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An Assurance of Compliance with the Office for Human Research Protections (OHRP) must describe procedures for ensuring that research involving human subjects adheres to ethical standards and regulatory requirements. This includes detailing the review process by an Institutional Review Board (IRB), obtaining informed consent from participants, and ensuring the protection of participants' rights and welfare. Additionally, it should outline how adverse events will be reported and how compliance with federal regulations will be monitored and enforced.

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