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Two years ago, Baylor College of Medicine had a dilemma: double its staff to accommodate the increase in study protocols being submitted to its IRB or find an electronic solution to its problem. They chose the latter.
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The Baylor College of Medicine in Houston has a prescribed inquiry process for complaints generated by human subject research at the institution, says Kathleen Motil, PhD, MD, associate professor of pediatrics and chair of two of the colleges IRBs.
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The Department of Veterans Affairs (VA) last month issued a nationwide ultimatum to its medical centers involved in research to shape up or else.
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One of the major changes promoted in the Institute of Medicine (IOM) report Responsible Research: A Systems Approach to Protecting Research Participants, is a call for federal legislation expanding protections to all human subjects involved in research, regardless of funding or setting.
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It would seem that two recent publications by the Office of Inspector General (OIG) indicate a desire by the agency to be less stringent when it comes to the use of inducements for clinical trial participation involving Medicare and Medicaid patients.
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Although some researchers are doing a better job of presenting informed consent documents in language that subjects can understand, too many still rely on jargon and overly technical language that can stymie people with limited literacy.
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As research institutions begin to digest the new recommendations from the Institute of Medicine (IOM) of the National Academies in Washington, DC, theres general agreement that many changes it promotes in IRB structure and research activities are necessary to better protect human subjects.
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Its as simple as typing in an Internet URL, entering a few keywords, and hitting return across any persons computer screen comes a nationwide listing of clinical trials under way at various research institutions. Some sites even offer matching services. Could use of these listing services be considered recruitment?
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Schwetz named acting director of OHRP; Books help prepare for FDA inspections; NEJM retracts study after authors point to forgery;
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In the best of all worlds, there wouldnt be research conflicts of interest. Investigators would be focused on the intent of research uncovering previously unknown information. However, the reality falls a little short of the ideal, which is why many IRBs have had to deal with conflict of interest issues in addition to their primary goals and duties.
