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According to ICH guidelines, for how long must an Institutional Review Board (IRB) retain records?

User Woko
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Final answer:

IRBs must retain research records for at least 3 years after the completion of the research, as required by ICH guidelines, to ensure adherence to ethical standards and participant protection.

Step-by-step explanation:

According to ICH guidelines, an Institutional Review Board (IRB) must retain records related to research involving human participants for a minimum of 3 years after the completion of the research. This duration may be subject to the specific regulations of the country or region in which the research is conducted, as well as the policies of the institution hosting the IRB.

The role of an IRB is crucial in ensuring the ethical treatment of research participants by reviewing and approving research plans. Retention of records by the IRB serves as an essential part of research oversight, allowing for the potential audit of studies, and providing documentation that informed consent was obtained, participant privacy was protected, and ethical standards were upheld during the conduct of the research.

User OBV
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