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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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Researchers and physicians are increasingly speaking out on the issue of the geriatric population being excluded from clinical trials.
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Researchers using the Internet for recruitment and for electronic surveys have discovered that problems with online fraud can undermine the ease and efficiency of Web-based recruiting, an expert says.
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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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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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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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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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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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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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Electronic health records (EHRs) offer a rich resource for facilitating clinical research by identifying patients who fit the eligibility requirements for a study and allowing researchers to collaborate with primary care physicians to recruit them.
