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Researchers and IRBs should pay close attention to informed consent comprehension among all research participants, but this is especially true of people from a high-risk population.
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Improving the readability of informed consent involves more than a one-time education of researchers or IRB staff it's a process that requires ongoing commitment.
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As genetic testing becomes better able to pinpoint risk factors for various diseases, is there potential harm to subjects in giving them test results, particularly when there are limited treatment and prevention options?
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A new study looks at an intriguing strategy for improving study subjects' understanding and knowledge of clinical research.
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Transitioning to an electronic submission process is challenging. It also is a time when IRBs need to pay close attention to current compliance practices with an eye on updating standard operating procedures to reflect the new electronic practices and processes.
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As the human research protection program at Mount Sinai Medical Center prepared for accreditation in 2010, IRB Manager Stacy Chandna says she and her colleagues knew they had a daunting task ahead.
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In the fight against Alzheimer's disease dementia, researchers have long targeted beta-amyloid plaques, accumulated protein fragments in the brain that are a hallmark of the disease. The plaques are believed to contribute to the cognitive impairment associated with Alzheimer's disease.
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Research institutions increasingly conduct internal research site reviews or audits as a way to improve research regulatory compliance and prevent problems.
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One of the thorniest issues in tribal research is the question of who controls the use of the data taken from tribal members or tribal lands. Is it the researcher, who collected the data, or the tribe that gave permission for its collection and use?
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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.