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The American Heart Association (AHA) in Dallas has released new guidelines for preventing heart disease and stroke in women that are tailored to each individuals cardiac event risk.
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Better outcome not guaranteed for cancer research volunteers; FDA wants clinical trial database improvements; BRAAN gets smarter.
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Right now in Seattle, a lawsuit is pitting families of five research patients against the Fred Hutchinson Cancer Research Center. At issue is whether leukemia patients participating in a study on T-cell depletion fully understood the risks of the proposed treatment and gave informed consent.
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Imagine you had a very sick child and were approached about him or her being in a study. In your worry for your son or daughter, how much of the informed consent process would you understand? Would you be clear on what the study entailed? According to several studies published in the last year, maybe not.
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According to the U.S. Census Bureau, in 2000, just under 18% of the population thats more than 46 million people spoke a language other than English at home. For researchers doing work that can apply across populations, that has one big implication: Minority groups need to be actively recruited for clinical studies; and since many dont speak English, informed consent documents should be translated into a language they can read and understand.
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The possible relationship of an adverse event to use of study product is assessed by the investigator. The terminology for these assessments can vary from one reporting system to the next. The DMID (S)AE reporting system uses the following terms to describe the relationship of an AE to the study product.
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Reporting rules for adverse events in clinical trials only seem straightforward in the case of death or injury requiring hospitalization. Otherwise, those involved in clinical trials have to figure out how soon they need to report, what information needs to be included in the report, and who should get it.
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While an argument could be made that collecting genetic information from individuals is no different from collecting any other type of health information, the fact remains that the very word genetic may raise additional concerns among potential research participants.
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The brave new world of genetics and pharmacogenetics research provides some exciting possibilities as well as some major challenges to researchers. Recruiting subjects is top concern.
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In January, New Jersey became only the second state in the union to pass legislation formally permitting research using embryonic stem cells.
