however, the study was not approved by the irb in accordance with the requirements for research involving prisoners under subpart c. what is the best course of action

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31-10-2022
Social Studies

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however, the study was not approved by the irb in accordance with the requirements for research involving prisoners under subpart c. what is the best course of action

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singhanupama3490 singhanupama3490 · Answer 1 · 2022-11-03T09:12:02+01:00

The best course of action is to promptly notify the IRB and allow the subject to remain in the study while the IRB makes the regulatory determinations.

An Institutional Review Board is a group that has been formally designated by the FDA to review and monitor biomedical research involving human subjects. An IRB has the authority to approve, require modifications in (to secure approval), or disapprove research in accordance with FDA regulations.IRB review and approval is required for projects that: Meet the definition of research. Human subjects should be involved. Any interaction or intervention with human subjects that involves access to identifiable private information is included.

Learn more about IRB here:

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