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What are the 3 types of IRB review?

IRB must review all projects that meet the definition of research and that involve human participants prior to any data collection to determine the appropriate level of review, and, as appropriate, approve them. There are three major levels of human subjects' research review: Exempt, Expedited, and Full.

What is needed for IRB approval?

Criteria for IRB Approval of a Human Research Study 1. Risks to subjects are minimized. Procedures are consistent with sound research design and do not unnecessarily expose subjects to risk. Study utilizes procedures already performed for diagnosis/treatment -- when appropriate.

What is an IRB determination letter?

The letter documents the IRB's approval of the application. The letter may include administrative comments or conditions that must be met in the conduct of the research.

Where do I get my IRB approval letter?

1) Log into IRBmanager. Under \u201cMy Studies\u201d click on the blue link for the study. 4) You should see the Initial Approval letter listed in Attachments (as well as any other study docs) & you can click on it to open & view the letter.

What is the purpose of IRB approval?

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.

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What is an IRB approval letter?

The IRB approval letter lists the consent document(s) and other study documents that were approved with the submission. Please note, it does not list the study application. Investigators can obtain a list of these items by following the instructions listed below.

What is an IRB request?

Initial IRB Application (New Study) The IRB application is an online questionnaire/form that any member of the study team can initiate within U-M's eResearch Regulatory Management (eRRM) system.

What is IRB determination?

The IRB will render decisions on research activities and may make one of the following. determinations: Approved. The research activity, as submitted, meets the criteria for approval as defined in 45 CFR 46.111 (and 21 CFR 56.111 and/or 32 CFR 219.111, when applicable).

How much does it cost for IRB approval?

Similarly, the cost of IRB reviews varies dramatically. The cost of an exemption review may be free or cost between roughly $500 and $1,000. A full review often costs between $1,000 and $5,000 for the initial review, with additional charges for changes and renewals.

How long will it take to get approval from the IRB?

How long does IRB review take? An expedited or exempt review may take about two weeks. Studies requiring convened review may take three or more weeks.

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