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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.
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Some of the latest versions of electronic health records have created logistical dilemmas for research institutions as they find that providing access to information is more difficult for research monitors, researchers browsing for information about potential subject pools, and other activities.
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Research institutions occasionally have studies that involve a population or topic that brings up issues of social injustice, such as studies involving war refugee populations or pediatric HIV foster children.
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Research in environmental sciences, engineering and related fields can raise unique ethical issues that may be unfamiliar to many IRBs, particularly when it comes to community-based research.
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When reviewing cancer clinical trials, IRBs must weigh the risks and benefits to potential participants. But it's not always clear what participants themselves consider to be a risk or a benefit of their enrollment in a study.
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Sometimes an IRB's caseload grows so big and complex that new processes have to be implemented or the workload is unmanageable.
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If an IRB's policy and procedures manual needs updating, it might be time to write or revamp the section on criteria for review.
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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.
