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The following questions were among those asked during two recent surveys by the Joint Commission.
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Brace yourself: Flu season is right around the corner. Are you prepared? If an influenza pandemic hits, the entire U.S. population could be at risk. The annual impact of influenza on the United States is staggering: 10% to 20% of the population will get the flu. Some 36,000 people will die, and 114,000 will be hospitalized. Most of those who die will be older than 65, but children 2 and younger will be as likely to be hospitalized as the elderly.
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IRBs are no different from other boards in how their psychological structure could lead to personality clashes and conflicts. However, unlike many organizations, when IRBs ignore such conflicts, the outcome might be a less-effective human subjects protection program or regulatory problems.
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Improving consent form should be top priority: Think outside the box and go beyond regulations
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The consent form is the IRBs document, but the sponsor may say, If youre not willing to include this language, this disclaimer, then we wont open the trial at your institution, Joffe explains. Then the IRB can think of creative ways to put it in there without distracting from the message they want to convey in the consent form.
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IRB members and others in the research community sometimes have misconceptions about the use of the expedited review process, including the idea that an expedited review is different from a review by the full IRB.
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Drug and biotech companies that have paid government scientists for consulting services soon will receive a request from a House subcommittee to voluntarily release financial details of such agreements.
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A basic tenet of research involving human subjects is those who agree to be participate must give their informed consent after being informed about the known and unknown risks inherent in their participation. One category of risk is the possibility of injury.