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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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Educators often talk about "teachable moments," those times when the patient is ready to learn. This moment might be in a waiting area, exam room, or a hospital bed. To take advantage of these times, staff members in the Section of Patient Education at Mayo Clinic in Rochester, MN, look for new ways to deliver patient education.
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Disclosing a medical error is never easy, but it can become especially complicated when you need to tell the patient that a previous provider was in the wrong. This delicate situation often requires communication with the other provider before you tell the patient anything.
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A patient arrived from an assisted living facility with a documented allergy on the chart. Despite this safeguard, the patient still received an incorrect medication prior to the procedure. Fortunately, in this case, there was no lasting harm to the patient.
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A $3.3 million verdict against a surgeon who apologized to his patient's family for her death is leading some outpatient surgery professionals to wonder if the push for apologies and transparency has a dark side. Are managers encouraging physicians to say something that actually will work against them in court?
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Seemingly, no one is happy with his or her block schedule at the hospital or the surgery center. After spending too much time on this issue with our own centers and hearing about others concerns, it is, quite honestly, irritating that such a simple process can be such a conundrum for most everyone.
