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For about 30 years, the Indiana University School of Medicine in Indianapolis has had a research partnership with Moi University's Teaching and Referral Hospital in Eldoret, Kenya, including an exchange program for medical students. As the clinical collaboration grew, IU researchers partnered with researchers at Moi to conduct studies in Kenya and other parts of Africa.
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Not every clinical trial report sees the light of day. Some are abandoned when trial sponsors no longer actively seek publication, or when a study is misreported and no efforts are made to correct it.
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Research institutions nationwide continue to look for ways to improve quality while eliminating redundancy, regulatory creep, and inefficiencies. The key to success is flexibility and considering changes in any type of process that is not working as efficiently as possible, experts say.
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Informed consent discussions and recommendations are important and time-consuming. IRBs continually seek ways to improve the informed consent process while also finding better and more efficient ways of handling them. One way to streamline the IC process could be to make certain IRBs are not inundated with IC forms unnecessarily.
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Research programs and IRBs across the nation increasingly are focusing on streamlining their human subjects research programs. One change that has grown over the past decade involves "unchecking the box" on the Federalwide Assurance (FWA).
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Whenever an individual enters an ambulance (or medical helicopter) owned and operated by a hospital, the federal government deems the person to have come to the hospitals emergency department for purposes of triggering the hospitals obligations under the Emergency Medical Treatment and Labor Act (EMTALA).1
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Not surprisingly, if a consultant is unavailable and a bad outcome occurs, the emergency physician (EP) is potentially a defendant in any subsequent medical malpractice lawsuit, says Damian D. Capozzola, JD, an attorney with Crowell & Moring, LLP, in Los Angeles, CA.
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Forty percent of hospital readmissions within 30 days come through the ED, according to an analysis of data from the Healthcare Cost and Utilization Project state inpatient and ED databases on 4,028,555 patients discharged from acute care hospitals in California, Florida, and Nebraska between July 1, 2008, and September 31, 2009.1
