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[Editor's note: Wendy Lloyd, LPN, CCRP, CIP, regulatory affairs and compliance specialist, at Vanderbilt University Medical Center in Nashville, TN, has compiled a list of frequent audit findings of the informed consent document process. She answers questions for IRB Advisor about these findings in this question and answer session.]
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Practice-based researchers have long complained that IRBs don't understand their work, which is based in physicians' practices and often consists of low-risk activities such as chart reviews and surveys.
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IRB offices might improve their staff and IRB members' training and education if they provide an occasional refresher course on the National Institutes of Health (NIH) Guidelines for the Conduct of Research Involving Human Subjects, also known as the Rules of Review.
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Therapeutic misconception in clinical trials continues to be a significant concern for researchers and IRBs. Studies have shown that misunderstandings persist about the therapeutic value of research interventions among participants and even among research staff.
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IRB directors who think their areas are safe from natural disasters should think again. Some U.S. IRBs learned the hard way that even in non-coastal cities and areas they can find their IRB offices underwater. Or they could experience earthquakes, tornadoes, hurricanes, and fires. And any research institution and IRB is at risk of an epidemic that leaves them short-staffed.
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If one of your registrars followed payer requirements to obtain a required authorization, it might become a "he said/she said" situation if the claim is later denied.
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After Betty Bopst, director of patient access at Mercy Medical Center in Baltimore, MD, finishes telling a patient access applicant the extent of the commitment that comes with the job, he or she sometimes tells her flat out, "This job is not for me."
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If you don't pay this bill, we're going to send you to a collection agency." This was a commonly heard statement by patients at Tallahassee (FL) Memorial HealthCare, when Joan S. Braveman, director of patient access and financial services, took over the business office.
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Have you ever suspected that an applicant is just telling you what you want to hear in order to get hired? If Betty Bopst, director of patient access at Mercy Medical Center in Baltimore, MD, has any doubts about someone she's interviewing, she relies on what her staff has to say.
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One question that members of Tallahassee (FL) Memorial's patient access department have struggled with is whether it makes sense to keep going after a person who simply has no resources, says Joan S. Braveman, director of patient access and financial services. The department installed software in August 2010 that gives customer service representatives the ability to look at how likely a patient is to pay.
