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The U.S. Attorneys office in Western District of Washington state has announced that Richard W. Gibson, 42, of SeaTac, WA, pleaded guilty in federal court in Seattle to wrongful disclosure of individually identifiable health information for economic gain. The case is the first criminal conviction related to the health information privacy provisions of HIPAA that became effective in April 2003.
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This case highlights the problems that can stem from traumatic lacerations, a common childhood injury.
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Thomson American Health Consultants is offering an audio conference with the information necessary to help you recognize the ethical and regulatory issues related to working with children in clinical trials.
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A debate that has become more heated in the 21st century is whether all embryonic research should be subject to human subject research protection and IRB review.
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The furor surrounding the derivation and collection of embryonic stem cells has eclipsed the many other ethical, legal, and social issues that should be examined before these therapies move from the laboratory to human clinical application, say researchers working at Johns Hopkins University in Baltimore.
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Question: What rights to their research-related results do patients have?
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An adverse event is any undesirable experience associated with the use of a medical product in a patient. The event is SERIOUS and should be reported when the patient outcome is the following.
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IRBs often struggle with decisions regarding the reporting of adverse events and unanticipated problems, and the recent increases in IRBs workloads do not help the situation, experts say.
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In the year 2000, Health Care Financing Administration (now known as the Centers for Medicare & Medicaid Services) issued its National Coverage Determination (NCD) extending Medicare coverage to routine costs of qualifying trials, as well as those items and services made necessary to diagnose or treat complications arising from clinical trial participation.
