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It would seem that two recent publications by the Office of Inspector General (OIG) indicate a desire by the agency to be less stringent when it comes to the use of inducements for clinical trial participation involving Medicare and Medicaid patients.
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Although some researchers are doing a better job of presenting informed consent documents in language that subjects can understand, too many still rely on jargon and overly technical language that can stymie people with limited literacy.
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As research institutions begin to digest the new recommendations from the Institute of Medicine (IOM) of the National Academies in Washington, DC, theres general agreement that many changes it promotes in IRB structure and research activities are necessary to better protect human subjects.
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Its as simple as typing in an Internet URL, entering a few keywords, and hitting return across any persons computer screen comes a nationwide listing of clinical trials under way at various research institutions. Some sites even offer matching services. Could use of these listing services be considered recruitment?
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Schwetz named acting director of OHRP; Books help prepare for FDA inspections; NEJM retracts study after authors point to forgery;
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Given that fewer than half of families approached about organ donation give consent, it is essential that hospitals and procurement coordinators examine how they approach families at such a crucial time, say officials with the United Network for Organ Sharing (UNOS).
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UT Supreme Court upholds wrongful-life statute; Consumer group claims doctors strike unlawful; NEJM retracts study after authors point to forgery
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Even as this country struggles with a shortage of organs from donors, some ethicists are beginning to question the morality of harvesting organs from the group that serves as their primary source patients who are brain dead but have functioning hearts, lungs, and circulatory systems.
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As shortages continue, experts weigh alternatives. When a patient in Chicago nephrologist Paul W. Crawfords practice suddenly turned up with a new kidney after a trip to Mexico, the doctor didnt want to ask a lot of questions.
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State health policy experts and pharmaceutical company officials are anxiously awaiting the U.S. Supreme Courts decision on a controversial Maine program designed to help residents unable to afford prescription drug coverage get lower-cost medications.
