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When an institution's study portfolio gets large enough, its IRB must decide: Is it time for a new board? And if so, how do you divide the work? At many institutions, that division is based on methodology studies are assigned to either a biomedical IRB or one devoted to social-behavioral studies.
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Human research office managers sometimes need to identify ways to improve workflow and efficiency. One way to do this is to develop a process for evaluating resources and assessing needs, an expert advises.
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Multisite studies are a continuing challenge for IRBs how do you review these protocols quickly and efficiently while preserving the autonomy of individual IRBs?
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Keeping a small IRB in the know on the latest regulatory requirements, technological advances, etc., is a huge challenge. Some smaller IRBs have found that one cost-effective way to increase their knowledge of current requirements and trends is to be part of a networking group.
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Cybercrime and data exposure pose a relatively new risk to research participants. IRBs have been addressing this threat in recent years, but they haven't given as much thought to their own responsibility and risk from wireless technology, an expert says.
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At Cedars-Sinai Medical Center, research compliance depends on a continuous loop of quality improvement and education, each enhancing the other.
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IRB offices have evolved in the past 15 years. Early IRB offices often had limited support staff. But as the field of human subjects protection evolved, IRB offices' staffing needs increased, creating IRB office leadership roles and the need for more IRB coordinators and other support staff.
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Like many institutions, Dana-Farber/Harvard Cancer Center (DF/HCC) uses audits of studies to find areas in human subjects protection that need improvement and to educate researchers to address them.
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IRB offices seeking to create a sustainable leadership role might need to re-organize, examining their current processes and culture, experts suggest.
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Researchers and IRBs should pay close attention to informed consent comprehension among all research participants, but this is especially true of people from a high-risk population.
