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IRBs The Safety Gatekeepers

$30.00

Copyright: This PDF purchase is for a Single user for review or filing purposes only. The PDF is watermarked. If you are interested in a PDF reprint to post on your website or distribute electronically, or hard-copy reprints, please contact Marah Walsh at mwalsh@pharmavoice.com.

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Product Description

Current pressures to speed drugs to market have resulted in the increased use of independent, centralized institutional review boards as an alternative to academic IRBs, because they can offer faster and more efficient protocol reviews.
Institutional review boards, or IRBs, are an important piece of the clinical-trial puzzle. IRBs are the gatekeepers of ethical, regulatory, and policy concerns of human-subject research. And they take seriously their mandate of protecting the rights and welfare of study subjects to the best of their ability, as well as making sure those subjects are fully informed about the risks and benefits of participating in research…

Sidebars:
Accreditation Standards for IRBs
FDA’s View on Central IRBs

Experts on this topic
John Isidor. CEO and Founder, Schulman Associates Institutional Review Board Inc., Cincinnati; Shulman is an independent IRB that has more than 20 years of experience in reviewing research protocols and consent forms. For more information, visit sairb.com.
Darren McDaniel. CEO and Founder, Coast IRB LLC, Lake Forest, Calif.; Coast IRB is an independent review board that provides ethical and thorough review with an internal focus on quality and exceptional service. For more information, visit coastirb.com.
Lynn A. Meyer. President and Founder, IntegReview Ethical Review Board, Austin, Texas; IntegReview reviews studies of medical devices, social and behavioral, as well as Phase I to Phase IV clinical studies. For more information, visit integreview.com.
Mare Ryan. Director of Clinical Operations, Liberty IRB Inc., DeLand, Fla.; Liberty Institutional Review Board is an independent, central IRB. For more information, visit libertyirb.com.
James Saunders. VP, New England Institutional Review Board (NEIRB), Wellesley, Mass.; NEIRB, a division of Thomson, serves as an independent institutional review board for multisite studies and individual researchers. For more information, visit neirb.com.
Judy Stone, M.D. Physician and Principal Investigator in private practice, Memorial Hospital, Cumberland, Md. Dr. Stone is the author of “Conducting Clinical Trials: A Guide for Physicians, Nurses, Study Coordinators, and Investigators.” For more information, e-mail jstone@conductingclinical-research.com.

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