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Request to Continue Approved Research Protocol (Annual Review - utb

Request to Continue Approved Research Protocol (Annual Review - utb 2025

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The document outlines the annual review process for research protocols involving animal subjects at the University of Texas at Brownsville. It requires Principal Investigators to report on the status of their projects, indicating any significant changes that would necessitate further review by the Institutional Animal Care and Use Committee (IACUC). The document includes sections for protocol approval history, changes in study objectives, animal usage, literature findings, personnel changes, and a summary of the approved protocol.

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How often should an IRB continuing review be conducted?

An IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109(e)).

What is IRBs to review ongoing research studies?

The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.

What is IRB continuing review of a protocol is?

Continuing Review is the process by which the IRB re-evaluates whether a protocol is being conducted in compliance with the criteria for approval that are applied during initial review.

What is the maximum amount of time a protocol may be approved before IRB renewal of the protocol is needed?

Protocols that are approved as Exempt are valid for up to five years. The expiration date for exempt protocols is five years, or whatever date the study team lists as the study end date, whichever is sooner.

When should the research protocol must be approved by a designated institutional review board?

All projects that meet the definition of research with human subjects (45 CFR 46.102 ) must be reviewed and approved by an IRB, or receive an exempt determination, prior to beginning the research.

When should all ongoing research protocols be re-reviewed?

All ongoing research protocols must be re-reviewed annually (or more often, at the discretion of the ethics review committee).

Request to Continue Approved Research Protocol (Annual Review - utb 2025

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Request to Continue Approved Research Protocol (Annual Review - utb 2025

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How often should an IRB continuing review be conducted?

What is IRBs to review ongoing research studies?

What is IRB continuing review of a protocol is?

What is the maximum amount of time a protocol may be approved before IRB renewal of the protocol is needed?

When should the research protocol must be approved by a designated institutional review board?

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