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By now, everyone has seen footage of the horrible damage wrought by Hurricane Katrina on the Gulf Coast more than 1,000 people dead, more than a million displaced, cities flooded and left in ruins.
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Is it ethical to enroll an elderly person with Alzheimers disease in a new research study, even if he or she doesnt really understand what it entails? What if the research has real risks, is unlikely to benefit the patient, but could lead to advances that will help future patients with Alzheimers?
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Clinical trials that show a treatment effect early on face a dilemma. If the effect is real, one ethical argument goes, then it is imperative to give all involved access to the drug as quickly as possible, starting with the placebo group.
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A survey of patients who had suffered strokes found that most would be willing to participate in emergency research for stroke treatments, and if incapacitated, would accept surrogate decisions about enrollment by family members or even their doctors.
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Particularly at smaller institutions, IRB administrators who also serve as voting members can offer many benefits. They attend and coordinate all meetings, so counting them as members helps the board achieve quorum.
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In the past few years, Hispanics have become the largest minority group in the United States, numbering nearly 41.3 million in the most recent U.S. Census estimates.
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Only 75% of patients that begin clinical trials for drugs fully complete, according to a recent study by Cutting Edge Information in Research Triangle Park, NC, noting several reasons for this low completion rate.
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Physicians discussing clinical trials with their patients may not realize the importance of patients fears about side effects in making a decision about whether to participate.
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The cost of operating institutional review boards is higher than previous estimates had indicated, according to a survey published recently in the New England Journal of Medicine.
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What can IRBs do to help reach out to the Hispanic population in their own communities?