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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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More than a year after the Department of Health and Human Services released its proposed rewrite of the Common Rule, researchers and IRBs still are waiting for the other shoe to drop.
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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.
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Within one year of opening its doors in 2009, Opus IRB of Roswell, GA, had its first research review, and within the last year the independent IRB achieved full accreditation from the Association for the Accreditation of Human Research Protection Programs (AAHRPP) of Washington, DC.
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Involving a disability community in research from its inception can help shape the research so that it's more successful and addresses the community's needs better.