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Researchers and physicians are increasingly speaking out on the issue of the geriatric population being excluded from clinical trials.
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To ensure that a proposed study or clinical trial can fulfill its goals and remain within ethical guidelines, some IRBs have mandated that protocols go through scientific review prior to submission. The purpose of the review is to ensure that studies are built on a solid scientific foundation to achieve the objectives.
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Informed consent forms have one very daunting characteristic: They are visually numbing.
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Three large Ohio academic Clinical and Translational Science Award (CTSA) institutions recently formed an IRB collaboration to allow a central IRB review during multisite studies. This was the first time CTSAs collaborated in this way, and it could serve as a best practice for other research institutions and CTSAs, experts say.
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One of the biggest challenges IRBs face is keeping up with ethical issue updates during an ever-evolving period technologically, experts say.
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Like many other institutions, the Children's Hospital of Philadelphia often struggled to get and keep good IRB members. Its roster was full of busy physicians who couldn't make all the meetings, and some had to rotate off the board because of the demands of their work.
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Accreditation standards regarding community outreach and education encompass just two short paragraphs and elements in the standards written by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.
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While many IRBs complain about the quality of informed consent, there's been little substantive research into how to improve it, particularly for subjects with low literacy, says a researcher who has studied the issue.
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As institutions wait to find out what comes out of the ANPRM, there are steps they can take now to work within the current regulations and achieve the Department of Health and Human Service's goals of lessening the burden on investigators and IRBs while still protecting subjects.
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Physicians often are engaged in a research study at some point in their careers, but if they're working in the community primarily as clinicians they might not receive optimal mentoring and training in protecting human research subjects.