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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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While the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is clearly getting all the headlines and a great deal of attention in the research community, the recent Food and Drug Administration (FDA) Guidance for Industry on Electronic Records indicates it is not the only game in town.
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As genetics research yields more and more information about individuals predispositions to disease and illness, researchers are beginning to question whether study participants should have access to the genetic information obtained about them.
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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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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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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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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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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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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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Certain broad categories of research are exempt from full review of an institutional review board. Though federal regulations regarding exemptions are spelled out for investigators and IRBs alike, IRBs still are responsible for reviewing proposed protocols and approving exemptions.
