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In assessing the recent revisions to the Common Rule proposed by the Department of Health and Human Services (HHS), the accrediting agency for human subjects protection programs suggests that HHS may lack the necessary information to move forward with a final rule.
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Research ethicists and others have long described the value of recruiting more minorities in clinical research (CR) trials, but the question is whether or not IRBs have a role to play in advancing this goal.
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In the proposed revision of the Common Rule, the Department of Health and Human Services (HHS) responds to years of complaints about informed consent documents that they're too long, too complicated, too full of boilerplate and risk management language.
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When investigators seek an exception from informed consent (EFIC) for emergency research, they must show that they have engaged in community consultation and public disclosure, informing the public that they may encounter an experimental intervention while being treated in an emergency setting.
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In the waning days of the comment period for the advance notice of proposed rule-making (ANPRM) for human subjects protection regulation, some of the IRB community's heavy hitters have weighed in.
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In August 2011, emergency department (ED) registrars at University of Mississippi Health Care in Jackson were trained on patient estimator software, which increased collections by 124% compared to the previous year, while admissions areas saw a 319% increase.
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Mistakes in registration, such as missing information, are discovered by frequent audits done by managers at Gundersen Lutheran Health System in La Crosse, WI. These become part of the employee's annual evaluation.
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Payer requirements are the single most challenging area in training of patient access staff, according to Colette Lasack, MBA, executive director of revenue cycle at Gundersen Lutheran Health System in La Crosse, WI.
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When Michelle M. Mohrbach, CHAM, became manager of patient access and central scheduling at Blanchard Valley Health System in Findlay, OH, new hires typically "shadowed" another registrar for a short time before going out on their own. This approach has changed dramatically.
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After a price estimator system was implemented at St. Joseph East in Lexington, KY, the need for one-on-one training quickly became apparent, says Stephanie Stamper, patient access coordinator.
