IRB members and staff use these checklists to consider and document regulatory items and enhance compliance with federal, state and local requirements.
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401Pre-Review January 2021
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402Non-Committee Review February 2023
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410Waiver or Alteration of Consent Process February 2023
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411Waiver of Written Documentation of Consent January 2021
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412Pregnant Women February 2023
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413Non-Viable Neonates July 2021
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414Neonates of Uncertain Viability January 2021
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415Prisoners April 2022
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416Children January 2022
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417Adults with Impaired Decision-Making Capacity February 2023
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418Non-Significant Risk Device February 2023
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419Waiver of Consent for Emergency Research January 2022
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441HIPAA Waiver of Authorization July 2022
Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates: HRPP Toolkit Feedback Form.