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Clinical trial professionals and investigators should reconsider the inclusion/exclusion criteria and other factors to meet the needs of their study participants, an expert suggests.
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Put any group of IRB administrators into the same room and soon you'll hear a discussion about how they have to deal with so many poorly-written protocols.
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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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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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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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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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IRBs striving to ensure they're not inadvertently approving a seeding trial have a tough job ahead of them.
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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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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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Because practice-based research networks (PBRNs) conduct research across a web of physicians' offices, making sure the necessary staff are trained in human subjects protection can be a daunting task.