Ever-changing clinical-trial regulations and continued growth in multicenter and international studies have resulted in an exponential increase in the volume of data generated for IRB review, including large numbers of individual adverse event (AE) reports, which often lack the context and detail needed for full analysis and thus limit the IRB’s ability to ensure patient protection.
In January 2009, the FDA issued recommendations for sponsors and investigators conducting clinical research on how to identify which AEs represent “unanticipated problems” and must be reported to the IRB, as well as how best to convey the information. According to the FDA’s guidelines, sites should report an AE to the IRB if it is unexpected, serious, and has a major impact on the conduct of the study, like a significant – usually safety-related…
AAHRPP’s Principles for Accreditation of Human Research Protection Programs
Matt Baker, President and CEO, CompassIRB
Erin Brower, M.S., CIP, Director of Operations, New England IRB
John Isidor, Senior Director and Founder, Schulman Associates IRB
What is an “Accredited” IRB?
Jerry Menikoff, M.D., J.D. Director of the Office for Human Research Protections, The Department of Health and Human Services (HHS), the United States government’s principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. For more information, visit hhs.gov.
Marjorie A. Speers, Ph.D. President and CEO, the Association for the Accreditation of Human Research Protection Programs Inc. (AAHRPP), which promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs). For more information, visit aahrpp.org.