expedited review?

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Which of the following IRB determinations may not be used for an expedited review?

What are the two characteristics of studies eligible for expedited review by the Institutional Review Board?

When can expedited review be used?

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