IRB staff and members use these documents as a reference when reviewing IRB submissions to enhance compliance with federal, state, and local requirements.
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301Review Material January 2021
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302Approval Intervals January 2021
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303Communication of Review Results January 2021
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304IRB Composition July 2022
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305Quorum and Expertise January 2021
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306Drugs and Biologics July 2021
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307Devices July 2022
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308Pre-Review January 2022
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309Ancillary Review Matrix July 2021
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310Human Research Determination January 2021
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311Engagement Determination July 2022
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312Exemption and Limited IRB Review January 2021
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313Expedited Review January 2022
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314Criteria for Approval July 2022
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315Advertisements July 2021
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316Payments January 2021
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317Short Form of Consent Documentation January 2022
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318Additional Federal Agency Criteria February 2022
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320Scientific or Scholarly Review January 2021
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321Review of Information Items July 2022
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322Emergency Use January 2021
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323Criteria for Approval for HUD January 2021
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325Compassionate Use of an Unapproved Medical Device January 2021
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326Performance Evaluation for IRB Chairs August 2021
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327Performance Evaluation for IRB Members August 2021
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330HIPAA Authorization January 2022
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331FERPA Compliance January 2021
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332NIH GDS Institutional Certification January 2022
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333Certificate of Confidentiality July 2021
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334Vulnerable Populations January 2022
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335Data and Safety Monitoring July 2021
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336International Research July 2021
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830Communication and Responsibilities July 2022
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832Criteria for Relying on an External IRB July 2022
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833Considerations for Serving as the sIRB July 2022
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