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The aftermath of Hurricane Katrina shows that health care providers risk criminal prosecution after making difficult decisions, says Lester Johnson, JD, an attorney with the law firm of McGlinchey Stafford in New Orleans.
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With increasing frequency, health care providers confront the prospect of being involved in litigation or investigations by a regulatory body.
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An elderly man underwent cataract and glaucoma surgery in his left eye, after which he claimed his vision deteriorated. He sued the ophthalmologist.
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A nurse at a hospital severely burned a newborn baby while giving her a bath. The parties reached a settlement shortly after the suit was filed, including periodic payments to a trust fund for the girl for 12 years.
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Patient safety rounds can be an effective way to implement safety initiatives and assess ongoing efforts if the rounds are done properly, say those who have seen success with the strategy.
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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.
