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An advisory board to the Department of Health and Human Services (HHS) has recommended that a proposal to hold pediatric trials of the anthrax vaccine be reviewed by an ethics board before proceeding.
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A study published in the Journal of Cataract and Refractive Surgery, says that informed consent sheets that are concise and written at lower reading comprehension levels, as well as videotaped presentations, work well in helping patients understand the risks, benefits, and treatment alternatives to cataract surgery.
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According to published research, a program created to communicate the treatment preferences of those with advanced illness or frailty ensures those preferences are honored 94% of the time. The Program, called Physicians Orders for Life Sustaining Treatment (POLST), was launched in Oregon almost 20 years ago.
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Some institutions have created informational videos that help potential research subjects and their loved ones make a more informed decision about whether to enroll in a clinical trial.
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An advisory board to the U.S. Department of Health and Human Services has recommended that a proposal to hold pediatric trials of the anthrax vaccine be reviewed by an ethics board before proceeding.
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When a study is terminated because of low enrollment, it wastes the institutional resources that allowed it to be started including those of the IRB that approved it.
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Conflicts of interest (COI) have been an important priority for IRBs and research institutions for decades.
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When a human research protection office seeking accreditation finally has the site visit, the hard work that went into the process is not over. Now it's time to prepare the best possible response to the draft site visit report.
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Serving on an IRB is a very important role that requires commitment and training. Yet, many research institutions that have very good training and evaluation programs for their staffs lack any sort of ongoing oversight of their IRB members.
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The U.S. Department of Health and Human Services (HHS) recently published its final rule on research conflicts of interest, titled, "Responsibility of Applicants for Protecting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors," in the Federal Register, Vol. 76, No. 165, Aug. 25, 2011.
