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IRBs reviewing protocols involving HIV drug-using populations sometimes find that it's impossible to anticipate all of the ethical issues that will arise during the trials.
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A patient needing a transplant for a vital human organ often waits months or even years before one becomes available.
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A patient needing a transplant for a vital human organ often waits months or even years before one becomes available.
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After the FDA in 2000 highlighted the problem of investigators inadequately reporting protocol deviations, sponsors have required all deviations to be reported to the IRB.
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Education is the foundation of quality improvement, which is why one IRB's main educational tool for investigators is an on-line form for quality improvement through self-assessment.
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Biomonitoringmeasuring levels of environmental toxins in biological samples taken from volunteersis an important tool in public health research, providing valuable information about local exposure levels.
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As research participants confront ever more-complicated clinical trials, they also encounter longer, more complex consent forms. Concerns that informed consent isn't necessarily enhanced by these documents has led researchers to seek more useful ways of educating subjects about the study they're considering.
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Experienced and educated IRB professionals are in a very good position this year to command top salaries and find jobs in a variety of research settings, according to experts and the results of the 2007 salary survey conducted by IRB Advisor.
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Quality improvement (QI) is such an important part of the daily work process at one independent, Midwestern IRB that there are 17 employees on the regulatory affairs and quality improvement team.
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IRB members often begin their new role with many questions and concerns. While these may be answered during a formal training program, there is another way to help ease new members into the role, and that's through a formal mentoring program.
