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IRB offices seeking to create a sustainable leadership role might need to re-organize, examining their current processes and culture, experts suggest.
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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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Add another voice to the national conversation on improving protection of research participants: The Presidential Commission for the Study of Bioethical Issues, which recently released its recommendations for reforming federal oversight of human subjects research.
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The Presidential Commission for the Study of Bioethical Issues offered 14 recommendations for improving oversight of human subjects research:
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IRB offices that have more than one employee should also create a career track that helps staff develop leadership and other skills, experts say.A career track also can improve staff morale and improve retention by giving employees a way to move up without moving out.
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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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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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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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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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A new study looks at an intriguing strategy for improving study subjects' understanding and knowledge of clinical research.