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In late September, OHRP issued guidance concerning IRB review of clinical trial web sites. The guidance, which can be viewed at OHRPs web site, states that IRB review is required when information on a clinical trial web site includes more information than the study title, the purpose of the study, the protocol summary, basic eligibility criteria, study site locations, and how to get more information on the study.
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Are investigators morally obligated to provide research participants with the chance to see the results from the studies in which they enroll and should IRBs require them to do so?
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One unexpected result from Hurricane Katrina has been a sharp increase in proposals for social-behavioral studies, as social scientists seek to find out how Katrina survivors and evacuees have responded to the disaster.
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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.
