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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.
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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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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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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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Improving consent form should be top priority: Think outside the box and go beyond regulations
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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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Allen cheng reported that, as of march 20, 15 patients with melioidosis had been seen at the Royal Darwin Hospital during the 2003-2004 rainy season. The Royal Darwin is the referral center for the Top End region of the Northern Territory of Australia.
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Most emergency medicine textbooks agree that human bite wounds, as well as dog and cat bite wounds, require antibiotic prophylaxis in addition to usual wound care practices. This study from the University of Maryland challenges this belief, and attempts to define a group of human bites at low risk of infection that do not require any antibiotic prophylaxis.
