IRB Advisor – November 1, 2007
November 1, 2007
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Best Practices Update: IRB's quality improvement process identifies concerns and fixes problems
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. -
IRB's deviation reports increase exponentially, leading to process change
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. -
Institution's QI form serves as educational tool for PIs
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. -
Reporting results from biomonitoring studies
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. -
Decision aids in clinical trials can enhance informed consent
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. -
2007 Salary Survey Results: Good IRB professionals are hard to find
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.