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It's just about a given that informed consent documents making their way to the IRB for approval will need to be revised for comprehension and readability. Investigators and sponsors tend to include long sentences and paragraphs and technical jargon that leads the MEGO syndrome "my eyes glaze over," says Stewart A. Laidlaw, PhD, an associate vice president for compliance at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center (LA BioMed) in Torrance, CA.
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Quality assurance programs for clinical trials do more than improve the data coming out of studies and the validity of the results.
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A new web-based data management system serving clinical research has improved data collection and accuracy through an ongoing data collection and analysis process.
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Many in IRB circles have worried about the potential existence of "seeding" trials, which are defined as clinical trials that seek to market a product rather than answer a legitimate scientific question.
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IRBs striving to ensure they're not inadvertently approving a seeding trial have a tough job ahead of them.
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People participating in pain research report having complex combinations of reasons for enrolling part altruism, part seeking new treatments, part simply having their pain understood and taken seriously.
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Barbara Bierer, MD, professor of medicine at Harvard Medical School, and the senior vice president for research and the director of faculty development and diversity at Brigham and Women's Hospital in Boston, MA, is the new chair of the U.S. Health and Human Services (HHS) Secretary's Advisory Committee on Human Research Protections (SACHRP).
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IRB Advisor: Dr. Marjorie Speers, would you please explain how AAHRPP accreditation requirements work with regard to institutions that are seeking accreditation and have plans to use foreign IRBs for a multi-site study that includes clinical trials located in other countries? Foreign countries hosting clinical trials often require a local board to review the study.
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Accreditation for an academic research institution is a time-consuming and difficult process for the research office and the institution's IRB office. But for a small, private research organization, the task is Herculean.
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When a judge recently ordered a pharmaceutical company to provide an investigational drug to a teenage boy who had not met the enrollment criteria for a phase II trial, the IRB world took note.
