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Successful pill-taking is an important component for women who use oral contraceptives (OCs). Inconsistent use and method discontinuation are estimated to account for approximately 20% of the annual 3.5 million annual unintended pregnancies in the United States.
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A quick check of your next patients file shows that she is returning for yet another round of treatment for trichomoniasis. The infection is not responding to standard metronidazole therapy. What is your next move?
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Your next patient says she has a vaginal discharge. A closer examination reveals a white, noninflammatory discharge that smoothly coats the vaginal walls. What is your next step?
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Double up on your efforts to detect syphilis. Syphilis rates in the United States rose in 2002 for the second consecutive year, following a decade-long decline that resulted in an all-time low in 2000, according to new data from the Atlanta-based Centers for Disease Control and Prevention (CDC).1
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Human subjects research protection experts agree that IRBs are overburdened and that something should be done to improve the regulations and rules governing their work. However, there is less agreement on how this could be accomplished. IRB Advisor asked IRB and research professionals to discuss how IRB regulations or the interpretation of them might be improved.
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For the University of Pennsylvania School of Medicine in Philadelphia, there was no question that the only acceptable solution to the problems in human subjects research was to establish a comprehensive program that included all areas, including investigators, IRBs, and the institutions leadership.
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A 1999 National Institutes of Health-sponsored project to evaluate the results of a drug-testing program in Oregon public high schools was ultimately suspended after the federal Office for Human Research Protections (OHRP) decided that the goals of the research protocol appeared to have become intertwined with the drug-testing policy it was intended to study.
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Its a rare occurrence, but each year some institutions are subjected to a for-cause audit by the Office for Human Research Protections (OHRP). Such audits often turn up documentation problems and review process problems with the IRB, but occasionally they also highlight very serious problems relating to the clinical trials management, such as failure to provide adequate informed consent or failure to seek an IRB review, according to OHRP officials.
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