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Is the purpose of the IRB review of informed consent to protect the institution or the subject?

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About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management
Stephanie has over 20 years of clinical research experience working from the site, CRO, and sponsor perspectives.

The fundamental purpose of IRB review of informed consent is to assure that the rights and welfare of subjects are protected. A signed informed consent document is evidence that the document has been provided to a prospective subject (and presumably, explained) and that the subject has agreed to participate in the research. IRB review of informed consent documents also ensures that the institution has complied with applicable regulations.

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