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The longtime research tradition of sharing data has been challenged in recent years with the implementation of the Health Insurance Portability and Accountability Act (HIPAA) and its privacy requirements. However, the National Institutes of Health (NIH) has confirmed its commitment to the tradition with its mandate requiring certain grant proposals to describe how data will be prepared for public use.
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IRBs need to be aware that the tools and data collection techniques used in socio-behavioral research may appear riskier than they actually are, and the public benefits may be greater; therefore, its a good idea to refrain from categorically rejecting research that involves unknown factors, suggests John Laub, PhD, a professor of criminology and criminal justice at the University of Maryland in College Park.
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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.
