institutional review board
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The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled, ``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval.'' The guidance announced in this document finalizes the draft guidance of the same title dated January 2010. This document also supersedes the Information Sheet, Continuing Review After Study Approval. The guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations.
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In this article, I scrutinize the process by which scientific research on human subjects is regulated by Institutional Review Boards (IRBs). At the ou...
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The authors describe the three ethical principles that were developed as part of the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research, which are described in The Belmont Report.
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Largest Independent IRB in U.S. Chooses eResearch Portal Platform to Enhance Operational Efficiency and Customer Service
BEAVERTON, Ore. -- Click Co...
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