The application or protocol, the consent/assent document(s), tests, surveys, questionnaires and similar measures, and recruitment documents are examples of documents that the IRB reviews. The IRB process can be broken down into three sections: Criteria of Approval; Estimated Time of Review; Categories of Review

In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the...

2018年4月30日 · To provide guidance on the appropriate content of written procedures, while considering these variations, this guidance provides a Written Procedures Checklist to assist institutions and IRBs in preparing and maintaining detailed written procedures.

In the United States, the Food and Drug Administration (FDA) and the OHRP have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are "scientific", "ethical", and "regulatory".

Clinical trial procedures are reviewed by institutional review boards (IRBs). These boards are composed of at least five members that include scientists, doctors, and lay people. They...

The IRB provides the expiration date in the approval letter. If the IRB requires modifications to secure approval: Only address the required modifications from the determination letter and submit them in eIRB+ within 21 business days after receiving your determination letter. Do not add any new changes to the study submission at this stage.

2019年3月1日 · The institutional review board (IRB) is a group federally mandated to review and monitor research involving humans to ensure protection of their rights and welfare as research participants. Clinicians engaged in research require IRB approval for all research involving human participants, whether living individuals, data, or specimens.

2022年2月24日 · An IRB’s purpose is to protect the participant rights and welfare of human research. In accordance with FDA regulations, an IRB has the authority to approve, require modifications to, or disapprove research when it believes the participant’s rights or welfare are not properly protected.

2024年2月24日 · IRB approval is typically required before research can begin. A study protocol must meet specific criteria to be approved by the IRB. First, the protocol must have a clear scientific purpose. Second, the protocol must be designed to minimize the risks to participants.

Institutional review boards (IRBs) or research ethics committees provide a core protection for human research participants through advance and periodic independent review of the ethical acceptability of proposals for human research.