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Major corporate research sponsors and large institutional sponsors in the United States increasingly are conducting clinical trial research overseas. Sometimes this raises concerns among IRBs and human subjects protection leaders about human subjects protection measures taken by these organizations.
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One of the most important services an IRB can provide is rapid turnaround on protocol reviews. The next most important service is providing quality documents, says the president of a large independent IRB in Austin, TX.
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Many IRBs spend countless hours of review focusing on the consent documents needed for research studies. Are they too technical? Written at too high a level of readability? Too vague? Not extensive enough in their description of potential risks?
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Reams have been written about the logistical problems of dealing with local IRBs on multisite trials - the delays, the countless changes demanded by individual boards, the overall hassle.
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IRBs already are attuned to the dangers of therapeutic misconception, in which research subjects confuse research interventions with personalized medical care. Meaningful informed consent explaining clearly the potential risks and benefits of participation in a study is believed to be the best method of combating the problem.
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With Medicare's stricter reimbursement guidelines and the likelihood that commercial payers will follow suit, it's more important than ever before for patients to move as quickly and safely as possible through the continuum of care, the experts say.
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A simple communication tool used by case management and nursing has decreased the turnaround between when discharge orders are issued and the time the patient is out the door at North Broward Medical Center in Deerfield Beach, FL.
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It took more than 260 days, hundreds of hours on the telephone, and a lot of networking and brainstorming for Chesapeake General Hospital in Chesapeake, VA, to find post-acute care for a seriously ill pediatric patient.
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Reducing readmissions has become an increasingly important goal for hospitals. Medicare is evaluating various payment incentives to encourage lower rates of preventable readmissions.