How does the IRB process work?

Under this system, studies are assigned to one or more IRB members for a full review of all materials. Then, at the convened IRB meeting the study is presented by the primary reviewer(s) and, after discussion by IRB members, a vote for an action is taken.

What is a reliance agreement?

Definitions. Reliance Agreement: A formal, written document that provides a mechanism for an institution engaged in research to delegate institutional review board (IRB) review to an independent IRB or an IRB of another institution.

What is the institutional review board agreement?

An IRB Authorization Agreement (IAA) is a special agreement between two institutions who are engaged in human subjects research to establish the Single IRB reviewing. An IAA allows an institution with a Federalwide Assurance (FWA) to extend the applicability of its FWA to cover another institution.

How does smart IRB work?

The SMART IRB Letter of Acknowledgement (LOA) allows research teams to utilize a paper or electronic document to execute reliance agreements under the terms of the SMART IRB master reliance agreement. This document follows a similar process as other types of reliance agreements.

How do you get approval from IRB?

IRB staff assign submissions to a primary and secondary IRB reviewer for presentation at the full board meeting. Investigators may be invited to attend the meeting to answer questions from the board. At the conclusion of the meeting, the board votes and issues a determination for the submission.

How long does IRB approval take?

The IRB Cover Page is returned to the Principal Investigator (or Correspondent) to verify receipt. From the date of receipt, the amount of time a review takes is as follows: Exempt reviews generally take one to two weeks. Expedited reviews generally take two to three weeks, depending on the time of year.

What is the smart IRB?

SMART IRB is an IRB reliance model designed to streamline the IRB review process for multi-site studies, while ensuring a high level of protection for research participants.

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